- All > Quality and Safety: Medicines > Blood Products and Related Biologicals
- All > Quality and Safety: Medicines > Quality Assurance
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Keywords > biologicals - manufacture and quality control
- Keywords > blood products and related biologicals - quality assurance and safety
- Keywords > diagnosis - laboratory tests
- Keywords > ebola vaccines - quality, safety and efficacy
- Keywords > emergency situations
- Keywords > Good Manufacturing Practices (GMP)
- Keywords > vaccines - production and control
- Keywords > vaccines and related substances
- Keywords > in vitro Diagnostic (IVD)
- Keywords > WHO EUAL List - Candidate Medicinal Products, IVDs, Vaccines
(2015; 9 pages)
To provide interim guidance to Ministries of Health and other organizations on factors to consider in the selection and use of available in vitro diagnostic (IVD) assays for diagnosis of Ebola virus disease (EVD).
Selection of appropriate diagnostic assays for Ebola requires consideration not only of technical criteria but also the social and medical implications of test results. Given the consequences of a misdiagnosis, WHO recommends that only diagnostics that have undergone independent, comprehensive assessment of quality, safety and performance are used in diagnosing infection with Ebola virus. As incidence and prevalence of Ebola disease continues to decrease, assays with high specificity are required. This is because, in the context of low disease prevalence, widespread use of low specificity assays will generate more false positives than true positives. WHO recommends that nucleic acid testing using technologies such as polymerase chain reaction (PCR) should be the method of choice. A rapid antigen test that has reasonable sensitivity in patients with high concentrations of Ebola virus in the blood may have utility in settings without laboratory infrastructure if the benefits and limitations of the test are understood and appropriately managed.