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HIV-1/2 Saliva Rapid Screen Test kit
HIV-1/2 Saliva Rapid Screen Test kit

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A lateral flow, one step immunoassay for the rapid qualitative determination of HIV 1/2 antibodies level in human saliva.

 

HIV-1/2 Saliva Rapid Screen Test

A lateral flow, one step immunoassay for the rapid qualitative determination of HIV 1/2 antibodies level in human saliva

For in vitro diagnostic use

 

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.

ASSAY PROCEDURE

1. Do not open foil pouch until ready to begin testing. Refrigerated test devices should be allowed to come to room temperature (15- 28°C) before opening the pouch.

2. Remove the device from the protective pouch and label the device with specimen identification. The product is sensitive to the presence of moisture. After open the package, the test device should be used immediately.

3. Add 4 drops (150 ul) of fresh saliva specimen to the Sample Well.

4. Read the result within 15 minutes, Observe the colored band developed over the control region indicating the assay is complete.

INTERPRETATION OF RESULT

POSITIVE: Presence of two visible, pink-colored bands, one in the control region (C) and another 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 in sample is below the detection cut-off level.

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

 

 

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