If you notice discrepancies between the package insert and the WSLH instructions, follow the WSLH instructions!

Transcription

1 HIV Oral Fluid Testing Wisconsin State Laboratory of Hygiene

2 Introduction This training is based on the Wisconsin State Laboratory of Hygiene s (WSLH) experience with HIV oral fluid testing using the OraSure test kit. It incorporates information provided by the manufacturer in order to provide optimal conditions for testing the oral fluid specimen. If you notice discrepancies between the package insert and the WSLH instructions, follow the WSLH instructions!

3 Introduction Advantages of Oral Fluid Testing Needles and a phlebotomist are not required to collect specimen. Increased safety for health care workers. Acceptable option for patients who do not want a needle stick, or for whom drawing blood is difficult.

4 Introduction The oral fluid test is FDA approved ONLY for those 13 years of age and older.

5 Oral Fluid vs. Blood Testing The oral fluid HIV antibody test is similar to blood (or serum) testing. Both test for HIV antibodies using a screening test, the EIA, and a confirmatory test, the Western Blot. The oral fluid test identifies HIV-1 antibodies, whereas the State Lab s blood test identifies antibodies to HIV-1 & HIV-2. The oral fluid test may not pick up early infections (3-6 weeks from exposure) as often as the blood test does.

6 Oral Fluid vs. Blood Testing Oral fluid Blood Sensitivity 98.9% 100% Specificity 98.7% 99.9% X X Tests for HIV-1 Tests for HIV-2 X As the blood test is more sensitive and can pick up HIV infections earlier, it continues to be the gold standard for identifying HIV infection.

7 Test Basics The oral fluid assay tests oral mucosal transudate - not saliva. The oral fluid assay tests for HIV-1 antibodies - not the virus itself. A treated pad draws out antibodies from the capillaries of the cheek and lower gum.

8 The Device The device consists of a cotton pad on a nylon stick. It fits into a vial containing preservative. The collection pad is treated with sodium chloride (salt) and is generally painless, although it may sting individuals with mouth sores/abrasions.

9 The Device Devices should not be exposed to heat or direct sunlight. This could cause the preservative to evaporate and affect the test result. No medications or mouth conditions affect the reliability of the test. Food, alcohol, medical, or dental conditions do not interfere with the test. Blood on the collection pad will not affect the reliability of the test. It s OK if a patient talks during specimen collection. The quality of the specimen will not be affected.

10 Specimen Collection Oral fluid specimen collection is simple. In fact it s so simple and easy to use that individuals can make errors in specimen collection because it doesn t seem like a medical procedure. To obtain the best possible specimen, practice the following guidelines:

11 Specimen Collection : Preparation Allow for sufficient oral fluid to collect in the mouth. Patients should not smoke, chew gum, eat, rinse their mouth or drink (including water) for five minutes before specimen collection. Check the expiration date on the device. Dispose of the entire packet if it s expired. Wash your hands prior to specimen collection.

12 Specimen Collection : Preparation Your clinic or agency should make the decision regarding the use of gloves. Oral fluid is not considered a biohazard. Although previous studies have shown that low levels of HIV may be present in oral fluid - especially when visible blood is present - there have been no cases of HIV transmission clearly attributed to saliva or oral fluid.

13 Specimen Collection : Collection Open the outer package slowly, just enough to see the inner package containing the device. Secure the vial and the device to avoid it falling to the floor. Open the inner package at the corner, following the arrow. As you slowly pull open the package, hold your thumb against the nylon stick to hold it in place. Be careful the device does not fly out of the package. Avoid contaminating the pad or the preservative. Do not touch the pad with fingers. If the device is dropped or the preservative is spilled, dispose of it and use a new one.

14 Specimen Collection : Collection Under the direction of the staff person administering the test, the patient places the device in his/her mouth with the cotton pad between the lower gum and cheek. The staff person may also place the device in the patient s mouth. Do NOT have the patient rub the device against their gum as this may cause abrasions in the mouth.

15 Specimen Collection: Collection The device should remain in the mouth in place for 34 minutes. Use a timer and do not leave the device in for longer than 5 minutes.

16 Specimen Collection : Handling After the 3-4 minutes have passed, carefully twist the cap off of the vial so as not to spill the preservative. Do not to touch the inside of the cover or vial in order to avoid contamination.

17 Specimen Collection: Handling Take the device out of the patient s mouth and put the cotton pad directly into the preservative in the vial. Its a tight fit so push the device into the vial slowly. To avoid contamination, the staff member should hold the vial and remove the pad from the patient s mouth.

