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