India’s indigenous mpox kit has been approved by the Central Protective Drugs Standard Control Organisation (CDSCO). Read on to know more about the kit and how it can detect the infection.
India’s Mpox kit has been approved and will soon be seen on the shelves. It comes at a time when Mpox cases are affecting the healthcare sector across the world. New strains of mpox have been detected in different countries. The World Health Organization (WHO) has already announced its second Public Health Emergency of International Concern (PHEIC) due to monkeypox. The move came after a sudden surge in cases was recorded in parts of Africa. In India, around 30 cases of monkeypox have been detected since 2022. The most recent case in the country was reported in March 2024.
From now on, all countries have been alerted to be prepared with their health protocols. After cases were detected in neighbouring countries like Pakistan, India has also reserved beds in hospitals and issued advisories.
The new strain of this virus (Clad-1) is considered to be more transmissible and has higher mortality rates. Now, India has developed its own indigenous RT-PCR test kit to fight Mpox, which has been approved by the Central Drugs Protection Standard Control Organisation (CDSCO).
India’s Mpox RT-PCR kit is now approved
Siemens Healthineers’ IMDX monkeypox RT-PCR assay has received manufacturing approval from the Central Drugs Standard Control Organization (CDSCO). This is a significant milestone for our Make in India initiative and a critical step forward in the fight against the monkeypox public health emergency.
“The IMDX monkeypox RT-PCR assay will be manufactured at our molecular diagnostics manufacturing unit in Vadodara, which has a production capacity of 1 million reactions per annum. The factory is ready to make the kits available,” Siemens Healthcare Private Ltd. said.
All about Mpox RT-PCR kit
- The diagnostic test will reportedly target two distinct regions of the viral genome, spanning clade I and clade II variants of the virus. This ensures comprehensive detection across multiple viral strains and provides comprehensive results.
- Notably, this assay is platform-agnostic and fits seamlessly into existing laboratory workflows with standard PCR setups, eliminating the need for new instruments. The ability to utilize existing COVID testing infrastructure would improve efficiency. Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited, said the urgency for accurate and precise diagnoses could not be more crucial than now.
- According to Siemens Healthcare Private Ltd, test results will be available within 40 minutes. “With results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the assay helps reduce the turnaround time for reporting, leading to faster responses.
- “The assay, clinically validated by ICMR’s National Institute of Virology, Pune, boasts impressive sensitivity and specificity of 100 per cent. IMDX Monkeypox RTPCR assay kits comply with Indian legal guidelines and the highest global standards,” he said.
Skin rashes, persistent fever, headache, nausea, muscle pain, etc. are some of the signs and symptoms of mpox. If a combination of these warning signs is observed, it is best to get tested immediately and start treatment as soon as possible.
(With contributions from the Agency)