18 Specimen Collection : Handling Break off the nylon stick. To do this, place the stick flat against the inside of the vial, apply pressure, and snap it off against the rim. Again, be careful not to spill the preservative.

19 Specimen Collection : Handling Replace the cap immediately and push down until you hear a click. After capping the vial, gently shake it to moisten the pad with the preservative.

20 Specimen Collection : Handling Some people experience an unpleasant, salty taste in their mouth after specimen collection. As a courtesy, offer a drink of water or a hard candy. As with other medical procedures it is advisable to wash your hands before and after specimen collection to avoid the transmission of oral/ respiratory infections.

21 Specimen Collection : Patient Rights All persons who are tested for HIV must provide voluntary informed consent prior to testing. Your agency should have a written form to document that the individual has agreed to testing for HIV infection. Informed consent means that a patient has sufficient information to make a decision to test for HIV. Following is a list of the key pieces of information to provide patients:

22 Informed Consent 1. Briefly explain the specimen collection process. 2. The testing process may be confusing to some, who may say: I thought you can t get AIDS from saliva. Explain in a simple manner that the oral fluid test identifies antibodies, not the virus.

23 Informed Consent For Example: The test identifies whether your body has the substance that fights HIV. It does not identify HIV itself. HIV cannot be transmitted through sharing utensils or drinking glasses, or taking an oral fluid test.

24 Informed Consent 3. Explain the timeframe for accurately identifying HIV infection. By 3 months after infection, this test will identify the majority of individuals with HIV-1 infection. If the test result is negative and risk has occurred within the past 3 months, you should be re-tested 3 months after any risk exposure in order to be certain that you are not infected

25 Informed Consent 4. The FDA requires that all individuals who receive oral fluid testing be given a brochure (provided by WSLH) entitled, Testing for HIV Antibodies with OraSure, prior to specimen collection. If the client cannot read, staff can summarize the information verbally.

26 Informed Consent 5. It is not necessary to explain the differences between HIV-1 & HIV-2 to all individuals, as less than 100 cases of HIV-2 have been identified in the U.S. Assess for risk of HIV-2 (people from Africa, intimate partners of Africans) and recommend the blood test if needed.

27 Specimen Storage & Transport After specimen collection, each vial should be wrapped in an absorbent and placed in the plastic bag provided in the WSLH kit (one vial per bag). Lab requisition slips should be placed in the pocket of the bag. Oral fluid specimens may be sent to WSLH in the same mailer with blood specimens.

28 Specimen Storage & Transport Devices and specimens can be stored at temperatures between 39-98º Fahrenheit. When testing outside of the clinic setting, keep devices out of direct sunlight and place them in a cooler on warm days.

29 Specimen Storage & Transport Specimens are viable for 21 days after collection. Staff, however, should send the specimen to WSLH as soon as possible after collection. Seal the mailer with clear packing tape and affix the WSLH address label and biological substance category B (UN3373) label to the outside of the mailer. If you have specimens to mail on a Friday or Saturday and know they may sit in a hot mailbox over a weekend, wait until Monday to send them out. They can be stored at room temperature in the agency.

30 Test Results WSLH will provide results in approximately 2 weeks. Results are sent to 1 or 2 contact people designated by your clinic or agency. There are 3 possible interpretations for an oral fluid HIV antibody test. Be sure to read through to the Final Interpretation

31 Test Results FINAL INTERPRETATION 1. Positive: Indicates that the client is HIV infected. 2. Negative: Indicates that the client is not infected. However, if risk occurred within the last 3 months, the client should be re-tested 3 months after exposure. 3. Inconclusive: Indicates that the test could not identify whether the client is infected or not. The client should be immediately re-tested using a blood test.

32 Ordering Devices In order to obtain testing supplies, contact the Clinical Orders Department at or in Madison at The oral fluid test kit number is 22C-Bulk. Each kit contains: 1 device, absorbent, biobag, and the brochure Testing for HIV Antibodies with OraSure. Example : if you want 50 devices, order 50 22C-Bulk.

33 Ordering Devices Also, order mailers and labels: There are both large and small styrofoam mailers available from WSLH. Label 22A is the address label for the Retrovirus Laboratory. Label UN3373 : Biological Substances Category B should be placed on the outside of the mailer

34 More Information Questions? Contact: Kathleen Krchnavek HIV Testing Technology Specialist