Inova Catalog 2013

INOVA Diagnostics
2013 Catalog
Company Overview ..........................................3
NOVA Lite ..................................................36
Systems and Instrumentation .........................4
IFA Slide Kits ......................................................................44
QUANTA Link ................................................................... 5
IFA Substrate Slides ........................................................46
NOVA View........................................................................ 6
Common Components .................................................49
BIO-FLASH ........................................................................ 8
Demo Slides ......................................................................49
QUANTA-Lyser ...............................................................10
IFA Antibody Controls ...................................................50
QUANTA-Lyser 2 ...........................................................11
IFA Conjugates .................................................................52
DS2 ....................................................................................12
NOVA Gel ..................................................54
DSX/best 2000 ..............................................................13
Connective Tissue Disease Kits ..................................55
QUANTA Flash ...............................................14
Components .....................................................................55
Celiac Disease ..................................................................15

Vasculitis............................................................................15
Customer Support .......................................... 56
Antiphospholipid Syndrome .....................................16

BIO-FLASH Common Components .......................16
Connective Tissue Disease ..........................................17
QUANTA Lite .................................................18

Gastrointestinal Disease ..............................................19
Celiac Disease ..................................................................22
Liver Disease ....................................................................24
Antiphospholipid Syndrome .....................................26
Rheumatoid Arthritis ....................................................29
Connective Tissue Diseases ........................................30
Vasculitis ...........................................................................33
Autoimmune Thyroid Disease ...................................33
QUANTA Chek Quality Control Panels ..................34
Calibration and Standard Sets...................................35
1
Redefining Autoimmunity
INNOVATIVE ASSAYS
AND INSTRUMENTS
INSTRUMENTS
ASSAYS
BIO-FLASH random access

chemiluminescent analyzer
QUANTA-Lyser automated EIA/IFA
QUANTA Flash CIA

QUANTA Lite ELISA
NOVA Lite IFA
analyzer platforms
QUANTA Link workflow
management system
NOVA View digital IFA
DS2 and DSX/best 2000
automated EIA microtiter
NOVA Gel
Ouchterlony
plate platforms
2
Company Overview
Redefining the boundaries of

autoimmune testing with innovative
systems and reagents
INOVA Diagnostics, Inc., part of the Werfen Group,
has been the trusted source for autoimmune
disease diagnostics for over 20 years. Now, with
more assays and instruments than ever, all made
with the unmatched quality, reliable consistency,
and excellent value you have come to expect
from INOVA. Furthermore, our expertise and
collaborative approach means you have a partner
with extraordinary technical proficiency, product
support and impeccable service ready to help
ensure your lab is operating at its best.
Together we are redefining autoimmunity,
leveraging our innovative spirit to meet the quality
and efficiency requirements of todays dynamic
healthcare setting. We are proud to serve customers
in over 90 countries, many from the top healthcare
institutions in the world, and we look forward to
exceeding your expectations while meeting your
autoimmune testing needs.
Systems and Instrumentation
INTEGRATING THE
AUTOIMMUNE
LABORATORY
INOVA Diagnostics provides automation
that anticipates the unique requirements of
individual laboratories to improve the efficiency
and quality of autoimmune testing.
QUANTA Link
Centralized Intelligent Network
Workflow management made easy

QUANTA Link is a powerful, easy-to-use workflow management system
that gives you immediate control of all your autoimmune IFA, EIA and
chemiluminescence sample processing.
t Seamlessly integrates instruments with your
laboratory information system (LIS)
t Efficiently controls instrument workflow
t Optimizes quality control through
trending and analysis
Description
Part Number
QUANTA Link Workstation License
066LINK001
(includes Oracle License and 5 Connections)
QUANTA Link Workstation
066LINK010
Barcode Scanner
066LINK019
t Delivers positive patient ID for IFA testing
Eliminates transcription errors in IFA sample processing and analysis
NOVA
View
Digital IFA
The new world of digital IFA testing

NOVA View provides a platform
designed to standardize the analysis
of IFA slides. This fully automated
system has the potential to increase
productivity while providing more
consistent results. Step confidently
into the future of digital IFA testing
with NOVA View.
t Reduces hands-on time
t Supports standardization
t Prompts appropriate analysis
t Facilitates case review
Description
Desc
De
scri
ript
ptio
ion
n
Part Number
NOVA View Instrument
NV1000
HEp-2 Module license
NV1050
ANCA Module license
NV1051
Crithidia Module license
NV1052
Tissue Module license
NV1053

NOVA
View
Integrated Autoimmune Laboratory
Integration delivers positive patient

identification for IFA samples and slides
Eliminates transcription errors in IFA sample processing and analysis
BIO-FLASH
Rapid-Response Chemiluminescent Analyzer
A progressive solution to
common problems
Eliminates isotype batching and reagent waste
t Stable on-board reagents allow for samples
to be run as they arrive
Improves turn-around time
t Simultaneous random access
processing of all isotypes and assays
on a single sample
t Delivers results, including STAT orders,
in as little as 30 minutes
t BIO-FLASH can generate up to 450
results in a single shift
Helps reduce test send outs
t Makes even the most specialized
assays efficient to perform with stable
calibration curves
Frees up floor space
t Small benchtop analyzer achieves
excellent throughput
Description
Part Number
BIO-FLASH System
T3710-0344
QUANTA-Flash reagents
t Chemiluminescent technology delivers precise quantitation
and a broad analytical measuring range
t Cartridge barcode is internally scanned to import the master calibration
curve, lot number, expiration date and assay type
Reagent carousel
t Stores up to 20 reagent packs with on-board refrigeration
t Monitors reagent use and reports inventory
t Dedicated reagent probe
Sample carousel
t Primary samples placed directly onto the rack and scanned by internal
barcode reader
t Samples processed in random access with continuous load capability
t STAT orders can be run at any time
t Dedicated sample probe
230k
Calibration curves
200k
t Master calibration curve uploaded through the reagent

pack barcode
t Calibrators are processed in the sample carousel
t BIO-FLASH determines a stable working calibration curve
140k
*
x
x
RLU
170k
110k
90k
60k
30k
*
*
x
0 **
0
60
130 190 250 310 380 440 500
IU/mL
Intuitive software and touchscreen

t Simplifies training and day-to-day operation
t Status screen allows immediate access to system information
QUANTA-Lyser
Automated EIA/IFA Analyzer Platform
Easy-to-use platform satisfies all

Processing flexibility different strengths for
different tasks
t Both configurations process up to 6 EIA
plates and 30 IFA slides per run
t Allows you to meet future challenges
without changing platforms
t Operational flexibility on-board scheduler
determines optimal workflow sequence to
maximize productivity
t Sample flexibility supports a wide range of
sample tube sizes
QUANTA-Lyser 160/240
Efficiency
t Automation efficiency walk-away system
minimizes hands-on time
t Training efficiency easy-to-use software
and hardware components
t Throughput efficiency independent
4-probe system allows for rapid sample
pipetting to maximize throughput
10
Description
Part Number
160 Sample IFA
GS0162
160 Sample EIA + IFA
GS0160

with incubator
GS0163
240 Sample IFA
GS0242
GS0240

with incubator
GS0243

QUANTA-Lyser
2
Automated EIA/IFA Analyzer Platform
your EIA and IFA processing needs

Processing flexibility three configurations to
maximize flexibility and efficiency
t A combination 5 slide IFA, 1 plate EIA layout
t A dedicated 15 slide IFA layout
t A dedicated 2 plate EIA layout
t Allows you to choose the configuration to meet
your testing demands
Operational flexibility on-board scheduler
maximizes productivity
Sample flexibility supports a wide range of
QUANTA-Lyser 2
Description
Part Number
IFA Only
GS2002
EIA + IFA
GS2000
sample tube sizes

Automation efficiency offers walk-away capability
with minimal hands-on time
Training efficiency easy-to-use software and
hardware components
11
DS2
Reliable sample in/result out

microtiter plate processor
t Compact design is ideally suited for
laboratories where space is limited
t Processes two 96-well microplates
and up to 12 different assays
simultaneously
t Walk-away automation provides up
to two hours of free time for other
laboratory tasks
DS2 is a registered trademark of DYNEX Technologies, Inc.
12
Description
Part Number
DS2
D62010
DSX/best 2000
A high-performance walk-away
EIA processing system
t A fully automated 4-plate processing
system capable of performing up to 12
different assays simultaneously
t Employs a modular design that
provides flexible configuration and
ease of use
t Incorporates many features to ensure
the quality and security of results
t Ability to handle a wide variety of
assay protocols
Description
Part Number
With No Incubators
D65100
With 2 Incubators
D65200
With 4 Incubators
T3710-0337
DSX is a registered trademark of DYNEX Technologies, Inc.
13
QUANTA Flash
Chemiluminescent
Immunoassays (CIA)
QUANTA Flash CIA technology offers a faster response and
broader analytical measuring range than enzyme-based
assays for more precise quantitation
ANALYTICAL MEASURING RANGE
and confidence in results.
Antiphospholipid Syndrome
Connective Tissue Diseases
Celiac Disease
Vasculitis
Rheumatoid Arthritis
ELISA
QUANTA Flash
Measured units
Chemiluminescence immunoassay (CIA) technology can

significantly increase the analytical measuring range1
14
1. Martis P, et al. The QUANTA Flash Chemiluminescent Immunoassays for Celiac Disease
Show Excellent Analytical and Clinical Performance Characteristics. AMLI Minneapolis, 2011.
Celiac Disease
QUANTA Flash celiac assays provide accurate results across multiple markers and isotypes.
NAME
DESCRIPTION
PRODUCT ITEM
PACKAGE
PART #
QUANTA Flash
h-tTG IgA
This assay is designed for the semi-quantitative

determination of IgA anti-human tissue
transglutaminase (h-tTG) antibodies in human serum
on the BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
2 X 2 vials (0.3 mL each)
701103
701101
701102
QUANTA Flash
h-tTG IgG

determination of IgG anti-human tissue
transglutaminase (h-tTG) antibodies in human serum
on the BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701108
701106
701107
QUANTA Flash
DGP IgA

determination of IgA anti-deamidated gliadin peptide
(DGP) antibodies in human serum on the BIO-FLASH
system.
Reagents
Calibrators
Controls
50 Test Cartridge
701168
701166
701167
QUANTA Flash
DGP IgG

determination of IgG anti-deamidated gliadin peptide
(DGP) antibodies in human serum on the BIO-FLASH
system.
Reagents
Calibrators
Controls
50 Test Cartridge
701173
701171
701172
QUANTA Flash
DGP Screen

determination of IgG and IgA anti-deamidated gliadin
peptide (DGP) antibodies in human serum on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701113
701111
701112
Vasculitis
QUANTA Flash MPO, PR3 and GBM allow for rapid response in critical cases.
NAME
DESCRIPTION
PRODUCT ITEM
PACKAGE
PART #
QUANTA Flash
MPO

determination of IgG autoantibodies to myeloperoxidase
(MPO) in human serum on the BIO-FLASH system.
Reagents
Calibrator
Controls
50 Test Cartridge
701133
701131
701132
QUANTA Flash
PR3

determination of IgG autoantibodies to serine protease 3
(PR3) in human serum on the BIO-FLASH system.
Reagents
Calibrator
Controls
50 Test Cartridge
701138
701136
701137
QUANTA Flash
GBM

determination of IgG autoantibodies to glomerular
basement membrane (GBM) in human serum on the
BIO-FLASH system.
Reagents
Calibrator
Controls
50 Test Cartridge
701143
701141
701142
15
QUANTA Flash (CIA)

