These days, the threat of monkeypox is looming over the world. This disease, which has spread to many countries, has been declared a second public health emergency of international concern by the World Health Organization (WHO). The new strain of this virus (Clade-1) is considered more infectious and has a higher mortality rate.
To combat this serious disease, India has now developed its own indigenous RT-PCR test kit to fight monkeypox. It has been approved by the Central Drugs Standard Control Organization (CDSCO). The IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Drugs Standard Control Organization. This is a significant achievement for our “Make in India” initiative and a significant advancement in the fight against the monkeypox public health emergency.
The IMDX Monkeypox Detection RT-PCR assay will be manufactured at our molecular diagnostics manufacturing unit in Vadodara, which has a manufacturing capacity of 1 million reactions per year. The factory is fully prepared to make the kit available,” Siemens Healthcare Pvt Ltd said.
The IMDX Monkeypox Detection RT-PCR assay is a groundbreaking 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 deep detection across various viral strains, delivering comprehensive results. Notably, this assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new equipment. The ability to use existing COVID testing infrastructure will enhance efficiency,” it went on.
Hariharan Subramanian, Managing Director, Siemens Healthcare Pvt Ltd said that the need for accurate and precise diagnosis has become more important today than ever before. He added, “By providing India with advanced assay kits specifically designed to combat monkeypox, we are taking a proactive approach in fighting this disease and prioritising quick and accurate detection, which can truly play a vital role in saving lives. These kits are a testament to our focus on improving ‘access to care’ and these assay kits are an important step towards that goal.”
According to Siemens Healthcare Pvt Ltd, the test results will be available in 40 minutes. “With results available in just 40 minutes compared to conventional methods (which take 1-2 hours), this test helps reduce the turnaround time for reporting, leading to a quick response. Clinically validated by ICMR-National Institute of Virology, Pune, this test boasts an impressive sensitivity and specificity of 100 per cent. The IMDx Monkeypox RTPCR Assay Kit follows Indian statutory guidelines and complies with the highest global standards.
