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No Major Report of Discordant Results Reported by Covid-19 Testing Labs: Government | India News


NEW DELHI: So far, Covid-19 testing labs have not reported any “major reports of discordant test results,” Health Minister Ashwini Choubey told Rajya Sabha on Monday.
I was answering a question about whether the price limitation on Covid-19 tests has forced several labs to use relatively inexpensive kits, increasing the risk of false negatives and compromising data.
Taking into account the rapid monitoring of the approval of test kits, the increase in indigenous manufacturing, the inclusion of alternative platforms such as CBNAAT and GeneXperts, better market availability at competitive prices, the Ministry of Health of the Union has advised to state governments and administrations of the territory of the Union (UT) that negotiate with private companies. laboratories and set mutually acceptable prices for Covid-19 testing, Choubey said.
Therefore, states and UTs are carrying out the pricing of diagnostic products for Covid-19, it said in a written response.
To ensure the quality of the test kits, the Indian Council for Medical Research (ICMR) performs the validation of the diagnostic kits and provides reports to the manufacturers of the kits, which are used for marketing authorization, the minister said.
In addition, for RT-PCR testing, the ICMR under the “Inter-Laboratory Quality Control for Molecular-Based Testing Laboratories for COVID-19” has identified Quality Control (QC) laboratories in each state and UT and has assigned private testing labs to different QC labs. .
“All testing labs should contact recommended QA labs and will ensure regular participation in QA activity. So far, participating COVID-19 testing labs have not reported any major report of results from discordant evidence, “Choubey said in response.
In addition, the Central Organization for the Control of Medicines Standards grants “manufacturing / import licenses for diagnostic kits, under the provisions of the Medical Device Rules, 2017, to guarantee the quality, safety and performance of the products,” he said.

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