COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1948

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Specimen

Nasal swab, Oropharyngeal swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) is a lateral flow immunoassay for the qualitative detection of Nucleocapsid protein antigens of SARS-CoV-2 in swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 antigen is able to be detected in the upper respiratory tract during the acute phase of infection. The ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) tests for the SARS-CoV-2 nucleocapsid protein antigen in upper respiratory specimens. While a positive result indicates the existence of the viral antigen, further evaluation of patient history and diagnostics are necessary to confirm these results. A patient may experience concurrent infection with other viruses or a bacterial infection which are not ruled out by a positive SARS-CoV-2 antigen result. Detection of the antigen does not surely certify it as the cause of the disease. Negative results should be treated as presumptive and confirmation with a molecular assay may be necessary for patient management. Negative results do not rule out SARS-CoV-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.

Assay Type

Immuno-Antigen

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.006 AU

False negatives

0.063 AU

Precision

Evaluated

Accuracy

96.7 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

93.7 %

Clinical Specificity

99.4 %

Type of antigen

Nucleocapside