Corona virus, InTec sneltest SARS-CoV-2 IgM/IgG antilichamen duo test; 25 stuks

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We leveren nu uit: batch met houdbaarheid t/m juni 2021

InTec is een producent gespecialiseerd in testen voor infectie ziekten, 2 van hun andere sneltesten hebben een WHO Pre-qualification status, hetgeen inhoudt dat hun dossiers, kwaliteitssysteem en productie sites (tot 500.000 testen per dag) de WHO audits hebben doorstaan.

The Rapid SARS-CoV-2 Antibody (IgM/IgG) Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of IgG and/or IgM to SARS-CoV-2 in human whole blood (venous and figerstick), serum or plasma specimens.

Results in 15-20 minutes.

This test is intended for use by healthcare professionals and trained healthcare workers as an aid in the diagnosis of SARS-CoV-2 infection.

Clinical sensitivity: 94,4%, clinical specificity 98% (n = 454, CDC Wuhan)

Additional datasets will be generated with FIND, WHO, US FDA, Erasmus Medical Center, RIVM the Netherlands and other reputable institutes.

On the IgM side of the cassette, the IgM antibody (SARS-CoV-2 specific and non-specific) in the specimen will combine with the gold conjugated mouse anti-human IgM monoclonal antibody pre-coated on the sample pad to form animmune complex. The complex will move forward along the test strip. If the test sample contains SARS-CoV-2 specific IgM and the concentration is above the minimum detection limit, the complex will be captured by the SARS-CoV-2 antigen pre-coated at the test band region, and form a purplish red band. If the specimen does not contain SARS-CoV-2 specific IgM or the concentration is below the minimum detection limit, there will be no purplish red band shown at the test band region.

On the IgG side of the cassette, the IgG antibody (SARS-CoV-2 specific and non-specific) in the specimen will combine with the gold conjugated mouse anti-human IgG monoclonal antibody pre-coated on the sample pad to form an immune complex. The complex will move forward along the test strip. If the test sample contains SARS-CoV-2 specific IgG and the concentration is above the minimum detection limit, the complex will be captured by the SARSCoV-2 antigen pre-coated at the test band region, and form a purplish red band. If the specimen does not contain SARS-CoV-2 specific IgG or the concentration is below the minimum detection limit, there will be no purplish red band shown at the test band region.

Regardless of whether the analyte exist in the sample, a purplish red band will appear at the both of the two control band regions. Only when the control band appears the correlated result is valid.

Storage at room temperature.

Patients with positive results should be retested with other technological method such as RT-PCR under the guidance of local regulations before the clinical diagnosis is made.

Package contains:

• 25 Test cassettes
• 25 Droppers
• 4x 2 ml Sample Diluent
• 25 Sterile safety lancets
• 25 Alcohol Swabs
• 1 Package Insert, instructions for use

Downloads:

• CE Notification of Conformity from  EU Authorized Representative
• CE Declaration of Conformity from manufacturer
• ISO 13485:2016 certificate

Full IFU available on request