COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2495

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC, Semi-automated

Physical Support

Dipstick

Target type

Antigen

Specimen

Saliva, Sputum

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Principle The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line that develops on the strip. Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C. Kit Content 1) Test device (individually packed in a foil pouch with desiccant). 2) Instruction for use. Materials required but not provided Timer Precautions • For in vitro diagnostic use only. • Do not re-use the test device. • Do not use after the expiration date. • Do not use the test kit if the pouch is damaged or the seal is broken. • Perform test at room temperature 15 to 30°C. •Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window. • All samples and used accessories should be treated as infectious and discarded according to local regulations. • Avoid using blood samples.

Assay Type

Immuno-Antigen

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Sandwich

LOD

25 TCID50/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

4.65 % (6 on 129)

False negatives

0 % 0 on 200

Precision

Evaluated

Accuracy

98.21 % (98,21 %)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

95.6 %

Clinical Specificity

99 %

Type of antigen

Nucleocapsid protein