INTENDED USE
Rapid Dengue IgG/IgM Test is a rapid immunochromatographic assay for the simultaneous detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum or plasma. The assay is used as a screening test for Dengue viral infection and as an aid for differential diagnosis of primary and secondary infections in conjunction with other criteria.
PERFORMANCE CHARACETERISTICS
1. Accuracy
A panel of 60 positive and 40 negative patient sera was tested with a reference rapid Dengue Test, Dengue Duo Cassette (Panbio, Australia). The results are summarized in the following table. The agreement is 100%.
Dengue Duo Cassette | |||
Rapid Dengue Test | Positive | Negative | |
IgM Positive | 35 | 0 | |
IgG Positive | 12 | 0 | |
IgM/IgG Pos. | 13 | 0 | |
Negative | 0 | 40 |
2. Cross Reactivity
No cross reactivity with bilirubin (10 mg/dL), hemoglobin (18mg/dL) or triglycerides (up to 600 mg/dL).
Accu-Tell Rapid Dengue IgG/IgM Test (CE)