The Central Drugs Standard Control Organisation has granted approval to Siemens Healthineers for the manufacture of RT-PCR testing kits for detection of Mpox, a senior Health Ministry official said on Tuesday.
The kits will be manufactured by the company’s molecular diagnostics manufacturing unit in Vadodara, which has a production capacity of one million tests per annum.
With the RT-PCR kits, the test results will be available in 40 minutes, which is significantly faster than traditional methods that take one to two hours. This will help reduce the turnaround time for reporting, leading to quicker 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 thorough detection across various viral strains, providing comprehensive results. This assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new instruments. The ability to use existing COVID testing infrastructure would enhance the efficiency,’’ Hariharan Subramanian, managing director, Siemens Healthcare, said, adding that the urgency for precise and accurate diagnostics could not be more crucial now.
“By providing India with advanced assay kits tailored to combat Mpox, we are taking a proactive stance in battling this disease and prioritising prompt and precise detection that can truly make a difference in saving lives,’’ he added.
Clinically validated by the Indian Council of Medical Research-National Institute of Virology, Pune, the assay boasts 100% sensitivity and specificity. The RT-PCR kits adhere to Indian statutory guidelines and comply with the highest global standards, the company said.
The Union Health Ministry said the approval for the kit was given last week. India has 32 laboratories equipped for testing Mpox. The Ministry had earlier said India was at a moderate risk of getting Mpox cases with sustained transmission.
On August 14, the World Health Organization classified the outbreak of Mpox as a global health emergency. A new strain of the disease has spread beyond the Democratic Republic of Congo for the first time to at least 12 other African countries.
The WHO, said in a statement on Tuesday (August 27, 2024), it needed $87.4 million over 6 months, from September 2024 to February 2025, to work with countries, partners, and other stakeholders to stop and contain the current outbreak of Mpox.
“These funds will be used by WHO to implement critical activities outlined in the global strategic preparedness and response plan (SPRP) recently. The SPRP is a comprehensive framework developed by WHO to guide the global response to Mpox, emphasizing surveillance, research, equitable access to medical countermeasures, and community empowerment. The required funds will be used across WHO headquarters, regional and country offices, to enable coordination of the response, provide technical assistance, run operations and deliver medical supplies,’’ it said.
