The government has finalized guidelines for the use of Covid-19 antibody test kits.
Antibody test kits cannot be used to diagnose the disease and will instead be used to find more accurate information on the spread of the virus as well as to find donors for plasma therapy, according to the guidelines.
The Health Ministry is in the process of testing and approving antibody test kits, after which the Directorate General of Drug Administration (DGDA) will allow import and manufacturing.
The guidelines said antibody test kits would need the following label: “This is not a diagnostic kit. This kit will be used only for detecting antibodies, not in the acute stage.”
The guidelines also said: “Antibody tests can be used for sero-surveillance, convalescent plasma therapy, and for research purposes.”
Furthermore, they said all antibody tests, including rapid antibody tests, should only be conducted in laboratories in order to prevent “misuse.”
DGDA Deputy Director Md Salauddin said: “Antibody test kits are used to check if antibodies to the coronavirus have been created in patients who have recovered from Covid-19. There are two benefits to knowing a person has antibodies: it means they have less chance of future infection and plasma can be collected from them for plasma therapy.”
A technical committee formed to treat Covid-19 patients and evaluate drugs, investigational drugs, vaccines and medical devices, finalized the guidelines at two meetings on June 21 and 23.
For the import and production of antibody test kits, the guidelines said a no objection certificate (NOC), emergency use authorization and registration application needs to be filed with the DGDA. The NOC will be provided after the Ministry of Health and Family Welfare and Directorate General of Health Services gives their approval.
Initially, emergency use authorization will be provided for a few days.
Both rapid antibody test kits and laboratory-based kits are required to have Combined IgG+IgM sensitivity of 90% and specificity of 95%.
The sensitivity refers to the percentage of antibodies in the blood 14 days after Covid-19 symptoms subside, said Deputy Director Md Salauddin.
