| 1 |
BioMedomics, Inc |
COVID-19 IgM-IgG dual antibody rapid test |
Qualitatively detect IgG and IgM antibodies |
This test detects both early and late marker, of corona virus-associated IgM/IgG antibodies in human |
10–15 min per test |
Whole blood, serum, or plasma |
EU (CE mark), USA (EUA) |
120
|
| 2 |
Guangzhou wondfo biotech (Guangzhou, China) |
Finecare SARSCoV-2 antibody test |
Antibody test |
Lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2 |
15 min |
Serum or plasma sample |
National medical products administration EUA in China; CE mark in Europe |
121
|
| 3 |
InTec PRODUCTS, INC. |
Rapid SARS-CoV-2 antibody (IgM/IgG) test |
IgM and IgG antibody detection |
Apid immunoassay for the qualitative detection of IgM and IgG antibodies |
NR |
Single drop of fingerpick whole blood |
EU, CE-IVD |
122
|
| 4 |
Snibe diagnostic |
MAGLUMI 2019-nCoV IgM/IgG (CLIA) |
MAGLUMI 2019-nCoV IgM/IgG kit |
Automated central laboratory rapid test that runs on MAGLUMI chemiluminescence immunoassay system |
30 min |
Blood sample |
Automated IA, CEIVD |
123
|
| 5 |
Sugentech |
COVID-19 IgM/IgG |
SGTi-flex COVID-19 IgM/IgG |
SGTi-flex COVID-19 IgM/IgG |
10 min |
Human whole blood (finger prick or venous), serum or plasma |
CE-IVD |
124
|
| 6 |
VivaChek biotech (hangzhou) Co., Ltd |
VivaDiag™ |
SARS-CoV-2 IgM/IgG rapid test (colloid gold) |
In vitro qualitative assay to detects IgM and IgG antibodies against SARS-CoV-2 |
15 min |
Whole blood (fingertip/venous), serum or plasma |
CE-IVD |
125
|
| 7 |
Quidel corporation |
Sofia 2 SARS antigen FIA |
SARS-CoV-2 antigen detection |
Immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2 |
15 min |
Nasal swab, nasopharyngeal swab |
FDA EUA |
126
|
| 8 |
Avacta group plc |
AffiDX®
|
SARS-CoV-2 antigen detection |
Lateral flow test |
20 min |
Saliva, nasopharyngeal swabs or serum |
CE (Europe), FDA (USA) |
127
|
| 9 |
Coris bio concept |
Affimer® biotherapeutics and reagents |
COVID-19 antigen detection |
COVID-19 antigen detection |
NR |
Saliva, nasopharyngeal swabs or serum |
|
128
|
|
|
CORIS COVID-19 Ag respi-stri |
COVID-19 antigen detection |
Immunochromatography assay based on a membrane technology with colloidal AuNPs fabricated with monoclonal antibodies directed against the conserved nucleoprotein antigen of SARS-CoV-2 |
15 min |
Nasopharyngeal specimens |
EU, CE-IVD |
128
|