QUANTA Flash APS assays can bring clarity to the complicated diagnosis of Antiphospolipid Syndrome.
NAME
DESCRIPTION
PRODUCT ITEM
PACKAGE
PART #
QUANTA Flash
Cardiolipin IgG

determination of anti-cardiolipin (aCL) IgG antibodies in
human citrated plasma and serum on the BIO-FLASH system.
Reagents
Controls
50 Test Cartridge
2 X 3 vials (1 mL each)
701233
701232
QUANTA Flash
Cardiolipin IgM

determination of anti-cardiolipin (aCL) IgM antibodies in
Reagents
Controls
50 Test Cartridge
701238
701237
QUANTA Flash
Cardiolipin IgA*

determination of anti-cardiolipin (aCL) IgA antibodies in
Reagents
Controls
50 Test Cartridge
701228
701227
QUANTA Flash
2 GPI IgG

determination of anti-2 glycoprotein-1 (2GP1) IgG
antibodies in human citrated plasma and serum on the
BIO-FLASH system.
Reagents
Controls
50 Test Cartridge
701248
701247
QUANTA Flash
2 GPI IgM

determination of anti-2 glycoprotein-1 (2GP1) IgM
BIO-FLASH system.
Reagents
Controls
50 Test Cartridge
701253
701252
QUANTA Flash
2 GPI IgA*

determination of anti-2 glycoprotein-1 (2GP1) IgA
BIO-FLASH system.
Reagents
Controls
50 Test Cartridge
701243
701242
QUANTA Flash
2 GPI Domain1*
Available Outside the USA Only in 2013
Reagents
Controls
50 Test Cartridge
701188
701187
Calibrators are included in the cardiolipin and 2 kits
* Available Outside The USA Only
BIO-FLASH Common Components

NAME
DESCRIPTION
PACKAGE
PART #
1 X 5L
T3000-8205
2 x 250mL
T3000-8204
1,400 per box
T3000-8206
6 x 4mL
T3000-8211
BIO-FLASH System Rinse
System rinse for use with the BIO-FLASH instrument.
Trigger 1&2
Package of both triggers for use with the BIO-FLASH instrument.
Cuvettes
Cuvettes for use with the BIO-FLASH instrument.
System Cleaning Solution
Cleaning solution for BIO-FLASH instrument maintenance.
Low Volume Cups
Low volume sample cups for use with the BIO-FLASH system.
500 Cups
T3000-8209
Low Volume Caps
Low volume sample cup caps for use with the BIO-FLASH system.
500 Caps
T3000-8210
16
Connective Tissue Disease

QUANTA Flash CTD assays fully leverage the capabilities of the BIO-FLASH system to accurately detect analytes at a combined screening
level as well as the more disease specific autoantibodies.
NAME
DESCRIPTION
PRODUCT ITEM
PACKAGE
PART #
QUANTA Flash
ENA 7 *
This assay is designed for the qualitative determination

of IgG anti Sm, anti-RNP, anti-Ro60, anti-Ro52, anti-SS-B,
anti-Scl-70 and anti-Jo-1 antibodies.
Reagents
Calibrators
Controls
50 Test Cartridge
2 X 2 vials (0.3mL each)
701258
701256
701257
QUANTA Flash
Jo-1 *

determination of anti-Jo-1 antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701163
701161
701162
QUANTA Flash
RNP *

determination of anti-RNP antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701118
701116
701117
QUANTA Flash
Sm *

determination of anti-Sm antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701123
701121
701122
QUANTA Flash
Ro60 *

determination of anti-Ro60 (SSA) antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701148
701146
701147
QUANTA Flash
Ro52 *

determination of anti-Ro52 (TRIM21) antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701263
701261
701262
QUANTA Flash
SS-B *

determination of anti-SSB (La) antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701153
701151
701152
QUANTA Flash
Scl-70 *

determination of anti-Scl-70 antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701158
701156
701157
QUANTA Flash
Centromere *

determination of anti-centromere antibodies on the
BIO-FLASH system.
Reagents
Calibrators
Controls
50 Test Cartridge
701198
701196
701197
QUANTA Flash
RiboP *
Reagents
Calibrators
Controls
50 Test Cartridge
701193
701191
701192
QUANTA Flash
DFS70 *
Reagents
Calibrators
Controls
50 Test Cartridge
701268
701266
701267
QUANTA Flash
dsDNA *
Reagents
Calibrators
Controls
50 Test Cartridge
701178
701176
701177
17
QUANTA Lite
ELISA
QUANTA Lite ELISA tests are made of the
highest quality components to enable semiquantitative detection of autoantibodies for
a variety of disease states:
Antiphospholipid
Gastrointestinal Disease
Syndrome
Connective Tissue
Diseases
Rheumatoid
Arthritis
18
Celiac Disease
Liver Disease
Vasculitis
Autoimmune Thyroid
Disease
QUANTA Lite ELISA tests are semi-quantitative unless otherwise indicated in the product description
The cause of chronic intestinal upset can come from a number of sources, often making diagnosis difficult. The QUANTA Lite and
NOVA Lite (in the case of ANCA) tests below provide reliable results to help clinicians assess the root cause.
CELIAC & GI DIAGNOSTIC PATHWAY
tTG, DGP, EMA

(+)
()
Suggestive of
Celiac Disease
ASCA, pANCA, H. pylori, GPA, Intrinsic Factor

(+)
(+)
(+)
(+)
ASCA
pANCA
H. pylori
GPA/intrinsic
factor
Suggestive of
Crohns Disease
Suggestive of
Ulcerative Colitis
Suggestive of
Gastritis
()
Suggestive of
Atrophic Gastritis/
Pernicious Anemia
Non-celiac gluten sensitivity testing

Gliadin IgG (Non-celiac gluten sensitivity testing)
(+)
()
Suggestive of
Irritable Bowel
Syndrome
Abbreviations
ANCA
Anti-neutrophil cytoplasmic antibodies
ASCA
Anti-Saccharomyces cerevisiae antibody
DGP
Anti-deamidated gliadin peptide
EMA
Anti-endomysial antibody
GPA
Anti-gastric parietal antibody
H. pylori
Anti-Helicobacter pylori antibody
tTG
Anti-tissue transglutaminase antibody
Suggestive of
Non-Celiac Gluten
Sensitivity
Test
Associated disease state
Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.
1. Green, P. H. (2009). "Mortality in celiac disease, intestinal inflammation, and gluten sensitivity." JAMA 302(11): 1225-1226.
2. Rubio-Tapia, A. and Murray, J. A. (2010). "Celiac disease." Curr Opin Gastroenterol 26(2): 116-122.
3. Leffler, D. A. and D. Schuppan (2010). "Update on serologic testing in celiac disease." Am J Gastroenterol 105(12): 2520-2524.
19
QUANTA Lite (ELISA)

IBD
Differential Diagnosis
of Crohns Disease or
Ulcerative Colitis
RESULTS:
ASCA IgG ASCA IgA pANCA +
(atypical)
PR3+
RESULTS:
ASCA IgG +
ASCA IgA +
pANCA (atypical)
INFLAMMATORY BOWEL
DISEASE DIAGNOSIS
ASCA LEVEL
OVERLAP CONDITIONS
ANCA LEVEL
Suggestive of
Suggestive of
CROHNS DISEASE
ULCERATIVE COLITIS
Abbreviations
ASCA
Anti-Saccharomyces cerevisiae antibody
pANCA
Perinuclear anti-neutrophil cytoplasmic antibody
PR3
Proteinase 3
1. Desplat-Jego, S., Johanet, C., et al. (2007). "Update on Anti-Saccharomyces cerevisiae antibodies, anti-nuclear associated anti-neutrophil antibodies and
antibodies to exocrine pancreas detected by indirect immunofluorescence as biomarkers in chronic inflammatory bowel diseases: results of a multicenter
study." World J Gastroenterol 13(16): 2312-2318.
2. Arai, R. (2010). "Serologic markers: impact on early diagnosis and disease stratification in inflammatory bowel disease." Postgrad Med 122(4): 177-185.
3. Arias-Loste, et al. (2012). "Presence of Anti-proteinase 3 Antineutrophil Cytoplasmic Antibodies (Anti-PR3 ANCA) as Serologic Markers in Inflammatory Bowel
Disease" Clinical Reviews in Allergy & Immunology, in press
20
NAME
ANTIGEN
PACKAGE
PART #
QUANTA Lite H. pylori IgA
A qualitative ELISA assay for the detection of anti-H. pylori

(Helicobacter pylori) IgA antibodies in human serum. The
presence of these antibodies can aid in the diagnosis of
H. pylori infection in adult patients with clinical signs and
symptoms of gastrointestinal disease.
Native
1 X 96 wells
708720
QUANTA Lite H. pylori IgG
A qualitative ELISA assay for the detection of anti-H. pylori

(Helicobacter pylori) IgG antibodies in human serum. The
H. pylori infections in adult patients with clinical signs and
symptoms of gastrointestinal disease.
Native
1 X 96 wells
708715
QUANTA Lite ASCA

(S. cerevisiae) IgA
This assay is designed for the detection of antiSaccharomyces cerevisiae IgA antibodies in human serum.
The presence of these antibodies can aid in the diagnosis of
patients with Crohn's disease.
Native
1 X 96 wells
708870
QUANTA Lite ASCA

(S. cerevisiae) IgG
This assay is designed for the detection of antiSaccharomyces cerevisiae IgG antibodies in human serum.
patients with Crohn's disease.
Native
1 X 96 wells
708865
This assay is designed for the detection of anti-gastric

parietal cell (H+/K+) ATPase IgG antibodies in human serum.
QUANTA Lite GPA (Gastric
Parietal Cell Antibody)
conditions with elevated levels of anti-gastric parietal cell
antibodies including pernicious anemia.
Native
1 X 96 wells
708765
Recombinant
1 X 96 wells
708780
QUANTA Lite
Intrinsic Factor
DESCRIPTION
This assay is designed for the detection of anti-Intrinsic

Factor IgG antibodies in human serum. The presence of
these antibodies can aid in the diagnosis of pernicious
anemia.
21
QUANTA Lite (ELISA)

Celiac Disease
Celiac disease remains highly under diagnosed, especially in children. INOVA is very proud to have introduced QUANTA Lite Gliadin II (DGP),
the first commercial deamidated gliadin peptide (DGP) ELISA, in 2005. This assay is particularly useful in pediatric populations.
NAME
ANTIGEN
PACKAGE
PART #
QUANTA Lite h-tTG IgA
This assay is designed for the detection of anti-tissue

transglutaminase (endomysium) IgA antibodies in human
serum. The presence of these antibodies can aid in the
diagnosis of certain gluten sensitive enteropathies such as
celiac disease and dermatitis herpetiformis.
Native
(human red
blood cell)
1 X 96 wells
10 X 96 wells
708760
708760.10
QUANTA Lite h-tTG IgG
This assay is designed for the detection of anti-tissue

transglutaminase (endomysium) IgG antibodies in human
serum. The presence of these antibodies can aid in the
diagnosis of certain gluten sensitive enteropathies such
as celiac disease and dermatitis herpetiformis. This test is
intended for providing added sensitivity when testing IgA
deficient patients.
Native
(human red
blood cell)
1 X 96 wells
708755
QUANTA Lite R h-tTG IgA
This assay is designed for the in-vitro measurement of

specific IgA autoantibodies against tissue transglutaminase
(tTG) present in human serum, as an aid in the diagnosis of
celiac disease.
Recombinant
1 X 96 wells
10 X 96 wells
704605
704605.10
QUANTA Lite R h-tTG IgG

specific IgG autoantibodies against tissue transglutaminase
(tTG) present in human serum, as an aid in the diagnosis of
celiac disease.
Recombinant
1 X 96 wells
10 X 96 wells
704610
704610.10
QUANTA Lite
h-tTG Screen
This assay is designed for the detection of IgA and IgG

human tissue transglutaminase (h-tTG) antibodies in human
serum. The presence of these antibodies can be used to aid
in the diagnosis of IgA sufficient and IgA deficient celiac
disease.
Native
(human red
blood cell)
1 X 96 wells
704570
QUANTA Lite
Gliadin IgA II (DGP)
This assay is designed for the detection of IgA antibodies

to synthetic, deamidated gliadin-derived peptides (DGP) in
human serum. The presence of these antibodies can aid in
the diagnosis of celiac disease.
Synthetic,
deamidated
peptide
1 X 96 wells
10 X 96 wells
704525
704525.10
QUANTA Lite
Gliadin IgG II (DGP)
This assay is designed for the detection of IgG antibodies

to synthetic, deamidated gliadin-derived peptides (DGP) in
human serum. The presence of these antibodies can aid in
the diagnosis of celiac disease.
Synthetic,
deamidated
peptide
1 X 96 wells
10 X 96 wells
704520
704520.10
QUANTA Lite
Celiac DGP Screen

antibodies to synthetic, deamidated gliadin-derived
peptides in human serum. The presence of these antibodies
can be used to aid in the diagnosis of celiac disease in both
IgA sufficient and IgA deficient patients as well as dermatitis
herpetiformis.
Synthetic,
deamidated
peptide
1 X 96 wells
704545
22
DESCRIPTION
Celiac Disease (continued)

NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
h-tTG native
(human red
blood cell);
DGP peptide
(synthetic,
deamidated)
1 X 96 wells
704575
QUANTA Lite
h-tTG/DGP Screen

antibodies to synthetic, deamidated gliadin-derived
peptides (DGP) and human tissue transglutaminase (h-tTG)
in human serum. The presence of these antibodies can be
used to aid in the diagnosis of celiac disease in both IgA
sufficient and IgA deficient patients as well as dermatitis
herpetiformis.
QUANTA Lite Gliadin IgA
This assay is designed for the detection of anti-gliadin

IgA antibodies in human serum. The presence of these
antibodies can aid in the diagnosis of gluten sensitive
enteropathies such as celiac disease and dermatitis
herpetiformis.
Native
1 X 96 wells
708655
QUANTA Lite Gliadin IgG
This assay is designed for the detection of anti-gliadin

IgG antibodies in human serum. The presence of these
antibodies can aid in the diagnosis of gluten sensitive
enteropathies such as celiac disease and dermatitis
herpetiformis.
Native
1 X 96 wells
708650
QUANTA Lite F-Actin IgA
This assay is designed for the detection of IgA antibodies to

the F-Actin component of smooth muscle in human serum.
In patients with clinical findings consistent with celiac
disease, the presence of anti-F-actin IgA antibodies may
assist in estimating the likelihood of significant intestinal
villous atrophy.
Native
1 X 96 wells
704500
23
QUANTA Lite (ELISA)

Liver Disease
INOVA offers a comprehensive menu of tests to aid in the diagnosis of autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
DIAGNOSTIC ALGORITHM
Liver Disease of Unknown Cause
ANA+
SMA+
LKM+
AIH
F-actin+
(lgG)
PBC
SLA/LP+
AIH
LC1+
Additional assays to
establish &/or clarify
diagnosis**
Atypical
ANCA+
AMA+
AIH
PSC
AMA specific
antigens
M2EP (MIT3)*+
gp210+
&/or
sp100+
PBC
Abbreviations
AIH
autoimmune hepatitis
AMA
anti-mitochondrial antibodies
ANA
anti-nuclear antibodies
ANCA
anti-neutrophil cytoplasmic antibodies
DGP
deamidated gliadin peptide
EMA
endomysium antibody
LKM
liver-kidney microsomal antibody
PBC
primary biliary cirrhosis
PSC
primary sclerotic cholangitis
SLA
soluble liver antigen
SMA
smooth muscle antibody
tTG
tissue transglutaminase
EMA+
tTG+
DGP+
Celiac
Test
Negative
Cryptogenic
chronic
hepatitis
From: A.J. Czaja & G.L. Norman, J. Clin. Gastrenterol, 2003, 37:315-327, modified by G.L. Norman 01/09
** Other assays with possible prognostic value: chromatin and dsDNA
* M2 EP (MIT3) ELISA contains immunodominant epitope of PDC-E2, OGDC-E2 & BCOADC-E2
24
AIC
Liver Disease
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite Actin IgG
This assay is designed for the detection of IgG antibodies to

the actin component of smooth muscle in human serum.
autoimmune liver diseases such as autoimmune hepatitis
(AIH) and primary biliary cirrhosis (PBC).
Native
1 X 96 wells
10 X 96 wells
708785
708785.10
QUANTA Lite
M2 EP (MIT3)
This assay is designed for the detection of anti-mitochondria

IgG antibodies in human serum. The presence of
mitochondria antibodies can aid in the diagnosis of primary Recombinant
biliary cirrhosis. MIT3 recombinant antigen consists of
PDC-E2, BCOADC-E2, and OGDC-E2.
1 X 96 wells
10 X 96 wells
704540
704540.10
QUANTA Lite gp210
This assay is designed for the detection of anti-gp210

antibodies can aid in the diagnosis of primary biliary
cirrhosis (PBC).
Synthetic
peptide
1 X 96 wells
708995
QUANTA Lite sp100
This assay is designed for the detection of anti-sp100

antibodies can aid in the diagnosis of primary biliary
cirrhosis (PBC).
Synthetic
peptide
1 X 96 wells
708990
QUANTA Lite
PBC Screen IgG/IgA
MIT3
This assay is designed for the detection of antirecombinant;
mitochondrial, -gp210 and -sp100 IgG and/or IgA antibodies
sp100 &
in human serum. The presence of these antibodies can aid in
gp210
the diagnosis of primary biliary cirrhosis.
synthetic
peptides
1 X 96 wells
704560
QUANTA Lite SLA
This assay is designed for the detection of anti-SLA

antibodies can aid in the diagnosis of conditions with
elevated levels of SLA antibody including autoimmune
hepatitis (AIH).
Recombinant
1 X 96 wells
708775
QUANTA Lite LKM-1
This assay is designed for the detection of anti-LKM-1

antibodies can aid in the diagnosis of autoimmune
hepatitis, type 2. Utilizes recombinant human cytochrome
P450 2D6 antigen.
Recombinant
1 X 96 wells
708745
25
QUANTA Lite (ELISA)

INOVA Diagnostics has long been at the forefront of laboratory tests that aid in the diagnosis of antiphospholipid syndrome,
offering a comprehensive menu of serological markers including criteria as well as specialty non-criteria markers. 1
aCL antibodies, IgG, IgM, IgA*

2GP1 antibodies, IgG, IgM, IgA*
Lupus anticoagulant (LAC)**
All negative
APS is not likely
If clinical suspicion
is high, test aCL/
aB2GP1 IgA and
aPS/PT IgG and IgM
LAC positive
(regardless of other
antibodies)
aCL and/or 2GP1

IgG and/or IgM
moderate/high
positive
If clinical criteria
fulfilled, APS is very
likely; Treat patient,
repeat testing in
12 weeks
fulfilled, APS is very
likely; Treat patient,
repeat testing in
12 weeks
aCL and/or 2GP1

IgG and/or IgM
weak positive
fulfilled, APS is
possible; Treat
patient, repeat
testing in 12 weeks;
Consider testing for
aCL/aB2GP1 IgA and
aPS/PT IgG and IgM
Consider aPS/PT
testing
Test
Abbreviations
aCL
anti-cardiolipin
APS
anti-phospholipid syndrome
-2 GP1
beta-2 glycoprotein I
LAC
lupus anticoagulant
* IgA aCL and 2GP1 antibodies are not part of the current APS classification criteria.
** Lupus anticoagulant test is not provided by INOVA
1. Bertolaccini, M. L., Amengual, O., Atsumi, T., Binder, W. L., de Laat, B., Forastiero, R., Kutteh, W. H., et al. (2011). Non-criteria aPL tests: report of a task force and preconference workshop at the 13th International Congress on Antiphospholipid Antibodies, Galveston, TX, USA, April 2010. Lupus, 20(2), 191-205. doi:10.1177/0961203310397082
2. Galli M. Interpretation and recommended testing for antiphospholipid antibodies. Semin Thromb Hemost. 2012 Jun;38(4):348-52.
3. Otomo K, Atsumi T, Amengual O, Fujieda Y, Kato M, Oku K, Horita T, Yasuda S, Koike T. Efficacy of the antiphospholipid score for the diagnosis of antiphospholipid syndrome and its predictive value for thrombotic events. Arthritis Rheum. 2012 Feb;64(2):504-12.
26
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite ACA IgG III
This assay is designed for the detection of anti-cardiolipin IgG

antibodies in human serum. The presence of these antibodies
can aid in assessing the risk of thrombosis in individuals with
systemic lupus erythematosus (SLE) or lupus-like disorders.
Native
1 X 96 wells
10 X 96 wells
708625
708625.10
QUANTA Lite ACA IgM III
This assay is designed for the detection of anti-cardiolipin IgM

Native
1 X 96 wells
10 X 96 wells
708630
708630.10
QUANTA Lite ACA IgA III
This assay is designed for the detection of anti-cardiolipin IgA

Native
1 X 96 wells
10 X 96 wells
708635
708635.10
QUANTA Lite ACA

Screen III
This assay is designed for the detection of anti-cardiolipin

IgG, IgM and IgA antibodies in human serum. The presence of
these antibodies can aid in assessing the risk of thrombosis in
individuals with systemic lupus erythematosus (SLE) or
lupus-like disorders.
Native
1 X 96 wells
708620
QUANTA Lite 2GPI IgG
This assay is designed for the detection of anti-2GPI IgG

can aid in the diagnosis of certain autoimmune disease
thrombotic disorders, such as those secondary to systemic
lupus erythematosus (SLE) or other lupus-like thrombotic
diseases.
Native
1 X 96 wells
10 X 96 wells
708665
708665.10
QUANTA Lite 2GPI IgM
This assay is designed for the detection of IgM anti-2GPI

diseases.
Native
1 X 96 wells
10 X 96 wells
708670
708670.10
QUANTA Lite 2GPI IgA
This assay is designed for the detection of anti-2GPI IgA

diseases.
Native
1 X 96 wells
10 X 96 wells
708675
708675.10
QUANTA Lite 2GPI

Screen
A qualitative ELISA assay for the detection of anti-2GPI

IgG, IgM and IgA antibodies in human serum. The presence
of these antibodies can aid in the diagnosis of certain
autoimmune thrombotic disorders, such as those secondary
to systemic lupus erythematosus (SLE) or other lupus-like
disorders.
Native
1 X 96 wells
708660
27
QUANTA Lite (ELISA)

Antiphospholipid Syndrome (continued)
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite aPS/PT

IgG
This assay is designed for the detection of IgG class

antibodies to phosphatidylserine/prothrombin complex
(PS/PT) in serum or plasma, as an aid in the diagnosis of
autoimmune thrombotic disorders such as anti-phospholipid
syndrome (APS), in conjunction with other laboratory and
clinical findings.
Native
1 X 96 wells
708835
QUANTA Lite aPS/PT

IgM
This assay is designed for the detection of IgM class

antibodies to phosphatidylserine/prothrombin complex
(PS/PT) in serum or plasma, as an aid in the diagnosis of
autoimmune thrombotic disorders such as anti-phospholipid
syndrome (APS), in conjunction with other laboratory and
clinical findings.
Native
1 X 96 wells
708845
QUANTA Lite
Phosphatidylserine IgG
This assay is intended for the in-vitro measurement of IgG

anti-phosphatidylserine antibodies in human serum, as an
aid in the diagnosis of anti-phospholipid syndrome (APS).
Native
1 X 96 wells
10 X 96 wells
704625
704625.10
QUANTA Lite
Phosphatidylserine IgM
This assay is intended for the in-vitro measurement of IgM

Native
1 X 96 wells
10 X 96 wells
704630
704630.10
QUANTA Lite
Phosphatidylserine IgA
This assay is intended for the in-vitro measurement of IgA

