The first mpox test that enables health facilities to test people and get results onsite has been given Emergency Use List (EUL) approval by the World Health Organization (WHO).

Abbott’s Alinity m MPXV assay is a polymerase chain reaction (PCR) test that can give an mpox diagnosis within around two hours from a swab of a patient’s lesion.

Until now, African countries affected by mpox have had to send samples away to laboratories, often waiting days for the results.

Although a suspected 34,297 mpox cases have been identified in 16 African countries since the beginning of the year, a mere 6,806 have been confirmed by a laboratory test.

In addition, the positivity rate of tests has been under 50% (47% average) – particularly in the Democratic Republic of Congo (DRC) where the majority of cases have been identified. Only 37% of suspected cases in the DRC have been tested this year.

Dr Jean Kaseya, Director-General of the Africa Centres for Disease Control and Prevention, has pointed to numerous problems with testing including that specimens have not been collected properly, been compromised during transportation or have been processed by people without the necessary experience.

The WHO described its EUL as “pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply”. 

“Early diagnosis of mpox enables timely treatment and care, and control of the virus,” it stressed.

Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, described the listing of the first mpox diagnostic test as a “significant milestone in expanding testing availability in affected countries”.

“Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”

The WHO is considering the EUL of three other mpox tests from Cepheid, Roche and CerTest Biotec after calling on mpox IVDs manufacturers to submit an expression of interest for EUL on 28 August.

The Alinity test can detect both clade I and clade II of the mpox virus. However, it needs to be administered by “trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures”, according to WHO.

The EUL process accelerates the availability of life-saving medical products in a Public Health Emergency of International Concern (PHEIC). 

“The EUL for Alinity m MPXV assay, allowing for its use, will remain valid as long as the PHEIC, justifying the emergency use of mpox in vitro diagnostics, is in effect,” said the WHO.