COVID-19 In Vitro Diagnostic Medical Device - detail

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 %