Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)（For Saliva)）
Manufactured by Changzhou Biowin Pharmaceutical Co. Ltd., China - www.czbiowin.cn
Device identification number
2749
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Saliva
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. Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples. 2. Users should test specimens as quickly as possible after specimen collection. 3. Positive test results do not rule out co-infections with other pathogens. 4.The test results should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. 5. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of COVID-19 infection. 6.The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 7 of illness are more likely to be negative compared to a RT-PCR assay. 7.Failure to follow the test procedure may adversely affect test performance and/or invalid the test result. 8.The contents of this kit are to be used for the qualitative detection of SARS- CoV-2 antigens from saliva swab specimens only
Assay Type
Immuno-Antigen
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
8.11 %
False negatives
0.8 %
Precision
Evaluated
Accuracy
96 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.89 % (Antigen)
Clinical Specificity
99.2 % (Antigen)
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