India Unveils New Standards for HMPV Testing Kits: Quality Protocols Set to Enhance Healthcare

New Delhi: The Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR) are working on new standards for Human Metapneumovirus (HMPV) testing kits. This move comes after a recent increase in HMPV cases in India.

On January 6, the union health ministry reported two HMPV cases in Karnataka found by the ICMR during routine checks. Just a few days later, reports indicated around 200 cases had been recorded in India by December.

Currently, there’s a lack of consistency in how these test kits are evaluated, leading to varying results. The global focus on HMPV intensified after China noted a rise in respiratory illnesses with flu-like symptoms in December.

The CDSCO and ICMR aim to ensure reliable and high-quality diagnostic tools are available in India. Their draft guidelines seek to standardize how in-vitro diagnostic (IVD) kits are tested. They will verify that manufacturers’ claims about their kits are accurate, particularly for HMPV testing.

HMPV can infect people of all ages, especially during the winter and early spring. The guidelines are open for industry feedback until March 15 before finalization.

An official emphasized that accuracy in testing is crucial. “Currently, the National Institute of Virology (NIV) conducts tests, but these guidelines aim to provide consistency,” the official noted.

For effective HMPV detection, nasopharyngeal or oropharyngeal swabs are typically used. The guidelines suggest that if a kit claims to work with multiple sample types, it should be evaluated accordingly.

Market research indicates that India’s in-vitro diagnostics market was valued at approximately $1.69 billion in 2023 and may reach around $2.56 billion by 2030.

The draft also highlights the need for proper training for all personnel involved in evaluating HMPV kits. They must be skilled in handling kits, storing samples, and interpreting results accurately.

Another critical point in the guidelines is that if a kit is deemed substandard, requests for repeat testing will not be accepted. A new request will only be considered if there’s proof of changes in the kit’s composition.

These kits may also be useful for detecting other pathogens like Rhinovirus and Respiratory Adenovirus, adding another layer to their importance in public health.

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