COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2522

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Manual, Near POC / POC

Physical Support

Lateral flow, Strip

Target

Antigen

Specimen

Other, Saliva, Sputum

Pathogens detected

SARS-CoV

Lineages detected

B.1.1.7 (United Kingdom), B.1.351 (South Africa), P.2 (Brazil),

Commercial Status

Commercialised

Last Update

2021-08-03 09:23:33 CET

Comments

■ Clinical performance was evaluated with frozen samples, and test performance may be different from fresh samples. Do not use repeatedly freeze-thaw samples. Specimen stability recommendations are based upon stability data from influenza testing and performance may be different from SARS-CoV-2. Users should test specimens as quickly as possible after specimen collection, and within one hour after specimen collection, if not please follow the “specimen collection and preparation” section. ■ The contents of this kit are to be used for the qualitative detection of COVID-19 Antigens from sputum or posterior oropharyngeal saliva specimens only ■ Please use the extraction reagent solution provided in this kit when sampling. Do not mix test cassettes and extraction reagent solutions from different batches. ■ It indicates an error if no line appears in the quality control area (C) and test area (T). Please retest. ■ This device has been evaluated for use with human specimen material only.

Assay Type

Immuno-Antigen

Reader Required

No

Subcategory

Visualisation system

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

LOD

2 TCID50/ml

Calibration

Not evaluated

Crossreactivity

Evaluated

Fp

4 % (4)

Fn

1 % (1)

Precision

Evaluated

Accuracy

99.17 % (99,17)

Reproducibility

Not evaluated

Robustness

Evaluated

Clinical Sensitivity

98.67 %

Clinical Specificity

99.67 %

Type of antigen

Nucleocapsid protein