New Delhi, April 25 (PTI): States and Union Territories have been asked to put on hold the use of Covid-19 rapid antibody test kits till their accuracy is rechecked by apex health research body the Indian Council of Medical Research (ICMR), official sources said on Saturday.
According to the sources, teams constituted by ICMR are analysing the rapid antibody test kits, procured from two Chinese firms, to check their efficacy after some states reported that they are faulty and giving inaccurate results.
Union Health Minister Harsh Vardhan on Friday said the results of the test kits vary from place to place and "it can't be relied upon".
"Moreover, 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 said, "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."
Head of Epidemiology and Communicable Diseases at ICMR, Dr Raman R Gangakhedkar at a press briefing on Tuesday said high variations between the results of the rapid tests and RT-PCR tests, ranging from 6 to 71 per cent, were reported in some states. He had also said that if batches of the rapid test kits are found to be faulty, the company will be asked to replace them.
India has recently procured five lakh rapid antibody test kits from two Chinese firms and they were distributed to states for districts with high burden of Covid -19 infection.
The ICMR on April 22 had issued a protocol reiterating the usage of these kit for surveillance purpose while stating that RT-PCR tests must be continued vigorously as the principal diagnostic test for Covid -19.
"The ICMR has always emphasised that the confirmatory test for diagnosis of Covid -19 infection is RT-PCR test of throat and/or nasal swab for detection of the virus at early stage," the apex health research body had said.
At present, the government uses the polymerase chain reaction (PCR) test from throat or nasal swab samples of people to detect coronavirus. This test takes around five to six hours to show results. In the rapid antibody test, blood samples of suspected cases are collected for examination and the wait period for the result is around 15-30 minutes.
Earlier the government had said that rapid antibody test kits are to be used for surveillance and epidemiological purposes in coronavirus hotspot areas.
"The RT-PCR test is the gold standard for frontline test and antibody test cannot replace this. Utility of rapid antibody test is primarily for assessing prevalence of infection in a particular area," an official had said earlier.
Ready to cooperate with Indian agencies — Chinese suppliers of rapid test kits
Two Chinese pharma companies, which supplied 5.5 lakh rapid testing kits for Covid -19 to India, said they are ready to cooperate with Indian agencies looking into allegations of poor accuracy of their products.
In separate statements, Guongzhou Wondfo Biotech and Livzon Diagnostics said they follow strict quality control of their products, asserting that specified guidelines must be followed in storage of the kits as as well in their usages to get accurate results.
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 following complaints that they are not fully effective in detecting coronavirus infection.
Last week, India procured 5.5 lakh rapid antibody test kits from these two Chinese firms and they were distributed to several states reporting rising cases of coronavirus infection.
While Guongzhou Wondfo Biotech supplied 3 lakh test kits, Livzon Diagnostics delivered 2.5 lakh.
Livzon Diagnostics, in its statement said: "We are shocked to receive negative reports from India related to poor accuracy of Covid 19 rapid testing kits made in China including our brand. We have shown great concern on this issue, and we are willing to coordinate with the related government departments for investigation."
The company said it fulfilled all required quality control standards prescribed by Chinese government and that the company has been exporting the product to at least 10 countries including Brazil, Peru, Columbia and several European nations.
"The test kits should be stored at a temperature between 2 and 30 degree celsius and should not be frozen... If the storage temperature is too high, the accuracy of the test may be influenced," it said.
In its statement, Guongzhou Wondfo Biotech said the company has been exporting the kits to more than 70 countries and that the product was validated and approved by the ICMR through National Institute of Virology in Pune.
"In the process of exporting the products to overseas countries, Wondfo fully cooperates with relevant health authorities in each country to carry out various verifications on the sensitivity and specificity of our products," it said.
The statements by the two companies were released to the media by an official of the Chinese embassy here.
At present, the government hospitals have been using 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.
India has been facing severe shortage of testing kits in view of rising cases of the coronavirus.