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File photo used for representational purpose only | Photo credit: Reuters
The Central Drugs Standard Control Organisation has approved Siemens Healthineers to manufacture RT-PCR test kits for detecting mumps, a senior Health Ministry official said on Tuesday.
These kits will be manufactured by the company’s Vadodara-based molecular diagnostics manufacturing unit, which has a production capacity of one million tests per year.
With the RT-PCR kit, test results will be available in 40 minutes, which is much faster than traditional methods that take one to two hours. This will help reduce the turnaround time for reporting, leading to faster responses, the company said.
“The IMDX Monkeypox Detection RT-PCR assay is a molecular diagnostic test that targets two distinct regions in the viral genome, spanning both Clade I and Clade II variants of the virus. This ensures deep detection across various viral strains, delivering comprehensive results. The assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new equipment. The ability to use existing COVID testing infrastructure will enhance efficiency,” said Hariharan Subramanian, Managing Director, Siemens Healthcare, adding that the need for accurate and precise diagnosis could not be more critical now.
“By providing India with advanced testing kits to combat ampox, we are taking a proactive approach in fighting this disease and prioritising early and accurate detection, which can truly play a vital role in saving lives,” he said.
Clinically validated by the Indian Council of Medical Research-National Institute of Virology, Pune, the test boasts 100% sensitivity and specificity. The company said the RT-PCR kits adhere to Indian statutory guidelines and comply with the highest global standards.
The Union Health Ministry said the kit was approved last week. There are 32 laboratories in India to test for ampox. The ministry had earlier said the risk of ampox cases being detected in India was medium.
On August 14, the World Health Organization declared the ampox outbreak a global health emergency. A new variant of the disease has spread beyond the Democratic Republic of Congo for the first time and into at least 12 other African countries.
The WHO said in a statement on Tuesday (August 27, 2024) that it needs $87.4 million over the 6 months from September 2024 to February 2025 to work with countries, partners and other stakeholders to prevent and control the current outbreak of ampox.
“These funds will be used to implement critical activities outlined in the WHO’s recent global Strategic Preparedness and Response Plan (SPRP). The SPRP is a comprehensive framework developed by WHO to guide the global response to ampox, with an emphasis on surveillance, research, equitable access to medical countermeasures, and community empowerment. The required funds will be used to enable coordination of the response across WHO headquarters, regional and country offices, provide technical support, run operations, and deliver medical supplies,” it said.
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