2)
In development
Manual NAT
Genetic Signatures Ltd (validated)
AB ANALITICA Srl, REALQUALITY RQ-SARS-CoV-2 (proof of concept) Contact
Huwel Lifesciences Pvt. Ltd., Quantiplus CORONA Virus (2019nCoV) detection kit (proof of concept) Contact
CerTest biotec, VIASURE 2019-nCoV Real Time PCR Kit (concept)
Automated lab-based, near-POC or POC NAT
BioFire Defense, LLC, BioFire COVID-19 Test (lab-based or near-POC; validated) Contact
Caspr Biotech: caspr.bio, Phantom 1.0 Dx, (near-POC; validated) Contact
Coyote Bioscience, 2019-nCoV Prep Free QPCR Assay (near-POC; validated) Contact
Cepheid (lab-based or near-POC; proof of concept)
Diagnostics for the Real World Ltd, SAMBA II COVID-19 Test (automated POC NAT; proof of concept) Contact
Hibergene (lab-based or near-POC; proof of concept)
Molbio Diagnostics Pvt Ltd, Truenat SARS CoV-2 (lab-based or near-POC; proof of concept) Contact
Roche Molecular Diagnostics, cobas® SARS-CoV-2 (for use on the cobas® 6800/8800 Systems; proof of concept) Contact
Mobidiag, Novadiag® COVID-19 + InfA/B (lab-based & near-POC; concept) Contact
IMMUNOASSAYS
Commercialized
Manual or automated immunoassays
Epitope Diagnostics, Inc. (CE-IVD) Contact
EDITMNovel Coronavirus COVID-19 IgG ELISA Kit
EDITMNovel Coronavirus COVID-19 IgM ELISA Kit
Boditech Med, Inc. (RUO) Contact
AFIAS COVID-19, Viral Antigen (automated)
AFIAS COVID-19 Ab, IgM/IgG (automated)
Ichroma COVID-19, viral antigen (manual)
Ichromia COVID-19 Ab, IgM/IgG (manual)
EUROIMMUN AG (RUO) Contact
Anti-SARS-CoV-2 ELISA (IgA) (manual; automated)
Anti-SARS-CoV-2 ELISA (IgG) (manual; automated)
Guangzhou Wondfo Biotech Co., Ltd, Finecare SARS-CoV-2 Antibody Test (manual, RUO) Contact
Sugentech, Inc. (manual, RUO) Contact
SGTi-flex COVID-19 IgM/IgG
SGTi-flex COVID-19 IgM
SGTi-flex COVID-19 IgG
Rapid diagnostic tests
Dynamiker Biotechnology (Tianjin) Co., Ltd., 2019 nCOV IgG/IgM Rapid Test (CE-IVD) Contact
Getein Biotech, Inc., One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) (CE-IVD) Contact
Guangzhou Wondfo Biotech Co., Ltd, Wondfo SARS-CoV-2 Antibody Test (lateral flow method) (Chinese FDA-EUA; CE-IVD) Contact
SD BIOSENSOR, Inc., STANDARD Q COVID-19 IgM/IgG Duo Test (CE-IVD) Contact
servoprax GmbH, Cleartest Corona, Covid-19 (CE-IVD) Contact-1; Contact-2
Shenzhen Bioeasy Biotechnology Co., Ltd. (CE-IVD) Contact
Novel Coronavirus (2019-nCoV) Fluorescence Antigen Rapid Test
Novel Coronavirus (2019-nCov) Colloidal Gold Antigen Rapid Test
Novel Coronavirus (2019-nCoV) IgG/IgM detection kit (colloidal gold immunochromatography)
Wuhan EasyDiagnosis Biomedicine Co.,Ltd, (CE-IVD; RUO) Contact
Novel Coronavirus IgM antibody test kit (colloidal gold method)
Novel Coronavirus IgG antibody test kit (colloidal gold method)
Jiangsu Bioperfectus Technologies Co. Ltd (RUO) Contact
PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit
Sugentech, Inc. (RUO) Contact
SGTi-flex COVID-19 IgM/IgG
SGTi-flex COVID-19 IgM
SGTi-flex COVID-19 IgG
Xiamen Biotime Biotechnology Co., Ltd., SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit (RUO) Contact
In development
Manual or automated immunoassays
BluSense Diagnostics ApS, ViroTrack COVID IgA+IgM/IgG/Total Ig Ab (automated; proof of concept) Contact
Kephera Diagnostics, 2019-nCoV ELISA (manual; proof of concept) Contact
DART Diagnostics, DART COVID-19 (manual; concept) Contact
St. Petersburg Research Institute of Vaccines and Sera (FSUE SPbSRIVS FMBA), SARS-CoV-2 Tru-EIA (manual; concept) Contact
Rapid diagnostic tests
Baiya Phytopharm, Co, Ltd., Baiya Rapid COVID-19 IgM/IgG test kit (WHO EUA; NRA; proof of concept) Contact
Kephera Diagnostics, 2019-nCoV Rapid LF Test (proof of concept) Contact
Sona Nanotech, Sona-COVID-19 LFA (proof of concept) Contact
Great Basin – Vela Operations, Great Basin 2019-nCoV Test (concept) Contact
Nanotech (concept)
DIGITAL SOLUTIONS
Beijing Infervision Technology Co. Ltd, InferRead CT Pneumonia (validated) Contact
OTHER DIAGNOSTICS
Pinpoint Science Inc., Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer (proof of concept) Contact
Twist Bioscience, NGS-based target capture for SARS-CoV-2 detection and screening (proof of concept) Contact
EUA – Emergency Use Authorization
HSA – Health and Safety Authority
MFDS – Ministry of Food and Drug Safety
NRA – National Regulatory Authority
RUO – Research Use Only