Native
1 X 96 wells
10 X 96 wells
704635
704635.10
28
Rheumatoid Arthritis
The revised classification criteria issued in 2010 for rheumatoid arthritis (RA) emphasize the need for early and accurate diagnosis. The
QUANTA Lite CCP3.1 IgG/IgA ELISA offers superior detection of early RA compared with CCP21. Clearly defined positive and high positive
cut-offs provide results that rheumatologists require.
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite CCP3.1

IgG/IgA
This assay is designed for the detection of anti-CCP 3.1 IgG

and IgA antibodies in patient sera, citrated or EDTA plasma.
rheumatoid arthritis (RA), including RA diagnosed within 2
years of presentation of symptoms.
Synthetic
peptide
1 X 96 wells
10 X 96 wells
704550
704550.10
QUANTA Lite CCP3 IgG
This assay is designed for the detection of anti-CCP 3 IgG

antibodies in patient sera, citrated or EDTA plasma. The
rheumatoid arthritis.
Synthetic
peptide
1 X 96 wells
10 X 96 wells
704535
704535.10
QUANTA Lite RF IgG
This assay is designed for the detection of anti-rheumatoid

factor (RF) IgG antibodies in human serum. The presence
of these antibodies can aid in the diagnosis of rheumatoid
arthritis (RA).
Native
1 X 96 wells
708685
QUANTA Lite RF IgM

factor (RF) IgM antibodies in human serum. The presence
arthritis (RA).
Native
1 X 96 wells
708690
QUANTA Lite RF IgA

factor (RF) IgA antibodies in human serum. The presence
arthritis (RA).
Native
1 X 96 wells
708695

1. Source : QUANTA Lite CCP 3.1 IgG/IgA ELISA direction insert. Early RA defined as detection within 2 years of onset of symptoms.
29
QUANTA Lite (ELISA)

Connective Tissue Diseases
Lupus and lupus-like diseases present clinicians with a tremendous diagnostic challenge. Tests which stand apart from the rest include
the QUANTA Lite ANA ELISA with a broad array of antigens as well as HEp-2 nuclear extracts, and the QUANTA Lite Chromatin ELISA with
excellent performance.
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite ANA
This assay is designed for the detection of anti-nuclear IgG

antibodies (ANA) in human serum. The presence of these
antibodies can aid in the diagnosis of rheumatic diseases such as
systemic lupus erythematosus, Sjgren's Syndrome, scleroderma,
and mixed connective tissue disease.
Native,
recombinant,
extracts from
HEp-2 nuclei
and nucleoli
1 X 96 wells
708750
QUANTA Lite dsDNA
This assay is designed for the detection of anti-dsDNA IgG

antibodies in human serum. The presence of these antibodies can
aid in the diagnosis of systemic lupus erythematosus (SLE).
Native
1 X 96 wells
708510
This assay is intended for the in-vitro measurement of specific

IgG autoantibodies against dsDNA present in human serum, as
QUANTA Lite dsDNA SC an aid to the diagnosis of systemic lupus erythematosus (SLE), in
conjunction with other clinical findings. Five calibrators allow for
creation of standard curve (SC).
Native
1 X 96 wells
704650
This assay is intended for the in-vitro measurement of specific

high avidity IgG autoantibodies against dsDNA present in human
QUANTA Lite HA dsDNA
serum, as an aid to the diagnosis of systemic lupus erythematosus
(High Avidity)
(SLE), in conjunction with other clinical findings. Five calibrators
allow for creation of standard curve.
Native
1 X 96 wells
704615
QUANTA Lite
Chromatin
This assay is designed for the detection of anti-chromatin IgG

can aid in the diagnosis of drug-induced lupus (DIL) and systemic
lupus erythematosus (SLE).
Native
1 X 96 wells
708710
QUANTA Lite C1q CIC
This assay is designed for the in-vitro measurement of circulating

immune complexes (CIC) that bind C1q, present in human serum.
It is intended for the determination of CIC in serum of patients
with various autoimmune and other CIC-related diseases, and is
used in conjunction with other clinical findings.
Native
1 X 96 wells
704620
This assay is designed for the detection of anti-C1q antibodies in

human serum. The presence of anti-C1q antibodies in patients
QUANTA Lite Anti-C1q* with systemic lupus erythematosus can be used in conjunction
with clinical findings and other laboratory tests to aid in detecting
people at risk of developing glomerulonephritis.
Native
1 X 96 wells
704565
Recombinant
1 X 96 wells
708770
QUANTA Lite
Centromere (CENP-A &
CENP-B)
This assay is designed for the detection of anti-centromere

IgG antibodies specifically reactive to the CENP-A and CENP-B
antigens in human serum. Presence of these antibodies can aid
in the diagnosis of certain connective tissue diseases such as the
CREST variant of scleroderma.
30
Connective Tissue Diseases (continued)

NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite Histone
This assay is designed for the detection of anti-histone IgG

can aid in the diagnosis of systemic lupus erythematosus (SLE),
drug-induced SLE and related connective tissue diseases, such as
rheumatoid arthritis, dermatomyositis and Sjgren's Syndrome.
Determination of the patient's histone antibody status may be
useful in the differential diagnosis between SLE and drug induced
SLE.
Native
1 X 96 wells
708520
QUANTA Lite Jo-1
This assay is designed for the detection of anti-Jo-1 IgG

aid in the diagnosis of polymyositis and other related connective
tissue diseases.
Native
1 X 96 wells
708585
QUANTA Lite
Ribosome P
This assay is designed for the detection of anti-Ribosome P IgG

aid in the diagnosis of systemic lupus erythematosus (SLE) and
other related connective tissue diseases.
Synthetic
peptide
1 X 96 wells
708600
QUANTA Lite RNA

Polymerase III
This assay is designed for the detection of anti-RNA Polymerase III

IgG antibodies in patient sera. The presence of these antibodies
Recombinant
can aid in the diagnosis of systemic sclerosis (scleroderma) with
increased incidence of skin involvement and renal crisis.
1 X 96 wells
704555
QUANTA Lite RNP
This assay is designed for the detection of anti-RNP IgG

related connective tissue diseases. Native purified RNP/Sm.
Native
1 X 96 wells
708565
QUANTA Lite Scl-70
This assay is designed for the detection of anti-Scl-70 IgG

aid in the diagnosis of scleroderma.
Native
1 X 96 wells
708580
QUANTA Lite Sm
This assay is designed for the detection of anti-Sm IgG antibodies

in human serum. The presence of these antibodies can aid in
the diagnosis of systemic lupus erythematosus (SLE) and related
connective tissue diseases.
Native
1 X 96 wells
708560
QUANTA Lite SS-A
This assay is designed for the detection of anti-SS-A (60kDa

& 52kDA) IgG antibodies in human serum. The presence of
these antibodies can aid in the diagnosis of systemic lupus
erythematosus (SLE) and related connective tissue diseases, such
as Sjgren's Syndrome.
SS-A 52
recombinant;
SS-A 60
native
1 X 96 wells
708570
QUANTA Lite SS-A 52
This assay is designed for the detection of anti-SS-A 52 IgG

antibodies in patient sera. The presence of these antibodies is
an aid in the diagnosis of systemic lupus erythematosus (SLE),
Sjgren's Syndrome (SS), systemic sclerosis (SSC), polymyositis
(PM) and dermatomyositis (DM).
Recombinant
1 X 96 wells
704505
31
QUANTA Lite (ELISA)

Connective Tissue Diseases (continued)
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite SS-B
This assay is designed for the detection of anti-SS-B IgG

related connective tissue diseases, such as Sjgren's Syndrome.
Native
1 X 96 wells
708575
QUANTA Lite ssDNA
This assay is designed for the detection of anti-ssDNA IgG

antibodies in human serum. When used in conjunction with
QUANTA Lite dsDNA, can aid in the diagnosis of systemic lupus
erythematosus (SLE) and certain other rheumatic diseases.
Native
1 X 96 wells
708525
QUANTA Lite ENA 4
SS-A 52
This assay is designed for the detection of anti-Sm, RNP, SS-A
recombinant;
(60kDa and 52kDA) and SS-B IgG antibodies in human serum. The
SS-A 60
presence of these antibodies can aid in the diagnosis of systemic
native; SS-B
lupus erythematosus (SLE) and related connective tissue diseases, native; Sm
such as Sjgren's Syndrome.
native; RNP
native
1 X 96 wells
708555
QUANTA Lite ENA 5

(60kDa and 52kDa), SS-B and Scl-70 IgG antibodies in human
serum. The presence of these antibodies can aid in the diagnosis
of systemic lupus erythematosus (SLE), and related connective
tissue diseases, such as Sjgren's Syndrome.
SS-A 52
recombinant;
SS-A 60
native; SS-B
native; Sm
native; RNP
native; Scl-70
native
1 X 96 wells
708610
QUANTA Lite ENA 6
SS-A 52
recombinant;
SS-A 60
(60kDa and 52kDa), SS-B, Scl-70 and Jo-1 IgG antibodies in human native; SS-B
native; Sm
serum. The presence of these antibodies can aid in the diagnosis
native; RNP
of systemic lupus erythematosus (SLE), and related connective
native; Scl-70
tissue diseases, such as Sjgren's Syndrome.
native; Jo-1
native
1 X 96 wells
708615
QUANTA Lite ENA

Profile*
This kit is designed for the in-vitro qualitative screening of

human serum for the presence of specific IgG autoantibodies
against extractable nuclear antigens (ENAs) namely; SSA/Ro (60
and 52kD), SSB/La, Sm, Sm/RNP, Scl-70 and Jo-1, as an aid in the
diagnosis of certain systemic rheumatic diseases.
1 X 96 wells
704715
32
Combined
Vasculitis
Newly acquired technology has allowed for an important expansion in INOVAs vasculitis menu with the addition of the QUANTA
Lite PR3 SC and QUANTA Lite MPO SC, both offering 5 point standard curve calibration.
NAME
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite MPO IgG
This assay is designed for the detection of antimyeloperoxidase (MPO) IgG antibodies in human serum.
The presence of these antibodies can aid in assessing certain
autoimmune vasculitides such as microscopic polyarteritis,
and crescentic glomerulonephritis.
Native
1 X 96 wells
10 X 96 wells
708700
708700.10
QUANTA Lite MPO SC
This assay is intended for the in-vitro measurement of

specific IgG autoantibodies against myeloperoxidase (MPO)
present in serum, as an aid to the diagnosis of certain types
of autoimmune vasculitis. Five calibrators allow for creation
of standard curve.
Native
1 X 96 wells
10 X 96 wells
704655
704655.10
QUANTA Lite PR-3
This assay is designed for the detection of anti-serine

protease 3 (PR-3) IgG antibodies in human serum. The
presence of these antibodies can aid in assessing certain
autoimmune vasculitides such as Wegener's granulomatosis.
Native
1 X 96 wells
10 X 96 wells
708705
708705.10
QUANTA Lite PR3 SC

specific IgG autoantibodies against proteinase 3 (PR3)
present in human serum, as an aid in the diagnosis of
Wegener's granulomatosis and certain forms of autoimmune
vasculitis. Five calibrators allow for creation of standard
curve.
Native
1 X 96 wells
10 X 96 wells
704660
704660.10
QUANTA Lite GBM
This assay is designed for the detection of anti-glomerular

basement membrane (GBM) IgG antibodies in human serum.
The presence of these antibodies can aid in the diagnosis
of autoimmune renal disorders such as Goodpasture's
syndrome.
Native
1 X 96 wells
10 X 96 wells
708740
708740.10
DESCRIPTION
ANTIGEN
PACKAGE
PART #
QUANTA Lite Thyroid T
This assay is designed for the detection of anti-thyroglobulin

antibodies can aid in the diagnosis of Hashimoto's
Thyroiditis.
Native
1 X 96 wells
708595
QUANTA Lite TPO
This assay is designed for the detection of anti-thyroid

peroxidase (TPO) IgG antibodies in human serum. The
presence of these antibodies can aid in the diagnosis
of autoimmune thyroid diseases such as Hashimoto's
Thyroiditis and Graves' Disease.
Recombinant
1 X 96 wells
708725
Autoimmune Thyroid Disease

