India has taken a major step in combating the Monkeypox outbreak with the development of an indigenous RT-PCR detection kit. The World Health Organization (WHO) recently declared Monkeypox a public health emergency of international concern, with the new strain, Clad-1, noted for its increased transmissibility and higher mortality rates. In response, India has introduced its own home-grown solution.
The newly developed IMDX Monkeypox Detection RT-PCR Assay, created by Siemens Healthineers, has received approval from the Central Drugs Standard Control Organisation (CDSCO).
This marks a significant advancement under India's "Make in India" initiative and is a crucial tool in the fight against the Monkeypox public health crisis.
Siemens Healthcare has announced that the IMDX RT-PCR Assay will be produced at its molecular diagnostics unit in Vadodara, which has the capacity to manufacture up to one million reactions per year.
The new assay is designed to detect two distinct regions of the viral genome, covering both clade I and clade II variants of the Monkeypox virus. This comprehensive approach ensures thorough detection across various strains of the virus.
One of the key advantages of this assay is its compatibility with existing laboratory infrastructure. It can be integrated into current PCR setups without requiring new equipment, allowing for a more efficient use of existing COVID-19 testing resources.
The test results are available in just 40 minutes, significantly faster than traditional methods, which typically take 1-2 hours. This rapid turnaround time facilitates quicker responses and better management of the outbreak.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, emphasised the importance of precise and timely diagnostics. He stated that the advanced assay kits are crucial for prompt detection and could play a vital role in saving lives.
The assay has been clinically validated by the ICMR-National Institute of Virology in Pune, boasting a 100 percent sensitivity and specificity, and complies with both Indian statutory guidelines and global standards.
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