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Table 2 Diagnostic kits for COVID-19

From: SARS coronavirus 2: from genome to infectome

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]