Complaints received from West Bengal on quality of RT-PCR kits; temporary arrangements made: ICMR

The ICMR has received complaints related to repeat testing of patients in West Bengal as the RT-PCR kits were not working properly, it said on Monday.

Temporary arrangements have been made so as to enable the state to handle the crisis, it added.

Addressing its daily briefing on COVID-19, head of Epidemiology and Communicable Diseases at the Indian Council of Medical Research (ICMR) Raman R Gangakhedkar said the RT-PCR kits are approved by the US FDA.

The RT-PCR test is the gold standard for frontline test for COVID-19.

"They (West Bengal) complained that the RT-PCR kits were not working properly because of which they had to do repeat tests.

"One has to keep in mind that such kits need to be kept below 20 degrees Celsius temperature. If the temperature is higher, proper test results are not obtained. The complaint about repeat testings may have arisen since the technician may have kept the kits and tried the tests at room temperature.

"We have told the West Bengal government that the kits we use at NIV are sufficient for 10,000 tests and these kits are available at NICED, Kolkata," Gangakhedkar said, adding that these are being provided for temporary use to enable the state deal with the crisis.

Replying to a question on rapid antibody tests coming under the scanner over quality issues, he said rapid tests are not used for individual diagnosis the world over.

"The rapid antibody test is not used for individual diagnosis, as we do not know how powerful the antibody developed will be against the virus. It can be used for surveillance and consistent errors will not affect assessment of infection trends in epidemiological surveys," Gangakhedkar added.

India procured five lakh rapid antibody testing kits from China last week and these were being distributed to states for the districts with a high-burden of the infection, health ministry officials said.

Regarding some states raising concerns over the quality of the kits, Gangakhedkar said rapid antibody tests are CE-IVD approved and quality tests were already done to check their sensitivity and specificity as claimed, and they were found to be satisfactory.