ICMR approves 13 out of 16 antibody rapid test kits

The Indian Council of Medical Research (ICMR) has carried an evaluation of 16 antibody (IgM, IgG)-based rapid test kits and approved 13 to conduct the novel coronavirus (COVID-19) test. The evaluation of these kits has been carried at the ICMR’s National Institute of Virology (NIV), Pune.

According to a spokesperson of ICMR, the list of ICMR-approved antibody test kits will be used for screening in the areas declared as COVID-19 hotspots in India.

List of ICMR-approved antibody (IgM, IgG)-based rapid test is as follows:

1. SARS-CoV-2 Antibody test (Lateral flow method): Guangzhou Wondfo Biotech, Mylan Laboratories Limited (CE-IVD)
2. COVID-19 IgM IgG Rapid test: BioMedomics (CE-IVD)
3. COVID-19 IgM/IgG Antibody Rapid test: Zhuhai Livzon Diagnostics (CE-IVD)
4. New Coronavirus (COVID-19) IgG/IgM Rapid Test: Voxtur Bio Ltd, India
5. COVID-19 IgM/IgG Antibody Detection card Test: Vanguard Diagnostics, India
6. Makesure COVID-19 Rapid test: HLL Lifecare Limited, India
7. YHLO SARS-CoV-2 IgM and IgG detection kit (additional equipment required): CPC Diagnostics
8. ACCUCARE IgM/IgG Lateral Flow Assay kit: LAB-CARE Diagnostics, India
9. One Step Corona Virus (COVID-19 ) IgM/IgG Antibody Test: Alpine Biomedicals
10. Abchek COVID-19 IgM/IgG Antibody Rapid Test: NuLifecare
11. Standard Q COVID -19 IgM/IgG Duo test – One Step Rapid Antibody test: SD Biosensors
12. Immuno Quick Rapid Test for Detection of Novel Coronavirus (COVID-19) IgM/IgG Antibodies: ImmunoScience India
13. COVID-19 IgM/IgG Rapid Test Kit: Medsource Ozone Biomedicals

ICMR has also issued an advisory on the feasibility of using pooled samples for molecular testing of COVID-19 for surveillance purpose.

Thyrocare, a private laboratory, which has received the approval from ICMR for conducting the COVID-19 tests, began testing 15 days back, and as of now, conducts around 500 PCR tests per day in Mumbai.

Speaking about the delivery of antibody tests, Dr A Velumani, Managing Director, Thyrocare, mentioned, “Antibody kits were approved almost 20 days back by the ICMR. We have placed orders already with advanced payments. But no kits are received, either by us or by any other labs or even by the ICMR. We are all eagerly awaiting and it looks like it may not arrive before 25th April, 2020. So, only PCR tests possible as of now.”

He also adds, “The capacity of approved labs is not adequate to fulfill the needs of 1.3 billion people. We need to scale up the capacity.  Another 200 labs should be approved to handle the surge that might be generated post-withdrawal of lockdown.”

The complete list of CE-marked rapid COVID-19 antibody tests is available at https://www.finddx.org/covid-19/pipeline/.

CE-IVD-approved kits can be used directly after due marketing approval from DCGI.

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