Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)
Manufactured by Changzhou Biowin Pharmaceutical Co. Ltd., China - www.czbiowin.cn
Device identification number
2588
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Lab-based, Manual, Near POC / POC
Physical Support
Card, Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
1.. For in vitro diagnostic use. 2. This test has been authorized only for the detection of the nucleocapsid protein from SARS- CoV-2, not for any other viruses or pathogens. 3. Do not use this kit beyond the expiration date printed on the outside carton. 4. Test results are meant to be visually determined. 5. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. 6. Do not reuse any kit components. 7. Proper specimen collection, storage and transport are critical to the performance of this test 8. The SARS-CoV-2 external positive controls have been prepared from recombinant viral proteins and do not contain infectious material. 9. Dispose of used test kits as biohazards waste in accordance with the local requirements. 10. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS). 11. Wear suitable protection when handling the contents of this kit if it is necessary.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Detection Principle
Colloidal gold
LOD
170 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.7 %
False negatives
4.4 %
Precision
Evaluated
Accuracy
97.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.6 %
Clinical Specificity
98.3 %
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