The Central Drugs Standard Control Organisation (CDSCO) has approved a locally developed RT-PCR testing kit for Monkeypox, marking a significant advancement in addressing the Monkeypox public health emergency.
Created by Siemens Healthcare Private Ltd, the IMDX Monkeypox Detection RT-PCR Assay will be produced at its molecular diagnostics facility in Vadodara, which has an annual capacity of 1 million reactions.
As reported by msn.com, Siemens Healthcare Private Ltd announced that the IMDX Monkeypox Detection RT-PCR Assay is an innovative molecular diagnostic test designed to identify two distinct regions within the viral genome, covering both clade I and clade II variants. This comprehensive approach ensures broad detection of various viral strains. The assay is compatible with existing PCR equipment, allowing it to integrate seamlessly into current laboratory workflows without requiring new instruments. This compatibility with existing COVID-19 testing infrastructure aims to improve operational efficiency.
The test provides results within 40 minutes and has been clinically validated by the ICMR-National Institute of Virology in Pune. It demonstrates 100% sensitivity and specificity and meets both Indian regulatory standards and international quality benchmarks.