tech
guide
Microbiology Systems
1. What is the brand name of
your company’s microbiology
system?
2. Specify the authorizing agency,
type, and year of the product’s
regulatory authorizations.
3. What is the intended use or
primary function of the
product?
4. What types of specimen/sam-
ple does the product employ?  
5. What types of diseases, condi-
tions, or analytes does the
system detect?
6. Which methodology or clini-
cal standard of care does the
product use?
7. If you answered “other,” explain
briefly.
8. What are the product’s maxi-
mum specimen capacity and
throughput under ideal condi-
tions?
9. Briefly describe any automa-
tion or connectivity features or
options.
10. What types of technical sup-
port are available?
11. What capabilities, features,
or accessories distinguish this
product from others on the
market?
24 May 2018 | clpmag.com
BD Diagnostics Systems
Sparks, Md
(800) 638-8663
www.bd.com
BD Bactec FX40
CE mark 2008, 2012; FDA 510(k),
2008.
Automated blood culture
instrument designed for rapid
detection of bacteria and fungi in
clinical specimens; specimens are
drawn from patients and injected
directly into vials, and then placed
into the instrument for incubation
and testing.
Clinical blood culture specimens.
Assists in the diagnosis of sepsis.
q Sputum adequacy by Gram stain
q Enrichment cultures
n Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
q Other
40 blood culture bottles.
Offers remote connectivity fea-
tures, allowing for standardized
support workflow, remote system
management, software updates,
and proactive monitoring; offers
expanded insights to data analytics
and reporting.
In-house corporate training and
onsite training at customer loca-
tions.
Offers a solution from sample col-
lection to actionable results; the
combination of Aerobic Plus blood
culture bottles and Lytic anaerobic
blood culture bottles offers resin
and lyzing technology, with
differentiated proven performance
in the diagnosis of sepsis.
BD Diagnostics Systems
Sparks, Md
(800) 638-8663
www.bd.com
BD Bactec FX200
CE mark 2008, 2012; FDA 510(k),
2008.
Automated blood culture
instrument designed for the rapid
detection of bacteria and fungi in
clinical specimens; specimens are
drawn from patients and injected
directly into vials, and then placed
into the instrument for incubation
and testing.
Clinical blood culture specimens.
Assists in the diagnosis of sepsis.
q Sputum adequacy by Gram stain
q Enrichment cultures
n Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
q Other
200 blood culture bottles.
Offers remote connectivity fea-
tures, allowing for standardized
support workflow, remote system
management, software updates,
and proactive monitoring; offers
expanded insights to data analytics
and reporting.
In-house corporate training and
onsite training at customer loca-
tions.
Offers a solution from sample col-
lection to actionable results; the
combination of Aerobic Plus blood
culture bottles and Lytic anaerobic
blood culture bottles offers resin
and lyzing technology, with
differentiated proven performance
in the diagnosis of sepsis.
BD Diagnostics Systems
Sparks, Md
(800) 638-8663
www.bd.com
BD Bactec FX400
CE mark 2008, 2012; FDA 510(k),
2008.
Automated blood culture
instrument designed for the rapid
detection of bacteria and fungi in
clinical specimens; specimens are
drawn from patients and injected
directly into vials, and then placed
into the instrument for incubation
and testing.
Clinical blood culture specimens.
Assists in the diagnosis of sepsis.
q Sputum adequacy by Gram stain
q Enrichment cultures
n Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
q Other
400 blood culture bottles.
Offers remote connectivity fea-
tures, allowing for standardized
support workflow, remote system
management, software updates,
and proactive monitoring; offers
expanded insights to data analytics
and reporting.
In-house corporate training and
onsite training at customer loca-
tions.
Offers a solution from sample col-
lection to actionable results; the
combination of Aerobic Plus blood
culture bottles and Lytic anaerobic
blood culture bottles offers resin
and lyzing technology, with
differentiated proven performance
in the diagnosis of sepsis.
BioFire Diagnostics LLC
Salt Lake City
(801) 736-6354
biofiredx.com
FilmArray EZ
CLIA waiver, 2016.
Diagnostic testing.
Nasopharyngeal swab.
