In a setback to India’s rapid testing-based surveillance, the first samples of state-owned HLL Lifecare Ltd’s indigenous rapid antibody test kits failed quality tests, three people said, requesting anonymity.
“Out of the 100-odd samples, the first batch had accuracy problems. We have sent the samples for a second round of testing, based upon HLL’s request," said a Kerala government official. The first batch of HLL’s test kits were sent to Kerala.
The second testing, on a fresh batch of samples, will be done at the Alappuzha field station of the National Institute of Virology (NIV), he added.
The development could delay rapid antibody testing and India’s surveillance programme for determining the extent of covid-19 spread in hotspots across the country.
The sample kits are being tested as part of an internal trial before HLL can start mass production, but they have failed to meet standards, the second person said.
The raw material for these kits were sourced from Canada, and was assembled by HLL, he added.
Kerala Medical Services Corp., the nodal agency for medical procurement, had floated a tender for purchasing 100,000 testing kits as it expects 500,000 expats from West Asia to return to the state soon.
Thiruvananthapuram-based HLL Lifecare had won the tender with the lowest bid at ₹336 per kit.
The first report was sent to the state health secretary Rajan Khobragade on Wednesday, he said.
Khobragade was unavailable for comment, despite several calls. Calls and messages to K. Beji George, HLL Lifecare chairman and managing director, and Balram Bhargava, health research secretary and director Indian Council of Medical Research (ICMR), remained unanswered at press time.
ICMR operates the NIV, which had validated the antibody test kits.
While reverse transcriptase-polymerase chain reaction (RT-PCR) tests measure the viral load of the disease using throat or nasal swabs and are considered the gold standard for the diagnosis of covid-19, the rapid antibody test has been approved for surveillance, and not for diagnosis.
Rapid testing kits, which measure whether a person has developed an antibody against the novel coronavirus, shows whether a person has been exposed to the virus.
However, while the rapid kits can provide results in less than half an hour, they can only be used at a much later stage than RT-PCR test kits due to the time taken for antibodies to develop in the bloodstream.
Earlier this week, ICMR issued an advisory discontinuing the use of two brands of rapid antibody testing kits imported from China—Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics—after tests in field conditions showed “wide variation in sensitivity" and failed to meet quality norms.
On Tuesday, Drug Controller General of India V.G. Somani informed state drug controllers that it has stopped imports of the kits from China.
Somani also issued a show-cause notice to the two companies.