Rapid Antigen Test Kits for COVID-19 (Oropharyngeal / Nasopharyngeal swabs)

Rapid Antigen Test Kits for COVID-19 (Oropharyngeal / Nasopharyngeal swabs)

Please Note:

  • Below listed kits are validated with the mentioned batch number only. Responsibility for the batch to batch consistency does not lie with ICMR.
  • Minimum acceptance criteria of sensitivity and specificity of Rapid Ag Test Kits: & Validated as a Point of Care Test (POCT) without transport to a laboratory setup-Sensitivity: 50% and above; Specificity: 95% and above & Validated in a laboratory setup with samples collected in Viral Transport Medium (VTM)- Sensitivity: 70% and above; Specificity: 99% and above
  • Antigen based rapid tests which are US-FDA approved can be used directly after due marketing approval from DCGI.

Till date, 42 Antigen based Rapid Test Kits have been validated (including 6 revalidated Kits), and the following are found to be satisfactory

S. NoName of companyName of the kitLot no. / Batch No.Sample used for validation
1.SD Biosensor, South Korea / IndiaSTANDARD Q COVID-19 AgE055003Nasopharyngeal swab
2.LabCare  Diagnostics Ltd., Valsad (Gujarat), India (Supplied by MyLab Discovery  Solutions)COVID-19 Antigen Lateral Test DeviceCVG200601 CVG200602 CVG200603Oropharyngeal and Nasopharyngeal swabs
3.Trivitron Healthcare Pvt. Ltd., Chennai (TN), IndiaBIOCARD Pro COVID-19 Rapid Ag test kitCOVPGL-001 COVPGL-002 COVPGL-003Nasopharyngeal swab
4.Coris Bioconcept, Belgium”COVID-19 Ag Respi Strip43242F2003 43512G2030 43464G2016#OropharyngeaI swab in VTM
5.Panion & BF Biotech., TaiwanVSTRIP COVID-19 Antigen Rapid TestIG10020S-R2004 IG10020S-R2005 IG10020S-R2006Nasopharyngeal swab
6.PCL Inc, South KoreaPCL COVID-19 Rapid FIA2005K104 2005K105 2005K106Nasopharyngeal swab
7.Premier Medical Corporation, Valsad (Gujarat), IndiaSure status COVID-19 Ag Test97101205 97102205 9710320SNasopharyngeal swab
S. NoName of companyName of the kitLot no. / Batch No.Sample used for validation
8.Angstrom Biotech Pvt. Ltd., Alwar (Rajasthan), IndiaAngcard COVID-19 rapid Antigen Test kitBCOVA03 BCOVA04 BCOVAOS BCOVA06Nasopharyngeal and Oropharyngeal swabs
9.GenBody Inc., South Korea  GenBody COVID-19 Ag rapid Test kit (POCT)FMFC20201 FMFC16201 FMFC02201Nasopharyngeal swab
10.Ubio Biotechnology Systems Pvt. Ltd., Kochin (Kerala), India  SENSIT Rapid COVID-19 Ag kit5064012010 SO64012011 SO64012012Nasopharyngeal swab
11.Meril Diagnostics, Vapi (Gujarat), IndiaCOVID-19 Antigen Detection TestMRD131 MRD132 MRD133Nasopharyngeal swab

*Guidance for use is placed at Annexure I

List of Rapid Ag Test kits validated and not approved is placed at Annexure II

Individual validation reports of the above-listed kits can be shared with the State Governments on request. The request may be sent at [email protected]

Guidance for use of 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.

Brief methodology of use of COVID-19 Ag Respi-Strip (CorisBioConcept):

  • The Nasopharyngeal and/or Oropharyngeal swab will be collected from COVID-19 suspect patient in Viral Transport Medium (VTM).
    • The collected swab in VTM will be brought to the laboratory inappropriate cold chain conditions.
    • 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 & 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.
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Rapid Antigen Test Kits for COVID-19 (Oropharyngeal / Nasopharyngeal swabs)

c9375be852261e7d14e7598670cdf542?s=130&d=retro&r=g - Rapid Antigen Test Kits for COVID-19 (Oropharyngeal / Nasopharyngeal swabs)
Rajat Singhhttps://bioinformaticsindia.com
Rajat Singh is the chief Author at Bioinformatics India, he has been writing for the past 3 years and has a special interest in SEO, Technology, Health, Life Sciences and gaming.

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