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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay)

Manufactured by Biosino Bio-Technology and Science Inc., China - www.sinobio.com.cn/ 

Device identification number
2856
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Throat secretion, Throat swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is a lateral flow chromatographic immunoassay intend for in vitro qualitative detection of SARS-CoV-2 nucleocapsid(N) protein antigen in human nasal swab specimens directly from individuals within 7 days of symptom onset or without symptom or other epidemiological reasons to suspect COVID-19 infection. The SARS-CoV-2 belongs to a novel coronavirus of genus β. It has an envelope, the particles are round or oval, often polymorphic, and its diameter is 60-140 nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. SARS-CoV-2 nucleocapsid(N) protein antigen detection is generally used in the acute infection period, and used for sample testing within 7 days of the onset of symptoms in suspected populations. Antigen detection should be used in combination with diagnostic information such as nucleic acid assay and imaging data, and medical history and exposure history to determine the infection status. This product is applicable to the detection of SARS-CoV-2 nucleocapsid(N) protein antigen for people suspected of SARS-CoV-2 infection, and not applicable to the screening of general populations. Regardless of negative or positive test results, further nucleic acid detection should be performed.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
0.1 ng/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.6 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95 % (nasal swab)
Clinical Specificity
100 % (nasal swab)
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