Test instructions: HIV - Saliva

CONTENT OF THE KIT

1. Test cassette
2. Dropper bottle with saliva dilution buffer
3. Sterile saliva collection swab
   

PRECAUTIONS

1. Carefully follow the instructions exactly.
2. Only use supplied materials.
3. Wash the hands thoroughly to avoid contamination of the specimen. Contamination may cause erroneous result.
4. This kit is for in vitro use only. Do not swallow.
5. Discard after first use. The test can only be used once.
6. Do not use test kit beyond the expiration date.
7. Do not use the kit if the pouch is punctured or not well sealed.
8. Keep out of children's reach.

STORAGE AND STABILITY

1. Store at 4°C to 30°C in the sealed pouch up to expiration date.
2. Keep away from sunlight, moisture and heat.
3. Use the test shortly after opening the pouch.

SPECIMEN COLLECTION AND PREPARATION

Do not place anything into the mouth (including food, drink, gum and tobacco products) for at least 10 minutes prior to saliva collection.

1. Remove the saliva collector from the sealed pouch and insert the sponge end of the collector into the mouth. Actively swab the inside of the mouth and tongue to collect saliva for a total of 5 minutes until the sponge becomes fully saturated. Gently pressing the sponge between the tongue and teeth will assist saturation. No hard spots should be felt on the sponge when saturated.
2. Place saturated collector into dropper bottle and press sponge fully against the strainer to transfer saliva. Make sure the total volume is around 2 ml (see marks on the side).
3. Close the cap and mix well before using.

Specimens can be stored in room temperature if used within 24 hours, refrigerated if used within 2 weeks. For longer storage period the specimen must be frozen.

TEST PROCEDURE

1. When the test have been stored in a cold room, wait for it to reach room temperature (10 - 30°C).
2. Do not open foil pouch until ready to begin testing.
3. Twist open the screw cap to expose dropper tip and transfer 4 drops to the sample well of the device.

HOW TO INTERPRET THE RESULT

Read the test result after 10 minutes. Do not read the result after 15 minutes.

Positive (HIV infection):

Colored lines are visible in the control region and the test region. This means that infection by HIV is likely. As with a laboratory test it needs to be confirmed with a secondary test before a diagnosis can be made. Therefore it is very important that, in case of a positive result, another test is made at a clinic.

Note: There is no meaning attributed to line color intensity or width.

Negative (No HIV infection):

One colored line is visible in the control region and no colored line in the test region. This means that no HIV infection was detected.

Invalid:

No visible band at all, or there is a visible band only in the test region but not in the control region. The most common reason for this is that the instructions have not been followed exactly.

LIMITATIONS:

1. This test is a qualitative test. The test can not be used to determine the quantitative concentration of HIV.
2. A negative test does not rule out infection by HIV because the antibodies to HIV may be absent or may not be present in sufficient quantity to be detected at early stages of infection.