Mindray Immunoassay to COVID-19

Ida Faridah

© 2020 Mindray Confidential

Main Laboratory diagnosis and management solution of COVID-19

Positive

Diagnosis/Screening 3, 5 days….
Treatment and prognosis monitoring Discharge

Test items Classes Information Purpose

CBC+CRP Hematology/Chemistry Immune and inflammatory

PCT Immunoassay response

D-dimer Coagulation Haemostasis

Suspected screening,
Liver function Chemistry
clinical assessment
kidney function Chemistry/Urine Organ function injury and prognosis

Cardiac CK/CK-MB+ MYO+ Chemistry/ assessment monitoring

Troponin Immunoassay

Virus protein and Immune

Virus antigen/antibody test Immunoassay
response

RT-PCR/Viral gene sequencing Molecular test Virus nucleic acid Confirmed diagnosis

*Clinical characteristics of 2019 novel coronavirus infection, http://www.nhc.gov.cn

*WHO: Clinical Management of Severe Acute Respiratory Infection When Novel Coronavirus (nCoV) Infection Is Suspected: Interim Guidance, http://www.who.int

© 2020 Mindray Confidential

Role of Ab Test in COVID-19: WHO Guideline
• Serology tests can support diagnosis in cases where nucleic acid tests are negative and
epidemiological evidence is strong.
• Serology tests can also be used for epidemiological assessment.

Category Test Timing

Patient
Contact
in health-care centre associated outbreaks or
other settings where contacts have symptoms,
or where asymptomatic contacts have had
high-intensity contact with a COVID-19 case.
Paired samples are necessary for confirmation with the
initial sample collected in the first week of illness and the
Serology
second ideally collected 2-4 weeks later (optimal timing
for convalescent sample needs to be established).
Baseline serum taken as early as possible within
incubation period of contact and convalescent serum
Serology
taken 2-4 weeks after last contact (optimal timing for
convalescent sample needs to be established).

World Health Organization. (2020). Laboratory testing for coronavirus disease (‎COVID-19)‎in suspected
© 2020 Mindray Confidential
human cases: interim guidance, 19 March 2020 (No. WHO/COVID-19/laboratory/2020.5). World
Health Organization.
Methodological Comparison of COVID-19 Specific Tests

RNA
Can confirm COVID-19 diagnosis
PCR
High price, Special Laboratory, Need high skill

Ab
Best test method for SARS-CoV-2 specific Ab
CLIA
Reliable and cost-effective, only support the diagnosis

Ab Rapid Simple when the sample volume is small, cheapest

Test Unreliable, poor performance

© 2020 Mindray Confidential

MR Mindray COVID-19 Reagents
• Serology test kits of COVID-19 on Mindray
CLIA systems:
1. SARS-CoV-2 IgM (CLIA)
2. SARS-CoV-2 IgG (CLIA)

Running in Fully Automatic Machine

Mindray CL-1000i (listed in E. Catalog)
With Chemilumenescence (CLIA) Technology

Small Package : 2*50 tests/kit Time to first result : 29 minutes

Principle : Sandwich CLIA (GLOW CLIA) Sample volume : 10 μL
Sample type : Serum Shelf life : 2-8°C，6 months

SARS-CoV-2 IgM SARS-CoV-2 IgG

Sensitivity* 89.66 % Sensitivity* 100 %
Specificity* 93.32 % Specificity* 94.92 %

© 2020 Mindray Confidential

MR Immunology Paramter to Support Diagnose CoViD-19

CL-900i CL-1000i
Terdaftar E. Catalog
Serology test to support
diagnose COVID-19 with :
• SARS-CoV-2-IgG (CLIA)
• SARS-CoV-2-IgM (CLIA)
With advance Technology
GLOW Chemiluminescent
(GLOW CLIA) CL-2000i CL-6000i

All Mindray Immunoassay Analyzer

© 2020 Mindray Confidential

MR Mindray Immunoassay Analyzer to Support CoViD-19

Through Put : 120 tests/hour

New Technology : GLOW CLIA

Full Automatic :
From pipetting until out of
Result be done by Machine

Runing with Close Machine

to avoid Contamination

Ready to used reagent and

Consumable
Mindray CL-1000i
Good Precision Listed in E. Catalog
Price IDR 501,119,378,- Without Robotic Arm
Good Stability IDR 612,801,878,- with Robotic Arm

Small Package Reagent :

2 x© 2020
50Mindray
Tests/kit
Confidential