Saliva SARS-Cov-2(2019-nCoV) Antigen Combined Test Kit (Nanocarbon Assay)
Manufactured by Ningbo Beautiful Life Medical Biotechnology Development Co. Ltd., China - www.nbmlrs.com
Device identification number
2250
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test kit is a rapid chromatographic immunoassay test device based on the principle of sandwich antibody and antigen binding. During testing, SARS-CoV-2 N / S antigen, if the virus antigens present in the saliva specimen, it will bind to the antibody conjugates to form a complex. This complex will migrate upward by capillary and then be captured by the immobilized antibody coated at the Test line region (T line) on the NC membrane. A visible black line will show up in the Test line region (T line). The black line will not form in the Test line region (T line) if there is no virus antigen in the sample.
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
2 minutes
Subclass
Sandwich, Double
LOD
125 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
12.12 %
Precision
Evaluated
Accuracy
95.09 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.38 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
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