AIIMS launches study to test accuracy of HPV kits for cervical cancer screening

FOR THE first time, made in India testing kits for the human papilloma virus (HPV), that causes cervical cancer, will be validated across multiple study centres with global samples for accuracy. The project, which has been launched by AIIMS, Delhi, will begin by studying 1,200 samples from France, drawn from a biorepository of WHO’S International Agency for Research on Cancer.

According to study investigator, Prof Neerja Bhatla, the project will assess the efficacy of HPV screening test kits as per international quality standards. Once these are validated, they can benefit millions of women in India and other low-income and middle-income countries to get rid of cervical cancer as early as possible at affordable costs.

Currently the available HPV test kits are priced between Rs 1,500 and Rs 3,000 but the indigenous kits will be priced lesser.

The study will be conducted with the support of DBT-BIRAC Grand Challenges India in collaboration with IARC. The testing will be performed at AIIMS, New Delhi, National Institute of Cancer Prevention and Research (NICPR) Noida and Icmrnational Institute For Research In Reproductive and Child Health Mumbai. The lab activities will begin from Monday.

Launching the study on Friday, Dr Bhatla said, “Altogether 127,000 of the 600,000 cases per year are in India. Of the 300,000 deaths across the world, 80,000 deaths are from India... That’s why an indigenous HPV test was developed to make it user-friendly, operable and accessible even in the periphery hospitals”.

“It’s not that simple to validate these testing kits as it involves stringent international standards. The clinical versus analytical validity is something we need to balance,” Dr Bhatla said.

The process of testing is similar to a Pap smear test and the sample will be collected by brush or a swab from the cervix.

“In a Pap smear, we stain the sample so that we can read the cytology or the map of cells. This will be a molecular test like that of COVID,” said Dr Bhatla.

During an HPV test, a metal or a plastic speculum is inserted into the vagina.

A small sampler, a tiny spatula or a brush, extracts cells from the cervix. A HPV positivity does not mean cancer per se. This flags an infection, which could lead to cancer if allowed to persist.

The study will be conducted over the next three months and Drbhatlahopedtheresultswould be credible. After this, quality assuranceexchangeswillbedoneas well. “By the third quarter of the year,wewillhavegoodresultsand we will be rolling it out in the national programme,” she said.

“In 2018, WHO announced a cervical cancer elimination strategy and was rolled out in 2020 and India was a signatory. It was decided then that if we could screen and treat 70 per cent women before they turned 40 by 2030 and started, we could control cervical cancer to a large extent,” Dr Bhatla said.

Dr Shalini Singh, one of the study investigators, and Director at the National Institute of Cancer Prevention and Research, said,

“We took samples from the IARC biobank which have already been proven to have clinical validity and will get them tested on our indigenous systems. This has helped us cut the time span of the study by onefifth. Collecting samples takes up to four years, including multiple sites and coordination.”