NAME
33
QUANTA Lite (ELISA)

QUANTA Chek Quality Control Panels
NAME
DESCRIPTION
PACKAGE
PART #
QUANTA Chek
ANA Panel
The QUANTA Chek ANA Panel is used for quality control of IFA and ELISA
antinuclear antibody procedures. Each serum serves as both a pattern
control and a titratable sensitivity control. The staining pattern and intensity
for each serum has been calibrated by testing it on NOVA Lite HEp-2 slides
and QUANTA Lite ANA kits.
10 X 0.15mL
708111
QUANTA Chek
ANCA Panel
The QUANTA Chek ANCA Panel is used for quality control of IFA and ELISA
autoantibody procedures. Each serum serves as both a pattern control and
a titratable sensitivity control. The staining pattern and intensity for each
serum has been calibrated by testing it on INOVA Diagnostics' Neutrophil
slides and QUANTA Lite MPO and PR-3 kits.
8 X 0.15mL
708112
QUANTA Chek
Celiac Panel
The QUANTA Chek Celiac Panel is used for quality control of IFA and ELISA
autoantibody procedures. Each serum serves as both a pattern control and
a titratable sensitivity control. The staining pattern and intensity for each
serum has been calibrated by testing it on NOVA Lite Endomysial slides and
QUANTA Lite h-tTG IgA, h-tTG IgG, Gliadin IgG II and Gliadin IgA II kits.
8 X 0.15mL
708113
QUANTA Chek
Coagulation Panel
The QUANTA Chek Coagulation Panel is used for quality control of ACA
and 2GPI autoantibody ELISA procedures. Each serum serves as both a
sensitivity and specificity control. Each serum has been calibrated by testing
it on QUANTA Lite ACA and QUANTA Lite 2GPI kits.
8 X 0.15mL
708114
QUANTA Chek
ENA Panel
The QUANTA Chek ENA Panel is used for quality control of extractable
nuclear antibody (ENA) assay in the QUANTA Lite ENA ELISA procedure. Each
serum serves as both a sensitivity and a specificity control. Each serum has
been calibrated by testing it on QUANTA Lite ENA ELISA kits.
8 X 0.15mL
708115
34
Calibration and Standard Sets

NAME
DESCRIPTION
PACKAGE
PART #
IgG Sapporo Standard

(HCAL)
The IgG Sapporo Standard (HCAL) is used as an international standard for

the quality control of anti-cardiolipin IgG (aCL) and anti-2 glycoprotein I
(2GPI) IgG antibody ELISA products. The IgG Sapporo Standard (HCAL) can
be serially diluted in order to make a standard curve, or it can be used as a
single point control.
1 X 0.1mL
508668
IgM Sapporo Standard

(EY2C9)
The IgM Sapporo Standard (EY2C9) is used as an international standard for

the quality control of anti-cardiolipin IgM (aCL) and anti-2glycoprotein I
(2GPI) IgM antibody ELISA products. The IgM Sapporo Standard (EY2C9) can
be serially diluted in order to make a standard curve, or it can be used as a
single point control.
1 X 0.1mL
508673
QUANTA Lite dsDNA

Standard Set*
Pre-diluted 5-point standard curve and positive curve to be used in

conjunction with QUANTA Lite dsDNA (708510)
5 X 1.2mL
508512
QUANTA Lite Gliadin IgA

II Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in

conjunction with QUANTA Lite Gliadin IgA II ELISA (704525)
6 X 1.2mL
504528
QUANTA Lite Gliadin IgG

II Calibrator Set*

conjunction with QUANTA Lite Gliadin IgG II ELISA (704520)
6 X 1.2mL
504524
QUANTA Lite h-tTG IgA

Calibrator Set*

conjunction with QUANTA Lite h-tTG IgA ELISA (708760)
5 X 1.2mL
508763
QUANTA Lite GBM

Calibrator Set

conjunction with QUANTA Lite GBM ELISA (708740)
6 X 1.2mL
508744
QUANTA Lite MPO

Calibrator Set*

conjunction with QUANTA Lite MPO ELISA (708700)
6 X 1.2mL
508703
QUANTA Lite PR-3

Calibrator Set*

conjunction with QUANTA Lite PR-3 ELISA (708705)
6 X 1.2mL
508708
35
NOVA Lite
NOVA Lite IFA Barcoded Slides

As your partner in autoimmunity testing, INOVA Diagnostics
is redefining autoimmunity with innovative systems and
products. Barcoded slides offer the opportunity to advance
your IFA process. Barcoded slides, in combination with
QUANTA Link software, allow for:
Efficiency by eliminating transcription and related errors
Patient sample traceability
To learn more about NOVA Lite
barcoded slides, scan this QR code
using your PDA or smartphone or
visit barcodedslide.com
36
IFA Slide Kits

NOVA Lite has long been synonymous with quality immunofluorescence assays. INOVA is commited to customer support and supplies training
materials such as reference books written by Carol Peebles, MS, MT (ASCP). Proprietary methods used to craft our slides make NOVA Lite assays
easy to read and interpret, helping your lab provide the reliable and consistent results demanded by the current healthcare environment.
ANCA IFA
pANCA / cANCA
negative
atypical ANCA
positive
pANCA or cANCA
positive
Clinical suspicion of
autoimmune small vessel
vasculitis low
Clinical suspicion of
autoimmune small vessel
vasculitis low; consider
testing for ASCA
Order PR3 and

MPO ELISA
Abbreviations
MPO
myeloperoxidase
PR-3
proteinase 3
ANCA
anti-neutrophil cytoplasmic antibodies
ASCA
anti-Saccharomyces cerevisiae antibody
MPO positive
PR3 positive
Consider
microscopic
polyangiitis
(60% positive) or
granulomatosis
with polyangiitis
(Wegener's)
(25% positive)
Consider
microscopic
polyangiitis
(30% positive) or
granulomatosis
with polyangiitis
(Wegener's)
(60% positive)
Test
Savige, J. et al, Am J Clin Path 112 (1), 1999
37
NOVA Lite (IFA)
HEp-2
DIAGNOSTIC ALGORITHM
HEp-2
POSITlVE
Nuclear
staining
Coarse
speckled
Fine
speckled
Homogeneous
Nuclear
Dots
Nucleolar
Centromere
PCNA
Consider Progressive
Systemic Sclerosis or
Polymyositis/
Scleroderma overlap
(mixed pattern with
positive chromosomes
may indicate ScI-70)
CREST variant
of Progressive
Systemic
Sclerosis
Marker
antibody for
SLE
Confirmatory
Testing
dsDNA and/or
chromatin
Histone
Sm
RNP
SS-A 52
SS-A 60
SS-B
Scl-70
RNA Pol III
Active
SLE
Drug induced
SLE
SLE marker
antibody
MCTD or
milder SLE
SLE,
Sjgren's
Syndrome,
Systemic
Sclerosis,
PM/DM
SLE,
Sjgren's
Syndrome,
Systemic
Sclerosis
SLE,
Sjgren's
Syndrome,
Neonatal
SLE
Scleroderma
marker
antibody
associated
with
Scleroderma
Scleroderma,
especially
diffuse
cutaneous form;
also associated
with risk of
renal crisis
Abbreviations
CREST
calcinosis, raynaud's phenomenon, esophageal dysmotility,
sclerodactyly, telangiectasia
ds-DNA
double stranded DNA
ENA
extractable nuclear antibody
MCTD
mixed connective tissue disease
PBC
primary biliary cirrhosis
PCNA
Proliferating Cell Nuclear Antigen
PM/DM
RNP
Scl-70
SS-A
SS-B
Sm
SLE
polymyositis/dematomyositis
ribonucleoprotein
scleroderma antigen (70kD)
Sjgrens syndrome A antigen
Sjgrens syndrome B antigen
Smith antigen
systemic lupus erythematosus
38
NEGATIVE
No further follow-up testing indicated.

(SS-A testing may be indicated if there is strong
clinical evidence of connective tissue disease)
Cytoplasmic
staining
Nuclear
membrane
(rim)
sp100
Mitochondrial
gp 210
Retest on
rodent tissue
Primary Biliary
Cirrhosis (PBC)
M2 EP
(MIT-3)
Mitotic
Jo-1
Spindle
Ribosomal P
Jo-1
Various
rheumatic
diseases
Low % of SLE
patients but
highly specific
PM/DM
Ribosomal
Golgi
Immunofluorescent (IF)
major patterns
Reflex test
Centromere
CREST
THE HEp-2 DIAGNOSTIC ALGORITHM

For additional information on HEp-2 testing or to view additional images, please visit our website at www.inovadx.com. This diagnostic
algorithm was assembled by a panel of experts and is based on years of experience in conjunction with published guidelines. It is
provided as a guide to aid in the diagnosis of disease based on laboratory results and is not intended as a definitive diagnosis of any
disease condition. Please consider all clinical findings when making diagnostic decisions.
39
NOVA Lite (IFA)
ANCA PATTERNS
SUBSTRATE PATTERN CHART
ANCA ASSOCIATED PATTERN CHART
SUBSTRATE
ETHANOL
FIXED SLIDE
FORMALIN FIXED
SLIDE
HEp-2
SLIDE
Granular Cytoplasmic
Negative
Perinuclear
Negative
Very Perinuclear
Negative
Negative
Perinuclear or Homogeneous
Negative or Low Positive
Positive
Negative
Negative
Negative
CANCA*
PANCA*
ATYPICAL P-ANCA*
ANA POSITIVE
NEGATIVE
* Consider confirmatory testing with QUANTA Lite or QUANTA Flash MPO and PR-3.
40
ADDITIONAL IFA SUBSTRATES

SELECTED IMAGES
Find below a collection of immunfluorescent (IFA) images highlighting a few of the substrate offerings available from INOVA. To
review our complete product offering and to view additional images please visit our website at www.inovadx.com.
AMA on NOVA Lite Rat Kidney/Stomach/Liver
AMA on NOVA Lite ANA Plus
ASMA on NOVA Lite ANA Plus
F-Actin on IEC-6
NOVA Lite IgG F-Actin
GBM antibody on NOVA Lite GBM

(Primate Kidney)
Endomysial on NOVA Lite Endomysial

(Primate Distal Esophagus)
Pemphigus on NOVA Lite Endomysial

(Primate Esophagus)
Pemphigoid on NOVA Lite Endomysial

(Primate Esophagus)
Thyroid on NOVA Lite Thyroid
41
NOVA Lite (IFA)

NOVA Lite HEp-2 IMMUNO
HEp-2 cells as an immunofluorescence assay (IFA) substrate provide a valuable test for the screening and titration of
circulating autoantibodies in human serum. The ability to identify key patterns will aid in the laboratory diagnosis of
systemic lupus erythematosus (SLE), Sjgrens Syndrome, Scleroderma and other connective tissue disorders.
HOMOGENEOUS
SPECKLED
Uniform, diffuse fluorescence of entire nucleus in interphase

cells with pronounced fluorescence of mitotic cells.
Coarse speckles in interphase cells with nucleolar sparing and

negative metaphase mitotic cells.
SS-A
Scl-70
DFS-70
Fine to discrete, uniformly distributed, speckles

in the nuclei of the interphase cells. Unstained
metaphase mitotic cells and possible weak
cytoplasmic staining.
Homogeneous or dense fine speckling of

nuclei with many of these cells having weak
nucleolar staining. Positive mitotic cells.
Dense fine speckling of interphase nuclei with

positive mitotic cells.
LAMIN
42
gp210
Homogeneous or fine, ground glass appearance of

nuclei in interphase cells associated with staining of
the nuclear rim and negative mitotic cells.
Rim like staining of the cell

nucleus.
CENTRIOLE
RIBOSOMAL
Metaphase mitotic spindles display discrete

fluorescent dots at each pole. Interphase cells
adjacent to nucleus display 1 or 2 bright dots.
Fine, dense granular to homogeneous

cytoplasmic staining with weak
nucleolar staining.
RNA POL I
RNA POL I speckling of the nuclei in interphase

cells with speckled nucleolar staining.
Jo-1
Fine cytoplasmic staining concentrated around the

nucleus which diminishes towards the periphery of
the cytoplasm.
FLUORESCENCE PATTERNS
CENTROMERE
NUCLEOLAR
Discrete speckles throughout the

interphase cells. Condensed, speckled
metaphase mitotic cells.
PCNA
Large, typically homogeneous clustered granules in

nucleoli of interphase cells with surface staining of the
mitotic cells.
.
PM-Scl
AMA + sp100
Homogeneous nucleolar staining associated with

weak, diffuse staining of the nuclei and negative
mitotic cells.
Coarse granular staining throughout the cytoplasm.

