Immunoassay Update

By Ida Faridah © 2010 Mindray Confidential  2018-4-30 0

 IMMUNOLOGY?

IMMUNOASSAYS?

© 2015 Mindray Confidential

 IMMUNOLOGY?

Study of the body's reactions to foreign substances

Study of immune system disorders

Different applications in several

medical disciplines

© 2015 Mindray Confidential

 IMMUNOASSAYS?

in vitro diagnosis techniques

based on the specific reaction between

antigens and antibodies

Identification and/or quantification of micro-organisms,

hormones, markers specific to certain diseases…

© 2015 Mindray Confidential

 ANTIGENS? ANTIBODIES?

Some foreign substances are called Antigens (Ag)

when introduced in the body they trigger the production of
Antibodies (Ab).
Antibodies help to recognize and neutralize
Antigens
ONE ANTIBODY recognizes ONLY ONE ANTIGEN

© 2015 Mindray Confidential

 BASIC STRUCTURE OF ANTIBODIES

© 2015 Mindray Confidential

 5 CLASSES OF ANTIBODIES

Five different types of heavy chains

FIVE ISOTYPES OF ANTIBODIES

Play different roles

help to direct the appropriate immune response for each

different type of antigen.

© 2015 Mindray Confidential

 5 ISOTYPES OF ANTIBODIES

7 © 2015 Mindray Confidential

 ANTIGENS

An antigen is a foreign substance in the organism,

capable of triggering an immune response.

Virtually any foreign macro-molecule can act as an antigen.

Particular sites on the antigen's surface fit and bind to specific

antibodies: These sites are called epitopes

© 2015 Mindray Confidential

 Ab-Ag Reaction

A lock and key concept

© 2015 Mindray Confidential

 Immunoassay principle

+
Indicator /

+ detection
system

• Radioactive
material
Antigen • Enzyme
Antibody
• Particles
• Colloidal gold

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K
 IMMUNOASSAYS TECHNIQUES

Directly visible visible using different technologies

Agglutination
Precipitation Immuno- ELFA CLIA
fluorescence RIA ELISA
Lateral flow

Manual techniques
Automated techniques

11 © 2015 Mindray Confidential

 Agglutination

Ag

particle

Antibody

© 2015 Mindray Confidential

 Agglutination

Antigen

13 © 2015 Mindray Confidential

 Immunochromatograph (Lateral flow)

Colloidal gold

Antibody

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
 ELISA Methode - Sandwich

HIV Ag + enzyme E
substrat

Anti-HIV

Ag

15 © 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
 ELISA Methode – Indirect Sandwich

Anti-human Ig+enzyme E
substrat

Anti-HIV

Ag

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
 ELISA Methode - Competitive EIA

substrate
Antibodiy + enzyme
E
Antibody

Ag Ag Ag

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
 ELISA Methode - Immunocapture

Antigen + enzyme substrate

E

Antibody

Anti-human Ig G / M

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
 Chemiluminescence Immunoassay
(CLIA)

Chemiluninescence is defined as emmision of

electromagnetic radiation caused by chemical
reaction to produce light

CLIA:
chemiluminescence + immunochemical reaction

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
The Idea behind CLIA

© 2015 Mindray Confidential

 CLIA Detection Method

ALP ALP
ALP
Wash
+ +
ALP

ALP

ALP ALP

+ AMPPD
Enhanced Enzymatic Chemiluminescence

-2 0 moles

0
Signal

Glow 1
Flash

Time

© 2010 Mindray Confidential  2018-4-30  22

 Advantages of CLIA
 Most sample have no background signal
 Lower detection limit than conventional photometry
 Possibility to be multiplexed

© 2015 Mindray Confidential

Source : dr. July Kumalawati, SpPK (K)
 We are
The medical device company.

Drager ranking #39,

NihonKohden ranking #44
Source: S&P Capital IQ. Top 100 public medical device companies by sales, 2015. 

© 2015 Mindray Confidential

 WE ARE…
VISION • 10K+ people from 40+ countries
We will make better healthcare solutions
more accessible to humanity. • working in 32 branches in China

MISION • 41 international branches in 31

Improve healthcare by optimizing and countries
sharing medical technologies with the
world. • 8 RnD center in US, CN, SW

• and serving190+ countries and regions.

25 © 2015 Mindray Confidential

26 © 2015 Mindray Confidential
 Our Products: In-Vitro Diagnostics

Cellular Analysis Line Hematology Analyzer and Reagents Hemoglobin System Flow Cytometry

Chemiluminescence Immunoassay Chemiluminescence Immunoassay Chemistry Analyzer and Reagents

Chemistry Analysis Line Analyzer and Reagents

27 © 2015 Mindray Confidential

 Hematology

Global #5
#2 in China market
6 of the top 10 hospitals in
Shanghai using Mindray's cellular
analysis line

Mindray In Indonesia
#1  3PD
#2  All HM

Reference case:
Cellular analysis line solutionfor the Qilu Hospital of Shandong University, China.
© 2015 Mindray Confidential
International standard quality system

 Manufacturing quality control: every product must pass stringent tests before
shipment.

