Antigen Test Kit

Description

Performance

Relative Sensitivity: 97.1% (83.8%-99.9%)*

Relative Specificity: 99.6% (97.7%-99.9%)*

Accuracy: 99.3% (97.5%-99.9%)*

*95% Confidence Intervals

Test Highlights

Cassette Format

Detects the nucleocapsid protein antigen from SARS-CoV-2

Nasal Specimen sample

Results in 15 minutes

Feature                        Specification

Test Format                 Cassette

Specimen Format        Nasal Swab

Detects                        The nucleocapsid protein antigen from SARS-CoV-2

Sample Volume           4 to 5 drops of the prepared specimen

Relative Sensitivity      97.1% (83.8%-99.9%) 95% Confidence Intervals

Relative Specificity      99.6% (97.7%-99.9%) 95% Confidence Intervals

Accuracy                     99.3% (97.5%-99.9%) 95% Confidence Intervals

LOD                             1.6*102 TCID50/mL

Test Time                    15 minutes

Shelf Life                     24 Months

Store Temperature     2 – 30 °C

For professional in vitro diagnostic use only.

This product is CE-IVD marked for professional use and complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC).

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