COVID-19 Antigen Test Kit (Colloidal gold immunochromatographic assay)
Manufactured by Langfang Xinruikang Biotechnology Co. Ltd., China
Device identification number
3092
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
performances Alpha(98;96);Beta(97;94);Gamma(98;95);Delta(98;96);Omicr on(97;96)
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
25 (pg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
All diagnostic tests may be subject to false positive results, especially in low prevalence settings
False negatives
Improper sample collection, transport and handling, and low virus concentrations in samples can le
Precision
Evaluated
Accuracy
95 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89 % (Antigen)
Clinical Specificity
97 % (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