Multiple nuclear dots throughout the nuclei with
negative metaphase cells.
NuMA
CENP-F
PERICENTROSOMES
Diffuse fine speckled nuclear staining of the

interphase cells. Fluorescence of the spindle
poles and spindle fibers in metaphase and
anaphase mitotic cells.
Fine speckling throughout nucleus in interphase

cells; staining of centromeres in prophase and
metaphase; spindle poles in metaphase; spindle and
midbody of mitotic cells in anaphase and telophase.
1-2 large dots at the periphery of the nucleus in

interphase cells.
GW BODIES
GOLGI
RODS AND RINGS
Large, discrete speckles throughout the

cytoplasm of interphase cells with negative
mitotic cells.
Speckled polar staining adjacent to one part of

the nucleus with negative mitotics.
Multiform cytoplasmic structures. with negative

mitotic cells.
Highly variable staining in both pattern and

intensity of interphase cells. Fine to coarse
speckling in approximately 30-60% of interphase
cells (S phase cells).
.
43
NOVA Lite (IFA)

IFA Slide Kits
NAME
PACKAGE
PART #
10 X 6 wells
(new formulation)
(classic formulation)
708299
708290
20 X 12 wells
(new formulation)
(classic formulation)
708298
708296
(DAPI conjugate)*
708301
NOVA Lite ANCA

(Formalin Fixed)
An indirect immunofluorescent assay for the screening and titration of

circulating anti- neutrophil cytoplasmic antibodies (ANCA). These
antibodies are markers to aid in the diagnosis and treatment of various
systemic vasculitides. Fluorescein labeled IgG conjugate with Evan's Blue ready to use.
10 X 6 wells
20 X 12 wells
(DAPI conjugate)*
708295
708297
708300
NOVA Lite HEp-2

IgG (Fc specific)
An indirect immunofluorescent assay for the screening and semiquantitative determination of anti-nuclear IgG antibodies (ANA) in
human serum. The presence of these antibodies can aid in the diagnosis
of systemic lupus erythematosus (SLE), or other connective tissue or
rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with
Evan's Blue - ready to use.
5 X 12 wells
20 X 12 wells
(DAPI conjugate)*
708101
708100
708102
NOVA Lite HEp-2 ANA

IgG (H+L)
Immunoglobulin
An indirect immunofluorescent assay for the screening and titration of

circulating antinuclear antibodies by means of an immunofluorescence
test. It is to be used as an aid in the diagnosis and treatment of systemic
lupus erythematosus (SLE), Sjgren's Syndrome, rheumatoid arthritis and
other connective tissue disorders. External Evans blue provided as optional
counterstain.
10 X 6 wells
20 X 12 wells
704230
704235
NOVA Lite dsDNA

Crithidia luciliae
An indirect immunofluorescent assay for the screening and semiquantitative determination of anti-double stranded DNA (dsDNA) IgG
antibodies in human serum. The presence of these antibodies can aid in
the diagnosis of systemic lupus erythematosus (SLE). Fluorescein labeled
anti-human IgG conjugate no Evan's Blue - ready to use.
10 X 6 wells
20 X 12 wells
708200
708205
NOVA Lite ANA

KSL Mouse Kidney/
Stomach/Liver
An indirect immunofluorescent assay for the screening and semiquantitative determination of IgG anti-nuclear antibodies (ANA), antimitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal
antibodies (GPA) in human serum. The presence of these antibodies can aid
in the diagnosis of systemic lupus erythematosus (SLE), or other connective
tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate
with Evan's Blue - ready to use.
10 X 4 wells
25 X 8 wells
708390
708380
NOVA Lite Rat Liver,

Kidney, Stomach
This product is intended for use in the screening and titration of circulating
autoantibodies in human serum as an aid in the diagnosis and treatment
of various autoimmune diseases. The four major autoantibodies detected
10 X 5 wells 25 X 10
are antinuclear antibodies (ANA), antimitochondrial antibodies (AMA),
wells
antismooth muscle antibodies (ASMA) and antigastric parietal cell antibodies
(AGPCA). Fluorescein labeled anti-human IgG (H&L) conjugate - ready to use.
NOVA Lite ANCA

(Ethanol Fixed)
DESCRIPTION
An indirect immunofluorescent assay for the screening and semiquantitative determination of anti-neutrophil cytoplasmic IgG antibodies
(ANCA) in human serum. The presence of these antibodies can aid in the
assessment of various systemic vasculitides. Fluorescein labeled antihuman IgG conjugate with Evan's Blue - ready to use.
* DAPI conjugate does not contain Evan's Blue
44
704170
704180
IFA Slide Kits (continued)

NAME
DESCRIPTION
PACKAGE
PART #
NOVA Lite ANA Plus

Mouse Kidney &
Stomach
An indirect immunofluorescent assay for the screening and semi-quantitative

determination of anti-nuclear antibodies (ANA), anti-mitochondrial (AMA),
anti-smooth muscle (ASMA) and gastric parietal IgG antibodies (GPA) in human
serum. The presence of these antibodies can aid in the diagnosis of systemic
lupus erythematosus (SLE), or other connective tissue or rheumatic diseases.
Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use.
10 X 4 wells
20 X 8 wells
708155
708150
NOVA Lite IgG

F-Actin*
An indirect immunofluorescent assay for the screening and semi quantitative

determination of IgG anti-F-Actin antibodies in human serum The presence of
IgG anti-F-Actin antibodies can be used in conjunction with clinical findings and
other laboratory tests to aid in the diagnosis of autoimmune liver diseases such
as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
5 x 6 wells
708255
NOVA Lite Monkey

Esophagus
(IgG and IgA
conjugates)
Monkey esophagus sections are intended for use as a substrate for the screening
of antibodies to intra-epidermal antigens or basement membrane zones in
human serum, as an aid in the diagnosis of pemphigus and bullous pemphigoid 10 X 5 wells
respectively. The sections can also be used for detection of endomysial
25 X 10 wells
antibodies as an aid in the diagnosis of celiac disease. Fluorescein labeled antihuman IgG (H&L) conjugate and anti-human IgA conjugate - ready to use.
704145
704150
NOVA Lite Monkey

Esophagus
(IgA conjugate only)
Monkey esophagus sections are intended for use as a substrate for the detection
25 X 10 wells
of endomysial antibodies as an aid in the diagnosis of celiac disease. Includes
(multi channel)
IgA conjugate only. Fluorescein labeled anti-human IgA conjugate - ready to use.
704155
704255
NOVA Lite Monkey

Esophagus
(skin antibodies only)
Monkey esphagus sections are intended for use as a substrate for the screening
of autoantibodies to intra-epidermal antigens or basement membrane zones
in human serum, as an aid in the diagnosis of bullous pemphigus and bullous
pemphigoid respectively. The sections may not contain endomysial tissue
and therefore, should not be used for detection of endomysial antibodies.
Fluorescein labeled anti-human IgG (H&L) conjugate - ready to use.
10 X 5 wells
25 X 10 wells
704160
704165
NOVA Lite Skin

Antibody Primate
Esophagus

determination of anti-skin IgG antibodies in human serum. The presence
of these antibodies can aid in the diagnosis of autoimmune skin diseases,
especially pemphigus and pemphigoid. Fluorescein labeled anti-human IgG
conjugate (FC specific) with Evan's Blue - ready to use.
10 X 8 wells
708330
NOVA Lite Monkey

Kidney*
This product is intended for use in the screening of circulating antiglomerular

basement membrane (GBM) autoantibodies in human serum. Anti-human IgG
(H&L) biotin conjugate and fluorescein labeled-strepavidin conjugate ready to use.
10 X 5 wells
704240
NOVA Lite Thyroid

determination of antithyroid microsomal and colloid/thyroglobulin IgG
antibodies in human serum. The presence of these antibodies can aid in the
diagnosis of autoimmune thyroid disease. Fluorescein labeled primate absorbed
anti-human IgG conjugate (FC specific) with Evan's Blue - ready to use.
10 X 8 wells
708350
Monkey and Primate used interchangeably

45
NOVA Lite (IFA)

IFA Substrate Slides
With a comprehensive offering of slide configurations and robust quality standards, INOVA stands ready to meet your IFA substrate slide needs.
NAME
PACKAGE
PART #
Ethanol-fixed human neutrophil substrate slide
1 X 6 wells
1 X 12 wells
10 X 6 wells
20 X12 wells
508299
508298
508299.10
508298.20
NOVA Lite ANCA

(Formalin Fixed)
Formalin-fixed human neutrophil substrate slide
1 X 6 wells
10 X 6 wells 1
X 12 wells
20 X 12 wells
508295
508295.10
508297
508297.20
NOVA Lite ANCA

(Methanol Fixed)*
Methanol-fixed human neutrophil substrate slide
1 X 6 wells
508280
508105
508100
508100.10
508100.20
508100.80
508105.10
NOVA Lite ANCA

(Ethanol Fixed)
DESCRIPTION
NOVA Lite HEp-2 ANA
HEp-2 (human epithelial cell) substrate slide
1 X 6 wells
1 X 12 wells
10 x 12 wells
20 x 12 wells
80 x 12 wells
10 X 6 wells
NOVA Lite ANA

(HEp-2 actin)
HEp-2 (human epithelial cell) substrate slide fixed to detect actin fibers
1 X 6 wells
1 X 12 wells
508095
508090
NOVA Lite dsDNA

(Crithidia luciliae)
Crithidia luciliae substrate slide
1 X 6 wells
1 X 12 wells
10 X 6 wells
20 X 12 wells
80 X 12 wells
508200
508205
508200.10
508205.20
508205.80
NOVA Lite ANA

(Mouse Kidney)
ANA (Mouse Kidney) tissue section slide
1 X 8 wells
508170
Mouse kidney and stomach tissue substrate slide
1 X 4 wells
1 X 8 wells
10 X 4 wells
30 X 8 wells
508155
508150
508155.10
508150.30
Mouse kidney, stomach and liver tissue substrate slide
1 X 4 well
1 X 8 wells
10 X 4 wells
30 X 8 wells
508385
508380
508385.10
508380.30
NOVA Lite Rat Liver,

Kidney, Stomach
Rat Liver, Kidney, Stomach IFA slide
1 X 5 wells
1 X 10 wells
10 X 5 wells
25 X 10 wells
504170
504180
504170.10
504180.25
NOVA Lite Rat Kidney/

Stomach/Liver*
Rat kidney, stomach and liver tissue substrate slide
1 X 4 wells
1 X 8 wells
508392
508393
NOVA Lite ANA

(Mouse Kidney/
Stomach)
NOVA Lite ANA KSL

(Mouse Kidney/
Stomach/Liver)
46
IFA Substrate Slides (continued)

NAME
DESCRIPTION
PACKAGE
PART #
504145
504150
504145.10
504150.25
NOVA Lite Monkey

Esophagus
Monkey esophagus substrate slide
1 X 5 wells
1 X 10 wells
10 X 5 wells
25 X 10 wells
NOVA Lite Monkey

