Table 1. Studies included in the systematic review and meta-analysis on the diagnostic accuracy of rapid tests for Ebola virus disease.
| Study | Country | Sample size, no. | Study design | Reference standarda | Specimen | Year of specimen collection | Industry funded | Index test | No. of samples |
% (95% CI) |
Prevalence, % | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| True positive | False positive | False negative | True negative | Reported sensitivity | Reported specificity | |||||||||||
| Moran et al., 202015 | Guinea | 205 | Cross-sectional | RT–PCR (altona) | Stored serum | 2014–2015 | No | Fever Panel Antigen System | 98 | 9 | 11 | 87 | 90 (83–95) | 91 (83–96) | 53 | |
| Ebola Antigen System | 84 | 8 | 25 | 88 | 77 (68–84) | 92 (84–96) | 53 | |||||||||
| Ebola–Malaria Antigen duplex system | 85 | 4 | 24 | 92 | 78 (69–85) | 96 (89–99) | 53 | |||||||||
| Makiala et al., 201916 | Democratic Republic of the Congo | 928 | Cross-sectional | GeneXpert® Ebola | Whole blood | 2018 | No | QuickNaviTM-Ebola | 68 | 2 | 12 | 846 | 85 (75–92) | 100 (99–100) | 9 | |
| Wonderlyet al., 201917 | Sierra Leone | 428 | Cross-sectional | RT–PCR (altona) | Whole blood | 2015 | No, but tests donated | DEDIATEST Ebola | 0 | 0 | 0 | 98 | – | 100 (96–100) | – | |
| RT–PCR (altona) | Stored plasma | 2015 | No, but tests donated | SD Ebola Zaire Ag | 109 | 2 | 20 | 196 | 85 (77–90) | 99 (96–100) | – | |||||
| RT–PCR (Trombley) | Stored plasma | 2015 | No, but tests donated | SD Ebola Zaire Ag | 110 | 1 | 46 | 170 | 71 (63–78) | 99 (97–100) | – | |||||
| RT–PCR (altona) | Stored plasma | 2015 | No, but tests donated | ReEBOV™ Antigen Rapid Test kit | 123 | 39 | 9 | 159 | 93 (88–97) | 80 (74–86) | – | |||||
| RT–PCR (Trombley) | Stored plasma | 2015 | No, but tests donated | ReEBOV™ Antigen Rapid Test kit | 133 | 29 | 23 | 142 | 85 (79–90) | 83 (77–88) | – | |||||
| RT–PCR (altona) | Stored plasma | 2015 | No, but tests donated | One step Ebola test | 125 | 39 | 2 | 158 | 98 (94–100) | 80 (74–86) | – | |||||
| RT–PCR (Trombley) | Stored plasma | 2015 | No, but tests donated | One step Ebola test | 138 | 26 | 16 | 144 | 90 (84–94) | 85 (78–90) | – | |||||
| RT–PCR (altona) | Stored plasma | 2015 | No, but tests donated | DEDIATEST EBOLA | 101 | 31 | 26 | 167 | 80 (72–86) | 84 (79–89) | – | |||||
| RT–PCR (Trombley) | Stored plasma | 2015 | No, but tests donated | DEDIATEST EBOLA | 108 | 24 | 46 | 147 | 70 (62–77) | 86 (80–91) | – | |||||
| Colavita et al., 201818 | Sierra Leone | 210 | Cross-sectional | qRT–PCR (altona) | Stored residual plasma samples | 2014–2015 | Yes | EBOLA Ag K-SET | 93 | 2 | 12 | 103 | 89 (81–94) | 98 (93–100) | 50 | |
| Gallais et al., 201719 | Guinea | 137 | Cross-sectional | qRT–PCR (altona; and Weidmann) | Whole blood | 2015 | No | eZYSCREEN® | 32 | 1 | 17 | 87 | 65 (50–78) | 99 (94–100) | 36 | |
| 144 | Cross-sectional | qRT–PCR (altona; and Weidmann) | Serum | 2015 | No | eZYSCREEN® | 41 | 0 | 14 | 89 | 75 (61–85) | 100 (96–100) | 38 | |||
| Phan et al., 2016b,20 | Liberia | 290 | Cross-sectional | rRT–PCR (Trombley) | Plasma | 2014–2015 | No | NMRC Ebola virus lateral flow immunoassay | – | – | – | – | 88 (75–94) | 98 (95–99) | – | |
| 237 | Cross-sectional | rRT–PCR (Trombley) | Postmortem oral swabs | 2014–2015 | No | NMRC Ebola virus lateral flow immunoassay | – | – | – | – | 89 (57–98) | 96 (93–98) | – | |||
| Boisen et al., 201621 | Sierra Leone | 176 | Cross-sectional | Ebola virus-specific qRT–PCRc | Stored plasma | 2014 | Yes | ReEBOV™ Antigen Rapid Test kit | 72 | 2 | 44 | 58 | 62 (53–71) | 97 (89–100) | 53 | |
| Broadhurst et al., 201522 | Sierra Leone | 105 | Cross-sectional | RT–PCR (altona) | Plasma (for the reference test) and capillary blood (for the rapid tests) | 2015 | No, but tests donated | ReEBOV™ Antigen Rapid Test kit | 28 | 6 | 0 | 71 | 100 (88–100) | 92 (84–97) | 27 | |
| 277 | Cross-sectional | RT–PCR (altona) | Whole blood | 2015 | No, but tests donated | ReEBOV™ Antigen Rapid Test kit | 45 | 18 | 0 | 214 | 100 (92–100) | 92 (88–95) | 16 | |||
| Walker et al., 201523 | Sierra Leone | 131 | Cross-sectional | RT–PCR (altona) | Capillary blood | 2015 | No | Defence Science and Technology Laboratory Ebola virus disease rapid diagnostic test | 15 | 9 | 107 | 0 | 100 (78–100) | 92 (86–96) | 12 | |
CI: confidence interval; PCR: polymerase chain reaction; RT–PCR: reverse transcription PCR; rRT–PCR: real-time RT–PCR; qRT–PCR: quantitative RT–PCR.
a altona refers to RealStar Filovirus Screen RT–PCR Kit 1.0 (altona Diagnostics GmbH, Hamburg, Germany), Trombley refers to the Trombley assay,14 GeneXpert® Ebola (Cepheid, Sunnyvale, United States of America) is a specific RT-PCR that targets the glycoprotein and nucleoprotein genes, Weidmann refers to the Weidmann technique (that is, a quantitative one-step RT–PCR).19
b We were unable to accurately reconstitute the two-by-two table used to calculate specificity and sensitivity.
c RT–PCR specific for Ebola (while not specifically mentioned in the article, the authors cite the Trombley assay in their methods).