SARS-CoV-2 Antigen Test Kit(Colloidal Gold Method)
Manufactured by Cofoe Medical Technology Co. Ltd., China - /
Device identification number
2632
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
1.When the titer of the SARS-CoV-2 culture is 2.5×105TCID50/ml, the test result of this test card does not show a hook effect; when the concentration of the SARS-CoV-2 positive quality control product is within the range of 0.5mg/ml, the test result of this test card does not show a hook effect . 2.Nasopharyngeal swab specimens can be stored at 2℃-8℃ for at least 8h. 3.The loading volume of theSARS-CoV-2 antigen test strip is 50μl. 4.After opening the foil bag, the SARS-CoV-2 antigen test strip meets the requirements within 60 minutes. But the test result will fail after opening for 90 minutes. Therefore, the bag-opening stability is set at 60 minutes. 5.The general storage temperature of the kit is about 25°C. According to the Arrhenius formula, the logarithm of the expiration date and the reciprocal of the absolute temperature have a linear relationship. Accelerated at 37°C for 3 months (90 days), converted to approximately 12 months (360 days) stored at 25°C. Therefore, in the absence of real-time stability test results, it is temporarily assumed that the SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) is valid for 12 months.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0.1 ng/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4 %
False negatives
1 %
Precision
Not evaluated
Accuracy
98 % ((Antigen))
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
96.04 % ((Antigen))
Clinical Specificity
99 % ((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