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Introduction
The Ebola virus disease (EVD) outbreak in Guinea started in December 2013 and affected 25 of the 34 administrative prefectures of the country.1 Laboratory-enhanced surveillance is critical for rapid detection of the potential re-emergence of EVD. The capacity of the laboratory system in Guinea is characterised by poor infrastructure, insufficient numbers of qualified personnel, lack of instrumentation and a limited quality assurance system. To support the diagnostic capacity to adequately respond to the EVD outbreak, multiple countries and organisations deployed mobile laboratories and/or diagnostic equipment for rapid detection of the Ebola virus. While these laboratories were critical to ensuring prompt and effective case management during the response,2 many are downsizing or ending operations. Yet the need for consistent and ongoing capacity for diagnosis of EVD still exists in Guinea. Testing capacity is limited throughout the country, and Guinea currently lacks a timely and reliable specimen referral system for the safe transfer of specimens to centralised testing facilities.
Current EVD diagnosis relies heavily on reverse transcription polymerase chain reaction (RT-PCR) technology. While RT-PCR is highly sensitive and specific and is considered the gold standard for EVD diagnosis, it requires skilled technicians and an appropriate laboratory infrastructure, including stable power supply, controlled temperature, and appropriate biosafety procedures. Rapid diagnostic tests (RDTs), such as lateral flow assays that detect Ebola antigens, could address many of the challenges of relying on laboratory-based RT-PCR. Compared to PCR, antigen-based RDTs are better adapted to use in the field, can be designed to require limited or no cold chain, require less training and equipment and can provide results in minutes.3 In November 2014, the World Health Organization (WHO) issued a call for ‘rapid, sensitive, safe and simple Ebola diagnostic tests’ adapted for severely resource-constrained settings.4 In response, several companies developed antigen-based RDTs. As of late 2015, two of these had received regulatory approval by the WHO or the US Food and Drug Administration for Emergency Use Authorization. The ReEBOV™ Antigen Rapid Test (Corgenix, Broomfield, Colorado, United States) was approved by WHO and was issued an Emergency Use Authorization for use with whole blood by the US Food and Drug Administration in February 2015. The OraQuick® Ebola Rapid Antigen test (OraQuick® Ebola RDT; OraSure Technologies,...