Antibody test guidelines for private labs issued

The government has issued orders allowing private-sector laboratories to conduct COVID-19 antibody testing (IgG and IgM) and framing guidelines regarding the selection of labs, antibody test kits to be used, selection criteria of the testing population, timing of the tests, sample collection, and declaration of results.

NABL-accredited labs will be given permission for testing using body fluids. Those labs which have secured Indian Council Medical Research (ICMR)’s accreditation alone will be allowed to do antibody testing. The labs will have to register on a portal of ICMR and the State government and send relevant documents to for government registration.

The labs will have to sign a non-disclosure agreement and hand over the results to the State Health Department through online portal. The results may not be directly informed to clients.

Current guidelines say that antibody testing may be done in those who are clinically suspected of having COVID-19 but who tested negative in RT-PCR ( Reverse Transcription Polymerase Chain Reaction) tests, besides symptomatic high-risk contacts of confirmed cases. Health workers who are treating COVID-19 patients and those with severe acute respiratory infection will also be tested for antibodies.

Cost of test

Only ICMR-approved test kits may be used. The list of ICMR-approved antibody test kits are available on covid-19. The State Drugs Controller has been asked to inspect the test kits used by labs. Testing will be done free of cost for the vulnerable sections identified by the government. For others, the test will be charged ₹800. BPL (below the poverty line) patients covered by the Karunya Arogya Suraksha Padhati (KASP) may be offered the tests free of cost. The labs will be reimbursed under KASP.

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Printable version | Jun 15, 2021 7:40:29 PM |

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