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After kits from China showed inaccurate results, the government of India has decided to withdraw "faulty" rapid antibody test kits from use and cancel all procurement orders.
"The kits will be withdrawn, and the orders will be cancelled," The Economic Times quoted a senior government official as saying on the condition of anonymity.
In a meeting held by PM Narendra Modi on Monday, April 27, with the Indian Council of Medical Research (ICMR) chief Balram Bhargava, it was decided that all procurement orders will be cancelled and the kits will be withdrawn from use.
India had imported the kits from China after struggling to scale up testing. Once the first set arrived last week, they were dispatched to various states. Several countries reported issues with the kits but China maintained that there was no problem with the quality.
The ICMR then began analysing results from the evaluation of antibody kits that were imported from China, with expert teams being sent to eight states following complaints that inaccurate results were being generated by the kits.
"The results from the field test by ICMR experts showed that they were giving inaccurate results. A batch of Chinese-made kits brought by the ICMR will be pulled as they have been discovered to be unreliable," said the official.
The ICMR has also been under fire for procuring these testing kits at a higher price following a legal dispute that occurred in the High Court between the distributor and importer of the kits unearthed massive profiteering and over-pricing in those sold to ICMR.
It was observed by the court that 61 percent mark-up on these kits is on the "higher side" but "more than sufficient". A 145 pc mark-up was disallowed by the Delhi High Court single bench of Justice Najmi Waziri from landed price of Rs 245 to ICMR's purchase price of Rs 600 per test. He instead slashed the price for every kit by 33 per cent from Rs 600 to Rs 400 per test.
The ICMR officials claimed that they had procured the kits at the states' request. It was disclosed by a DGHS led panel of experts that ICMR took the decision to procure these kits without enough consultation.
After receiving complaints about inaccuracies, ICMR had last week halted antibody testing for two days. It later repeated that the "prescribed protocol" must be followed and the tests should be used only as a surveillance tool for Covid-19 cases.
Claiming that the results have shown "wide variation" in their sensitivity, ICMR said that they will return the antibody test kits to the suppliers.
The kits of Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics were evaluated in field conditions.
"The results have shown wide variation in their sensitivity, despite early promise of good performance for surveillance purposes. States are advised to stop using these kits procured from these companies and return them to be sent back to the suppliers," it said in a statement.
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