29 © 2015 Mindray Confidential

 Mindray Ecosystem
One Solution for Laboratory

30 © 2015 Mindray Confidential

Mindray e-Catalog

 IVD-Lab: Hema, Photometer-Kimia, Urine, Coagulasi,

Mikrobiologi

 Patient Monitor and Life Support: Pasien Monitor, Lampu

Operasi, Meja Operasi, Anastesi, dll

 Imaging System: USG B/W – 4D, Radiology, MRI

© 2015 Mindray Confidential 31

Mindray IVD E-Catalog

© 2015 Mindray Confidential 32

 018
l 2
p ri • SF Cube Technology
n A
u l a
i b
d
cat • 125 tests/hour (CBC+DIFF)
i E
d • 100 sample tubes capacity
aru
erb
T
• Malaria Screening
• 3D SF Cube Technology
• PLT Optical

• Modular with SC 120, up to 4

units BC-6800 and 2 units SC-
120
BC-6800
No more: PLT clump, Giant PLT, Lipaemic
IDR 825 jt + 30 jt
sample, NRBC >< WBC, etc

© 2015 Mindray Confidential

Hematology BC-20s

RBC PLT WBC

MCV MPV Lymph#
HCT PCT Lymph%
RDW-SD PDW Mid#
RDW-CV Mid%
HGB Gran#
MCH Gran%
MCHC

8 4 7 410mm
300mm
Bahasa Indonesia
19 reportable parameters
34
© 2015 Mindray Confidential
Photometer BA-88A
• Test mode: flow-cell or cuvette
• 7.0” TFT touch screen & popup
keypad
• External keyboard or mouse
support via USB
• User friendly yet powerful
software
• Wavelengths range 340 to 670nm
• Easy maintenance
• Support Bi-chromatic tests for all
three methods

© 2015 Mindray Confidential 35

Urinalysis
UA-600T

26,812,800
 11 parameter
 Reflectane photometer
 3 panjang gelombang, Merah, Biru dan hijau

© 2015 Mindray Confidential 36

 Hematology BC-5000

320mm
 5 Diff dengan layar sentuh
 3 laser scatter dan flow cyto
 Display besar dan berwarna
 Menyimpan 20.000 sample
410mm
 23 parameter, 3 histogram, 3
scattergram
 40 sampel/jam
 15 µl sampel WB 400mm
 3 reagent dan 1 cleaner IDR 171.9 jt

37 © 2015 Mindray Confidential

 BC-5380
 5 part differential, 27 parameters, 3
histograms and 1 scatter plots;
 Laser scatter, flow cytometry and
chemical dye method;
 Up to 60 samples per hour;
 Micro-sampling of 20 µl for CBC+5DIFF;
 PC software;
 Low reagent consumption;
 Large storage capacity: up to 40,000
samples; IDR 264 jt + 30 jt
 Bi-directional LIS connection;

38 © 2015 Mindray Confidential

Kimia

BS-120
Alat kimia otomatis 100
test/jam
Konsumsi air 2.5 L/jam
 Bisa untuk pemeriksaan
160,607,660
ADA (untuk TBC)

* Perlu tambahan set komputer dan UPS Rp. 30.000.000,

© 2015 Mindray Confidential 39

 Kimia

BS-220E
 Alat kimia otomatis 200
test/jam
 Posisi sample, 58 posisi
reagen
323,400,000
Bisa untuk pemeriksaan
ADA (untuk TBC)

*Perlu tambahan set komputer dan UPS Rp. 30.000.000,

*Perlu pengolah air RO kecil Rp. 60.000.000
40 © 2015 Mindray Confidential 40
 Kimia

BS-380
Alat kimia otomatis 300
test/jam
75 posisi sample, 58 posisi
reagen
323,400,00
Bisa untuk pemeriksaan ADA 0
(untuk TBC)

*Perlu tambahan set komputer dan UPS Rp. 30.000.000,

*Perlu pengolah air RO sedang Rp. 80.000.000
41 © 2015 Mindray Confidential 41
 Is Adenosine deaminase (ADA) an ideal
biomarker?
Liang QL, Shi HZ,Wang K et al. Respir.Med.2008; 102: 744–54.