Adenovirus, Bordetella pertussis,
Chlamydophila pneumoniae, coro-
navirus, human metapneumovirus,
human rhinovirus/enterovirus, influ-
enza A, influenza A/H1, influenza
A/H3, influenza A/H1-2009, influ-
enza B, Mycoplasma pneumoniae,
parainfluenza virus, respiratory
syncytial virus.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Polymerase chain reaction.
FilmArray requires 2 minutes of
hands-on time; results are available
in about 1 hour. Respiratory Panel 2
results are available in 45 minutes.
One sample per pouch running unit.
FilmArray platforms offer scalability
from one pouch running unit to 12
pouch running units. Run time is 45
to 60 minutes.
24/7 phone technical support; email
technical support.
Designed to be the new standard
for syndromic infectious disease
molecular diagnostics; integrated
sample preparation, amplification,
detection, and analysis; delivers
accurate results in about 1 hour.
BioFire Diagnostics LLC
Salt Lake City
(801) 736-6354
biofiredx.com
FilmArray Torch
FDA 510(k), 2011.
Diagnostic testing.
Cerebrospinal fluid, nasopharyngeal
swab, positive blood culture, stool
in Cary Blair medium.
Blood culture identification; menin-
gitis/encephalitis; gastrointestinal
and respiratory infections.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Polymerase chain reaction.
FilmArray requires 2 minutes of
hands-on time; results are available
in about 1 hour.
One sample per pouch running unit.
FilmArray platforms offer scalabil-
ity from one pouch running unit to
12 pouch running units. Run time is
45 to 60 minutes.
24/7 phone technical support;
email technical support.
FilmArray Torch is designed to be
the new standard for syndromic
infectious disease molecular diag-
nostics; integrated sample prepara-
tion, amplification, detection, and
analysis; delivers accurate results
in about 1 hour.
Clever Culture Systems
Zurich, Switzerland
www.cleverculturesystems.com
Automated plate assessment
system (APAS) Independence
FDA 510(k) de novo, 2016.
The standalone automated culture
plate reading instrument screens
plates and sorts them into signifi-
cant and insignificant growth; iden-
tifies organism morphologies; iden-
tifies negative plates and removes
them from the workflow.
Microbiological cultures on Petri
dishes.
Urinary tract infections and
infection control.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Uses sophisticated algorithms
to capture and read full plates,
biplates, and multiple agar types.
200 Petri dishes per hour.
Triages plates using machine-
learning algorithms that are
specific to specimen type and
media used; results are processed
by decision packages based on
national and international
guidelines.
Training and in-service engineering.
Automated culture plate reader;
technology was first applied to
the FDA-cleared APAS Compact
manual reader; a variety of analysis
modules and plate media varia-
tions are available, such as
urinalysis and infection control
analysis.
Curetis USA Inc
San Diego, Calif
(619) 452-3644
www.curetis.com
Unyvero LRT
CE mark, 2012; FDA 510(k) de novo,
2018.
Syndromic molecular diagnostic
testing of patients with suspected
lower respiratory tract infections.
Tracheal aspirates.
Lower respiratory tract infections;
panel covers more than 30 bacte-
rial species and subspecies and
10 genetic antibiotic resistance
markers.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Endpoint multiplex polymerase
chain reaction combined with
microarray detection on native
samples.
In a setup with two A50 analyzers,
8 to 12 samples per day; random
access.
Fully integrated cartridge-based
sample-to-answer molecular
diagnostics system; integrated
workflow control; full traceability
through barcoding; intuitive touch-
screen operation; no calibration
required; minimal user
maintenance.
User handbooks and instructions
for use; support hotline, field-based
clinical application specialists, field
service engineers.
Addresses lower respiratory tract
infections specifically, with a broad
coverage of microorganisms and
corresponding resistance mark-
ers, and a panel that includes
Legionella pneumoniae; rapid high-
plex molecular diagnostic for the
detection of pathogens and genetic
antibiotic resistance markers.
clpmag.com | May 2018 25
Randox Biosciences
Crumlin, UK
+44 (0)28 9442 2413
www.randox.com
Respiratory Tract Infections (RTI)
array for the Vivalytic analyzer.
