ABtex AG
Manufactured by JIAXING WISETEST BIO-TECH Co. Ltd., China - http://www.biotech-crm.com/
Device identification number
2528
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antibody
Specimen
Saliva
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The company would like to work with us to sell their products in Switzerland. One requirement from Switzerland is to be listed on your list. More information about the Product: At present, the main detection method for the new coronavirus virus is nucleic acid detection, which has strict requirements on detection equipment and personnel. Therefore, the establishment of a detection method with faster detection time, easier operation, and lower cost is of great significance to the control of the epidemic. The saliva novel coronavirus antigen detection kit independently developed by JIAXING WISETEST BIO-TECH CO., LTD. is used for people who have symptoms in the early stage of infection (window period). Highly sensitive, convenient saliva collection, 15 minutes on-site results. The tested person can operate and interpret by himself, which is convenient and quick. There is no need for sample collection, storage, transportation and testing equipment.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 none
False negatives
11 AU
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 % (Highly sensitiv)
Clinical Specificity
95 %
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