INTENDED USE

The Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of both dengue virus NS1 Ag and IgM& IgG antibodies to dengue virus (DV) in human whole blood, serum or plasma, and serves as an aid in the diagnosis of Dengue infections. It only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and using more specific alternative diagnosis methods to make final decision. This test is a screening test, and all positives must be confirmed using an alternate test. The test is intended for healthcare professional use only.

CE-marked

Sensitivity: 99.2%

Specificity: 99.3%

Specimen: whole blood, serum or plasma

Storage temperature : 2-30℃

Test result: 15-20 minutes

ISO 13485

INTENDED USE

The AQ+ COVID-19 Ag Rapid Self-Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/nasal specimen collected by swabs from individuals who are suspected of having COVID-19. The test is used as an aid in the diagnosis of SARS-CoV-2 infection. The test is suitable for use under healthcare professional supervision. Individuals should have appropriate training in how to administer the test correctly. Remote healthcare professional supervision can be used with appropriate clinical governance, once training has been completed and verified.

The test is for self-test with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. Or self-test with adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset.

Sensitivity: 100%

Specificity: 99.43%

ISO 13485

INTENDED USE

The Advanced Quality Rapid Anti-HIV (1&2) Test is a colloidal gold enhanced immunochromatographic assay for the qualitative detection of antibodies to human immunodeficiency virus (HIV) in human whole blood, serum or plasma from all groups (including neonates, pregnant women, etc). This is a screening test, and all positives must be confirmed using an alternative test such as western blot.

HIV

Sensitivity: 100.0%

Specificity: 100.0%

TP

Sensitivity: 100.0%

Specificity: 99.0%

CE-marked

Sensitivity: 99.61%

Specificity: 99.83%