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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 (Nasal Swab)

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

Device identification number
2267
CE Marking
Yes
HSC common list (RAT)
×No
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 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
Crossreactivity
Evaluated
Fp
0.054 AU
Fn
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

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