Esophagus (skin
antibodies only)
Monkey Esophagus (skin antibodies only) IFA Slide (the sections may not
contain endomysial tissue)
1 X 5 wells
1 X 10 wells
10 X 5 wells
504160
504165
504160.10
NOVA Lite Skin Antibody

(Primate Esophagus)
Primate esophagus tissue substrate slide
1 X 4 wells
1 X 8 wells
508335
508330
NOVA Lite Monkey

Espohagus/Jejunum*
Monkey esophagus/jejunum tissue substrate slide
1 X 5 wells
10 X 5 wells
504215
504215.10
NOVA Lite Endomysial

(Primate Distal
Esophagus)
Primate distal esophagus tissue substrate slide
1 X 4 wells
1 X 8 wells
508336
508337
NOVA Lite Thyroid

(Primate)*
Primate thyroid tissue substrate slide
1 X 4 wells
1 X 8 wells
508355
508350
NOVA Lite Adrenal

(Primate)*
Primate adrenal tissue substrate slide
1 X 4 wells
1 X 8 wells
10 X 4 wells
508375
508370
508375.10
NOVA Lite Monkey

Cerebellum/Cerebrum &
Mouse Stomach *
Monkey cerebellum/cerebrum & mouse stomach tissue section slide
1 X 5 wells
10 X 5 wells
504225
504225.10
NOVA Lite Cerebellum

(Primate)*
Primate cerebellum tissue substrate slide
1 X 4 wells
10 X 4 wells
508357
508357.10
NOVA Lite Cerebrum

(Primate)*
Primate cerebrum tissue substrate slide
1 X 4 wells
508362
NOVA Lite Ear (Primate)*
Primate ear tissue substrate slide
1 X 4 wells
508358
NOVA Lite GBM (Primate

Kidney)*
Primate kidney tissue substrate slide
1 X 4 wells
508345
NOVA Lite Heart tissue

(Primate)*
Primate heart tissue substrate slide
1 X 4 wells
10 X 4 wells
508356
508356.10
NOVA Lite ICA (Primate

Pancreas)*
Primate pancreas tissue substrate slide
1 X 4 wells
1 X 8 wells 10
X 4 wells
508315
508310
508315.10
47
NOVA Lite (IFA)

IFA Substrate Slides (continued)
NAME
DESCRIPTION
PACKAGE
PART #
NOVA Lite Lip (Primate)*
Primate lip tissue substrate slide
1 X 4 wells
508364
NOVA Lite Liver (Primate)*
Primate liver tissue substrate slide
1 X 4 wells
508373
NOVA Lite Monkey Ovary, Testis, Adrenal *
Monkey ovary, testis, adrenal tissue section slide
1 X 5 wells
10 X 5 wells
504220
504220.10
NOVA Lite Ovary (Primate)*
Primate ovary tissue substrate slide
1 X 4 wells
10 X 4 wells
508366
508366.10
NOVA Lite Salivary Gland (Primate)*
Primate salivary gland tissue substrate slide
1 X 4 wells
10 X 4 wells
508367
508367.10
NOVA Lite Sciatic Nerve (Primate)*
Primate sciatic nerve tissue substrate slide
1 X 4 wells
508368
NOVA Lite Skeletal Muscle (Primate)*
Primate skeletal muscle tissue substrate slide
1 X 4 wells
10 X 4 wells
508320
508320.10
NOVA Lite Stomach (Primate)*
Primate stomach tissue substrate slide
1 X 4 wells
508369
NOVA Lite Testes (Primate)*
Primate testes tissue substrate slide
1 X 4 wells
508372
NOVA Lite Urinary Bladder (Primate)*
Primate urinary bladder tissue substrate slide
1 X 4 wells
508360
NOVA Lite Monkey Peripheral Nerve*
Monkey peripheral nerve tissue substrate slide
1 X 5 wells
10 X 5 wells
504210
504210.10
NOVA Lite Monkey Kidney
Monkey kidney tissue substrate slide
1 X 5 wells
10 X 5 wells
504240
504240.10
NOVA Lite IgG F-Actin*
Optimally fixed rat epithelial cell substrate slide
1 X 6 wells
508255
48
Common Components
NAME
DESCRIPTION
PACKAGE
PART #
IFA System Negative

Control
IFA System Negative Control
1 X 1.0mL
508007
IFA System Negative

Control Pre-diluted
1 X 1.0mL
508186
Evan's Blue 0.5%
0.5% Evan's Blue Stain
1 X 2.5mL
508115
Evan's Blue 1.0%
1.0% Evan's Blue Stain
1 X 2.5mL
504049
High Contrast Diluent
High contrast diluent - ready to use
1 X 25.0mL
508003
PBS Concentrate (40X)
40X concentrate of PBS
1 X 25.0mL
508002
PBS Concentrate II (40X)
40X concentrate of PBS (New Formulation)
1 X 25.0mL
508998
Mounting Medium
Mounting medium - ready to use
1 X 3.0mL
1 X 7.0mL
1 X 10.0mL
508006
508001
508005
Mounting Medium-PVA
Mounting medium polyvinyl alcohol (PVA) - ready to use
1 X 3.0mL
1 X10.0mL
504046
504047
Urea Buffer*
Urea Buffer (as used with the NOVA Lite Monkey Kidney Kit 704240)
1 X 13.0mL
504084
Anti AB Neutralising
Reagent *
Anti AB Neutralising Reagent
1 X 5.0mL
504056
Coverslips
10 coverslips
20 coverslips
10 each
20 each
508122
508112
PACKAGE
PART #
Demonstration Slides
NAME
DESCRIPTION
HEp-2 Demonstration
Slide
HEp-2 Demonstration Slide. 12 wells/slide pre-stained with antibodies/

patterns
1 X 12 wells
518100
HEp-2 Demonstration
Slide Actin
HEp-2 Demonstration Slide. HEp-2 Actin specific

12 wells/slide pre-stained with antibodies/patterns
1 X 12 wells
518090
2 X 6 wells
518290
*ANCA
Available
Outside The USA Only
Demonstration
ANCA Demonstration Slide. 1 Ethanol and 1 Formalin, 2x6 wells
Slide
Distal Esophagus
Demonstration Slide
Primate distal esophagus substrate slide pre-stained with antibodies/

patterns (pemphigus, pemphigoid, ASMA, endomysial)
1 X 4 wells
518336
NOVA Lite; ANA Plus

(Mouse Kidney/Stomach)
Mouse kidney/stomach substrate slide pre-stained with antibodies/patterns

(ANA homogenous, speckled, nucleolar, dsDNA, negative control, AMA,
ASMA, GPA)
1 X 8 wells
518150

49
NOVA Lite (IFA)
NOVA Lite antibody controls are designed for use with the NOVA Lite slides. Convenient volumes and ready to use dilutions make these a
sensible choice for any laboratory.
NAME
DESCRIPTION
PACKAGE
PART #
ANA Homogenous/dsDNA
Pattern Control
Pre-diluted human serum antibodies to the cell nucleus and dsDNA
1 X 0.5mL
508181
ANA Speckled Pattern Control
Pre-diluted human serum antibodies to the cell nucleus
1 X 0.5mL
508182
ANA Nucleolar Pattern Control
1 X 0.5mL
508183
ANA Centromere Pattern

Control
1 X 0.5mL
1 X 1.0mL
508184
504089
ANA Scl-70 Pattern Control
Pre-diluted human serum antibodies to the cell nucleoli
1 X 0.5mL
508185
ANA Nuclear Dot Pattern

Control
1 X 0.5mL
508193
ANA PCNA Pattern Control
Pre-diluted human serum antibodies to PCNA
1 X 0.5mL
508192
ANA Ribsomal Pattern Control
Pre-diluted human serum antibodies to ribosomes in cell cytoplasm
1 X 0.5mL
508195
Autoantibody Control Panel

(includes 508181 to 508185)
Panel of five vials of pre-diluted controls including ANA

Homogeneous/dsDNA Pattern, ANA Speckled Pattern, ANA Nucleolar
Pattern, ANA Centromere Pattern and ANA Scl-70 Pattern
5 X 0.5mL
708180
ANA Homogenous Pattern

Control
1 X 0.5mL
1 X 1.0mL
508101
504054
Homogeneous Pattern Control
Pre-diluted homogeneous pattern controls for use with conjugate

504070 or 504088
1 X 1.0mL
504090
Titratable ANA Pattern Control
1 X 0.5mL
508171
cANCA Positive Control
Pre-diluted human serum antibodies to cANCA antigens
1 X 0.5mL
1 X 1.0mL
508191
504087
pANCA Positive Control
Pre-diluted human serum antibodies to pANCA antigens
1 X 0.5mL
1 X 1.0mL
508291
504086
Atypical ANCA Positive Control
Pre-diluted human serum antibodies to aANCA antigens
1 X 0.5mL
508292
Glomerular Basement
Membrane Pattern Control
Pre-diluted human serum antibodies to GBM
1 X 0.5mL
1 X 1.0mL
508194
504085
dsDNA Positive Control
Pre-diluted human serum antibodies to dsDNA
1 X 0.5mL
508211
Gastric Parietal Cell (GPA)

Pattern Control
Pre-diluted human serum antibodies to gastric parietal cell
1 X 0.5mL
508190
Yo Purkinje Cell Positive Control* Pre-diluted human serum antibodies to Yo (Purkinje cell)
1 X 0.5mL
504009
Hu ANNA-1 Positive Control*
1 X 0.5mL
504073
50
Pre-diluted human ANNA-1 positive control
IFA Antibody Controls (continued)

NAME
DESCRIPTION
PACKAGE
PART #
Pre-diluted negative control
1 X 0.5mL
1 X 1.0mL
508186
508007
IgG F-Actin Positive Control*
Pre-diluted human serum antibodies to F-Actin
1 X 0.5mL
508251
MAG (Myelin Associated

Glycoprotein) Positive Control
Pre-diluted human serum antibodies to MAG (Myelin Associated

Glycoprotein)
1 X 0.5mL
504003
Mitochondrial (AMA) Pattern

Control
Pre-diluted human serum antibodies to the cell mitochondria
1 X 0.5mL
1 X 1.0mL
508187
504052
Endomysial (Celiac) Positive

Control
Pre-diluted human serum antibodies to endomysium
1 X 0.5mL
1 X 1.0mL
508154
504050
Pancreatic Islet Cell Positive

Control *
Pre-diluted human serum antibodies to pancreatic islet cell
1 X 0.5mL
504005
Skeletal Muscle Positive Control
Pre-diluted human serum antibodies to skeletal muscle
1 X 0.5mL
508321
Skin (Pemphigoid) Positive

Control
Pre-diluted human serum antibodies to pemphigoid
1 X 0.5mL
1 x 1.0mL
508331
504055
Skin (Pemphigus) Positive

Control
Pre-diluted human serum antibodies to pemphigus
1 X 0.5mL
1 X 1.0mL
508332
504051
Smooth Muscle (ASMA) Pattern

Control
Pre-diluted human serum antibodies to smooth muscle
1 X 0.5mL
1 X 1.0mL
508188
504053
Thyroid Positive Control
Pre-diluted human serum antibodies to thyroid
1 X 0.5mL
508351
51
NOVA Lite (IFA)
IFA Conjugates
Conjugates are arguably the most critical component of the immunofluorescence assay process. The vast menu of NOVA Lite
conjugates provides a host of concentrations, specificities and contrast levels to fit individual laboratory needs.
Undiluted Antibody Conjugates

NAME
DESCRIPTION
PACKAGE
PART #
FITC IgA Monkey

Absorbed Conjugate
Fluorescein labeled anti-human monkey absorbed IgA conjugate
1 X 1.0mL
504016
FITC IgA Conjugate
Fluorescein labeled anti-human IgA conjugate
1 X 1.0mL
504034
FITC IgG Conjugate*
Fluorescein labeled anti-human IgG conjugate
1 X 1.0mL
504033
FITC IgG (gamma)

