The World Health Organization (WHO) has authorized the first emergency-use diagnostic test for mpox, significantly enhancing testing capabilities in nations facing disease outbreaks.
The Alinity m MPXV assay is a real-time polymerase chain reaction (PCR) test that identifies monkeypox virus (MPXV) DNA from swabs of human skin lesions. Produced by Abbott Molecular Inc., a U.S.-based company, this test is intended for use by trained clinical laboratory professionals.
“This initial mpox diagnostic test included in the Emergency Use Listing process marks a significant achievement in increasing testing accessibility in impacted countries,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
PCR testing, which detects viral DNA, is considered the gold standard for diagnosing mpox.
Early detection is vital for timely treatment and virus control, but limited testing resources and delays in case confirmations continue to obstruct efforts in Africa, where mpox is still prevalent.
This year, Africa has reported over 30,000 suspected mpox cases, with the highest figures 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 viral infection caused by MPXV, presenting symptoms such as a painful rash, swollen lymph nodes, fever, headaches, and muscle aches.
This year has seen an unprecedented surge in mpox cases in Africa, fueled by two distinct strains of the virus, with transmission primarily occurring in the DRC.
The WHO’s Emergency Use Listing (EUL) process expedites the distribution of life-saving medical products—including vaccines, diagnostics, and treatments—during a Public Health Emergency of International Concern (PHEIC).
In August, the WHO called on manufacturers to submit expressions of interest for EUL to address the urgent need for increased testing as the virus continued to spread.
So far, WHO has received three additional submissions for EUL evaluation, with ongoing discussions with other manufacturers.
The DRC, at the epicenter of the mpox outbreak, has initiated a vaccination campaign in the eastern city of Goma. The launch, initially set for last Wednesday, was postponed due to logistical issues.
Healthcare workers were the first to receive doses, while the general public is expected to start vaccinations on Monday in the eastern region where the current outbreak began a year ago.
The DRC has received 265,000 vaccine doses and is awaiting millions more from France, Japan, and the United States.
Mpox Vaccine Requires Boosters After One Year, Study Finds
A recent study has revealed that the mpox vaccine necessitates booster doses after approximately one year to maintain protection.
Dr. Ai-ris Yonekura Collier, co-director of the Clinical Trials Unit at Beth Israel Deaconess Medical Center (BIDMC) in Boston, emphasized the importance of providing broad access to the complete vaccine series.
The study, published in the Journal of the American Medical Association, indicates that individuals vaccinated during the 2022 outbreak require booster shots to sustain immunity.
The research followed immune responses over a 12-month period in 45 individuals who were either vaccinated during the outbreak or diagnosed with mpox. Participants received one or two doses of the Jynneos mpox vaccine.
Researchers assessed antibody and T-cell responses initially, at three weeks, and quarterly for a year. The findings revealed that the protection offered by the vaccine significantly decreased within six to 12 months.
Public health officials prioritized vaccination during the 2022 outbreak for high-risk populations, including individuals with new or multiple sex partners, men who have sex with men, healthcare workers, laboratory personnel, and travelers to regions where the virus was present.
Dr. Dan Barouch, director of BIDMC’s Center for Vaccine and Virology Research, underscored the necessity for larger human studies to evaluate the long-term efficacy of the vaccine.
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