ICMR validates 13 COVID-19 antigen test kits and approves 3 other test kits to diagnose COVID-19

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The Indian Council of Medical Research (ICMR) has recently validated 13 COVID-19 antigen test kits and approved 3 kits for use till date. The three approved kits are STANDARD Q COVID-19 Ag of SD Biosensor, COVID-19 Antigen Lateral Test Device of Lab Care Diagnostics Ltd and COVID-19 Ag Respi-Strip (CorisBioConcept).

COVID-19 Ag Respi-Strip (Coris BioConcept) involves a different methodology of testing as compared to the other two antigen testing kits approved by ICMR till now. This test cannot be performed bedside and requires a BSL-2 set-up for running the test.

As per the brief methodology of use of COVID-19 Ag Respi-Strip (CorisBioConcept), as a first step, the Nasopharyngeal and/or Oropharyngeal swab will be collected from COVID-19 suspect patient in Viral Transport Medium (VTM). In the second step, the collected swab in VTM will then be brought to the laboratory in appropriate cold chain conditions. In step 3, once the sample is brought to the laboratory, it will need to be handled in a BSL-2 level cabinet for aliquoting, putting in lysis buffer and loading the test strip.

Steps 1 and 2 will be performed as per the standard practice followed for collection and transport of samples for COVID-19 RT-PCR test. Step 3 will need to be performed as per manufacturers’ instructions given with the test kit. Differences between COVID-19 Ag Respi-Strip (CorisBioConcept) and other antigen test kits approved by ICMR are as follows. COVID-19 Ag Respi-Strip (Coris BioConcept) cannot be employed as a point of care test. STANDARD Q COVID-19 Ag (SD Biosensor) and COVID-19 Antigen Lateral test Device (Lab Care Diagnostics Ltd) can be employed as a point of care test.

COVID-19 Ag Respi-Strip (Coris BioConcept) Test kit has a sample collection swab. STANDARD Q COVID-19 Ag (SD Biosensor) and COVID-19 Antigen Lateral test Device (Lab Care Diagnostics Ltd) test kit does not have a sample collection swab. Nasopharyngeal and/or Oropharyngeal swab in VTM should be used COVID-19 Ag Respi-Strip (Coris BioConcept) Test kit.

For STANDARD Q COVID-19 Ag kit, only nasopharyngeal swab should be used. For COVID-19 Antigen Lateral test device, throat/nasal/nasopharyngeal swab can be used.

Sample has to be collected using the standard swab provided with VTM. Once collected, the sample needs to be put into the VTM tube in the case of COVID-19 Ag Respi-Strip (Coris BioConcept) Test kit. In case of STANDARD Q COVID-19 Ag (SD Biosensor) and COVID-19 Antigen Lateral test Device (Lab Care Diagnostics Ltd) test kit, sample needs to be collected using the swab provided with the kit. Once collected the swab needs to be directly put into the extraction buffer (in tube) provided in the kit which inactivates the virus. The swab needs to be stirred and squeezed (about 5 times) to extract the sample.

In case of COVID-19 Ag Respi-Strip (Coris BioConcept) Test kit, the collected sample needs to be transported into a BSL-2 lab in cold chain conditions 100 µl of the VTM sample needs to be added to the dilution buffer in a test tube provided with the kit. Read results in 15 minutes or earlier after insertion of strip into tube containing sample and dilution buffer. The strip should be discarded after 15 minutes and Control line may not appear in a positive test and storage temperature is 4 to 30°C.

In case of STANDARD Q COVID-19 Ag (SD Biosensor) and COVID-19 Antigen Lateral test Device (Lab Care Diagnostics Ltd) test kit, No transport to a BSL-2 lab is required as this is a point of care test. The extracted sample should be shaken and 2-3 drops to be added to the well of the lateral flow strip. For STANDARD Q COVID-19 Ag, results should be read between 15-30 minutes. For COVID-19 Antigen Lateral test device, results should be read within 15-20 minutes. Control line must appear for the test to be valid and storage temperature is 2 to 30°C.

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