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This test, referred to as the Alinity m MPXV assay, utilizes real-time polymerase chain reaction (PCR) technology to identify monkeypox virus (MPXV) DNA from swabs taken from human skin lesions. Developed by Abbott Molecular Inc., a U.S.-based company, the test is intended for use by qualified clinical laboratory staff.
“This initial mpox diagnostic test included in the Emergency Use Listing process marks a crucial advancement in increasing testing accessibility in impacted regions,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
PCR testing, which identifies viral DNA, is considered the gold standard for mpox diagnosis. Timely diagnosis is essential for facilitating prompt treatment and managing the virus; however, inadequate testing resources and delays in case confirmations continue to obstruct efforts in Africa, where mpox is still prevalent.
This year, over 30,000 suspected mpox cases have been reported in Africa, with the highest incidences occurring in the Democratic Republic of the Congo (DRC), Burundi, and Nigeria. Alarmingly, only 37% of suspected cases in the DRC have undergone testing.
Mpox, previously known as monkeypox, is a contagious disease caused by the MPXV. Symptoms include a painful rash, swollen lymph nodes, fever, headaches, and muscle aches.
Africa is witnessing an unprecedented surge in mpox cases this year, attributed to two separate strains of the virus, with the Democratic Republic of the Congo (DRC) being the primary site of transmission.
The World Health Organization's (WHO) Emergency Use Listing (EUL) process facilitates the rapid availability of essential medical products, including vaccines, diagnostics, and treatments, during a Public Health Emergency of International Concern (PHEIC).
In August, WHO called on manufacturers to express their interest in EUL to meet the urgent demand for enhanced testing capabilities as the virus continued to proliferate.
To date, WHO has received three additional submissions for EUL assessment, and discussions with other manufacturers are ongoing.
The DRC, which is at the epicenter of the mpox outbreak, has initiated a vaccination campaign in the eastern city of Goma. Although the campaign was initially set to commence last Wednesday, it faced delays due to logistical issues.
Healthcare workers have received the first doses, and vaccinations for the general population are scheduled to begin on Monday in the eastern region, where the outbreak originated a year ago.
The DRC has received 265,000 vaccine doses thus far and is expecting millions more from France, Japan, and the United States.
A recent study indicates that the mpox vaccine necessitates booster doses after about one year to ensure ongoing protection.
Dr. Ai-ris Yonekura Collier, co-director of the Clinical Trials Unit at Beth Israel Deaconess Medical Center (BIDMC) in Boston, emphasized the critical need for widespread access to the complete vaccine series.
The findings, published in the Journal of the American Medical Association, indicate that individuals vaccinated during the 2022 outbreak will require booster shots to sustain their immunity.
The study monitored immune responses over a 12-month period in 45 participants who were either vaccinated during the outbreak or had a confirmed case of mpox.
These individuals received one or two doses of the Jynneos mpox vaccine. Researchers assessed both antibody and T-cell responses at the outset, three weeks later, and subsequently every three months for a year. The findings indicated that the protective effects of the vaccine diminished notably within six to twelve months.
During the 2022 outbreak, public health officials focused on vaccinating high-risk populations, which included individuals with new or multiple sexual partners, men who have sex with men, healthcare workers, laboratory staff, and travelers to regions where the virus was circulating.
Dr. Dan Barouch, who leads the Center for Vaccine and Virology Research at BIDMC, highlighted the necessity for more extensive human studies to evaluate the vaccine's long-term efficacy.