Table 3.
Characteristics of tests that received EUA by the FDA for POC or OCT use to detect SARS-CoV-2.
| Name | Specimen (swab type(s)) | Amplification method | Target(s) | Control(s) | App | Time-to-result | Re-useable reader | Ref. |
|---|---|---|---|---|---|---|---|---|
| Accula (Mesa Biotech) |
Nasal or MT | RT-PCR + lateral flow | N-gene | Internal positive process control & Internal negative process control | No, visual read-out | ∼30 min | Y | (Loeffelholz and Tang, 2021; Mesa Biotech, 2021; Ravi et al., 2020; Yu et al., 2021) |
| BioFire (BioMerieux) |
NP | Nested multiplex PCR | 19 targets, S-gene and M-gene | RNA process control & PCR2 control | No | ∼45 min | Y | (BioMerieux, n.d.; Loeffelholz and Tang, 2021) |
| cobas (Roche Molecular Systems) |
Nasal, NP or MT | RT-PCR | N-gene and ORF1ab | Internal process control | No | ∼20 min | Y | (Loeffelholz and Tang, 2021; Roche Molecular Systems, n.d.-b) |
| Cue (Cue Health) |
Nasal | Isothermal | N-gene | Human cellular material | Yes | ∼20 min | Y | (Cue Health Inc, 2021; Donato et al., 2021; Loeffelholz and Tang, 2021; Ravi et al., 2020; Yu et al., 2021) |
| Detect (Detect Inc.) |
Nasal | Isothermal: RT-LAMP + lateral flow |
ORF1ab | Human gene | Yes (with IFU) |
>60 min | Y | (Detect Inc, 2021) |
| ID NOW (Abbott) |
Nasal, NP or OP | Isothermal: NEAR |
RdRp | Internal control | No | ≤13 min | Y | (Abbott Diagnostics Scarborough, n.d.; Loeffelholz and Tang, 2021; Ravi et al., 2020) |
| Lucira (Lucira Health) |
Nasal swab | Isothermal: RT-LAMP |
2 non-overlapping N-genes | Positive IC & Lysis IC | No, but digital ‘LUCI PASS’ | ≤30 min | N | (Loeffelholz and Tang, 2021; Lucira Health Inc, n.d.-a) |
| Talis (Talis Biomedical Corporation) |
MT | Isothermal: RT-LAMP |
N-gene and ORF1ab | Sample processing control | No | ∼27 min | Y | (Talis Biomedical Corporation, n.d.-b) |
| Visby (Visby Medical) |
Nasal, NP or MT | RT-PCR + lateral flow | N1-gene | Positive IC | No, visual read-out | ∼30 min | N | (Loeffelholz and Tang, 2021; Visby Medical, 2021a) |
| Xpert Xpress (Cepheid) |
Nasal, NP, MT or OP | RT-PCR | N2-gene and E-gene | Sampling processing control & Probe check control | No | ≤45 min | Y | (Cepheid, n.d.-e; Loeffelholz and Tang, 2021; Ravi et al., 2020) |