Self-test for the diagnosis of HPV is launched in Brazil – 06/30/2023 – Health

The launch of a self-test promises to make the diagnosis of HPV more accessible to women and transgender men who kept the uterus, in addition to helping to expand access to health in the country.

In countries that have already adopted the modality, the patient receives the medical request and the kit for self-collection and conservation of the vaginal sample from the gynecologist. She does the collection at home and then takes the material to a laboratory for investigation. The process is less invasive and has accuracy comparable to the procedure performed in the doctor’s office.

The multinational BD (Becton Dickinson Indústrias Cirúrgicas Ltda), in the field of medical technology, sells three types of kits in the country: the Rovers Evalyn Brush, from Rovers Medical Devices BV, the Copan FLOQSwabs and the Copan Self FloqSwabs (also represented by Roche ), from the company Copan Italia SPA —all approved by Anvisa (National Health Surveillance Agency).

“The technology was created as an alternative to traditional clinical testing and makes preventive testing more accessible, more convenient and just as safe as the method performed in clinics and laboratories. People who live in remote areas or with limited access to health care can be tested in a shorter period of time”, says gynecologist Neila Speck, professor at Unifesp (Federal University of São Paulo) and president of the National Commission Specialized in the Lower Genital Tract of Febrasgo (Brazilian Federation of Gynecology and Obstetrics Associations).

There are countries that already use self-collection as the first strategy for cervical cancer screening.

“In Australia, the woman no longer goes to a health center to have the pap smear. She collects the material at home and sends it to a health service. The patient will only be called to go to the health center if the test result is positive for HPV”, explains the specialist.

“In our area, there is a stigma of women having an annual Pap smear, which has its limitations. Only those with high-risk HPV have cervical cancer. So, having a Pap smear on someone who has not been exposed to HPV is unnecessary. On the other hand, for women exposed to HPV, the Pap smear has a low diagnostic sensitivity and may fail”, says the doctor.

“The self-test has a much higher sensitivity than the pap smear, it can be done at longer intervals, every five years, and represents a saving in health. Thinking about public health, it is much better, it provides greater sensitivity and safety and generates savings in the long term. Of course, if the woman has pain, bleeding, discharge or any other complaint, she needs to go to the doctor”, says the gynecologist.

Hospital Sírio-Libanês, in São Paulo, will start offering the new technology in the second half of this year. The institution awaits the delivery of the self-collection device to carry out the training of the assistance teams. The forecast is that the technology will be available from August.

The test will be carried out upon medical request. The patient may opt for self-collection, after receiving guidance from the care team, or for conventional collection.

According to the Sírio-Libanês press office, it is not a different test from the one already offered. So, the price doesn’t change for the patients and health plans attended. The difference is just the way to collect.

The tests for the validation of the new modality were carried out in partnership with Unifesp, through the analysis of around 20 samples collected in two ways: conventional and by self-collection.

“The results were equivalent and safe in relation to existing tests. The idea is to expand the study and produce scientific work”, says physician Leonardo Testagrossa, head of the institution’s pathological and molecular anatomy department.

Self-collection is not part of the List of Health Procedures and Events of the ANS (National Supplementary Health Agency), and therefore is not mandatory coverage by health plans. The current list includes three types of tests for the investigation of HPV: typing by PCR, DNA detection by hybridization techniques and detection by immunohistochemical techniques, according to the agency.

The Ministry of Health said that there is still no request for evaluation at Conitec (National Commission for the Incorporation of Technologies in the Unified Health System) for the technology to be offered by the SUS.

The only exam covered by the SUS for the prevention of cervical cancer is the papanicolau. “The scientific and academic circles are in a big fight for the Ministry of Health to start doing the HPV virus DNA test as a screening strategy for cervical cancer, even if it is not self-collection at first”, says Neila Speck .