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Абстрактный

Performance Evaluation of a Dengue IgG/IgM and NS1 Rapid Test Device for Profesional in Vitro Diagnostic Use in Whole Blood/Serum/Plasma.

Zhang Lei*, Yang Feng, Zhu Junzhe

Objective: The objective of this evaluation report was to determine the reliability and performance of the All Test Dengue Combo Rapid Test Cassette, which is a qualitative test for the detection of NS1 antigen, IgG and IgM antibodies of Dengue virus in human whole Blood, serum or plasma.

Method: Run a rapid in vitro diagnostic test device for detection of Dengue IgG/IgM and NS1 in Whole Blood/Serum/Plasma whose clinical samples were compared with the leading commercial ELISA test for Dengue IgG/IgM and NS1 to verify its performance.

Results: The results demonstrated that the relative sensitivity of the Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) was 95.8%, and the relative specificity was 96.1%. The overall relative sensitivity for the primary and secondary infection of the Dengue Rapid Test (Whole Blood/Serum/Plasma) was 94.3%, the relative specificity was 99.1%, and the relative accuracy was 98.3%.

Conclusion: The Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of NS1 antigen, and IgG and IgM antibodies of Dengue virus in human whole blood, serum or plasma. The test utilizes a combination of NS1 antigen, IgG and IgM antibodies of the Dengue virus in human whole blood, serum or plasma.