After assessing rapid antibody testing kits which were reportedly showing faulty results, the Indian Council of Medical Research (ICMR) on Monday asked states to stop using kits made by two Chinese companies Wandfo Biotech and Livzon Diagnostics. They have also asked states to return the kits to the suppliers.
“Some States have raised issues regarding their performance during the testing exercise that they have undertaken. ICMR, thereafter, has also evaluated the kits of Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics in field conditions. The results have shown wide variation in their sensitivity, despite early promise of good performance for surveillance purposes. In view of this, States are advised to stop using these kits procured from the above mentioned companies and return them to be sent back to the suppliers,” it adds.
ICMR also reiterated that rapid antibody kits were only to be used for surveillance purposes and not for diagnosis of COVID-19. The real-time reverse transcription polymerase chain reaction (RT-PCR) are the only ones to be used for COVID-19 testing, it said.
On April 26, the Union government ordered for an indefinite suspension of the use of rapid testing kits after several queries were raised about the uniformity of the results given with the use of these tests. This came after the announcement by officials from the Rajasthan state government on April 21 that the state would no longer be using the rapid test kits after several inaccuracies in reporting of results came to light. The ICMR shortly thereafter asked all states to hold on the use of the testing kits for a period of two days. It then constituted several teams to look into the issue and prepare a report accordingly.
Over 5 lakh rapid test kits were procured by India from two Chinese companies – Wondfo Biotech and Livzon Diagnostics. These kits were to be used to check if an individual has recently been exposed to SARS-CoV-2 based on the presence of antibodies in their blood.
However, the Chinese manufacturers of the kits claimed that the kits are working fine; and the fault must have lain with how the healthcare workers administered the tests. Apart from India, complaints regarding the kits have also been raised in the United States.
Rapid tests are conducted by taking a small blood sample via a pinprick which is then checked for presence of antibodies to SARS-CoV-2. Not only do these test results yield quicker results than the standard RT-PCR test, they are also cheaper. RT-PCR (real-time polymerase chain reaction) is done by taking nasal and throat swabs of an infected person which are then analysed for the presence of viral genetic material. One test can cost up to Rs 4500 at a private hospital.