The Diagnostic Accuracy of Rapid Diagnostic Tests for Ebola Virus Disease: a Systematic Review.
Dagens AB., Rojek A., Sigfrid L., Plüddemann A.
BACKGROUND: Ebola Virus Disease (EVD) is a dangerous condition with potential to cause epidemics. Several rapid diagnostic tests (RDTs) have been developed to diagnose EVD. These RDTs promise to be quicker and easier to use than the current gold standard diagnostic test, PCR. OBJECTIVE: To assess the diagnostic accuracy of rapid diagnostic tests for EVD. DATA SOURCES: The following bibliographic databases were searched from inception to present: Medline (Ovid MEDLINE), Embase, Global Health, Cochrane Central Register of Controlled Trials, WHO Global Index Medicus database, Web of Science, PROSPERO register of Systematic Reviews, Clinical Trials.Gov. STUDY ELIGIBILITY CRITERIA: Diagnostic accuracy studies. PARTICIPANTS: Patients presenting to Ebola Treatment Units with symptoms of EVD. TESTS: Rapid diagnostic tests. REFERENCE STANDARD: RT PCR. RISK OF BIAS ASSESSMENT: Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. METHODS OF DATA SYNTHESIS: Summary estimates of diagnostic accuracy study were produced for each device type. Subgroup analyses were performed for RDT type and specimen material. Sensitivity analysis was performed to assess the effect of trial design and bias. RESULTS: We included 15 diagnostic accuracy studies. The summary estimate of sensitivity for lateral flow assays is 86.1% (95% CI 86-86.2%) with a specificity of 97% (95% CI 96.1-97.9%). The summary estimate for rapid PCR devices is a sensitivity of 96.2% (95% CI 95.3-97.9%) with a specificity of 96.8% (95% CI 95.3-97.9%). Pre-specified subgroup analyses demonstrate that rapid diagnostic tests are effective on a range of specimen material. Overall, the risk of bias throughout the included studies was low, but high in the patient selection and uncertain in the flow and timing domains. CONCLUSIONS: RDTs possess both a high sensitivity and specificity compared to RT-PCR amongst symptomatic patients presenting to Ebola Treatment Units. Our findings support the use of RDTs as a 'rule in' test to expedite treatment and vaccination.