Table 5.
Clinical performance of tests that received EUA by the FDA for POC or OCT use to detect SARS-CoV-2.
| Name | Specimen | Number of samples | Clinical performance |
Ref. | |
|---|---|---|---|---|---|
| PPA |
NPA |
||||
| CI 95%, vs. EUA comparator assay | |||||
| Accula (Mesa Biotech) | NP swab | 100 | 68.0% (53.3–80.5%) | 100% (92.6–100%) | (Hogan et al., 2020) |
| BioFire | Currently no peer-reviewed scientific literature available | ||||
| Cobas (Roche) | NP swaba | 524 | 94.6% | 97.7% | (Mahmoud et al., 2021a) |
| NP swab and salivab | 79 | 100% (97.7–100%) | 100% (97.7–100%) | (Tsang et al., 2021) | |
| NP swab | 357 | 100% (97.7–100%) | 97.4% (94.1–98.9%) | (Hansen et al., 2021) | |
| NP and oral swab | 100 | 100% (92.4–100%) | 96.4% (86.0–100%) | (Daum and Fischer, 2021) | |
| NP, OP and nasal swab | NAc | 96.3% (83.6–99.3%) | 99.8% (99.1–100%) | (Ulhaq and Soraya, 2021) | |
| Cue (Cue Health) | Nasal swab | 267 | 91.7% | 98.4% | (Donato et al., 2021) |
| Detect (Detect Inc.) | Currently no peer-reviewed scientific literature available | ||||
| ID NOW (Abbott) | NP swab | 200 | 80.3% (71.9–87.1%) | 100% (95.4–100%) | (Moore et al., 2020) |
| NP swab | 61 | 71.7% | 100% | (Mitchell and George, 2020) | |
| Nasal swab | 974 | 91.30% (70–98%) | 100% (82–100%) | (Tu et al., 2021) | |
| NP swab | 395 | 96.2% | 98.7% | (Van et al., 2021) | |
| NP swab | 686 | 95.2% | 96.9% | (Mahmoud et al., 2021a) | |
| NP swab | 113 | 73.9% (63.2–82.3%) | 100% (83.4–100%) | (Smithgall et al., 2020) | |
| NP swab | 182 | 53.3% (26.6–78.7%) | 100% (97.8–100%) | (Thwe and Ren, 2020) | |
| Quality controld | 23 | 70.6% | 100% | (Aupaix et al., 2021) | |
| Respiratory specimens | N/Ae | 78.6% (73.7–82.8%) | 99.8% (99.2–99.9%) | (Dinnes et al., 2021) | |
| Respiratory specimens | N/Af | 73.0% (66.8–78.4%) | 99.7% (98.7–99.9%) | ||
| Respiratory specimens | N/Ag | 79% (69–86%) | 100% (98–100%) | (Lee and Song, 2021) | |
| Nasal or NP swab | 239 | 83.3% | 97.2% | (Procop et al., 2021) | |
| Nasal swab | 88 | 48% (30–67%) | 100% (94–100%) | (Lephart et al., 2021) | |
| NP swab | 108 | 87.7% (76–95%) | 100% (93–100%) | (Dinnes et al., 2021; Lee and Song, 2021; Lephart et al., 2021; Procop et al., 2021; Serei et al., 2021; Ulhaq and Soraya, 2021; Zhen et al., 2020) | |
| Nasal swabd | 105 | 60% | 100% | (Serei et al., 2021) | |
| NP and nasal swab | N/Ah | 91.6% (80.5–96.6%) | 94.2% (70.8–99.1%) | (Ulhaq and Soraya, 2021) | |
| Lucira (Lucira Health) | Currently no peer-reviewed scientific literature available | ||||
| Talis (Talis Biomedical Corporation) | Currently no peer-reviewed scientific literature available | ||||
| Visby (Visby Medical) | NP swab | 78 | 95.1% (86.3–99%) | 100% (80.5–100%) | (Renzoni et al., 2021) |
| NP swab | 100 | 96.7% | 98.6% | (Katzman et al., 2021) | |
| Xpert Xpress (Cepheid) | Respiratory specimens | N/Ai | 99.1% (97.7–99.7%) | 97.9% (94.6–99.2%) | (Dinnes et al., 2021) |
| Respiratory specimens | N/Aj | 100% (88.1–100%) | 97.2% (89.4–99.3%) | ||
| Nasal or NP swab | 238 | 97.6% | 93.0% | (Procop et al., 2021) | |
| NP swab | 113 | 98.9% (92.9–99.9%) | 92.0% (72.4–98.6%) | (Smithgall et al., 2020) | |
| Respiratory specimens | N/Ak | 99% (97–99%) | 97% (95–98%) | (Lee and Song, 2021) | |
| NP swab | 104 | 98.1% (90.1–100%) | 100% (94.2–100%) | (Stevens et al., 2020) | |
| NP swabl | 26 | 100% (75–100%) | 100% (75–100%) | (Lieberman et al., 2020) | |
| Nasal and NP swabj | 103 | 100% (92–100%) | 98% (91–100%) | (Moran et al., 2020) | |
| NP or OP swab | 90 | 100% (94.0–100%) | 100% (88.6–100%) | (Jokela et al., 2020) | |
| OP swab | 285 | 96.1% (91.3–98.4%) | 96.2% (90.9–98.6%) | (Hou et al., 2020) | |
| Saliva | 40 | 100% | 100% | (Vaz et al., 2021) | |
| NP, OP, NP/OP swabs and tracheal aspirates | 481 | 99.5% (97.5–99.9%) | 95.8% (92.6–97.6%) | (Loeffelholz et al., 2020) | |
| NP swab | 38 | 100% | 100% | (Dust et al., 2020) | |
| Nasal swab | 88 | 100% (87–100%) | 97% (87–99%) | (Lephart et al., 2021) | |
| NP swab | 108 | 98.3% (91%–100%) | 100% (93%–100%) | ((Dinnes et al., 2021; Lee and Song, 2021; Lephart et al., 2021; Procop et al., 2021; Serei et al., 2021; Ulhaq and Soraya, 2021; Zhen et al., 2020)) | |
| NP and nasal swab | N/Am | 95.6% (84.9–98.8%) | 96.4 (77.9–99.5%) | (Ulhaq and Soraya, 2021) | |
The cobas Liat SARS-CoV-2 & Influenza A/B assay.
The cobas Liat SARS-CoV-2 & Influenza A/B assay compared to the Xpress SARS-CoV-2 assay.
Overall PPA and NPA based on 2 studies.
Analytical performance, compared to the Xpress SARS-CoV-2 assay.
Overall PPA and NPA based on 12 studies.
Overall PPA and NPA based on 4 studies, whereby the studies were restricted to be IFU-compliant.
Overall PPA and NPA based on 10 studies.
Overall PPA and NPA based on 4 studies, among which Procop et al. and Lephart et al. (Lephart et al., 2021; Procop et al., 2021).
Overall PPA and NPA based on 13 studies.
Overall PPA and NPA based on 2 studies, whereby the studies were restricted to be IFU-compliant.
Overall PPA and NPA based on 11 studies.
PPA and NPA not given in the article itself, but calculated by Dinnes et al. (2021)
Overall PPA and NPA based on 2 studies, i.e. Procop et al. and Lephart et al. (Lephart et al., 2021; Procop et al., 2021).