HOFCARE Dengue NS1 Ag/IgG/IgM Combo Rapid Test Mechanism of Action

Performance Characteristics: Clinical trial results: A clinical evaluation was conducted on 400 samples comparing the results obtained using the Dengue NS1 Ag IgG/IgM Combo Rapid Test and Diagnostic Kit for Dengue Virus RNA (RT-PCR Fluorescence Probing). (See Table 1.)

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A clinical evaluation was conducted on 400 samples comparing the results obtained using the Dengue NS1 Ag IgG/IgM Combo Rapid Test and Dengue Virus IgG ELISA. (See Table 2.)

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A clinical evaluation was conducted on 400 samples comparing the results obtained using the Dengue NS1 Ag IgG/IgM Combo Rapid Test and Dengue Virus IgM ELISA. (See Table 3.)

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Explanation of Terms: PPA: Positive Percent Agreement = True Positives/(True Positives + False Negatives).
NPA: Negative Percent Agreement = True Negatives/(True Negatives + False Positives).
OPA: Overall Percent Agreement = (True Positives + True Negatives)/Total CI: Confidence Interval Analytical specificity: Interfering Substances: 1000 μmol/L bilirubin, 5.65 mmol/L triglyceride, 6.5 g/L hemoglobin have no effect on the test result. The reagent is not affected by the antinuclear antibodies and anti-mitochondrial antibodies.
Cross-reactivity: By testing HBV, HAV, HCV, HIV antibody there are no effect on the test result.