CE mark, 2018.
In vitro diagnostic sample-to-
answer, cartridge-based point-of-
care instrument.
Nasopharyngeal swab
Respiratory pathogen (viral and
bacterial) nucleic acid targets.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Biochip microarray-based approach
using simple chemiluminescent
chemistries similar to enzyme-
linked immunosorbent assay.
One cartridge result (22 infections)
every 2 hours; six samples on a
12-hour shift using one analyzer.
Fully automated standalone device
(no peripherals); easy to integrate
into the IT systems of hospitals,
laboratories, or practices using
standard interfaces.
Remote diagnostics available glob-
ally; online connectivity to support
predictive maintenance.
Detects 35 infections; Vivalytic
supports the most widespread
laboratory test detection meth-
ods for molecular diagnostics; it
uniquely integrates microarray,
melting curve, real-time poly-
merase chain reaction (PCR), and
endpoint PCR in one device.
26 May 2018 | clpmag.com
Randox Biosciences
Crumlin, UK
+44 (0)28 9442 2413
www.randox.com
Sexually Transmitted Infections
(STI) array for the Vivalytic ana-
lyzer.
CE mark, pending.
In vitro diagnostic sample-to-
answer, cartridge-based point-of-
care instrument.
Urine or urogenital swab.
STI (viral and bacterial) nucleic
acid targets.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Biochip microarray-based
approach using simple chemilu-
minescent chemistries similar to
enzyme-linked immunosorbent
assay.
One cartridge result (10 infections)
every 2 hours; six samples on a
12-hour shift using one analyzer.
Fully automated standalone device
(no peripherals); easy to integrate
into the IT systems of hospitals,
laboratories, or practices using
standard interfaces.
Remote diagnostics available glob-
ally; online connectivity to support
predictive maintenance.
Only 10-plex cartridge-based,
sample-to-answer STI diagnostic
on the market.
Roche Diagnostics Corp
Indianapolis
(800) 428-507
usdiagnostics.roche.com
Cobas C. difficile test for use on
the Cobas 4800 system
CE mark, 2013; FDA 510(k), 2015.
An automated, qualitative in vitro
diagnostic test for the direct
detection of the toxin B gene of
toxigenic Clostridium difficile (C.
difficile).
Unformed (liquid or soft) stool
specimens obtained from patients
suspected of having C. difficile
infection.
C. difficile.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Real-time polymerase chain reac-
tion testing.
The instrument can run up to 96
tests at a time (94 samples and 2
controls) in under 4 hours.
Simplified sample preanalytics;
automated sample preparation;
automated amplification and
detection; laboratory information
system connectivity; ability to
parallel process multiple analytes
(MRSA/MSSA, C. difficile, herpes
simplex virus 1 and 2).
Directly through Roche
Diagnostics.
Flexibility to adapt to variable
testing volumes while maintaining
optimal workflow and cost effi-
ciency; broad strain coverage vali-
dation for detection confidence.
Roche Diagnostics Corp
Indianapolis
(800) 428-5076
usdiagnostics.roche.com
Cobas MRSA/SA test for use on
the Cobas 4800 system
CE mark, 2013; FDA 510(k), 2015.
A qualitative in vitro diagnostic
assay for the direct detec-
tion of methicillin-resistant
Staphylococcus aureus (MRSA)
and S. aureus (SA) DNA.
Nasal swabs.
MRSA and SA.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Real-time polymerase chain reac-
tion testing.
The instrument can run up to 96
tests at a time (94 samples and 2
controls) in under 4 hours.
Direct sample vial loading;
automated sample preparation;
automated amplification and
detection; laboratory information
system connectivity; ability to
parallel process multiple analytes
(MRSA/MSSA, C. difficile, herpes
simplex virus 1 and 2).
Directly through Roche
Diagnostics.
Up to 90% less hands-on time
compared to other test options;
broad strain coverage validation
for detection confidence; provides
two results in one test (MRSA
surveillance screening and presur-
gical SA screening).
Roche Diagnostics Corp
Indianapolis
(800) 428-5076
usdiagnostics.roche.com
Cobas influenza A/B assay for use
on the Cobas Liat system
CLIA waived, 2015; FDA 510(k),
2015.
