Download Oral Fluid Testing - The WI HIV/AIDS Project

HIV Oral Fluid Testing
Wisconsin State
Laboratory of Hygiene
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!
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.
Introduction
•
The oral fluid test is FDA approved ONLY for those
13 years of age and older.
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.
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.
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.
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.
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 client talks during specimen
collection. The quality of the specimen will not be
affected.
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:
Specimen Collection :
Preparation
•
•
•
Allow for sufficient oral fluid to collect in the mouth.
Clients 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.
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.
Specimen Collection :
Collection
•
•
•
Open the outer package slowly. Secure the vial to
avoid it rolling 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.
Specimen Collection :
Collection
•
•
Under the direction of the
staff person administering
the test, the client 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 client’s
mouth.
Do NOT have the client rub
the device against their gum
as this may cause abrasions
in the mouth
Specimen Collection:
Collection
•
The device should remain in the mouth for 3-4
minutes. Use a timer and do not leave the device in
for longer than 5 minutes.
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.
Specimen Collection:
Handling
•
Take the device out of
the client’s mouth and
put the cotton pad
directly into the
preservative in the vial.
•
To avoid contamination,
the staff member should
hold the vial and
remove the pad from
the patient’s mouth.
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.
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.
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.
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 client has sufficient
information to make a decision to test for HIV.
Following is a list of the key pieces of information to
provide clients:
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.
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.”
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
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.
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.
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.
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.
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.
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.
Test Results

FINAL INTERPRETATION
Positive: Indicates that the client is HIV infected.

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.

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.
Ordering Devices
In order to obtain testing supplies, contact the Clinical
Orders Department at 1-800-862-1088 or in Madison at
265-2966.
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”.
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
More Information
Questions?
Contact:
Kathleen Krchnavek
HIV Testing Technology Specialist
608-267-3583
[email protected]
Please visit the following link to complete the quiz.
https://uwmadison.qualtrics.com/jfe/form/SV_bwS32wqO2EarxiJ