MedEx Dengue Combo Rapid Test Cassette Description

A rapid test for a qualitative test for the detection of NS1 antigen, IgG, and IgM antibodies of dengue virus in human whole blood, serum, or plasma. For professional in vitro diagnostic use only.
Materials provided: Test Cassettes, Droppers, Buffer, Package Insert.
Materials required but not provided: Specimen collection containers, Centrifuge, Micropipette, Timer, Lancets (for fingerstick whole blood only).
Performance Characteristics: Sensitivity and Specificity: The Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) has passed a seroconversion panel and compared with a leading commercial Dengue Ag ELISA test using clinical specimens for Dengue NS1 and has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Dengue ELISA test for IgG and IgM. The results show that the relative sensitivity of the Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is 95.8%, and the relative specificity is 96.1%. And the overall relative sensitivity for the primary and secondary infection of the Dengue Rapid Test (Whole Blood/Serum/Plasma) is 94.3%, and the relative specificity is 99.1%, and the relative accuracy is 98.3%. (See table.)

Click on icon to see table/diagram/image

Precision: Intra-Assay: Within-run precision has been determined by using 15 replicates of Dengue specimens. The specimens were correctly identified >99% of the time.
Inter-Assay: Between-run precision has been determined by 15 independent assays on the same Dengue specimens. Three different lots of the Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the lime.
Cross-reactivity: The Dengue Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, anti-Syphilis, anti-HIV, HCV, anti-H. Pylori, anti-MONO, anti-CMV, anti-Rubella, and anti-TOXO positive specimens. The results showed no cross-reactivity.