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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



COVID-19 Antigen Rapid Test (Colloidal Gold Method)

Manufactured by BIOLAN HEALTH, S.L., Spain - www.biolanhealth.com 

Device identification number
2519
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
BIOLAN HEALTH COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleoclapsid antigen of SARS-CoV-2 virus in nasal swab samples in only 15-20 minutes. The product is intended for use as an aid in the rapid diagnosis of COVID-19 in individuals who are suspected of COVID-19 within the first 7 days of symptoms onset or in asymptomatic individuals in line with the in existing national, regional, and local public health and occupational health regulations and recommendations , . This test provides preliminary test results. Positive results indicate the presence of viral antigens, but do not rule out a bacterial infection or co-infection with other viruses. Negative result does not preclude SARS-CoV-2 infection and it cannot be used as a sole basis for diagnosis or patient management decisions. Negative results must be combined with clinical findings, epidemiological information and if necessary, with a molecular test.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
TCID50/ml 3,5 x 10(2,5)
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1.7 %
Fn
3.5 % ((within 5 days of sympton onset). )
Fn
8.4 % ((7 days))
Precision
Evaluated
Accuracy
97.4 % ((within 5 days of symptom onset). )
Accuracy
94.4 % ( (7 days))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.5 % ((within 5 days of symptom onset). )
Clinical Sensitivity
91.6 % (( 7 days))
Clinical Specificity
98.3 %
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