2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Manufactured by CITEST DIAGNOSTICS INC, China - www.citestdiagnostics.com
Device identification number
2438
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Pathogens detected
Adenovirus, Enterovirus A71 (EV-A71), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
Lineages detected
A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),
Commercial Status
Commercialised
Last Update
2021-07-14 06:12:22 CET
Comments
The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
100 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % IgG
Fp
0.15 % IgM
Fn
0.02 % IgG
Fn
0.04 % IgM
Precision
Evaluated
Accuracy
98.6 % IgG
Accuracy
92.9 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
85 % IgM
Clinical Specificity
98 % IgG
Clinical Specificity
96 % IgM
Type of antigen
Nucleoprotein
Notes
Ares(2021)4569376
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements