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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit

Manufactured by Atlas Link Technology Co. Ltd., China - http://www.atlas-link.com/english/ 

Device identification number
2937
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the SARS-CoV-2 nucleocapsid protein from saliva specimen from patients who are suspected of COVID-19 by a healthcare provider. Performance of the test is limited to certified laboratories that meet the requirements to perform moderate, high or waived complexity tests.
Assay Type
Immuno-Antigen
Self Test
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
50 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Compared with PCR test, 154 individuals, 0 false positive
False negatives
2.63 % (Compared with PCR test, 76 individuals, 2 false negatives)
Precision
Evaluated
Accuracy
99.1 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.4 % (Antigen)
Clinical Specificity
100 % (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