Table 4.
Analytical and clinical performance of tests that received EUA by the FDA for POC or OCT use to detect SARS-CoV-2 (manufacturer info, comparator assay details not provided).
| Analytical performance |
Clinical performance |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Name |
Specimen (swab type) |
Analytical sensitivity (LOD) |
Analytical Reactivity/ Inclusivity |
Analytical Specificity/Exclusivity (cross-reactivity) |
Analytical Specificity (interfering substances) |
Number of samples |
PPA |
NPA |
Ref. |
| ≥ 95% confidence | In silico homology | No cross-reaction with | No interference with | CI 95%, vs. EUA comparator assay | |||||
| Singleplex assays | |||||||||
| Accula (Mesa Biotech) |
NP | 150 copies/mL | 100%a | 32 organisms In silico: Alignment with SARS-CoV-1 |
25 substances | 50 52 |
95.8%b (78.9–99.9%) 100%c (39.8–100%) |
100%b (86.8–100%) 100%c (92.6–100%) |
(Mesa Biotech, 2021) |
| cobas (Roche) |
NP | 12 copies/mL | >99.97%d | 27 organismse In silico: Alignment with SARS-CoV-1 |
No info | 230 207 |
96.1%f (89.0–98.6%) 100%g (84.5–100%) |
96.8%f (92.6–98.6%) 98.9%g (96.2–99.7%) |
(Roche Molecular Systems, n.d.-b) |
| Cue (Cue Health) |
Nasal | 20 genome copies/sample wand | ≥98.6% | 31 organisms In silico: Alignment with SARS-CoV-1 |
23 substances | 271 | 97.4% (86.5–99.5%) |
99.1% (96.9–99.8%) |
(Cue Health Inc, 2021) |
| Detect (Detect Inc.) |
Nasal | 313 copies/swabh | 98.6% | 31 organisms In silico: No alignment with SARS-CoV-1i |
19 substancesj | 112 | 90.9% (76.4–96.9%) |
97.5% (91.2–99.3%) |
(Detect Inc, 2021) |
| ID NOW (Abbott) | NP | 125 genome equivalents/ mL |
99.32% | 37 organismse In silico: No alignment with SARS-CoV-1 |
No info | 50 | 100%k (83.9–100%) |
100% (88.7–100%) |
(Abbott Diagnostics Scarborough, n.d.) |
| Lucira (Lucira Health) |
Nasal | 2700 cp/swab | Set 1: 95.9% Set 2: 98.35% |
33 organisms In silico: Alignment with SARS-CoV-1 |
15 substances | 404 | 91.7% (85.6–95.8%) |
98.2% (95.8–99.4%) |
(Lucira Health Inc, n.d.-a) |
| Talis (Talis Biomedical Corporation) |
MT | 500 copies/mL | ≥99.4% | 31 organisms In silico: No alignment with SARS-CoV-1 |
11 substancesl | 77 | 100% (90.8–100%) |
100% (91.0–100%) |
(Talis Biomedical Corporation, n.d.-b) |
| Visby (Visby Medical) |
NP | 1112 genomic copies/mL | ≥95% | 31 organisms In silico: Alignment with SARS-CoV-1 and Bat SARS like coronavirus |
13 substances | 60 | 100% (88.6–100%) |
100% (88.6–100%) |
(Visby Medical, 2021a) |
| Xpert Xpress (Cepheid) | NP | 0.0200 PFU/mL | E-gene: 99.14% N2-gene: 97.29% |
39 organismse In silico: Alignment with SARS-CoV-1 and Bat SARS like coronavirus for E-gene |
No info | 90 | 97.8% (88.4–99.6%) |
95.6% (85.2–98.8%) |
(Cepheid, n.d.-e) |
| Multiplex assaysm | |||||||||
| BioFire (BioMerieux) | NP | 500 copies/mL | >99.99% | 65 organismsn In silico: Alignment with Sarbecoviruses |
43 substanceso | 98 | 98% (89.3–99.6%) |
100% (92.7–100%) |
(BioMerieux, n.d.) |
| cobas SARS-CoV-2 & Influenza A/B (Roche) |
NP | 12 copies/mL | >98%p | 24 organismse In silico: Alignment with SARS-CoV-1 |
No info | 285 963 |
100%b (93.6–100%) 95.2%c (88.3–98.1%) |
100%b (98.4–100%) 99.6%c (99.0–99.9%) |
(Roche Molecular Systems, n.d.-a) |
| Xpert Xpress SARS-CoV-2/Flu/RSV (Cepheid) | NP | 131 copies/mL | E-gene: 99.5% N2-gene: 99.2% |
39 organismse In silico: Alignment with SARS-CoV-1 and Bat SARS like coronavirus for E-gene |
17 substances | 240 | 97.9% (88.9–99.6%) |
100% (98.1–100%) |
(Cepheid, n.d.-d) |
| Xpert Xpress CoV-2/Flu/RSV plus (Cepheid) |
NP | 138 copies/mL | E-gene: 99.4% N2-gene: 96.65% RdRP-gene: 99.05% |
39 organismse In silico: Alignment with SARS-CoV-1 and Bat SARS like coronavirus for E-gene |
17 substances | 279 | 100% (94.5–100%) |
100% (98.2–100%) |
(Cepheid, n.d.-c) |
In silico analysis revealed that the forward primer is predicted to be bound to the mismatch template at the annealing/extension temperatures of the assay (90.3% homology).
Retrospective study.
Prospective study.
For both target regions simultaneously.
Only in silico analysis.
Individuals suspected of COVID-19.
Asymptomatic individuals.
800 copies/mL if all virus is transferred from the swab to the buffer.
Greater than 80% homology was only apparent for a single SARS-CoV-2 primer with Pneumocystis jirovecii and two primers with Candida albicans.
Only biotin, dexamethasone and flunisolide in higher concentrations showed some false negatives.
For 2x LOD target concentration.
Only mucin and ayr nasal gel in higher concentrations showed some false negatives.
Only the values for the SARS-CoV-2 assay are given.
Off-panel organisms.
Only bleach can possibly interfere.
The (non-significant) mismatches on one gene had 100% perfect match on the other gene.