NEW DELHI: India’s apex medical research body ICMR on Tuesday advised states to stop using the rapid antibody test kits for next two days till it examines their quality in the wake of complaints that they are not fully effective.
Last week, India procured five lakh rapid antibody test kits from two Chinese firms and they were distributed to several states reporting rising cases of coronavirus infection.
Rajasthan government on Tuesday said that the kits were giving out inaccurate results.
At a press briefing, Head of Epidemiology and Communicable Diseases at Indian the ICMR, Dr Raman R Gangakhedkar, said the companies which supplied the kits will be asked to replace them if the kits are found to be faulty.
The Indian Council of Medical Research (ICMR) has been the nodal medical body in the country’s fight against the pandemic.
“We have received complaint from one state and so far discussed the issue with three states. High variations ranging from 6 to 71 per cent have been reported between the results of the rapid tests and RT-PCR tests. We will advise states not to use these testing kits for the next two days,” he said.
“These kits will be tested and validated in the field by teams from our eight institutes after which we will issue a clear-cut advisory for the states. If there is some fault in the batch, we will ask the company to replace the kits,” Gangakhedkar said.
Officials clearly indicated that the kits over which questions have been raised are from China.
Rajasthan health minister Raghu Sharma on Tuesday said the kits gave only 5.4 per cent accurate results against the expectation of 90 per cent accuracy and therefore were of no benefit.
In the wake of adverse reports about quality of Chinese medical equipment, spokesperson in the Chinese embassy Ji Rong last week said China attaches great importance to quality of medical products.
“We hope that foreign buyers can choose products certified by Chinese regulatory authorities and with production qualifications when importing relevant products,” Ji had said.
She said the Chinese authorities introduced stricter regulatory measures, requiring exporters to declare that their supplies have obtained the registration certificate for medical device from the State Food and Drug Administration and meet the quality standards of the importing country.
About questions over quality of the tests, Gangakhedkar said that these were first general tests and may show variations.
It has been just three-and-half months since the disease appeared and so any test will have to be refined further, he added.
At present, the government uses the polymerase chain reaction (PCR) tests to detect coronavirus from throat or nasal swab samples of people. These take around five to six hours to show the results.
In the rapid antibody tests, the blood samples of suspected patients are taken, and it normally takes around 15-30 minutes to give the result.
The government has recommended the use of rapid antibody tests in hotspot areas.
“It is to be used for surveillance and for epidemiological purposes in such areas. The RT-PCR test is the gold standard for frontline test and antibody test cannot replace this test. Utility of rapid antibody test is primarily for assessing prevalence of infection in a particular area,” officials earlier had said.
India has been facing severe shortage of testing kits amid rising cases of the coronavirus.
—PTI

Press Trust of India