Doubts Over Antibody Tests From China: Here's What We Know So Far

Doubts Over Antibody Tests From China: Here's What We Know So Far

After procuring around 5 lakh antibody kits from China, the government has now cancelled the order as some states complained of inaccuracy and fault.

In order to ramp up the number of COVID-19 tests, India, like many other countries has been trying to advance the usage of rapid antibody tests - surveillance tests that can indicate if someone has contracted coronavirus in the past, as reported by FIT earlier.

These tests indicate how far and wide an infection has spread and are called rapid tests because the result comes back within 20-30 mins. It is important to note that these are not diagnostic tests.

In order to boost the capacity, India imported 5 lakh test kits from two Chinese companies, which were further distributed to various states.

But all that came to a grinding halt on 28 April.

On Monday, the apex body dealing with India's COVID-19 strategy, the Indian Council of Medical Research asked the states and union territories to stop using the rapid antibody COVID-19 testing kits procured from China due to "wide variation" in their performance and also maintained that not a single rupee will be lost as payments were not made to the Chinese suppliers of the equipment.

Now, Congress is calling the whole mess a "scam," antibody testing has slowed down, and senior Congress Leader, Shashi Tharoor is asking a pertinent question. "Why did the government "waste" money on these kits when other countries had already complained of its accuracy and India has many options at home."

Here's what's happened:

Also Read: India Cancels Chinese Antibody Kits: Can You Trust Rapid Tests?

The first state to register an issue with the Rapid Antibody tests and and stop the use was Rajasthan. The state's CM Ashok Gahlot, as per Indian Express, said,

“ICMR had sent us 30,000 kits while 10,000 kits were directly procured by us. But unfortunately, the results of these kits - which were brought after much difficulty- are doubtful. And it is a very serious situation.”

Rajasthan had reported the accuracy of these tests as mere 5.4 percent. Further, West Bengal too had complained about the quality of the test kits.

Taking note of these grievances, ICMR in its daily press conference last week had asked the states to stop using antibody test kits for 2 days - which now has turned into full cancelation.

What is the Govt Saying?

On Monday, the Union Health Ministry said, "Based on scientific assessment of their performance, the order in question (Wondfo - one of the Chinese companies) along with an order from another company was found under-performing have been cancelled."

It further said,

"The ICMR has not made any payment in respect of these supplies. Because of the due process followed (not going for procurement with 100 percent advance amount), Government of India does not stand to lose a single rupee."

The government also said the ICMR tried to procure the kits directly from Wondfo in China, but the quotation received for direct procurement had a number of issues including a condition for making 100 percent direct payment as advance without any guarantees.

It said there was no commitment on timelines and rates were communicated in US dollars without any clause for accounting for fluctuations in prices.

"Hence, it was decided to go for Wondfo's exclusive distributor for India for the kit who quoted an all inclusive price for FOB (logistics) without any clause for advance," it added.

For now, while the order remains cancelled, what of the tests themselves?

Also Read: Rajiv Gandhi Centre for Biotechnology Develops Antibody Test Kits

What is ICMR's Advisory on Antibody Tests?

In one of its initial advisories for the use of antibody kits, ICMR had said, the kits will be used for reporting clusters (containment zone) and in large migration gatherings/evacuees centres. It maintained that the kits can't be used for diagnostic purposes.

ICMR's main goal to introduce these tests was to do population screening for COVID-19, say experts. Since these tests check the antibodies created by the body in response to coronavirus, they can only tell if the person was infected earlier. It is not a diagnostic test, for that the gold standard remains RT-PCR.

However, after cancelling the order of these kits from China and stopping the use, in a new advisory on Monday, ICMR said, "ICMR advocates that RT-PCR throat/nasal swab test is the best use for diagnosis of COVID-19. RT-PCR test detects the virus early and is the best strategy to identify and isolate the individual."

Chinese Companies Respond

After ICMR's new advisory was released, Guongzhou Wondfo Biotech, one of the companies whose order was cancelled, took to Twitter to respond.

Livzon Diagnostics too said they follow strict quality control of their products asserting that specified guidelines must be followed in storage of the kits as well as in their usages to get accurate results.

What are Politicians Saying?

Amid the row over the pricing for these kits, Rahul Gandhi, former Congress president alleged a "scam" and said,

“If any human being would try and profiteer from the immeasurable suffering of millions of his brothers and sisters, then it is beyond belief and comprehension. This scam is an insult to every Indian. I urge the PM to act swiftly to bring the corrupt to justice.”

The Congress cited media reports about the test kits being sold to the government at around 150 per cent profit. Congress chief spokesperson Randeep Surjewala also said it was "shameful and inhuman" that people were supplying test kits bought for Rs 225 at Rs 600 to the state exchequer.

In a fact sheet on the issue, the government said it had conducted a tender process to procure the kits and the evaluation committee received four bids of Rs 1,204, Rs 1,200, Rs 844 and Rs 600. Accordingly, bid offer of Rs 600 was considered as it was the lowest.

(With inputs from PTI)

Also Read: Rapid Antibody Tests on Hold, Some Have Issue in Detection: ICMR