Administering the OraQuick ADVANCE HIV Test
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Transcript Administering the OraQuick ADVANCE HIV Test
OraQuick ADVANCE
How to Run the Test
Overview
Background Presentation
Demo of the test
Practice tests - You will practice running 2 tests
– We will not be testing anyone in the room
Proficiency Test - You will run 5 tests without
assistance
– Run, read, and document 5 tests
– Read results of 10 test images
– Pass / fail course, must get 100% to pass
What Do You Know About
Rapid HIV Tests?
Intro to OraQuick ADVANCE
Rapid Test
One-step test
Visual interpretation
Uses blood or oral fluid
Looks for HIV antibodies
Results in 20 to 40
minutes
In California….
Individuals who have been trained by CDPH/OA and are
working in a OA-funded HIV testing site can run HIV/Hep C
rapid tests
OR
Are working in an HIV testing site that meets these two
criteria:
– Utilizes HIV counseling staff who are trained by OA or its
agents and
– Has a quality assurance plan (QA) approved by the local
health department in the jurisdiction where the site is
located and has HIV testing staff who comply with
specific QA requirements.*
They must also be certified to perform finger sticks (or be
occupationally exempt, like nurses)
* QA requirements are specified in Section 1230 of Title 17 of the California Code of Regulations
Package Insert
Contains instructions
CLIA requires following
the manufacturer’s
instructions to the
letter!!
Subject Information Brochure
Contains information about
the test that is relevant to the
client
Package Insert says, “All
subjects must receive the
Subject Information
Brochure”
Check in with your site to see
how this is handled
Test Accuracy
We’re going to talk about how well the test
works
You do not need to memorize the details
- only need to know test is very accurate
There are two components of test accuracy:
Sensitivity
Specificity
Specificity
When a test finds something, it should be the
right thing
Tests ability to detect a true negative
Specificity
Test
True Neg
Tested Neg
False Pos
Specificity
EIA 1
467
442
25
94.7%
EIA RR
467
463
4
99.1%
OraQuick I
464
463
1
99.8%
OraQuick RR
464
463
1
99.8%
More specific than standard HIV test (EIA)
–
–
–
–
Test is very accurate (but not perfect)
Screening test is designed to be very sensitive.
Due to this design, we sacrifice a little specificity.
Must confirm preliminary positives (SOC, false+)
• Draw blood and send to lab (conventional oral test is back up)
Sensitivity
The ability of a test to find what it’s looking
for and not miss anything.
Test’s ability to detect a true positive
Sensitivity
Test
True Pos
Tested Pos
False Neg
Sensitivity
EIA 1
340
340
0
100%
EIA RR
340
340
0
100%
OraQuick 1
340
340
0
100%
OraQuick RR
340
340
0
100%
Rapid test is at least as sensitive as conventional HIV test
(EIA)
– RR = repeatedly reactive
Combining Specificity
and Sensitivity
An ideal test would find the right thing
(specificity) and not miss anything
(sensitivity)
Think of a Tuna net….
A net that gets all the tuna and none
of the dolphins
Because Test is
Highly Sensitive…
We do not need to confirm negatives
We do, however, always need to confirm
reactive/ preliminary positives
2 Different Tests
Stat-Pak
1st Test
_
Negative,
please come back
and see us in 6 months
+
++
OraQuick Test
Reactive, 2nd Test
_
Lab Testing
Both tests were reactive
your next step is to see
a doctor and we can
help you with that
With Clients…
Emphasize that the
test is extremely accurate
De-emphasize statistics and
percentages
For example “This test is highly
accurate”
Quality Assurance
Requirements
QA are practices and procedures which
ensure that every client receives an accurate
test result
QA reduces human error as
much as possible
Components of
Quality Assurance
• Personal and logistical characteristics
• External controls
• Lab space
• Universal precautions
Must Have…
Steady hand
Good eye sight
Organizational skills
Adequate lighting
Full/bright light, task light
Do not use a flashlight
External Controls
Fluids made from human plasma
Biohazards – wear gloves!
Controls can be negative, positive for HIV-1,
or positive for HIV-2
Expire 56 days after opening
External Controls are Used for:
Training, we will use them today
Determining if test is working properly
Determining if lighting is adequate
Determining if the test reader has sufficient
eye site
HIV-1 vs HIV-2
Two different strains
Both are transmitted the same way
HIV-2 is less infectious
HIV-2 progresses more slowly
HIV-2 found in West Africa and is rarely found
elsewhere
When to Run
External Controls
• New operator
• New setting or conditions changed significantly
• New test kit lot or shipment
• Out of range testing area or storage area temperature
• Two invalid results in a row
• Every 40 tests or once a month (whichever comes
first) Why?