Monkey Absorbed
Conjugate
Fluorescein labeled anti-human monkey absorbed IgG (gamma) conjugate
1 X 1.0mL
504014
FITC IgG (H&L) Monkey

Adsorbed Conjugate*
Fluorescein labeled anti-human monkey adsorbed IgG (H&L) conjugate
1 X 1.0mL
504012
FITC IgG (H+L)

Conjugate*
Fluorescein labeled anti-human IgG (H+L) conjugate
1 X 1.0mL
504032
FITC IgGAM (H+L)

Conjugate*
Fluorescein labeled anti-human IgG, IgA and IgM (H+L) conjugate
1 X 1.0mL
504031
PACKAGE
PART #
Prediluted Antibody Conjugates

NAME
DESCRIPTION
FITC High Sensitivity

IgG Conjugate with EB
Fluorescein labeled high sensitivity anti-human IgG conjugate with

Evan's Blue
1 X 7.0mL
508126
FITC High Sensitivity

IgG Conjugate no EB*
Fluorescein labeled high sensitivity anti-human IgG conjugate no

Evan's Blue
1 X 15.0mL
504022
FITC IgG (H+L) Conjugate

no EB
Fluorescein labeled anti-human IgG (H+L) Conjugate no Evan's Blue
1 X 15.0mL
504021
FITC IgA
(Monkey Absorbed)
Conjugate no EB*
Fluorescein labeled anti-human IgA (Monkey Absorbed) conjugate

no Evan's Blue
1 X 7.0mL
504015
FITC IgA Conjugate

with EB
Fluorescein labeled anti-human IgA conjugate with Evan's Blue
1 X 4.0mL
1 X 7.0mL
508152
508153
52
IFA Conjugates (continued)

Prediluted Antibody Conjugates (continued)
NAME
DESCRIPTION
PACKAGE
PART #
FITC IgA Conjugate

no EB*
Fluorescein labeled anti-human IgA conjugate no Evan's Blue
1 X 7.0mL
1 X 15.0mL
504045
504023
Anti-Human IgG(H&L)
AFF FITC, 7ml
FITC IgG (H&L) chain Conjugate - ready to use
1 X 7.0mL
504072
FITC IgG (H+L) HEp-2

Conjugate no EB
Fluorescein labeled anti-human IgG (H+L) HEp-2 Conjugate no Evan's Blue
1 X 7.0mL
504070
FITC IgG (H+L) Monkey

Adsorbed Conjugate
no EB
Fluorescein labeled anti-human monkey adsorbed IgG (H+L) conjugate no

Evan's Blue
1 X 7.0mL
1 X 15.0mL
504011
504071
FITC IgG Conjugate EB
Fluorescein labeled anti-human IgG conjugate with Evan's Blue
1 X 4.0mL
1 X 7.0mL
1 X 15.0mL
508123
508125
508113
FITC IgG Conjugate no EB Fluorescein labeled anti-human IgG conjugate no Evan's Blue
1 X 4.0mL
1 X 15.0mL
508124
508114
FITC IgG Conjugate

Primate Absorbed EB*
Fluorescein labeled primate absorbed anti-human IgG conjugate with

Evan's Blue
1 X 7.0mL
508128
FITC IgG (Mky Abs)

Conjugate,NEB*
FITC IgG (Monkey Absorbed) Conjugate - ready to use
1 X 7.0mL
504013
FITC IgG/A/M Conjugate

no EB
Fluorescein labeled anti-human IgG, IgA and IgM conjugate no Evan's Blue
1 X 4.0mL
1 X 15.0mL
508127
508117
FITC IgM, NEB
FITC IgM Conjugate
1 X 15.0mL
504018
Streptavidin FITC
Conjugate*
Streptavidin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit
704240)
1 X 3.0mL
504082
Biotin FITC Conjugate*
Biotin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit
704240)
1 X 3.0mL
504083
53
NOVA Gel
OUCHTERLONY
INOVA Diagnostics produces double diffusion
test systems for the screening and semiquantitative determination of autoantibodies
to extractable nuclear antigens (ENA) in
human serum. The presence of antibodies can
be used in conjunction with other serological
tests and clinical findings to aid in the
diagnosis of connective tissue diseases.
54
Connective Tissue Disease Kits

NAME
DESCRIPTION
PACKAGE
PART #
NOVA Gel Jo-1 "T"
A double diffusion test system for the titering and semi-quantitative determination
of autoantibodies to Jo-1 in human serum. The presence of these antibodies can aid
in the diagnosis of polymyositis and other related connective tissue diseases.
8 X 6 wells
708495
NOVA Gel Scl-70 "S"
A double diffusion test system for the screening and semi-quantitative

determination of autoantibodies to Scl-70 in human serum. The presence of these
antibodies can aid in the diagnosis of scleroderma.
8 X 6 wells
708470
NOVA Gel Scl-70 "T"
of autoantibodies to Scl-70 in human serum. The presence of these antibodies aid in
the diagnosis of scleroderma.
8 X 6 wells
708475
NOVA Gel Sm/RNP "S"

determination of autoantibodies to Sm/RNP in human serum. The presence of these
antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and other
related connective tissue diseases.
8 X 6 wells
708410
NOVA Gel Sm/RNP "T"
of autoantibodies to Sm/RNP in human serum. The presence of these antibodies
can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related
connective tissue diseases.
8 X 6 wells
708415
NOVA Gel SS-A/SS-B "S"

determination of autoantibodies to SS-A/SS-B in human serum. The presence of
these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE) and
other related connective tissue diseases, such as Sjgrens syndrome.
8 X 6 wells
708450
NOVA Gel SS-A/SS-B "T"
of autoantibodies to SS-A/SS-B in human serum. The presence of these antibodies
can aid in the diagnosis of systemic lupus erythematosus (SLE) and other related
connective tissue diseases, such as Sjgrens syndrome.
8 X 6 wells
708455
PACKAGE
PART #
Components
NAME
DESCRIPTION
NOVA Gel "S" Plates
Pre-punched screening gel plate
8 X 6 wells
508400
NOVA Gel "T" Plates
Pre-punched titering gel plate
8 X 6 wells
508401
NOVA Gel Jo-1 Antigen
Lyophilized Jo-1 antigen
1 X 0.4mL
508490
NOVA Gel Jo-1 Control
Pre-diluted Jo-1 control
1 X 1.4mL
508491
NOVA Gel RNP Control
Pre-diluted RNP control
1 X 0.7mL
508412
NOVA Gel Scl-70 Antigen
Lyophilized Scl-70 antigen
1 X 0.4mL
508470
NOVA Gel Scl-70 Control
Pre-diluted Scl-70 control
1 X 1.4mL
508471
NOVA Gel Sm Control
Pre-diluted Sm control
1 X 0.7mL
508411
NOVA Gel
Sm/RNP Antigen
Lyophilized Sm/RNP antigen
1 X 0.4mL
508410
NOVA Gel SS-A/SS-B Antigen
Lyophilized SS-A/SS-B antigen
1 X 0.4mL
508450
NOVA Gel SS-A Control
Pre-diluted SS-A control
1 X 0.7mL
508451
NOVA Gel SS-B Control
Pre-diluted SS-B control
1 X 0.7mL
508452
55
Customer Support
Service is important to us. We believe

that we have some of the finest customer
service professionals in the industry. But
don't take our word for it - give us a call at
+1-800-545-9495 or +1-858-586-9900, email
us at service@inovadx.com or visit us at
www.inovadx.com for product information.
QUANTA-Lyser, QUANTA LLite,

ite, QUANT
it
QUANTA
TA Link, QUANTA Flash, N
NOVA View, NOVA Lite and NOVA Gel are
registered
regi
ist
ster
ered
ed trademarks
tra
trade
demarks of INOVA D
Diagnostics,
iagnostics, Inc. QUANTA Ch
Chek is a trademarks of INOVA Diagnostics,
registered
Inc. BIO-FLASH is a register
ered
ed trademark of biokit S.A. DS2 and DSX are registered trademarks of DYNEX
Technologies,
Tech
hnollogies,
i Inc.
Inc. 2013 INOVA Diagnostics, Inc. All rights reserved.
re
Conditions of Sale
56
ORDERS: Orders may be placed by fax or e-mail. Please specify the catalog number and product description.
SHIPMENTS: All shipping charges will be prepaid FOB San Diego, CA and added to the invoice. Unless otherwise specified,
shipments will be made via Federal Express or UPS. Customers requesting other carriers should specify at the time of order.
TERMS: All invoices are net 30 days unless otherwise prearranged. All invoices are in U.S. dollars.
TITLE: Title to the products passes to the customer upon delivery of items ordered to the carrier.
LOSS OR DAMAGE: Claims for loss or damage of products are the responsibility of the customer and should be reported to INOVA
at the earliest possible time.
PARTIAL SHIPMENTS: INOVA will make every possible attempt to fill orders promptly and completely. When this cannot be done,
we will make partial shipments unless otherwise notified at the time of order confirmation.
RETURNS: Prior to returning any products, customers must contact INOVA technical services for approval. Please provide the
reason for the return (ordering error, shipping error, technical problem, etc.). A restocking fee may apply.
CONDITIONS: Unless otherwise indicated the products listed herein are for in vitro diagnostic use only. Nothing disclosed herein
is to be construed as a recommendation to use our products in violation of any patents. The information presented is believed
to be accurate. However, said information and products are offered without warranty or guarantee since the ultimate conditions
of use and the variability of the materials tested are beyond our control. We cannot be responsible for patent infringements or
other violations that may occur with the use of these products.

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INOVA Diagnostics

Company Overview ..........................................3

NOVA Lite ..................................................36

Systems and Instrumentation .........................4

IFA Slide Kits ......................................................................44

QUANTA Link ................................................................... 5

IFA Substrate Slides ........................................................46

Common Components .................................................49

Demo Slides ......................................................................49

IFA Antibody Controls ...................................................50

IFA Conjugates .................................................................52

NOVA Gel ..................................................54

DSX/best 2000 ..............................................................13

Connective Tissue Disease Kits ..................................55

QUANTA Flash ...............................................14

Celiac Disease ..................................................................15

Customer Support .......................................... 56

Antiphospholipid Syndrome .....................................16

QUANTA Lite .................................................18

BIO-FLASH random access

QUANTA Flash CIA

Redefining the boundaries of

Systems and Instrumentation

Workflow management made easy

QUANTA Link Workstation License

(includes Oracle License and 5 Connections)

QUANTA Link Workstation

t Delivers positive patient ID for IFA testing

Eliminates transcription errors in IFA sample processing and analysis

Systems and Instrumentation

The new world of digital IFA testing

NOVA View Instrument

HEp-2 Module license

ANCA Module license

Crithidia Module license

Tissue Module license

Integration delivers positive patient

Eliminates transcription errors in IFA sample processing and analysis

Systems and Instrumentation

t Master calibration curve uploaded through the reagent

130 190 250 310 380 440 500

Intuitive software and touchscreen

Systems and Instrumentation

Easy-to-use platform satisfies all

160 Sample IFA

160 Sample EIA + IFA

160 Sample EIA + IFA

240 Sample IFA

240 Sample EIA + IFA

240 Sample EIA + IFA

your EIA and IFA processing needs

sample tube sizes

Systems and Instrumentation

Reliable sample in/result out

DS2 is a registered trademark of DYNEX Technologies, Inc.

DSX is a registered trademark of DYNEX Technologies, Inc.

Chemiluminescence immunoassay (CIA) technology can

This assay is designed for the semi-quantitative

This assay is designed for the semi-quantitative

This assay is designed for the semi-quantitative

This assay is designed for the semi-quantitative

This assay is designed for the semi-quantitative

This assay is designed for the semi-quantitative

This assay is designed for the semi-quantitative