The Union government has decided to place the use of rapid antibody tests for COVID-19 on hold indefinitely, raising several queries. On Saturday, Union Health Minister Dr Harsh Vardhan stated that this decision came in view of concerns regarding “uniformity of results” yielded by the rapid testing kits.
An official source told PTI that the results of the test kits vary from place to place and “it can't be relied upon.”
“Moreover, the WHO has also not commented on its accuracy. ICMR is reviewing the efficacy of the test and the kits in its own labs and shall come out with fresh guidelines soon," he was quoted as saying in a health ministry statement on Friday.
An official told PTI, "After a meeting, the Union health ministry held with states on Friday, they were asked to halt the use of COVID-19 rapid antibody test kits for the time being till their accuracy is validated by the ICMR."
So what is the controversy surrounding the testing kits?
It all began on April 21 when officials from the state of Rajasthan announced that they would not be using the kits to test for COVID-19 antibodies, after a series of test results were found to be inaccurate. Shortly after, the Indian Council for Medical Research (ICMR) had asked states to not use rapid tests for two days, as it looked into complaints of faulty results. The ICMR formed special teams to look into the complaints and analyse the antibody testing kits which were provided to India by a Chinese manufacturer.
The ICMR’s teams are in the process of preparing a report about the effectiveness of the rapid testing kits in producing accurate results, after analysing the results which have been produced so far.
In the meantime, the Chinese manufacturers of the tests have claimed that the kits themselves were not faulty and that the issue must have been due to how healthcare workers were administering tests.
Over 5,00,000 rapid testing kits were provided to India by two Chinese companies: Wondfo Biotech and Livzon Diagnostics. Officials from the ICMR have stated that if the kits are found to be faulty, replacements will be sought from the companies which provided the kits. In the meantime, all antibody-based testing via the rapid tests has been asked to be placed on hold.
Interestingly, complaints have been raised about the kits not only in India but also in the US. Earlier, several experts in New York had raised concerns about whether the test kits, which had also been imported from China, yielded accurate results. One report showed that out of 14 kits which were tested, only 3 showed reliable results.
The rapid testing kits aim to determine if an individual has recently been exposed to the novel coronavirus (officially called SARS-CoV-2) by checking for the presence of antibodies against the virus in the blood. Presence of antibodies indicates that someone has been exposed to the virus, but cannot give a definitive diagnosis for COVID-19.
With the tests temporarily suspended, officials are awaiting the release of the report from ICMR officials. Following this, further decisions will be taken. In the meantime, RT-PCR will continue to remain the standard of testing for COVID-19.