The HIV 1/2 Saliva Rapid Test contains HIV antibodies binding protein coated onto membrane and specific antigen conjugated with
HIV-1/2 Saliva Rapid Screen Test
INTENDED USE
The HIV-1/2 Saliva Rapid Screen Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) in human saliva. All positive specimens must be confirmed with Western Blot or other qualified EIA.
REAGENT PROVIDED
Instruction for use
The HIV 1/2 Saliva Rapid Test contains HIV antibodies binding protein coated onto membrane and specific antigen conjugated with colloidal gold.
Test Running Buffer, ready for use.
SPECIMEN COLLECTION AND STORAGEThe HIV 1/2 Saliva Rapid Screen Test is designed for the use of buffered human fresh saliva as the specimen. Collect specimen following standard clinical procedure for proper collection of saliva. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
ASSAY COMPARISONS & EQUIVALENCY
Accuracy and equivalency comparisons of HIV 1/2 Saliva Rapid Screen Test were evaluated against 350 individual external EIA-certified clinical laboratory samples. The results have been tabulated below.
HIV 1/2 Saliva Rapid Screen Test vs. EIA
HIV 1/2 Test | EIA (+) | EIA (-) | Row Totals |
(+) | 150 | 8 | 158 |
( - ) | 0 | 192 | 192 |
Col. Totals | 150 | 200 | 350 |
When compared to EIA Assay, the percent agreement with HIV 1/2 Saliva Rapid Screen Test positive samples was 150/150 or 100%. Negative samples recovered at 192/200 or 96.0%, while the overall relative accuracy obtained was 342/350 or 97.7%.