NO TESTING LAB REPORTED DISCORDANT RESULTS: GOVT
‘To ensure the quality of test kits, ICMR undertakes validation of diagnostic kits and provides reports to kit manufacturers’
NEW DELHI: Till now no "major report of discordant test results" has been reported by COVID-19 testing laboratories, Minister of State for Health Ashwini Choubey told Rajya Sabha on February 9. It was inadvertently reported as a reply given on March 8.
He was responding to a question on whether capping the price of COVID-19 tests has forced several labs to use relatively inexpensive kits raising the risk of false negative and compromising data.
Keeping in view fast tracking of approval of test kits, increasing indigenous manufacturing, inclusion of alternative platforms like CBNAAT and GeneXperts, improved market availability at competitive prices, the Union health ministry has advised state governments and union territory (UT) administrations to negotiate with private labs and fix mutually agreeable prices for COVID-19 testing, Choubey said.
Fixing price of diagnostic products for COVID-19 is therefore being undertaken by states and UTs, he said in a written reply.
To ensure the quality of test kits, the Indian Council of Medical Research (ICMR) undertakes validation of diagnostic kits and provides reports to kit manufacturers, which is used for marketing authorisation, 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 mapped private testing labs to different QC labs.
"All testing labs need to liaise with the recommended QC labs and will ensure regular participation in QC activity. Till now no major report of discordant test results has been reported by the participating COVID-19 testing laboratories," Choubey said in his reply.
In addition, the Central Drugs Standard Control Organization grants "manufacturing/import licenses for diagnostic kits, under the provisions of Medical Device Rules, 2017, to ensure quality, safety and performance of the products", he said.