Sars-CoV-2 antigen test kit (colloidal gold)
Manufactured by Shenzhen Dymind Biotechnology Co. Ltd., China - www.dymind.com
Device identification number
2415
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Antigen Test Kit is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab (NS) specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
150 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.59 %
False negatives
2.65 %
Precision
Evaluated
Accuracy
97.9 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.58 % ( (91.48% -99.06%))
Clinical Specificity
98.37 % ( (94.25% - 99.80%))
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