The diagnostic accuracy of rapid diagnostic tests for Ebola virus disease: a systematic review.

BACKGROUND

Ebola virus disease (EVD) is a dangerous condition that can cause an epidemic. Several rapid diagnostic tests (RDTs) have been developed to diagnose EVD. These RDTs promise to be quicker and easier to use than the current reference standard diagnostic test, PCR.

OBJECTIVES

To assess the diagnostic accuracy of RDTs for EVD.

METHODS

A systematic review of diagnostic accuracy studies.

DATA SOURCES: The following bibliographic databases were searched from inception to present: MEDLINE (Ovid), Embase, Global Health, Cochrane Central Register of Controlled Trials, WHO Global Index Medicus database, Web of Science, PROSPERO register of Systematic Reviews, and Clinical Trials.Gov.

STUDY ELIGIBILITY CRITERIA: Diagnostic accuracy studies.

PARTICIPANTS

Patients presenting to the Ebola treatment units with symptoms of EVD.

INTERVENTIONS: RDTs; reference standard, RT-PCR.

ASSESSMENT OF RISK OF BIAS: Quality Assessment of Diagnostic Accuracy Studies-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. A 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 was 86.1% (95% CI, 86-86.2%), with specificity of 97% (95% CI, 96.1-97.9%). The summary estimate for rapid PCR devices was 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 demonstrated that RDTs were effective on a range of specimen material. Overall, the risk of bias throughout the included studies was low, but it was high in patient selection and uncertain in the flow and timing domains.

CONCLUSIONS

RDTs possess both high sensitivity and specificity compared with RT-PCR among symptomatic patients presenting to the Ebola treatment units. Our findings support the use of RDTs as a 'rule in' test to expedite treatment and vaccination.