Siemens Healthineers Develops RT-PCR Testing Kit for Mpox Detection In India
The RT-PCR testing kit has already bagged manufacturing approval by the national drug regulator Central Drugs Standard Control Organisation.
Two weeks after the World Health Organisation declared Mpox a global health emergency, India has developed its own home-grown RT-PCR testing kit for detecting Mpox. The testing kit will show results in 40 minutes, which is significantly faster than the traditional testing kits, which take one to two hours to give the output.
The RT-PCR kit is developed by Siemens Healthineers (rebranded from Siemens Healthcare Pvt.) and has already bagged manufacturing approval by the national drug regulator, the Central Drugs Standard Control Organisation.
The IMDX Mpox detection RT-PCR assay by Siemens Healthcare will be manufactured at the company's manufacturing molecular diagnostics unit in Vadodara, which has a manufacturing capacity of 1 million reactions per year, the company told ANI. The factory is all set to make the kits available, it said.
The RT-PCR testing kit will reportedly target two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus, to detect viruses of different strains. The new testing system can be used with the Covid-19 testing infrastructure; hence, there is no need for new instruments.
The new testing kit is clinically approved by ICMR-National Institute of Virology, Pune. The assay has 100% sensitivity and specificity. IMDX Mpox RT-PCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards, ANI reported.
On Monday, the World Health Organisation launched a global strategic preparedness and response plan to tackle the Mpox outbreak seen in African countries. The plan will include strategic vaccination focused on individuals with higher risks, including people in close contact with recent cases and also healthcare workers to break transmission chains.
Further, at the global level, the emphasis is on strategic leadership, timely evidence-based guidance, and easy access to medical countermeasures for the most at-risk groups in affected countries.
"The plan covers the six-month period of September 2024-February 2025, envisioning a US$135 million funding need for the response by WHO, member states, partners including African Centres for Disease Control and Prevention Africa, communities, and researchers, among others," WHO said.
Several countries around the globe have reported cases of mpox, with Africa witnessing an outbreak. Thailand and Pakistan have also found patients with mpox symptoms, with the Pakistan-occupied Kashmir region reporting four cases. The central government in India has also given a heads-up against mpox but also cited that the risk of an outbreak is currently low for India.
However, healthcare centres and checking points have been planted at airports, while a few wards in some healthcare centres have been reserved as preventive measures. Meanwhile, the Serum Institute of India has also announced that it is working on the development of a vaccine against mumps.
