Validation of Rapid Antigen Test (RAT) for COVID-19 in India

This article deals with the Validation of Rapid Antigen Test (RAT) for COVID-19. The ICMR invites applications for the validation of the Rapid Antigen Tests (RAT) which is mainly used in the diagnosis and detection of SARS-CoV-2 in India. They can sell in India under 3 main categories

1. First Time Validation

1. Minimum 300 rapid antigen tests from three different batches (100 from each batch) is needed for validation
2. Minimum of 3-4 instruments is needed 
3. Kit insert / detailed IFU of test kit needs to be validated
4. In-house Performance Report must be done on 30 positive & 20 negative and the CT Values (<20; 20-30; >30) of their corresponding RT-PCR positives must be available 
5. Manufacturers need to provide training to the technical staff 
6. If the kit is approved, the manufacturer must be able to provide adequate samples to India immediately.
7. Import licenses must be obtained from CDSCO/DCGI. 

2. Revalidation

1. All the above requirements has to be fulfilled
2. Detailed changes should be made after the first attempt. These requirements need to be submitted in a table as below

3. Validation with Alternate Sample Type

1. 100 test strips of the RAT lateral flow assay.
2. In-house Performance Report must be done on 30 positive & 20 negative and the CT Values (<20; 20-30; >30) of their corresponding RT-PCR positives must be available. The validation must be conducted with alternate sample types ( nasal swab/ oral swab/ saliva) and must be compared with RT PCR which is conducted using nasopharyngeal (NP) or NP + oropharyngeal (OP) swabs.
3. Kit insert / detailed IFU of test kit needs to be validated
4. DCGI manufacturing license of the previously approved kit
5. Certificate of registration on the GeM portal of the previously approved kit

All documents must be submitted to Documents to – (1) drneetu.vijay@icmr.gov.in and (2) guptanivedita.hq@icmr.gov.in. The first line of the email must be – REQUEST FOR VALIDATION OF COVID-19 RAPID ANTIGEN TEST.

The list of Validation Centres of Rapid Antigen Test (RAT) for COVID-19 are

1. All India Institute of Medical Sciences, Delhi
2. SMS Medical College, Jaipur
3. King George Medical University, Lucknow
4. Kasturba Hospital for Infectious Diseases, Mumbai
5. Post Graduate Institute of Medical Education & Research, Chandigarh
6. Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry
7. National Institute of Virology, Kerala Unit, Alappuzha
8. Bangalore Medical College & Research Institute, Bengaluru
9. National Institute of Mental Health and Neurosciences, Bengaluru
10. All India Institute of Medical Sciences, Bhopal
11. All India Institute of Medical Sciences, Raipur
12. All India Institute of Medical Sciences, Jodhpur
13. B J Medical College, Ahmedabad
14. Kings Institute for Preventive Medicine & Research, Chennai
15. Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram
16. Maulana Azad Medical College, Delhi
17. Government Medical College, Aurangabad
18. Sri Venkateshwara Institute of Medical Sciences, Tirupati
19. Mysore Medical College and Research Institute, Mysore
20. SN Medical College, Jodhpur
21. King Edward Memorial Hospital and Seth GS Medical College, Mumbai
22. All India Institute of Medical Sciences, Nagpur
23. Government Institute of Medical Sciences, Gr. Noida
24. Government Medical College, Thrissur
25. Government Medical College, Thiruvananthapuram
26. Coimbatore Medical College, Coimbatore
27. Institute of Postgraduate Medical Education and Research,Kolkata

Guidance to Enhance Availability of COVID-19 Testing Kits and Newer Innovative Testing Solutions in India:

The RT-PCR and Rapid Antigen Tests (RAT) is mainly used in the diagnosis and detection of SARS-CoV-2 in India. ICMR has advised that if these kits are approved by the following 

1. United States Food and Drug Administration (USFDA), USA
2. Pharmaceuticals and Medical Devices Agency (PMDA), Japan
3. Therapeutic Goods Administration (TGA), Australia
4. WHO Emergency Use Listing (EUL) procedure

All test kits approved by other global agencies are subjected to Validation in India. All the Home Testing Kits would be validated in India. The following must be ensured by every manufacturer – 

1. The material for Testing, Disposal and Sample Collection must be a part of the Kit
2. The Kit must include the following – Detailed Instructions for Use, Interpretation and Disposal. They must have an inbuilt system of data capture through Mobile Based Softwares
3. Manufacturers would be advised to work with ICMR to ensure data flow into the ICMR COVID-19 testing portal. 
4. The main point of contacts are – (1) Dr Neetu Vijay (drneetu.vijay@icmr.gov.in) and (2) Mr Ajay Singh Dhama (ajaysinghdhama@gmail.com)

Manufacturers without an inbuilt system to synchronise with the ICMR may not be applicable to market in India. 

Advisory for COVID-19 Home Testing using Rapid Antigen Tests (RATs)

1. In Symptomatic Individuals and Immediate contact with COVID-Positive Patients 
2. Testing must be done as per the instructions of the Manufacturer Manual
3. Indiscriminate testing should not be performed
4. Home Testing Mobile App must be downloaded by users. The app will provide the test result of the patient 
5. Users must ensure to click a picture of the test strip after completion of the test in the same phone the app is installed on. Data on the phone will be centrally captured which is in turn connected to the ICMR COVID-19 testing portal 
6. Patient confidentiality is maintained
7. If the results are positive, no repeat testing is required
8. Symptomatic individuals who get a negative test result in the RAT should test themselves using the RT-PCR. This is to ensure that no positive cases are missed.

Conclusion

Contact Morulaa is you are a Manufacturer of Rapid Antigen Detection Assays for COVID-19 and would like to Market your product in India.

Source – Indian Council of Medical Research (ICMR)

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