COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1895

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow, Strip

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab, Saliva

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

INTENDED USE The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARSCoV- 2 Antigen Rapid Test can also be used for testing specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infec-tion. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARSCoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

LOD

160 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

Precision

Evaluated

Accuracy

98 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97.1 % ((95% CI: 93.1%-98.9%))

Clinical Specificity

99.5 % ((95% CI: 98.2%-99.9%))

Type of antigen

nucleocapsid

Notes

SARS-CoV-2 antigen rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab or saliva specimens.