Even as the Indian Council of Medical Research (ICMR) cancelled the rapid antibody test kit order from one Chinese company and asked states to put the use of such kits on hold, industry insiders say more accurate testing methods are getting evolved and may be considered by the country soon.
The controversy around the efficacy and pricing of the rapid tests may change the way India now tests for the novel coronavirus. Sources say once the final results on these tests are out, India is likely to include these in the testing protocol for coronavirus disease (Covid-19).
An industry source revealed that discussions are on with the government to consider these tests. “Once, the final outcomes on these tests come, in around a month or so, we can start importing these kits if the government approves,” said the source.
By the middle of May, more clarity is expected on ELISA (enzyme-linked immunosorbent assay) test that has better sensitivity and is expected to have 95 per cent accuracy as opposed to 60 per cent accuracy of the rapid antibody tests. Another test, using chemiluminescence technology, is also under consideration. The accuracy is expected to be higher, in the range of 99 per cent.
“ELISA is highly sensitive and specific and is able to detect HIV-1/ HIV-2 and variants. It requires sophisticated equipment, a constant supply of electricity, and skilled technicians. It is not suitable for small laboratories, but for testing large numbers of samples per day, as well as in blood banks or for surveillance studies. The simple or rapid tests are better for emergency testing, and in smaller laboratories with low numbers of tests per day,” the World Health Organization has said on its website.
Rapid antibody test kits work like home pregnancy kits which come with a test strip. A few drops of blood from a pinprick on the strip can show results in 15-20 minutes. The test basically detects both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies. As India’s total Covid-19 deaths neared the 900-mark, ICMR on Monday cancelled Chinese company Wondfo’s rapid testing kits. On April 16, India had taken delivery of 500,000 rapid antibody test kits from China, of which around 300,000 kits were sourced from Wondfo, the rest from another Chinese company Livzon.
This leaves India’s testing scene in a mess. ICMR had earlier advised rapid tests to be used in hotspots, only recalling the advisory later. India is estimated to have an inventory of just over 300,000 real-time polymerase chain reaction (RT-PCR) kits.
At present, close to 38,000 samples are being tested daily. Meanwhile, industry veterans said the rapid antibody tests are not very useful for diagnosis of Covid-19. A Velumani, founder and chairman of a private diagnostic lab chain Thyrocare, reasoned that here are a large number of patients who are Covid-19 positive, but they do not have sufficient antibodies in their body to be diagnosed through such tests.
“We were in a hurry, and we thought we could do rapid tests, and within minutes know if someone is Covid-19 positive. Easy to do is not what is right to do, and in this case, this test has its limitations,” said Velumani. A controversy erupted on the prices being paid for the Wondfo test kits as a Delhi High Court (HC) case revealed massive profiteering by an importer (Matrix Labs) and distributors Rare Metabolics Life Sciences and Aark Pharmaceuticals.
ICMR had placed an order of 500,000 kits with Aark at a price of Rs 600 plus goods and services tax. According to the details provided in Delhi HC, the antibody test kits procured from China were sold to ICMR at a huge mark-up of 145 per cent.
On Monday, ICMR said since it had not made any payments towards supplies of these test kits, it has not cost the government “a single rupee”.
On Tuesday last week, ICMR had asked states to stop using the test kits for two days after receiving complaints of poor detection and faulty results. The kits of two companies, Wondfo and Biomedemics, were identified for procurement by ICMR since both had the requisite international certifications.
ICMR had also tried to procure these kits directly from Wondfo, but could not go ahead with the order since the company asked for 100 per cent advance payment without any guarantees on timelines and quoted the dollar price without any clause for accounting for fluctuations in prices.
“It was decided to go for Wondfo’s exclusive distributor for India for the kit who quoted an all-inclusive price for free-on-board (logistics) without any clause for advance,” said ICMR.
For Wondfo, the lowest kit offer of Rs 600 was considered. The order was cancelled, based on ICMR’s “scientific assessment of performance”.
“It needs to be also remembered that this was the first-ever effort by any Indian agency to procure such kits and the rate quoted by the bidders was the only reference point,” said ICMR in a statement.