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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.

PRINCIPLE

It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, transfusion, use of contaminated blood products and sharing contaminated needles. HIV-1 and 2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), high risk person for AIDS. HIV-1/2 viruses deplete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV-1/2 was designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in specimens.

The HIV-1/2 Saliva Rapid Screen Test is a chromatographic immunoassay for the detection of antibodies to HIV-1/2 in human saliva. HIV-1/2 antibodies binding protein are precoated onto membrane as capture reagents on the Test region (T). During the testing, specimen is allowed to react with the colloidal gold reagents which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a purple colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the saliva specimen. Absence of this purple colored band in the test region (T) s ests a negative result. To serve as a procedural control, a purple colored band in the control region (C) will always appear regardless the presence or absence of antibodies to HIV-1/2 in human saliva.

REAGENT PROVIDED

1.    Instruction for use

2.    The HIV 1/2 Saliva Rapid Test contains HIV antibodies binding protein coated onto membrane and specific antigen conjugated with colloidal gold.

3.   Test Running Buffer, ready for use. 

MATERIALS REQUIRED BUT NOT PROVIDED

Saliva sample collection containers

Timer or clock

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 remain sealed in the pouch until use.  DO NOT FREEZE

PRECAUTION

1.    For in vitro diagnostic use only.

2.    Do not use a test device beyond the expiration date imprinted on the outside of the foil pouch.

3.   Nothing should be placed into the mouth of the subject for at least 10 minutes prior to saliva collection. This includes food, drink, tobacco products or any other materials.

4.    Avoid cross contamination of saliva samples by using a new saliva collection container and pipette for each sample

5.    Saliva specimens may be potentially infectious. Avoid contact with skin by wearing gloves and proper laboratory attire. Properly handle and dispose of all used test devices in an approved biohazard container

6.   Handle all specimens should be treated as if capable of transmitting diseases. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.

7.    Wear protective clothing such as laboratory coats, disposable gloves or eye protection when specimens are being tested.

8.    Immediately clean up any spillage of materials with a 1:10 dilution of 5% sodium hypochlorite. Autoclave any contaminated materials for 60 minutes at

121°C before disposal. All liquid waste should be treated with 5% sodium hypochlorite solution (the final concentration should not be lower than 0.5% sodium hypochlorite) for 30 minutes before disposal.

9.    Citric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. High humidity and temperature can adversely affect results. 

SPECIMEN COLLECTION AND STORAGE

The 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.

Remove the saliva collection system out of the pouch.

Place foam end of the saliva swap into mouth and gently move around root of the teeth for up to 5 minutesto let sufficient saliva collected in the foam.

Remove the saliva swap out of the mouth and place it inside the plastic tube.

Push the swap (with the foam inside) to squeeze out the saliva to a container that contains 1ml buffer.

Make sure the total volume is around 2mL.

Mixing well before use.

*Saliva specimens can be kept at room temperature if a test is performed within 2 4 hours after collection of the specimens. The specimens may be stored at 2-8°C for two weeks before use. If test is not performed within 2 weeks. Saliva specimens should be frozen for prolonged storage. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeatedly freezing and thawing of specimens.

ASSAY PROCEDURE

  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.

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.

Add 6 drops (250 ul) of fresh saliva specimen to the Sample Well.

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

IMPORTANT: In order to prevent an incorrect reading, do not read the test results after 15 minutes.  If the test is read after 15 minutes, the intensity of the colored lines may change or a new line may appear. To avoid confusion, discard all test devices after interpreting results.

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.

NOTE: Do not interpret results after 15 minutes.  The test band intensity may be weaker or stronger than that of the control band, but a very faint band in the test region indicates that the concentration of HIV 1/2 antibodies in the sample is lower than the detection cut-off level. The sample should be re-tested or confirmed with a more specific method before a positive determination is made.