| AAZ-LMB |
COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) – Cassette |
Rapid |
|
France |
| Abbott |
Panbio IgG/IgM Covid-19 rapid test |
Rapid |
|
Benelux |
| Avioq |
Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Assay (Colloidal Gold) |
Rapid |
|
Publication |
| BMT Bio marketing |
Lab on Time 2019-nCoV IgG/IgM rapid test cassette |
Rapid |
|
|
| Dynamiker Biotechnology (Tianjin) |
2019 nCOV IgG/IgM Rapid Test |
Rapid |
NCP |
Publication |
| Liming Bio |
StrongStep SARS-CoV-2 lgM/lgG Antibody Rapid Test |
Rapid |
|
Publication |
| Surescreen |
COVID-19 IgG/IgM Rapid Test Cassette |
Rapid |
|
Publication |
| VivaChek |
VivaDiag SARS-CoV-2 IgM/IgG Rapid Test |
Rapid |
|
Publication |
| Xiamen Boson Biotech |
RAPID 2019-NCOV IGG/IGM COMBO TEST CARD |
Rapid |
NCP |
Report |
| Zentech |
quickZen COVID-19 IgM/IgG rapid test |
Rapid |
RBD |
Publication |
|
|
|
|
|
| Abbott |
SARS-CoV-2 IgG Assay (Alinity, Architect) |
CMIA |
NCP |
to be published |
| SARS-CoV-2 IgM Assay (Alinity, Architect) |
CMIA |
|
Report |
| Beckman-Coulter |
Access SARS-CoV-2 IgG |
CLIA |
RBD |
Report |
| Beijing Wantai Biological Pharmacy Enterprise |
WANTAI SARS-CoV-2 Ab ELISA |
ELISA |
RBD |
to be published |
| bioMérieux |
VIDAS SARS-CoV-2 IgG |
ELFA |
|
Report |
| VIDAS SARS-CoV-2 IgM |
ELFA |
|
Report |
| Bio-Rad |
Platelia SARS-CoV-2 Total Ab Assay |
ELISA |
NCP |
Publication |
| Diasorin |
LIAISON SARS-CoV-2 S1/S2 IgG test |
CLIA |
S1/S2 |
Publication |
| Euroimmun |
Anti-SARS-CoV-2 ELISA IgG |
ELISA |
S1 |
Publication 1 |
| Publication 2 |
| ID.Vet |
ID Screen SARS-CoV-2-N IgG Indirect |
ELISA |
NCP |
to be published |
| Mikrogen Diagnostik |
recomWell SARS-CoV-2 IgG |
ELISA |
NCP |
to be published |
| NovaTec Immundiagnostica |
NovaLisa SARS-CoV-2 (COVID-19) IgG |
ELISA |
NCP |
Publication |
| Ortho Clinical Diagnostics |
VITROS Anti-SARS-COV-2 IgG |
CLIA |
S |
to be published |
| VITROS Anti-SARS-CoV-2 Total |
CLIA |
S1 |
to be published |
| Roche |
Elecsys Anti-SARS-CoV-2 |
ECLIA |
NCP |
Publication |
| Shenzhen YHLO Biotech |
iFlash-SARS-CoV-2 IgG |
CLIA |
|
Report |
| Siemens |
SARS-CoV-2 Total (COV2T) (Advia Centaur, Atellica Solution, Dimension Vista) |
CLIA |
RBD |
to be published |
| Snibe |
MAGLUMI SARS-CoV-2 IgM/IgG Test |
CLIA |
|
Publication |
| Vircell |
COVID‐19 ELISA IgG |
ELISA |
S, NCP |
Report |
|
|
|
|
|
|
|
|
|
|
| Antigen tests with sensitivity ≥ 90% AND specificity ≥ 99% as claimed in the IFU. |
| Manufacturer |
Test |
Sensitivity |
Specificity |
Specimen type |
| Abbott |
PANBIO COVID-19 Ag rapid test device |
93,3 |
99,4 |
NP swab |
| AMEDA Labordiagnostik |
AMP Rapid Test SARS-CoV-2 Ag |
97,3 |
100,0 |
NP swab |
| Biosynex |
BIOSYNEX COVID-19 Ag BSS |
96,0 |
100,0 |
NP swab |
| Biotical Health |
SARS-CoV-2 Ag CARD |
92,9 |
99,6 |
NP swab |
| DiaSorin |
LIAISON SARS-CoV-2 Ag |
97,1/94,6 |
100/99,5 |
Nasal swab/NP swab |
| Hangzhou Alltest Biotech |
Covid-19 Antigen Test |
90,4 |
99,5 |
NP swab |
| nal von minden |
NADAL COVID-19 Ag Rapid Test |
97,6 |
99,9 |
OP swab/NP swab |
| Ortho-Clinical Diagnostics |
VITROS SARS-CoV-2 Antigen test |
97,8 |
99,2 |
NP swab |
| SD Biosensor/Roche |
SARS-CoV-2 Rapid Antigen Test |
96,5 |
99,7 |
NP swab |
| Siemens |
CLINITEST Rapid COVID-19 Antigen Test |
96,7 |
99,2 |
NP swab |
| Surescreen |
COVID-19 Coronavirus Rapid Antigen Test Cassette |
93,3 |
100,0 |
OP swab/NP swab |
| Zhejiang Orient Gene Biotech |
Coronavirus Ag Rapid Test Cassette (Swab) |
96,3 |
99,1 |
NP swab |
|
|
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|
|
| Abbreviations |
|
|
|
|
| CLIA |
Chemiluminescent Immunoassay |
|
|
|
| CMIA |
Chemiluminescent Microparticle Immunoassay |
|
|
|
| ECLIA |
Electrochemiluminescence Immunoassay |
|
|
|
| ELFA |
Enzyme-linked Fluorescent Assay |
|
|
|
| ELISA |
Enzyme-linked Immunosorbent Assay |
|
|
|
| NCP |
Nucleocapsid Protein |
|
|
|
| NP |
Nasopharyngeal |
|
|
|
| OP |
Oropharyngeal |
|
|
|
| RBD |
Receptor-binding Domain |
|
|
|
| S |
Spike Protein |
|
|
|
| S1 & S2 |
Spike Protein subunit 1&2 |
|
|
|