OraQuick HIV and HCV Rapid
Test Kit Proficiency Training
Overview
 Background Presentation
 Demo of the basic OraQuick rapid test
 You will practice running 2 tests, 1 HIV and 1 HCV
 We will not be testing anyone in the room
 Proficiency Test - You will run 3 of each test
without assistance
 Run, read, and document 6 tests
 Read results of 10 test images
 Pass / fail course, must get 100% to pass
What Do You Know About
Rapid Tests?
Introduction to the
OraQuick Rapid Tests
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
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
One-step test
Visual interpretation
Uses blood
HIV test can also use oral fluid
Looks for HIV or HCV antibodies
Results in 20 to 40 minutes
Who can run tests?
 California Health and Safety Code
Section 120917 allows non-medical
personnel that have been trained as
HIV test counselors to perform CLIAwaived HCV tests if they:
(Next Slide)
(continue……..)
 1. Have been trained in HIV test counseling by OA or
its agents;
 2. Work in a HIV testing site that is funded by OA or
that uses staff trained by OA or its agents and has a
QA plan approved by the local health department and
has HIV testing staff that complies with state
regulatory QA requirements.
 3. Have been trained by OA or its agents in both HIV
and HCV test kit proficiency for finger-stick blood tests
and in universal infection control precautions,
consistent with best infection control practices.
Package Insert
 Contains
instructions
 CLIA requires
following the
manufacturer’s
instructions to the
letter!!
HIV 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
 No brochure for HCV test
Test Accuracy
 We’re going to talk about how well the tests
work
 You do not need to memorize what I’m
saying
- 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
HIV 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)


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
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)
HCV Specificity
Total tests
OraQuick
negative
True
negative
Difference
%
Specificity
1660
923
937
14
98.5
Not exact, but
very accurate
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
HIV 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)
 Same window period
 RR = repeatedly reactive
HCV Sensitivity
Total tests
OraQuick
reactive
True
positive
Difference
%
Specificity
1660
708
723
15
97.9
HCV
test
The test’s ability to
detect true positives
and not miss anything
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 the Two Tests are
Highly Sensitive…
 We do not need to confirm negatives
 For both HIV and HCV, additional testing
always needs to be done if a reaction is
detected
Testing Process for HIV
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
Testing Process for HCV
OraQuick Test
Negative
Reactive
Client referred to follow-up
HCV nucleic acid testing
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!
 3 HIV controls - Negative, Positive for HIV-1,
Positive for HIV-2
 2 HCV controls – Negative, Positive
 Store controls at 35 to 46 degrees F
 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
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
 Store test: HIV – 35 to 80 degrees
HCV – 36 to 86 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
 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/HCV Testing Form
Always use blue or black ink only!
Test Device
Control line
Test line
Flat pad
Paddle must be inserted
into the vial no later than
60 minutes after sample
has been introduced
Vent
holes –
Do NOT
obstruct
Trainers Demo
 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 or
HCV 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?
 Use blue or black ink only on all forms
 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 Test Proficiency:
Words of Caution
 Follow the checklist!!!!
 This is not a test of memorization
 Run 3 HIV and 3 HCV tests using 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