New Delhi: Amid the current outbreak of Mpox, the Central Drugs Standard Control Organization (CDSCO) approved an Indigenous RT-PCR test for the deadly infectious disease that delivers results in just 40 minutes, providing a swift and efficient solution, Siemens Healthineers said on Tuesday.
In a statement, Siemens Healthineers said it received manufacturing approval from the CDSCO for the IMDX Monkeypox Detection RT-PCR Assay. This approval signifies that the test has met the stringent regulatory standards set by the CDSCO, ensuring its reliability and safety in diagnosing Mpox.
“This is a significant achievement for our “Make in India” initiative and a critical advancement in the fight against the Monkeypox public health emergency,” said the company.
This comes as the World Health Organisation, early this month, declared Mpox as a global health emergency, underlining the urgent need for effective diagnostic solutions. The deadly infectious disease is currently causing an outbreak in Africa. It is majorly driven by the more virulent and deadly Clade Ib.
Clade Ib has spread to Sweden and Thailand outside Africa, where 1 case each has been reported so far.
The company said the novel test can produce results “in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours).” This helps reduce the turnaround time for reporting, leading to quicker responses.
The test has also been “clinically validated by ICMR-National Institute of Virology, Pune,” A process that involves rigorous testing and evaluation to ensure the test’s accuracy and reliability. It boasts an impressive 100 percent sensitivity and specificity.
“IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards,” the company said.
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“The urgency for precise and accurate diagnostics couldn’t be more crucial than now,” said Hariharan Subramanian, Managing Director, Siemens Healthcare.
“By providing India with advanced assay kits tailored to combat Monkeypox, 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.
Meanwhile, the company said that the RT-PCR test will be manufactured at its molecular diagnostics manufacturing unit in Gujarat’s Vadodara. The factory, with a capacity of 1 million reactions per annum, is all set to make the kits available.
The “groundbreaking molecular diagnostic test” RT-PCR test targets two distinct regions in the viral genome. It spans both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results.
Clade II was responsible for the 2022 Mpox outbreak that spread to more than a hundred countries.
The company noted that the RT-PCR test “is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups.”
This eliminates the need for new instruments and can be used on existing COVID testing infrastructure, enhancing the test’s efficiency.
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–IANS
