New-Delhi: India has developed its own home-grown indigenous RT-PCR testing kit to fight against Monkeypox (Mpox). It has been approved by Central Protection Drugs Standard Control Organisation (CDSCO).
IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO) as reported by ANI.
This is a significant achievement for our “Make in India” initiative and a critical advancement in the fight against the Monkeypox public health emergency.
“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 all set to make the kits available,” said Siemens Healthcare Private Ltd.
The test results from the IMDX Monkeypox Detection RT-PCR Assay will be available in just 40 minutes, significantly quicker than traditional methods, which typically take 1-2 hours.
“With results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the assay helps reduce the turnaround time for reporting, leading to quicker responses. Clinically validated by ICMR-National Institute of Virology, Pune, the assay boasts an impressive 100 per cent sensitivity and specificity. IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards,” it said.
The World Health Organization (WHO) declared the escalating global monkeypox outbreak a Public Health Emergency of International Concern.