India Develops Indigenous RT-PCR Testing Kit For Mpox

TheCentral Drugs Standard Control Organisationhas granted approval toSiemens Healthineers for the manufacture of RT-PCRtesting kits for detection ofMpox.

• The kits will be manufactured by the company’s molecular diagnosticsmanufacturing unit in Vadodara,which has a production capacity ofone 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.

IMDX Monkeypox Detection RT-PCR:

• “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.

Note:

The WHO, said in a statement on August 2, 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.

Global Strategic Preparedness and Response Plan:

The World Health Organization (WHO) launched a global Strategic Preparedness and Response Plan to stop outbreaks of human-to-human transmission of mpox through coordinated global, regional, and national efforts.

• This follows the declaration of a public health emergency of international concern by the WHO Director-General on August 14.

The current plan is subject to inputs by Member States, who were briefed on the plan.

The plan covers the six-month period of September 2024 – February 2025, envisioning a $135 million funding need for the response by WHO, Member States, partners including Africa Centres for Disease Control and Prevention (Africa CDC), communities, and researchers, among others.

The plan, which builds on the temporary recommendations and standing recommendations issued by the WHO Director-General, focuses on

iimplementing comprehensive surveillance, prevention, readiness and response strategies;

iiadvancing research and equitable access to medical countermeasures like diagnostic tests and vaccines;

iiiminimising animal-to-human transmission; and

ivempowering communities to participate in outbreak prevention and control actively.

• To interrupt transmission chains, strategic vaccination efforts will focus on individuals at the highest risk, including close contacts of recent cases and healthcare workers.
• At the global level, the emphasis is on strategic leadership, timely evidence-based guidance, and access to medical countermeasures for the most at-risk groups in affected countries.