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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 Antigen Rapid Test (Swab)

Manufactured by Acro Biotech Inc, United States - www.acrobiotech.com 

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
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Fp
0.006 AU
Fn
0.063 AU
Precision
Evaluated
Accuracy
96.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.7 %
Clinical Specificity
99.4 %
Type of antigen
Nucleocapside

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements