PCR approved for disease detection

monkey pox (mpox) was first discovered in Europe in May 2022 during an unexpected outbreak.which quickly spread to several countries on the continent. This was the first major outbreak of MOC to spread to other non-endemic regions, i.e. beyond Africa central and western regions where the virus has been endemic for decades.

To diagnose monkeypox virus infection, special laboratory tests are used that detect the presence of genetic material from the virus. But that previous step of knowing if a person is infected is about to change.

The World Health Organization (WHO) included the study Alinity m MPXVdeveloped Abbott Molecularas the first in vitro diagnostic (IVD) to detect mpox. A simple PCR test will allow you to control emerging pathology much faster. This is a significant step forward in improving global access to mpox testing.

The emergency approval of this test will increase diagnostic capacity in countries experiencing smallpox outbreaks, where demand for rapid and accurate tests has increased significantly. He early diagnosis It is extremely important to ensure adequate treatment, timely care and control of the virus.

This is promotion will especially benefit African countrieswhere WHO has identified limited capacity for testing and delays in confirming casesfactors that contribute to the further spread of the virus. In 2024 more 30,000 suspected cases in the region, including the Democratic Republic of the Congo, Burundi and Nigeria most affected countries. Only 37% of suspected cases in the DRC have been confirmed by testing this year, according to WHO.

The presence of monkeypox virus is confirmed using nucleic acid amplification tests (NAAT), such as conventional polymerase chain reaction or real-time polymerase chain reaction (PCR), as specified in the WHO Interim Guidelines for Diagnostic Tests for MPXV. Lesion material is recommended to be used to confirm infection in suspected cases.

Essay Alinity m MPXV is a real-time PCR test that detects MPox virus DNA (clade I/II) in human skin lesion samples. It is intended for use by clinical laboratory personnel trained in PCR and in vitro diagnostic techniques. This test allows laboratory workers to efficiently and accurately confirm suspected cases by detecting DNA in samples of pustular or vesicular lesions.

“The inclusion of this mpox diagnostic test in the emergency use listing process marks a key milestone in expanding access to testing in affected countries,” he said. Yukiko Nakatani Deputy Director General of WHO on access to medicines and health products.

To date, WHO has received three additional applications for evaluation under emergency use authorization and is in discussions with other in vitro diagnostic device manufacturers on mpox. This will provide a greater variety of high-quality diagnostic options.helping countries that do not have their own approval processes obtain the tests they need through UN agencies and other partners.