Chemtrue® COVID-19（SARS-CoV-2）Antigen Rapid Test Kit (Nasal Swab) - self-test
Manufactured by Shanghai Chemtron Biotech Co. Ltd., China - www.chemtronbio.com
Device identification number
3080
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
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), Chlamydia Pneumoniae, Coronaviruses (HCoV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.525 (Eta), B.1.526.1, B.1.526.2, B.1.616, B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Chemtrue® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Nasal Swab); 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
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
50 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
14.55 AU
Precision
Evaluated
Accuracy
97.17 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
85.45 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Envelop 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