Transcript Administering the OraQuick ADVANCE HIV Test

OraQuick HCV Rapid Test
How to Run the Test
Overview
 Background Presentation
 Demo of the test
 You will practice running 2 tests
 We will not be testing anyone in the room
 Proficiency Test - You will run 2 tests without
assistance
 Run, read, and document 2 tests
 Read results of 10 test images
 Pass/fail course, must get 100% to pass
Intro to OraQuick HCV
Rapid Test
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One-step test
Visual interpretation
Uses blood only
Looks for HCV
antibodies
 Results in 20 to 40
minutes
Who can run the test?
 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:
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 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 Inserts
 Contains
instructions
 CLIA requires
following the
manufacturer’s
instructions to the
letter!!
Test Accuracy
 We’re going to talk about how well the test
works
 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
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
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 Test is
Highly Sensitive…
 We do not need to confirm negatives
 We do, however, always need to do a followup test to find out if the client has HCV now
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
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Fluids made from human plasma
Biohazards – wear gloves!
Negative, Positive
Store controls at 36 to 46 degrees
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)
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: 36-86 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 developer
solution and vial
Reusable test stand
Specimen
collection
loop
Result
window
Test device
Flat pad
Absorbent packet
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 Demonstrate
 Trainer Reads
 Other Trainer preforms test
 Participants follow along (Expanded Checklist)
Participants’ 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
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 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 HCV Test Proficiency
Words of Caution
 Follow the checklist!!!!
 This is not a test of memorization
 Run 2 tests using 2 different control 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