In a big development on Tuesday, the Indian Council of Medical Research directed the state governments to not use the rapid testing kits for the next two days. This development comes after various states complained about the accuracy of the aforesaid kits. Addressing a press briefing on Tuesday, Dr.Raman Gangakhedkar- the head of Epidemiology and Communicable Diseases at ICMR conceded that there was a significant variation in the positive RT-PCR samples.
At the same time, he observed that tests might be in a crude form as only three and a half months had passed since the outbreak of the novel coronavirus pandemic. Additionally, Dr.Gangakhedkar announced that the ICMR would try to validate the kits in the field instead of laboratories in the coming two days and issue a detailed advisory subsequently.
ICMR's Dr.Raman Gangakhedkar remarked, "Till yesterday, we have conducted 4,49,810 samples have been tested out of which 35,852 samples were tested yesterday. You must have heard that the rapid test kits have been distributed in all the states. Yesterday, we received a complaint from a state that there is low detection. So, we asked three states today. After asking them, we have reached the conclusion that there is a lot of variation in the positive RT-PCR samples. In some places, ranging from 6% to 70%, the test on RT-PCR samples is coming positive. This is not a good thing as we will have to investigate it when the variation is huge."
He added, "There are variations in first-generation tests as it is in a crude form. As only three and a half months have elapsed since the outbreak of COVID-19, the test has to be refined. After looking at this variation, we have decided on two things. In the next two days, we will send our 8 institutes in the field and will try to validate the kits in the field. Second, we will advise all the state governments not to use these test kits for the next two days. If we observe that there is a problem in the batch, we can tell the company to replace the batch."
The rapid antibody test kits entail the testing of blood samples and are aimed at speeding up the screening and detection of suspect COVID-19 patients. This is because it takes more time for the results of swab-based tests in labs. It is pertinent to note that the RT-PCR is the only confirmatory test for COVID-19. Approved by the US FDA, the rapid test kits are meant only for surveillance and trend checking.
Earlier in the day, Rajasthan expressed its inability to continue with the rapid antibody tests and wrote to the ICMR in this regard. According to the Rajasthan Health Minister, a committee of the Head of the Microbiology Department and Medicine Department examined whether these tests are effective. They discovered that the accuracy of the rapid tests was only 5.4% instead of the expected 90%.