The rapid antibody testing for COVID-19 has been temporarily halted across India following complaints from the states that the rapid test kits, imported from China, are faulty and inaccurate.
The Indian Council of Medical Research (ICMR), the nodal agency in the fight against coronavirus, on Tuesday (April 21) asked the states to stop the testing for two days, dispatching teams of medical experts to carry out field validation of the kits.
Several variations have been reported in the results of rapid antibody test kits and RT-PCR (reverse transcription – polymerase chain reaction) kits.
“These kits will be tested and validated in the field by our teams. We will issue a clear-cut advisory in two days. If problems are detected in batches, we will ask the companies for replacement,” said Dr Raman R Gangakhedkar, head of ICMR’s epidemiology division.
Around 5 lakh rapid anitbody test kits were procured by the government and distributed around the country after the ICMR recommended that every resident in coronavirus hotspots — areas with a large number of cases — will be tested for the virus.
However, several states have complained about huge discrepancy and inaccuracies in the test results.
Rajasthan has stopped tests through the new kits, saying they had only 5.4 per cent accuracy.
“We have confirmed this with three states and found that the findings were true to an extent. This is not a good sign. We are working on it,” the ICMR official said.
India is not the only country to report faults in Chinese made protective gear and test kits. Many European countries including Spain and the Netherlands had rejected thousands of testing kits and medical masks as they were found below standard or defective, according to a BBC report.
While the Netherlands had recalled over 6 lakh face masks imported from China, the other countries like Spain, Turkey and Italy had a similar experience.
India is also sourcing test kits and personal protection equipment from other countries like South Korea. This is in tune with the plans to scale up testing and surveillance.
What are rapid tests?
The rapid tests use blood sample to determine whether the body has developed antibodies for coronavirus, which is the evidence that a person is infected and works even for people who are asymptomatic.
But, the test is not likely to work in the window period between infection and the development of antibodies.
The scientific community is divided over the efficacy of rapid antibody testing. Some argue that it may not be fool proof. However, in the face of a virus that is highly contagious, the need is increasingly felt for quick diagnosis and act
The rapid tests take less time to show results compared to the swab-based tests carried out in pathology labs.
Earlier this month, the ICMR had said that those found positive in the antibody tests will go through the RT-PCR tests which rely on throat and nasal swabs and provide concrete results.
The apex medical body has clarified that rapid antibody tests are not for diagnosis but for surveillance. The RT-PCR is the ultimate test for the novel coronavirus as of now.
Rajasthan halts tests
Rajasthan government on Tuesday stopped using the Chinese testing kits for coronavirus after they delivered inaccurate results.
The state health minister Raghu Sharma said the kits gave only 5.4 per cent accurate results against the expectation of 90 per cent accuracy.
The ICMR had also received complaints related to repeat testing of patients in West Bengal as the RT-PCR kits were not working properly.