Rapid diagnostic tests versus RT-PCR for Ebola virus infections: a systematic review and meta-analysis.

ABSTRACT

Objective: To evaluate the clinical accuracy of rapid diagnostic tests for the detection of Ebola virus. Methods: We searched MEDLINE®, Embase® and Web of Science for articles published between 1976 and October 2021 reporting on clinical studies assessing the performance of Ebola virus rapid diagnostic tests compared with reverse transcription polymerase chain reaction (RT-PCR). We assessed study quality using the QUADAS-2 criteria. To estimate the pooled sensitivity and specificity of these rapid diagnostic tests, we used a bivariate random-effects meta-analysis. Findings: Our search identified 113 unique studies, of which nine met the inclusion criteria. The studies were conducted in the Democratic Republic of the Congo, Guinea, Liberia and Sierra Leone and they evaluated 12 rapid diagnostic tests. We included eight studies in the meta-analysis. The pooled sensitivity and specificity of the rapid tests were 86% (95% confidence interval, CI 80-91) and 95% (95% CI 91-97), respectively. However, pooled sensitivity decreased to 83% (95% CI 77-88) after removing outliers. Pooled sensitivity increased to 90% (95% CI 82-94) when analysis was restricted to studies using the RT-PCR from altona Diagnostics as gold standard. Pooled sensitivity increased to 99% (95% CI 67-100) when the analysis was restricted to studies using whole or capillary blood specimens. Conclusion: The included rapid diagnostic tests did not detect all the Ebola virus disease cases. While the sensitivity and specificity of these tests are moderate, they are still valuable tools, especially useful for triage and detecting Ebola virus in remote areas.