SARS-CoV-2 Antibody Lateral Flow Test
SARS-CoV-2 Antibody Test (Lateral Flow Method) is intended for rapid (15 minutes) detection of IgM or IgG antibodies against SARS-CoV-2. The qualitative detection of SARS-CoV-2 (“coronavirus”) IgM & IgG antibodies in human whole blood, serum or plasma sample supports the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. An independently performed validation study performed by the Medical University Innsbruck with 500 samples showed a sensitivity of 98.4% and a specificity of 100%. Thus, the test is comparable to high-quality ELISAs and can be rapidly performed on site.
Der SARS-CoV-2-Antikörpertest (Lateral Flow-Methode) dient zum schnellen (15-minütigen) Nachweis von IgM- oder IgG-Antikörpern gegen SARS-CoV-2. Der qualitative Nachweis von IgM- und IgG-Antikörpern gegen das “Coronavirus” (SARS-CoV-2) in menschlichen Vollblut-, Serum- oder Plasmaproben unterstützt die Diagnose einer durch SARS-CoV verursachten Coronavirus-Infektionskrankheit (COVID-19). In einer unabhängigen Validierungstudie der Medizinischen Universität Innsbruck mit 500 Proben wurde eine Sensitivität von 98.4% und eine Spezifität von 100% nachgewiesen.
Rapid, qualitative detection of SARS-CoV-2 IgM & IgG antibodies in human whole blood, serum or plasma sample.
The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.
Results are obtained within 15 minutes.
This kit is based on the principle of capture immunoassay for determination of SARS-CoV-2 IgG/IgM antibodies in human whole blood (venous and capillary), serum and plasma. When the specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with the SARS-CoV-2 antigen-dye conjugate and flows across the pre-coated membrane.
When the SARS-CoV-2 antibody level in the specimen are at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen-dye conjugate are captured by anti-human IgG antibody and anti-human μ chain antibody immobilized in the Test Region (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Region (T) of the device. This indicates a negative result.
To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.
SARS-CoV-2 Antibody Test (Lateral Flow Method) is an immunochromatographic assay intended for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM & IgG antibodies in human whole blood (venous and capillary), serum or plasma sample. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision. It could be combined with PCR tests for direct detection of SARS-CoV-2 viral RNA in nose/throat swabs.