COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2267

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mumps Virus (MuV), Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)

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

2023-05-17 05:26:51 CET

Comments

The ACRO SARS-CoV-2 Antigen Rapid Test (Nasal 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 ACRO SARS-CoV-2 Antigen Rapid Test (Nasal 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

Rapid Diagnostic

Yes

Reader Required

No

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.054 AU

False negatives

0.006 AU

Precision

Evaluated

Accuracy

98.1 % ((Antigen))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

94.6 % ((Antigen))

Clinical Specificity

99.4 % ((Antigen))

Type of antigen

Nucleoproteins