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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 Saliva Test Kit

Manufactured by Assure Tech (Hangzhou) Co., Ltd, China - www.diareagent.com 

Device identification number
2037
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Saliva
Lineages detected
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
variants_detected: B.1.258.21 B.1.117 C.2.1
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
37 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % none, 100% specific
Fn
0 % no false negatives occurred on antigen level at 1.48 mg/mL or virus level at 1×10 6.4TCID50/mL.
Precision
Evaluated
Accuracy
93.9 % (Ct<31. Overall Agreement: 93.9 % (91.3% - 96.0%) . Ct<25 Overall Agreement: 99.5 % (98.0% ~ 99.9%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
86 % (Ct<31 Relative Sensitivity: 86.0 % (80.3% - 90.6%)* . Ct<25 Relative Sensitivity: 98.3 % (94.1% - 99.8%)*)
Clinical Specificity
100 % ((98.5%-100.0%))
Notes
The COVID-19 Antigen Saliva Test Kit detects SARS- CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti- SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. A sample is added to the extraction buffer, which is optimized to release the SARS-CoV-2 antigens from the specimen. During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess colored particles are captured at the internal control zone. The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, generally indicating that the proper volume of specimen has been added and membrane wicking is working. This is a unique 1 step antigen test, which contains an RNA inactivating and antigen releasing buffer, in contrast to all other 1 step saliva essays. Making this the most sensitive essay of its kind. Please find more information, including parts of the technical file, through the wetransfer link shared above.

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