Q-Check COVID-19 Antigen Rapid Test
Manufactured by Cold Spring Biotech Corp., Taiwan ROC - http://www.csbiotech.com.tw/
Device identification number
3011
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Influenza A, Influenza B, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Q-Check COVID-19 Antigen Rapid Test is a rapid immunochromatographic method intend for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP)specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
62.5 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3 %
False negatives
6.9 %
Precision
Evaluated
Accuracy
96.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.1 %
Clinical Specificity
97 %
Type of antigen
Nucleocapsid 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