Regulatory Focus™ > News Articles > WHO Gives OK to First Rapid-Result Ebola Diagnostic

WHO Gives OK to First Rapid-Result Ebola Diagnostic

Posted 23 February 2015 | By Michael Mezher 

WHO Gives OK to First Rapid-Result Ebola Diagnostic

The World Health Organization (WHO) has approved the first rapid-result diagnostic test for detecting Ebola.

The product, known as ReEBOV Antigen Rapid Test, can help health care workers quickly confirm suspected cases of Ebola. Despite international efforts, Ebola has caused more than 9,400 deaths in West Africa since the outbreak began in March 2014.

Rapid Results

ReEBOV has a number of advantages over other diagnostics. The product is simple to use and can give results in about 15 minutes. Additionally, ReEBOV does not require electricity, making it ideal for use in the field. WHO says the ReEBOV test is 92% accurate in detecting Ebola.

Previously, health care workers relied on nucleic acid tests (NAT), which are more accurate than antigen testing, but can take between 12 and 24 hours to give a result.

As ReEBOV is less accurate, WHO says wherever possible, healthcare workers should conduct a supplemental NAT to confirm the results.

Speeding Access to IVDs

WHO has invited manufacturers to submit in vitro diagnostics (IVDs) for detecting Ebola under its Emergency Use Assessment and Listing (EUAL) procedure to aid efforts to combat Ebola in West Africa. The agency says the EUAL procedure is designed to “provide minimum quality, safety and performance assurance for diagnostic products,” to make them available more quickly than if they had gone through a more stringent review process.

Because many potential diagnostics for Ebola are still being developed, WHO is asking companies to submit whatever data they have to support their products’ use, including product specifications, clinical data and evidence of the company’s quality management systems (QMS) plan.

To date, 21 products have been submitted for assessment under EUAL. Of them, only ReEBOV and another product, RealStar Filovirus Screen RT-PCR Kit 1.0, have been listed by WHO for procurement and use.

WHO’s Decision

The decision to list ReEBOV for use in detecting Ebola is based on limited data gathered during use in West Africa and at the Berhard Nocht Institute for Tropical Medicine in Hamburg, Germany.

WHO strongly recommends “monitor[ing] the performance of ReBOV … in comparison with supplemental NAT” to better understand the effectiveness of each diagnostic type.

Due to the limited nature of the data used to assess ReEBOV, WHO cautions that its listing “does not infer the product meets WHO prequalification requirements.” Both WHO and Corgenix Medical Corporation, the maker of ReEBOV, will conduct post-market surveillance on ReEBOV, and the company must inform WHO of any complaints or adverse events related to ReEBOV within 7 days.


WHO Press Release, EUAL Public Report

Categories: Regulatory News

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