Rapid test kit shipment delayed again amid urgent requirement

The rapid testing kits, which were supposed to be here on April 5, and then April 10, will now be here by April 15, the Indian Council of Medical Research (ICMR) said on Monday, commenting on what could well be the lynchpin of the next phase of India’s strategy to combat the coronavirus disease — widespread (and rapid) testing, not just in hot spots and containment zones but also areas relatively free of the virus.

Called Rapid Test Kits, or RTKs, these are blood tests that search for antibodies in the sample of those tested — a positive test means the person is or has been infected by the virus. Apart from being a fast way to identify the extent of infections in clusters, countries around the world are looking to use these tests to determine who has immunity to the Sars-CoV-2 virus that causes Covid-19.

As such, they are in demand everywhere. Unlike the RT-PCR tests currently in use, which take up to five hours to throw up a result, RTKs give out results in 30 minutes. However, ICMR’s protocol requires a confirmatory RT-PCR test to back up a negative RTK result.

“We cannot comment on whether our Chinese consignment of rapid testing kits got diverted to the US or somewhere else because we neither maintain commercial data nor are we manufacturers who would know where our supplies are going. Kits are coming from China, and we have been told some of the kits should reach us by April 15,” said Dr Raman R Gangakhedkar, head, division of epidemiology and communicable disease, ICMR.

An ICMR official who asked not to be named said that after many kits failed quality tests, the Chinese regulator, National Medical Products Administration, restricted exports, allowing only five to six companies to sell them.

“Quality control is important as there is no point in getting a product and then realising it is of no use. The products from China have to be cleared by their local regulator and we will also conduct tests on batches to check their accuracy on a random basis,” added this person.

In addition to the order for 500,000 kits that has already been placed, ICMR raised a tender on April 11 for 4.5 million more rapid testing kits to be delivered in batches. The plan is to have the first batch in by May 1 and the final batch latest by May 31.

India ordered 500,000 kits from Chinese suppliers on March 30, and in anticipation of the arrival of the kits first on April 5, India issued an advisory on starting rapid antibody testing on April 4, and revised the testing guidelines on April 9 to include rapid testing of all symptomatic individuals in hot spot areas with symptoms at least a week old.

In addition, several Indian states have also placed orders for RTKs.

Tamil Nadu, for instance, awaits 400,000 RTKs from China in order to scale up testing across the state

“The consignment which was to come to India is not for Tamil Nadu alone. Reports from the vendor’s side suggest seven lakh kits (700,000) were supposed to be shipped out, of which five lakh was for the government of India, one lakh for Tamil Nadu and another one lakh for other states. Unfortunately, due to some issues, these never made it out of China,” a state government official said on condition of anonymity.

Tamil Nadu health secretary Beela Rajesh said on Monday that the kits were expected to reach the state within two days, but Tamil Nadu has already expanded its testing pool using existing RT-PCR tests. “We have ordered rapid test kits that will serve as a screening and surveillance tool. We have already ordered four lakh kits, and they will reach us in a day or two. But we are not waiting for that [to scale up screening]. The confirmatory test is our PCR test and that is now deployed as part of a large-scale massive testing.”

On Saturday, Tamil Nadu chief secretary K Shanmugam told reporters that China had diverted kits meant for India to the US.

HLL Lifecare Limited, a public sector company whose rapid antibody testing kit is approved by ICMR, will start manufacturing kits this week and may be able to deliver some to the government for large-scale testing in the community by the end of the week.

But other domestic manufacturers are dependent on China for some components to manufacture these kits, and constrained by an embargo on exports of these components.

On April 10, the National Institute of Virology (NIV), Pune, said eight antibody-based rapid tests have been validated and found satisfactory by the facility. Some of those test kits are made by Indian manufacturers.

“HLL got a clearance from Indian Council of Medical Research, National Institute of Virology, Pune to manufacture rapid antibody testing kits but we were awaiting a license from the Central Drugs Standard Control Organisation (CDSCO) which we have received today. Manufacturing is likely to start in the next three to four days in our Manesar plant. In the initial phase, we plan to manufacture two million kits till May 30,” said an HLL executive who asked not to be named.

A member of the Association of Diagnostics Manufacturers of India (ADMI), a body representing testing kit manufacturers, said some of the important components for the kits are imported from China. “China has an embargo on exports now. This has slowed down manufacturing of these kits in India. The process takes time, if your order hasn’t been delivered by a vendor, you will have to then look for other vendors. Logistics are not at their best now.”

Dr Tarun Bhatnagar, epidemiologist, ICMR-National Institute of Epidemiology, said: “Antibody testing will not tell us who is currently infected. It will tell us who has been infected in the past. Generally, antibodies are developed five to seven days after contracting the infection. If people test positive, it tells us that they were exposed to the virus sometime in the past and developed no symptoms or very mild symptoms. Firstly, such testing tells us how widespread the infection is in the community and how large is the proportion of asymptomatic patients because infection spreads more from a person who is symptomatic. It tells us what is more common, mild symptoms or severe. Antibody tests are required to understand the virus. It is a surveillance tool and is cheaper than RT-PCR (which detects active infection).”

Veena Kohli, CEO of Vanguard Diagnostics Limited, which has also been validated for manufacturing of these kits and president of ADMI, said: “The Indian diagnostics manufacturers are working earnestly towards making the detection kits available for the screening of Covid-19 infection. Depending on the assay design of the manufacturer’s product, each kit has some imported and some indigenous components. A majority of these components including antibodies and antigens are imported from China. As we are given to understand, the Chinese government has slowed down the process of export. The Indian manufacturers are also developing alternative sources of raw materials and components to tide over the current situation.”