Table 2.
Developer | Name of Test | Technology | Specimen Indicated for Testing | Time to Result | Limit of Detection | Target Gene | Status | Reference |
---|---|---|---|---|---|---|---|---|
DnaNudge Ltd. | CovidNudge Test | RT-PCR | NP swab or sputum | 90 min | 250 viral copies/swab | N1, N2, N3, RdRp1, RdRp2, E | CE-IVD | [160] |
Diagnostics for the Real World Ltd. | SAMBA II SARS-CoV-2 Test | Isothermal amplification, lateral flow | Throat and nose swabs | <90 min | 250 copies/mL | Orf1ab, N | CE-IVD | [161] |
OptiGene Ltd. | COVID-19_Direct Plus RT-LAMP KIT-500 kit | RT-LAMP | OP/NP swab dilutions and saliva samples | <20 min | 103 copies/mL | NR | CE-IVD | [162] |
Caspr Biotech | Caspr Lyo-CRISPR SARS-CoV-2 Kit (FAM) Direct Sample | RT-LAMP, CRISPR | NP/OP and nasal swabs | <60 min | 25 copies/μL | 2 regions in N, Orf1ab | N/A | [163] |
Molbio Diagnostics Pvt Ltd. | Truenat SARS CoV-2 | Chip-based Real-Time RT-PCR | OP and NP swabs | 35 min | 407 genome copies/mL | RdRp | India CDSCO | [164] |
Mobidiag | Novodiag COVID-19 | RT-PCR | NP swab | 1 h 20 min | NR | Orf1ab, N | CE-IVD | [165] |
GeneReach Biotechnology Corp | POCKIT Central SARS-CoV-2 (Orf1ab) Premix Reagent | Insulated Isothermal PCR (iiPCR) technology | OP swab | 85 min | NR | Orf1ab | CE-IVD | [166] |
NP, nasopharyngeal; OP, oropharyngeal; NR, not reported.