New Delhi: The Indian Council of Medical Research (ICMR), the apex body for the formulation, coordination and promotion of biomedical research in the country, has urged all the state governments to India to stop using rapid antibody blood test kits for COVID-19 provided by two Chinese companies. The ICMR has also urged all states and union territories to return these kits, saying “their results have shown wide variation in the sensitivity”.
In a letter to all the chief secretaries of states and union territories, ICMR wrote that it had advocated that RT-PCR throat/ nasal swab test was deemed to be the “best use for diagnosis of COVID-19” as it “detects the virus early and is the best strategy to identify and isolate the individual.”
The Additional Director General of the Council said, “several states have procured rapid antibody test kits and on their demand, ICMR has also provided these kits with clear instructions that they are to be used only for surveillance purpose.”
States raised issues about performance of kits
The advisory to the States and UTs further noted as regards the rapid antibody blood tests “some states have raised issues regarding their performance during the testing exercise that they have undertaken.”
The Council said it thereafter “evaluated the kits of Guangzhou Wondfo Biotect and Zhuhai Livzon Diagnostics in field conditions” and “the results have shown wide variation in their sensitivity, despite early promise of good performance for surveillance.”
In view of this, it said “the States are advised to stop using these kits” procured from the two Chinese companies and to return them to the suppliers.
Also read: ICMR Purchased Rapid Test Kits at 145% of Landed Price, Delhi HC Case Reveals
Many states like West Bengal, Rajasthan complained
Earlier, the Council had on April 21, advised the states to stop using the test kits for two days as it wanted to examine their quality in the wake of a large number of complaints received from several states – including West Bengal and Rajasthan – that these kits were not very effective.
The two companies in question had, however, claimed that the problem lay not with their kits but with the manner in which they were being used by the healthcare workers.
The companies had together provided 500,000 rapid antibody test kits and these were distributed to several states that had reported a large number of COVID-19 cases.
`High variations reported with kits’
During a media interaction a couple of days ago, the Head of Epidemiology and Communicable Diseases at the ICMR, Dr Raman R. Gangakhedkar, had also stated that these kits would be returned to the companies if they were found to be faulty.
On the nature and quantum of complaints, he had said: “We have received complaint from one state and so far discussed the issue with three states. High variations ranging from 6 to 71 per cent have been reported between the results of the rapid tests and RT-PCR tests. We will advise states not to use these testing kits for the next two days.”
Australia, European countries also had problems with Chinese kits
Earlier, several European countries, including Spain, which has witnessed the highest number of COVID-related cases and deaths in the region, had also returned such testing kits bought from Chinese companies.
Other countries like The Netherlands, Slovakia and Australia have also had problems with Chinese kits and some other therefore went for South Koran made kits.
Company ‘disappointed’
One of the two companies – Wondfo Biotech – has issued a statement expressing ‘disappointment’ at ICMR’s decision. The company said it is confident about the quality of its products and is “investigating the ICMR’s concerns”.
