COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

635

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Lab-based

Target

Nucleic acid

Commercial Status

Commercialised

Last Update

2021-05-10 01:04:00 CET

Comments

This kit uses the principle of immuno-chromatography technology to detect the novel coronavirus (COVID-19) antigen in human saliva samples using the double antibody sandwich method. While testing, the sample contains the novel coronavirus (COVID-19) antigen and the concentration is higher than or equal to the minimum detection limit, the antigen reacts with the antibody to form a complex, and the novel coronavirus is coated in the detection area (T). The antibody is captured and a red reaction line is formed. The result is judged as positive; otherwise, the result without red line formed in T is judged as negative. Under normal testing conditions, the quality control area (C) should be colored to indicate that the test is valid.

Assay Type

Nucleic acid-PCR

Method

RT-PCR

LOD

10 copies/reaction

Analitical Specificity

tested negative with 75 species of microorganisms

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Throughput

single tubes

Notes

http://www.yd-diagnostics.com/2012/eng/pdf/Covid/Insert_MolecuTech%20Real-Time%20COVID-19.pdf