NEW DELHI/ERNAKULAM: In a setback, the first samples of state-owned HLL Lifecare Ltd’s indigenous rapid antibody test kits that was sent to Kerala has failed quality tests, three people in the know told Mint.
"Out of 100-odd samples, a first batch has failed the quality test. It had accuracy problems. We have sent the samples for the second round of testing, based upon HLL request," said one of the sources, a public official in Kerala who is privy to the talks, requesting not to be named.
The second testing, on a fresh batch of samples, will be done in the Alappuzha field station of National Institute of Virology, the official cited above said.
The sample kits are undergoing testing under an internal trial before the company can start mass production for a tender for the Kerala government as well as for other states, another source in the know told Mint, again on condition of anonymity.
The raw material for these kits were sourced from Canada, after which it was assembled by HLL Lifecare in India. The company was undertaking initial testing of the sample kits, which turned out to be a failure, the second source said.
Kerala Medical Services Corporation, the state’s nodal agency for medical procurement and public sector unit, had floated a tender for purchasing 1 lakh testing kits, anticipating an influx of large number of expats who will require screening. An estimated five lakh migrants are expected to return from West Asia.
Thiruvananthapuram-based HLL Lifecare had won the tender by quoting the lowest bid at ₹336 per kit. Following that, the first batch of samples were sent to an expert team at the state-run public health lab in Thiruvananthapuram for testing, which turned out to be a failure. The test's report was sent to the state health secretary Rajan Khobragade on Wednesday, the first source said.
Khobragade did not respond to queries. Calls and messages sent to HLL Lifecare chairman and manging director K. Beji George and Balram Bhargava, health research secretary and director Indian Council of Medical Research (ICMR), remained unanswered at the time of publishing.
The failure of the first batch of samples of these testing kits could delay rapid antibody testing and India’s surveillance programme for determining the extent of covid-19 spread in hotspots across the country, especially at a time when large parts of the country will be exiting the 40-day lockdown on Sunday.
Rapid antibody test has been approved for surveillance purpose and not for diagnosis. These kits measure whether a person has the antibody against the novel coronavirus, which shows that the 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 reverse transcriptase-polymerase chain reaction (RT-PCR) test kits due to the time taken for antibodies to develop in the blood stream.
RT-PCR test kits measure the viral load of the disease using throat or nasal swabs and are considered the gold standard for the diagnosis of covid-19.
ICMR operates the National Institute of Virology, which had validated the antibody test kits for use in India.
Earlier this week, ICMR issued an advisory to discontinue the use of two brands of rapid antibody testing kits imported from China—Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics—after their use in field conditions showed “wide variation in sensitivity", meaning they failed to meet quality norms.
Following that, on Tuesday, Drug Controller General of India V.G. Somani wrote a letter to state drug controllers telling them that the apex regulator has barred imports of the kits. Somani has also issued a show cause notice to the two companies.