Chemtrue® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit (Nasal Swab)
Manufactured by Shanghai Chemtron Biotech Co. Ltd., China - www.chemtronbio.com
Device identification number
3072
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
non-structural protein NS10, non-structural protein NS3a, non-structural protein NS3b, non-structural protein NS7a, non-structural protein NS9a, non-structural protein Ns9b, non-structural protein NSP1, non-structural protein NSP10, non-structural protein NSP12, non-structural protein NSP13, non-structural protein NSP14, non-structural protein NSP15, non-structural protein NSP16, non-structural protein NSP2, non-structural protein NSP3, non-structural protein NSP4, non-structural protein NSP5, non-structural protein NSP6, non-structural protein NSP7, non-structural protein NSP8, non-structural protein NSP9, Nonstructural protein NS7b, ORF1ab polyprotein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Influenza A, Influenza B
Lineages detected
A.23.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Evaluated by Centralne Laboratorium Kliniczne Uniwersyteckie Centrum Kliniczne, 80-214 Gdansk, ul. Mariana Smoluchowskiego 17 ( University Clinical Center, 80-214 Gdansk Mariana Smoluchowskiego 17 street) Person in charge of statistics and unit: Pawel Chrzan PhD Contact number :+48 585844380
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
13 minutes
Subclass
Membrane-based
LOD
50 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
14.5 %
Precision
Evaluated
Accuracy
% 97.17(Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
85.45 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
ORF1a protein
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