India plans standard evaluation and quality protocols for HMPV’ testing kits | Today News

New Delhi: Drug regulator Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR) are firming up standard evaluation and quality protocols for Human Metapneumovirus (HMPV) testing kits following a recent surge in cases.

The union health ministry on 6 January reported 2 cases of HMPV in Karnataka detected by ICMR during routine surveillance. However, on 9 January, Mint reported that India had witnessed around 200 HMPV cases till December last year.

There is no uniformity in the performance evaluation of such kits at present, which leads to variations in test results. HMPV attracted attention globally after China reported a surge in respiratory illness with flu-like symptoms in December.

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“CDSCO and ICMR have aimed at facilitating the availability of quality-assured diagnostics kits appropriate for use in India. The guidelines shall establish the uniformity in performance evaluation of in-vitro diagnostic kits (IVD). The performance evaluation is to independently verify the manufacturer’s claim regarding in-vitro diagnostic kit (IVD) performance. This recommendation focuses on the laboratory performance evaluation of Human Metapneumovirus (hMPV) virus real time PCR kit,” said a guidance document seen by Mint.

HMPV is one of many respiratory viruses that can cause infections in people of all ages, especially in the winter and early spring months. The draft guidelines have been issued, with the industry’ comment sought by 15 March to finalize the protocol. 

“Quality and safety are very important in testing samples. It should be100% accurate and most of the time, manufacturers claim, it is not. Right now, for HMPV, National Institute of Virology (NIV) does the testing along with other central labs. This guideline will bring uniformity and consistency,” said an official aware of the matter.

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The official added that the performance evaluation is to independently verify the manufacturer’s claim regarding in-vitro diagnostic kit performance.

The document stated that the sample type for HMPV detection is nasopharyngeal/oropharyngeal swab. “If a kit claims to detect HMPV across several sample types, an attempt should be made to evaluate the assay across all the sample types,” it said.

The market size of In-Vitro-Diagnostic tools in India was valued at around $1.69 billion in 2023 which is expected to reach $ 2.56 billion in 2030, according to the BlueWeave Consulting, a market research firm.

The document said that all the staff involved in HMPV virus IVD evaluation should undergo training and competency testing in handling the kits, samples, storage, recording, interpreting, privacy, and reports of the test results.

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The draft said that after following due procedure, if any kit is found to be Not of Standard Quality, no request for repeat testing of the same kit will be acceptable. 

“Any request of re-validation from the same manufacturer for the same test type will only be entertained if valid proof of change in the kit composition is submitted,” said the document. The kits can also be used for other bacterial and virus pathogens such as Rhinovirus, Enterovirus, Respiratory Adenovirus etc.