India has achieved a significant milestone in the battle against the mpox virus by introducing its home-grown RT-PCR kit specifically designed for the detection of the viral disease.
The two testing kits, developed indigenously in India, come at a crucial juncture as the World Health Organization (WHO) has declared a second public health emergency due to the rapid global spread of a more virulent and deadly strain of the mpox virus across the globe.
Approved by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, these testing kits not only boost the nation’s diagnostic capabilities but also highlight its growing prowess in advanced medical technology.
Here’s a closer look at India’s very own mpox RT-PCR kits.
Introduced under the brand name ‘ErbaMDx Monkeypox RT-PCR Kit’, this diagnostic kit was developed by Andhra Pradesh MedTech Zone (AMTZ), a research body of the state government, in collaboration with Transasia Diagnostics.
With a 12-month shelf life and zero cross-reactivity with other orthopoxviruses, the kit promises exceptional accuracy and dependability, Dr. Jitendra Sharma, Managing Director and Founder CEO of AMTZ, told The Times of India (TOI).
Additionally, the kit’s standout feature is its use of lyophilised components, which allows it to be shipped and stored at ambient temperatures.
This attribute can be a game-changer for regions lacking cold chain infrastructure, ensuring that the diagnostic tool remains accessible even in the most remote areas, the TOI report said.
“This innovation signifies a major advancement in the country’s healthcare landscape and epidemic preparedness efforts,” Dr. Sharma was quoted as saying by the national newspaper.
A ‘Make in India’ milestone
In addition to the ErbaMDx kit, Siemens Healthineers has also developed another RT-PCR testing kit, further bolstering India’s arsenal against mpox, ANI reported.
Approved by CDSCO for manufacturing, the testing kit named ‘IMDX Monkeypox Detection RT-PCR Assay’ is a ground-breaking molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus.
According to Siemens Healthcare Private Ltd, the testing kit promises to deliver accurate results in 40 minutes, significantly faster than traditional methods that take 1-2 hours.
“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,” the MedTech company said.
It further said the testing kit will be manufactured at Vadodara’s molecular diagnostics manufacturing unit, which has a manufacturing capacity of 1 million reactions per year. The factory is all set to make the kits available.
Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited said, “By providing India with advanced assay kits tailored to combat monkeypox, we are taking a proactive stance in battling this disease and prioritising prompt and precise detection that can truly make a difference in saving lives.”
“These kits are a testament to our focus on improving ‘Access to Care’ and these assay kits are a significant step towards that goal,” Subramanian added.
How India is preparing for mpox outbreak?
While mpox has created a frenzy all over the world, India has remained a safe zone so far.
The Indian government has issued health guidelines as well as directed airports, ports, and border authorities to stay vigilant in response as mpox spreads its wings across continents.
Earlier, the Directorate of Public Health and Preventive Medicine (DPH) in Tamil Nadu heightened alert levels. Airport Health Officers and Port Health Officers in the state were instructed to focus on passengers arriving from the Democratic Republic of Congo and Central African countries.
According to reports, central hospitals in Delhi such as Safdarjung, Ram Manohar Lohia, and Lady Hardinge have also set up facilities for isolating suspected mpox cases. Additionally, Andhra Pradesh has also set up its first mpox isolation ward in Vijayawada with a capacity of six beds as a precaution.
As of 2022, the World Health Organisation (WHO) had reported 99,176 Mpox cases and 208 deaths in 116 countries. In India, a total of 30 cases had been detected since the 2022 declaration.
“The current upsurge of mpox in parts of Africa, along with the spread of a new sexually transmissible strain of the virus, is an emergency, not only for Africa but for the entire globe,” Professor Dimie Ogoina, Chair of the IHR Emergency Committee was quoted as saying by The Indian Express,
“Mpox, originating in Africa, was neglected there, and later caused a global outbreak in 2022. It is time to act decisively to prevent history from repeating itself,” he added.
With input from agencies
