Biowin COVID-19 Antigen Nasal Test (Self-test)
Manufactured by Changzhou Biowin Pharmaceutical Co. Ltd., China - www.czbiowin.cn
Device identification number
3148
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Card, Cassette, Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
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, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Rhinovirus, SARS-CoV
Lineages detected
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.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
[Warning and Precautions] 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 is critical to the performance of this test. 8. Dispose of used test kits as biohazards waste in accordance with the local requirements.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
N.A.
LOD
395 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1.6 %
Precision
Evaluated
Accuracy
99.62 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.4 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Nucleocapsid protein
Notes
antigen_epi N protein antibody B2 ( MAB2) aa44-aa175 N protein antibody B3 ( MAB3) aa74-aa105
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