One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva)
Manufactured by Getein Biotech Inc., China - en.bio-gp.com.cn
Device identification number
2590
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human saliva samples from patients suspected of COVID-19 infection by a healthcare provider.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
200 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.38 % (1 of 257)
False negatives
1.29 % (2 of 154)
Precision
Evaluated
Accuracy
99.27
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.7 %
Clinical Specificity
99.61 %
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