COVID-19 Antigen Saliva Test Kit
Manufactured by Assure Tech (Hangzhou) Co., Ltd, China - www.diareagent.com
Device identification number
HSC mutual recognition
Manual, Near POC / POC
2021-05-10 01:04:00 CET
variants_detected: B.1.258.21 B.1.117 C.2.1
0 % none, 100% specific
0 % no false negatives occurred on antigen level at 1.48 mg/mL or virus level at 1×10 6.4TCID50/mL.
93.9 % (Ct<31. Overall Agreement: 93.9 % (91.3% - 96.0%) . Ct<25 Overall Agreement: 99.5 % (98.0% ~ 99.9%))
86 % (Ct<31 Relative Sensitivity: 86.0 % (80.3% - 90.6%)* . Ct<25 Relative Sensitivity: 98.3 % (94.1% - 99.8%)*)
100 % ((98.5%-100.0%))
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