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MpoxRt-PCR Kit, India’s indigenous mpox detection kit
Context
India has recently developed its own indigenous RT-PCR testing kit for Mpox, known as the IMDX Mpox Detection RT-PCR Assay. This significant advancement in diagnostic technology has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO).
About RT-PCR Testing Kit for Mpox
- The IMDX Mpox Detection RT-PCR Assay is a newly developed diagnostic tool designed to detect Mpox virus infections.
- This kit will be manufactured at Siemens Healthineers' molecular diagnostics unit in Vadodara, India, which has a production capacity of one million reactions per year.
- The assay is engineered to detect two distinct regions in the Mpox viral genome, covering both Clade I and Clade II variants, ensuring comprehensive and accurate detection across different viral strains.
- Its platform-agnostic design means it integrates seamlessly with existing PCR setups, eliminating the need for new instruments.
- The assay provides results in just 40 minutes, significantly faster than traditional methods that take 1-2 hours.
- It has been clinically validated by the ICMR-National Institute of Virology, Pune, with 100% sensitivity and specificity, adhering to both Indian and international standards.
- Technology Used
- The IMDX Mpox Detection RT-PCR Assay utilizes RT-PCR (Reverse Transcription Polymerase Chain Reaction) technology, which amplifies and detects specific genetic material from the Mpox virus. The process involves converting RNA into DNA through reverse transcription, followed by amplification to detectable levels.
- The assay's platform-agnostic design allows it to work with standard PCR equipment, making it compatible with existing diagnostic infrastructure.
About Mpox
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