Temperature
Control
Perform test,
59-99 degrees
If testing temperature is out of required
temperature range stop testing
If out of temp range, run controls before
proceeding (ask State)
Store test: 35-80 degrees
Lab Space
A space for undisturbed test
processing
Your site is a lab
Separate from counseling area
No smoking, eating or drinking
Universal Precautions
The universal practice of avoiding contact with
patients' bodily fluids (blood), by means of the
wearing of nonporous articles such as medical
gloves
Gloves
Wear them when handling blood or blood
products, and….
TODAY – whenever you touch the
control fluid vials!!!!
How often do
you change them?
How do you remove them?
Sharps: Handling & Disposal
Sharps are Medical instruments that
are used to puncture the skin
(syringes, lancets, needles)
Dispose of sharps immediately,
in a hard red plastic bio bin!
Do NOT dispose of sharps
in a red bio hazard bag
Biohazard Bags:
Handling & Disposal
Bandages, used cotton and
gauze, and gloves with
body fluids on them are
bio hazardous waste
By law, if fluid cannot be
squeezed out of the cotton,
gauze, etc., the waste item
can be disposed of in
regular trash.
For Today’s Training
Place loops and used Place gloves and all
test kits in the sharps
other trash in the
container
brown paper bag
Paperwork Needed
Expanded Checklist
Short Checklist (Competency
Assessment Test list)
Rapid testing log or lab slip
Lab stickers
HIV Testing Form
Always use blue or black ink only!
Introduction
to the Test
• Control line
• Test line
• Flat pad
Trainers Demonstrate
Trainer Reads
Other Trainer preforms test
Participants follow along (Expanded
Checklist)
Participants’ First Practice
No food or drink
Listen to detailed steps:
Only do what we tell you to do
Do all steps in order
If you finish a step quickly, wait for
the next step
Reading Time
Results in 20-40 minutes
If a reactive result appears before 20
minutes have passed, the result may still
not be read until at least 20 minutes have
passed
OraQuick Test Results
• Two lines:
“C” - Control line
“T” - Test line
• Negative result
• Reactive result
• Invalid result
What causes invalids?
Human error (e.g., no specimen)
Unknown
Manufacturer error
If you ever have an unusual result,
do not deliver it
What does it mean if a
client has an invalid test result?
What does the darkness of the
lines mean?
NOTHING
A
B
D
C
C
C
C
C
T
T
T
T
G
F
E
H
C
C
C
C
T
T
T
T
Participants’ Second Practice
Pair up
– One person run a test at their own pace, using
the short checklist
– Partner observe them and help only as needed
(e.g., if you see any steps that were missed, say
something)
– Switch
Use the checklist!!!!
Internal Control –
The “C” Line
The control line is the “C” line
Internal control tells us:
Specimen was adequately applied
Proper hydration
Migration of reagents past the “T” zone.
Internal & external controls are standard lab
practice – not a sign of test kit unreliability
Test Line –
The “T” Line
The “T” line is the “test line”. It works with the
external control fluids to:
tell us if the result is reactive or non-reactive.
tell us if the reader can see lines.
tell us if there is proper lighting.
tell us if the reader’s eyesight is adequate to run
the test.
Controls Work Together
If the internal control & the external controls
both tell us the test kit is working, why do we
need both?
Because they tell us something different!
“C” line tells us test kit is working properly
“T” line tells us the test kit can detect HIV
antibodies when they’re present
Results of Practice Test
Did you get the correct result?
Any questions?
The control fluid that we use provides a
“challenge sample”
Light control line verifies lighting is OK
Verifies test kit detecting small amount of antibody
Darkness of line NOT related to viral load, disease
progression, or anything else about the client
If a Client Asks to See the
Test Kit, What Would You Do?
Say “No”
–
Why?
Could compromise confidentiality
Only trained personnel may read the test
Test is disposed of in biohazard bag as soon as it’s
read
Think about the picture with the pink background – if
you have a light line would you be able to see it on
this test?
How Do You Correct a
Written Mistake?
A single crossed-out line, corrected entry written
clearly above, include date and initials of the
individual making the change.
At no time should an original entry be obliterated
or otherwise made illegible by a change on the
record.
7:22pm T.K. 12/15/2011
End time: 7:12pm
Any questions?
Proficiency tests coming next….
OraQuick HIV Test Proficiency:
Words of Caution
Follow the checklist!!!!
This is not a test of memorization
Run five tests using five different vials
Put your name on the top of your paper(s)
Take your time, double & triple checking your work
If you make a mistake on your paperwork
and you catch it, you can fix it.
and I catch it, you will have to come back another day