 A recent meta-analysis of 63 studies

 2796 patients with TB pleuritis

 5297 with non-TB effusion

 the sensitivity/specificity: 92% / 90%

 The positive likelihood ratio: 9.03,

 The negative likelihood: 0.10,

Studi di Indonesia
ADA was an accurate marker to distinguish between tuberculous and non-
tuberculous pleural effusions
This test yielded a sensitivity of 92.5% and a specificity of 78.4%, at a cut-off value
of 35 U/L
(Utomo, Timan, Kamelia: 2015)

42 © 2015 Mindray Confidential

Traceability
Alat+Reagent+Calibrator dalam satu
Vendor menjamin hasil yang AKURAT
dan memenuhi kaedah MAMPU
TELUSUR

Analyzer Reagent
Calibrator

43 © 2015 Mindray Confidential

 MRID E-Catalog Mapping

44
Chemiluminescence Immunoassay System

By Ida Faridah

45
 Mindray CLIA family
SAL 6000/ 8000

2018

CL-6000i
480 T/H

CL-2000i
240 T/H

CL-1200i
180 T/H
2018
CL-1000i
120 T/H
CL-900i
180 T/H
Small Lab Medium Lab Big Lab Core Lab
CL-1000i and CL-
1200i
120/
Tests per hour
180

25 Positions for reagents

60 Samples by rack system

0 Ready to use wash buffer

47 © 2015 Mindray Confidential

CL-2000i

240 Tests per hour

36 Positions for reagents

300 Samples in one batch

5’ Easy Daily Maintenance

48 © 2015 Mindray Confidential

 The World’s Smallest fully-auto
CL-900i CLIA analyzer performs up to
180t/h

S
Small
56cm

72cm
86cm

49 © 2015 Mindray Confidential

CL-900i

180 Tests per hour

15 Positions for reagents

50 Samples positions

17.5 Time for First result

0 Ready to use wash buffer

© 2015 Mindray Confidential

 SAL 6000 & SAL 8000

Seamless Integration Workflow Optimization

SAL 8000 SAL 6000

SAL 8000/6000 Modular System delivers high/medium throughput and seamless integration
of CL-2000i Chemiluminescence Immunoassay System and BS-2000/BS-800 Modular System.
In conjunction with the SPL 1000 Sample Processing System, this scalable platform not only
provides optimized workflow, it also offers satisfactory operator experience.

SAL 6000=CL-2000i+BS-800M
SAL 8000=CL-2000i+BS-2000M

51 © 2015 Mindray Confidential

 Reagent component and features
100 tests/kit, 50 tests/kit package . soon : smaller tests/kit

Reagent kit
Substrate calibrator, Control

52 © 2015 Mindray Confidential

 Mindray CLIA Menu
*: in development
Infectious Bone
Thyroid Fertility Cardiac Tumor marker Diabetes Others Liver Fibrosis ToRCH
Disease Metabolic
FT3 HIV Combo Total β-HCG Intact PTH CK-MB CEA Insulin DHEA-S LN Toxo IgG*
HBsAg
FT4 FSH Calcitonin Myoglobin AFP C-peptide Cortisol HA Toxo IgM*
Quantitative
T3 Anti-HBs LH Vitamin D total Troponin I CA125 　 ACTH PIIINP Rubella IgG*

T4 HBeAg Prolactin BNP CA15-3 CIV Rubella IgM*

TSH Anti-HBe E2 CA19-9 CMV IgG*

Anti-TG Anti-HBc E3 FPSA CMV IgM*

Anti-TPO Anti-HCV TESTO TPSA HSV-1/2 IgG*

Anti-TP
Tg PROG 　 NSE HSV-1/2 IgM*
(Syphilis)
HBeAg
rT3 ACTH 　 CYFRA 21-1 HSV-1 IgG*
quantitative* 　
TRAB* Anti-HBc IgM* DHEA-S 　 CA72-4 HSV-2 IgG*
　
Cortisol 　 　 PG I

Free Growth
Anemia Hypertension PG II Inflammation DS’ Screening
testosterone* Hormone

17-OH PROG* Ferritin Angiotension I* SCCA* hGH* PCT PAPP-A*

SHBG* Vitamin B12 Angiotension II* HE4* IGF-1* Free β-HCG*
AMH* Folate Renin* ProGRP*
RBC Folate Aldosterone* CA50*
© 2015 Mindray Confidential
CA242*
Embracing humanity

• Global marketing
• Humanitarian aid
• Medical assistance
• Environmental friendliness
• Education support
• Learn and Share

54
Summary
 Immunoassay Principle : Antigen + Antibody + Indicator/Detection System

 Immunoassay technique : Directly Visible or Visible using different

technique like : RIA, ELISA/EIA, ELFA, CLIA

 Advantages of CLIA : Most sample have no background signal, lower

detection limit than conventional photometry, possibility to be
multiplexed

 Product traceability and cost effectively become first concern for mindray
to give best service with high quality to the customers

55 © 2011 Mindray Confidential

Be with mindray,
Let’s change the world together.

THANK YOU

© 2010 Mindray Confidential  2018-4-30  56