SARS-CoV-2 Rapid Antigen Test

AMP Rapid Test SARS-CoV-2 Ag is a rapid immuno-chromatographic test for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human naso-, oropharyngeal- or anterior-nasal- swab samples, as an aid in quick and efficient diagnosis of Corona Virus Disease 2019 (COVID-19).
The test is normally intended for in-vitro diagnostic (IVD) use by healthcare professionals only, but nevertheless is easy to use and does not require any laboratory environment. As the result is available within 15 minutes, the test is a valuable tool for efficient screening in case of suspected SARS-CoV-2 infection.

As per the national council decision from January 2021 (§ 323c Abs. 18 der Bundesabgabenordnung, idgF) SARS-CoV-2 Antigen rapid tests for sample collection in the anterior nasal region or other similar minimal invasive sampling procedures are released for self-testing. The regulation applies in Austria for the time being limited until 30.06.2021.

Clinical studies evidenced high sensitivity and specificity of the test in comparison with RT-PCR.
Sensitivity: 97.3% (95% CI: 90.0% - 99.8%)
Specificity: 100% (95% CI: 96.6% - 100%)
LOD: 1,15 x 102 TCID50/mL
Potential cross-reactivity was tested with a variety of common pathogens and the concentrations at which no cross-reactivity was observed are provided in the IFU.

AMP Rapid Test SARS-CoV-2 Ag cassettes are packed individually in sealed pouches and are available in 2 different kit sizes of 10 or 25 cassettes. Sterile swabs for collection of naso-, oropharyngeal- or anterior-nasal- samples, as well as buffer and tubes for sample extraction are included in the kits.

Following products are available:
RT2952 AMP Rapid Test SARS-CoV-2 Ag, 25 Tests
RT2951 AMP Rapid Test SARS-CoV-2 Ag, 10 Tests
RT2952-C AMP Rapid Test SARS-CoV-2 Ag, 25 Tests,
includes one each positive and negative Ag QC swab
RT2952-S AMP Rapid Test SARS-CoV-2 Ag, 25 Tests with 25 prefilled extraction tubes
RT9295 AMP SARS-CoV-2 Ag controls set, one each positive and negative QC swab
RT2961 AMP Rapid Test SARS-CoV-2 Ag – Flu A+B, 10 Tests
RT2962 AMP Rapid Test SARS-CoV-2 Ag – Flu A+B, 25 Tests

Contact:

For more information and orders, please contact us at
covid19-AT@hvdgmbh.com or
office1@hvdgmbh.com

For urgent inquiries please call: +43 1 982 95 26 33

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