Table 2 Diagnostic kits for COVID-19
S. No | Name | Company name | Regulatory/Authorization | Refs |
|---|---|---|---|---|
Molecular assays for COVID-19 diagnosis | ||||
1. | ANDiS® SARS-CoV-2 RT-qPCR Detection Kit | 3D Medicine Science & Technology Co., Ltd | US FDA-EUA—CE-IVD | [154] |
2. | Abbott RealTime SARS-CoV-2 EUA test | Abbott Molecular Inc | US FDA-EUA—CE-IVD | [155] |
3. | Truenat™ Beta CoV (lab-based or near-POC) | Molbio Diagnostics Pvt Ltd | India DCGI | [156] |
4. | QIAstat-Dx Respiratory Panel 2019-nCoV | QIAGEN GmbH | US FDA-EUA—CE-IVD | [157] |
5. | cobas® SARS-CoV-2 (for use on the cobas® 6800/8800 Systems) | Roche Molecular Diagnostics | US FDA-EUA—WHO EUL | [158] |
6. | Senteligo Covid-19 qRT PCR Detection Kit | Sente Biolab | CE-IVD | [159] |
7. | VereCoV™ Detection Kit | Veredus Laboratories Pte Ltd | Singapore HSA—CE-IVD | [160] |
8. | VISION COVID19 Easyprep Test Kit | Vision Biotechnology Research & Development | IFA ISO 9001: 2015 | [161] |
9. | ePlex® SARS-CoV-2 Test | GenMark Diagnostics | US-FDA EUA | [162] |
Immunoassays for COVID-19 diagnosis | ||||
10. | Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette Specimen: Whole blood/Serum/Plasma | AccuBioTech Co. Ltd | CE-IVD | [163] |
11. | SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | BIOHIT HealthCare (Hefei) Co., Ltd | CE-IVD | [164] |
12. | COVID-19 IgM-IgG Dual Antibody Rapid Test | BioMedomics, Inc | CE-IVD | [165] |
13. | Cellex qSARS-COV-2 IgG/IgM Rapid Test Specimen: Whole blood/Serum/Plasma | Cellex Inc | US FDA-EUA—CE-IVD | [166] |
14. | Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test | KRISHGEN BioSystems | CE-IVD | [167] |
15. | SARS-CoV-2 IgM/IgG Ab Rapid Test Specimen: WB/S/P | Sure Bio-Tech (USA) Co., Ltd | CE-IVD | [168] |