COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2683

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Lateral flow

Target type

Antigen

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The SavvycheckTM SARS-CoV-2 Ag is an immunoassay in which SARS-CoV-2 nucleocapsid protein antigens extracted from nasal swabs of individuals suspected of COVID-19, interact during flow along the test strip with anti-SARS- CoV-2 nucleocapsid protein specific antibodies conjugated to a red latex particles used as a detector. The resulting complex flows along the strip and interacts with immobilized anti-SARS-CoV-2 nucleocapsid-specific antibodies in the detection zone(“T”), forming an observable red-colored line. The presence of a red line at the test line position indicates a positive result. The conjugated latex particles interact downstream the test line with other specific antibodies to create the control line. The presence of a green line at the control line position indicates proper function of the test.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Other ()

Measurement

Qualitative

Time

10 minutes

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

3 %

False negatives

1 %

Precision

Evaluated

Accuracy

98 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.2 %

Clinical Specificity

98.8 %