Table 3. Pooled positive agreement and specificity results for SARS-CoV-2 nucleic acid tests with confidence interval width ≤ 5% for either or both and based on at least two studies, up to 22 August 2020.
| Category | Test | Target | Case population | Positive agreementa | Specificitya |
|---|---|---|---|---|---|
| PCR | Altona Diagnostics, RealStar SARS-CoV-2 RT-PCR Kit 1.0 | E | Unk | 88.1 (80.4–93.1) b n = 101 CH, FR, NL, US |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | Altona Diagnostics, RealStar SARS-CoV-2 RT-PCR Kit 1.0 | S | Unk | 87.1 (79.2–92.3) b n = 101 CH, FR, NL, US |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | Altona Diagnostics, RealStar SARS-CoV-2 RT-PCR Kit 1.0 | S or E | Unk | 81.6 (75.8–86.3) b,c n = 207 FR(3), NL |
100.0 (98.4–100.0) n = 237 FR, NL, UK |
| PCR | AusDiagnostics, Coronavirus Typing Assay | ORF1ab | Na | Nd |
100.0 (98.5–100.0) n = 254 AU, UK |
| PCR | BGI, Real-time fluorescent RT-PCR kit for detecting 2019 nCoV | ORF1ab | Unk | 93.8 (88.7–96.7) b n = 146 CH, JP, NL, PL |
99.1 (95.1–99.8) n = 112 CH, NL |
| PCR, POC | Cepheid, GeneXpert Xpert Xpress SARS-CoV-2 | E or N | Unk |
98.8 (97.3–99.5) n = 427 BE, CH, CY, DE, FI, FR, NL, SE, US(5) |
100.0 (82.4–100.0) b n = 18 BE, CH, SE |
| PCR | CerTest Biotec, VIASURE SARS-CoV-2 Real Time PCR Detection Kit | N | Unk | 96.8 (89.1–99.1) b,c n = 63 CH, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | CerTest Biotec, VIASURE SARS-CoV-2 Real Time PCR Detection Kit | ORF1ab | Unk | 93.7 (84.8–97.5) b,d n = 63 CH, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | CerTest Biotec, VIASURE SARS-CoV-2 Real Time PCR Detection Kit | ORF1ab or N | Na | Nd |
100.0 (98.2–100.0) n = 207 NL, UK |
| PCR | DiaSorin, Simplexa COVID-19 Direct RT-PCR Kit | ORF1ab or S | Unk |
97.8 (94.4–99.1) n = 180 US(3) |
Nd |
| PCR | Hologic, SARS-CoV-2 Assay (Panther Fusion System) | ORF1ab | Unk |
98.3 (96.8–99.1) n = 525 FR, US(6) |
Nd |
| PCR | KH Medical, RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | RdRP | Unk | 96.8 (89.1–99.1) b,c n = 63 CH, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | KH Medical, RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit | S | Unk | 98.4 (91.5–99.7) b n = 63 CH, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | Primerdesign, genesig Real-Time PCR CoVID-19 kit | RdRP | Unk | 95.3 (89.4–98.0) b,c n = 106 CH, NL, PL |
100.0 (98.8–100.0) n = 307 CH, NL, UK |
| PCR | R-Biopharm, Ridagene SARS-CoV2 | E | Unk | 100.0 (94.3–100.0) b n = 63 CH, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | Roche, COBAS SARS-CoV-2 test | ORF1ab or E | Unk |
98.8 (97.9–99.3) n = 1,125 AT, CH, DE, FR, SI, US(5) |
100.0 (90.8–100.0) b n = 38 CH, FR |
| PCR | Seegene, Allplex 2019-nCoV assay | E | Unk | 85.0 (75.6–91.2) b,d n = 80 CH, FR, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | Seegene, Allplex 2019-nCoV assay | RdRP | Unk | 91.3 (83.0–95.7) b,c n = 80 CH, FR, NL |
100.0 (96.7–100.0) n = 112 CH, NL |
| PCR | Tibmolbiol, SARS-CoV (COVID19) E-gene | E | Unk | 100.0 (94.4–100.0) b n = 65 CH, UK |
100.0 (98.5–100.0) n = 250 CH, UK |
AT: Austria; AU: Australia; BE: Belgium; CH: Switzerland; COVID-19: coronavirus disease; CY: Cyprus; DE: Denmark; E: envelope gene; FI: Finland; FR: France; JP: Japan; N: nucleoprotein gene; Na: not applicable; Nd: not determined, either because there were no data or because there were data from only one country or study; NL: The Netherlands; PL: Poland; S: spike gene; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2; SE: Sweden; SI: Slovenia; UK: United Kingdom; Unk: unknown or unclearly defined; US: United States.
a Positive agreement and specificity values given as value (confidence interval), number of samples (n = X), list of countries (number of studies per country if > 1). Value in bold if both confidence interval width ≤ 5% and value ≥ 95% (for positive agreement) or ≥ 98% (for specificity).
b Confidence interval width > 5%.
c Moderate study heterogeneity (50.0 ≤ I2 < 75.0%).
d High study heterogeneity (I2 ≥ 75.0%).
Rows are sorted alphabetically by test, target and case population.