Saliva HIV 1/2 test kit

Rapid+Accurate+Simple+Patient-preferred+Safety+Long-term stability

 

INTENDED USE

The  HIV Tester 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.

 

MATERIALS PROVIDED

Each  HIV Tester (20 test kits per package) contains:

1.     20 Foil Pouches. Each pouch contains one device (assay test strip) and one desiccant.

2.     20 Dropper bottles of Saliva Dilution Buffer (1ml per bottle)

3.    20 Saliva Collectors.

4.    1 Package Insert.

 

STORAGE AND STABILITY

The test device is to be stored refrigerated or at room temperature (2-30°C) under dry conditions for the duration of its shelf life. The test device is stable through the expiration date printed on the sealed pouch. The test device must be kept sealed in the pouch until use.  DO NOT FREEZE

 

INTERPRETATION OF RESULT

POSITIVE: Presence of two visible, pink-colored bands, one in the control region (C) and the other in test region (T), indicates presence of HIV-1/2 antibodies in sample.

NEGATIVE: Presence of a single colored band in the control region (C) indicates the absence of HIV-1/2 antibodies or that the concentration of antibodies in sample is below the detection cut-off level.

INVALID: Results are invalid if no band appears in the control region, or a band appears only in the test region after 10 minutes.  An invalid result may be due to improper assay procedures or damage to the device. The assay is inconclusive and the specimen should be re-tested using a new test device.