Infection Disease Dengue NS1 Rapid Test with CE certificate uncut sheet

For professional in vitro diagnostic use only.

INTENDED USE

The Dengue NS1 Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue virus antigen (Dengue Ag) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses. Any reactive specimen with the Dengue NS1 Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings.

PERFORMANCE CHARACTERISTICS

Clinical Performance

A total of 114 patient samples from susceptible subjects were tested by the Dengue NS1 Rapid Test and by a commercial EIA. Comparison for all subjects is showed in the following table:

Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall Agreement: 95.6%

TEST PRINCIPLE

The Dengue NS1 Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-dengue NS1 antigen conjugated with colloid gold (Dengue Ab conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with rabbit anti-dengue NS1 antigen, and the C band is pre-coated with goat anti-mouse IgG antibody. The antibodies to dengue antigen recognize the antigens from all the four serotypes of the dengue virus.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the test cassette. Dengue NS1 Ag if present in the specimen will bind to the Dengue Ab conjugates. The immunocomplex is then captured on the membrane by the pre-coated rabbit anti-NS1 antibody, forming a burgundy-colored T band, indicating a Dengue Ag positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy-colored band of the immunocomplex of goat anti-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid, and the specimen must be retested with another device.