OraQuick HCV Rapid TestHow 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 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 Tests?
Intro to OraQuick HCV Rapid Test
One-step test Visual interpretation Uses blood Looks for HCV 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
CLIA requires following the manufacturer’s instructions to the letter!!
Contains instructions
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
The test’s ability to detect true positives and not miss anything
HCV test
Combining Specificity and Sensitivity
An ideal test would find the right thing (specificity)
and not miss anything
(sensitivity)
A net that gets all the tuna and none of the dolphins
Think of a Tuna net….
Because the Test is Highly Sensitive…
We do not need to confirm negatives
We do, however, always need to do a follow-up test to find out if the client has HCV now
OraQuick Test
Negative Reactive
Client referred to follow-upHCV nucleic acid testing
Testing Process for HCV
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…
Good eye sight
Organizational skills
Full/bright light, task light Do not use a flashlight
Steady hand
Adequate lighting
External Controls
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)
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
Temperature Control
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 test kits in the sharps container
Place gloves and all other trash in the 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
Test device
Reusable test stand
Specimen collection
loop
Absorbent packetFlat pad
Result window
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
C
T
C
T
C
T
C
T
C
T
C
T
C
T
C
T
A B C D
E F G H
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 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?
7:22pm T.K. 12/15/2011 End time: 7:12pm
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.
Any questions?Proficiency tests coming next….
OraQuick HCV Test Proficiency
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
Words of Caution