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The Alinity m MPXV assay, developed by Abbott Molecular Inc., is a real-time PCR (polymerase chain reaction) test that detects monkeypox virus DNA from swabs taken from human skin lesions. This assay is specifically intended for use by trained professionals in clinical laboratories.
‘A significant milestone’
Dr. Yukiko Nakatani, the WHO Assistant Director-General for Access to Medicines and Health Products, highlighted the importance of this new diagnostic tool, stating that it “represents a significant milestone in expanding testing availability in affected countries.” The assay is the first mpox diagnostic test to be approved under the Emergency Use Listing process, which aims to enhance access to essential medical diagnostics.
The ability to identify viral DNA through PCR testing is recognized as the gold standard for diagnosing mpox. Timely diagnosis is crucial for enabling appropriate treatment and management of the disease, as well as for controlling its spread.
Unfortunately, the capacity for testing is still limited in several African nations, and delays in confirming mpox cases have ongoing ramifications for efforts to curb the outbreak. Reports indicate that there have been over 30,000 suspected cases recorded across Africa this year, with the most significant occurrences in the Democratic Republic of the Congo (DRC), Burundi, and Nigeria. Alarmingly, only about 37 percent of suspected cases in the DRC have undergone testing.
Global health emergency
Mpox, formerly referred to as monkeypox, is an infectious disease caused by the monkeypox virus (MPXV), with symptoms that may include a painful rash, swollen lymph nodes, fever, headaches, and muscle pains. The World Health Organization (WHO) classified the global outbreak that began in May 2022 as a public health emergency of international concern (PHEIC), marking the highest alert level under international health regulations.
This year has witnessed a significant rise in mpox cases across Africa, particularly in the DRC, where the transmission is primarily associated with two distinct virus strains or clades. The spread of the newer and more virulent clade 1b strain, which has also reached areas outside Africa, prompted WHO to declare mpox a PHEIC once again on August 14.
Emergency Use Listing
The WHO’s Emergency Use Listing (EUL) procedure is designed to expedite the availability of crucial medical tools like vaccines, diagnostic tests, and treatments during public health emergencies. In light of the ongoing mpox outbreak, the WHO called on manufacturers on August 28 to express their interest in the EUL process, recognizing a pressing need to enhance global testing capabilities as the virus continues to spread.
The EUL is a risk-based assessment framework aimed at evaluating the quality, safety, and performance of unlicensed medical products to facilitate their rapid deployment in emergency situations. Currently, WHO has received several new submissions for EUL evaluation and is in discussions with additional manufacturers to address the urgent needs arising from the mpox outbreak.
Source
news.un.org