Automated multiplex assay for the
rapid in vitro qualitative detection
and discrimination of influenza A
virus and influenza B virus RNA in
patients with signs and symptoms
of respiratory infection in conjunc-
tion with clinical and epidemiologi-
cal risk factors.
Nasopharyngeal swabs.
Influenza A and influenza B viruses.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Real-time polymerase chain reac-
tion testing.
The instrument can conduct one
test at a time with a turnaround
time of 20 minutes.
Health Level Seven International
enabled connectivity.
Directly through Roche Diagnostics.
Fast detection and differentiation of
influenza A and B, with a 20-minute
turnaround time.
Thermo Fisher Scientific
Waltham, Mass
(800) 255-6730
www.thermofisher.com
Thermo Scientific Sensititre ARIS
2X system
FDA 510(k), 1992.
Automated organism identification
and antimicrobial susceptibility
testing (AST).
Antimicrobial susceptibility and
identification of bacterial, fungal,
and mycobacterial isolates.
Bacterial identification (ID) and
AST.
q Sputum adequacy by Gram stain
q Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
n Other
Fluorescence technology detection;
broth microdilution.
64 minimum inhibitory concentra-
tion (MIC), breakpoint, or identifica-
tion plates, for a combination of a
possible 192 tests on one instru-
ment.
Automatically incubates and reads
microtitre plates to identify organ-
isms and report susceptibility
results with laboratory information
system connectivity; customizable
expert system; quality control mod-
ule; automated reports/alerts; and
optional epidemiology module.
24/7.
Large selection of standard MIC
plates or tailor-made solutions
specific to formulary requirements,
prescription protocols, and local
resistance; earlier access to
antimicrobial susceptibility testing
of new, potent antimicrobials.
Thermo Fisher Scientific
Waltham, Mass
(800) 255-6730
www.thermofisher.com
Thermo Scientific automated
workflow solution: Copan WASP
Walkaway Specimen Processor +
Thermo Scientific Remel media
n/a
Automated specimen processing.
All specimen types.
n/a
q Sputum adequacy by Gram stain
n Enrichment cultures
q Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
q Other
378-plate capacity with nine-silo
carousel; throughput capacity that
matches two to three full-time
equivalents.
From planting and streaking to
Gram slide prep and enrichment
broth inoculation, provides full
automation of preanalytical pro-
cessing.
24/7.
Brings together the experts in
prepared media and automated
specimen processing; automates
all aspects of specimen process-
ing using Remel media products;
fully automated specimen process-
ing; valuable resources can be
redeployed to ensure optimal lab
productivity.
Thermo Fisher Scientific
Waltham, Mass
(800) 255-6730
www.thermofisher.com
Thermo Scientific VersaTrek auto-
mated microbial detection system
FDA 510(k), 2003.
Automated microbial detection,
including blood culture and myco-
bacteria testing.
Blood and other normally sterile
body fluids for cultivating and
recovering microorganisms; sterile
body specimens and digested-
decontaminated clinical specimens
for the recovery of mycobacteria.
Detection of all organism types,
including common and fastidious
organisms and mycobacteria, as
well as Mycobacterium tuberculosis
(Mtb) susceptibility testing.
q Sputum adequacy by Gram stain
q Enrichment cultures
n Blood cultures
q Fluorochrome staining for
acid-fast bacteria (AFB)
q Parasitemia (%)
q Cell lines and incubation time
for virus isolation
q Statistics for molecular tests
(summarizes all specimen types)
q Other
Maximum annual bottle volume for
a 5-day blood culture, 38,500; 7-day
blood culture, 27,500; maximum
annual bottle volume for myco,
4,700.
VersaTrek provides automated
microbial detection with laboratory
information system connectivity
and intuitive software for one-
touch access to patient samples
and results; search and reporting
functionality.
24/7.
Includes four FDA-cleared tests
on one platform (blood culture,
Mtb susceptibilities, mycobacteria
detection, and sterile body fluids);
can detect any gas produced or
consumed by organisms; two-
bottle media system for all
patients is FDA-cleared for draws
as low as 0.1 mL.
clpmag.com | May 2018 27