Clearview Stat-Pak HIV Rapid Test
How to Run and Read
Overview Background Presentation
Demo of the test
Practice tests - You will practice running 2 testsWe will not be testing anyone in the room
Proficiency Test - You will run 5 tests without assistanceRun, read, and document 5 testsRead results of 12 test imagesPass / fail course, must get 100% to pass
What do you know about rapid HIV tests?
Intro to Clearview Stat-Pak Rapid Test
One-step test Visual interpretation Uses blood Looks for HIV antibodies Results within 15 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
California State Law
State law allows certified HIV test counselors to conduct finger sticks for the purpose of collecting blood samples for HIV and hepatitis C testing
This law does not allow you to do venipuncture
Package Insert
CLIA requires following the manufacturer’s instructions to the letter!!
Contains instructions
Subject Information Notice Contains information
about the test that is relevant to the client
Package Insert says, “All subjects must receive the Subject Information Notice”
(Page 2)
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:SensitivitySpecificity
Specificity
When a test finds something, it should be the right thing
Tests ability to detect a true negative
Specificity Table 6 page 23 of package insert Study Population Samples STAT-PAK
Nonreactive EIA Nonreactive True Negative
Low-Risk 691 690 687 691
High-Risk 776 740 735 740
Total 1467 1430 1422 1431
1 time Stat-Pak read (+) when client was (-)9 times lab EIA tests read (+) when client was (-)
Calculated specificity of Clearview Stat-Pak assay in these studies is 99.9%
EIA was 99.3%
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 Table 1 page 12 of package insert
Stat-Pak missed 2 positivesEIA missed 0 positives
(however EIA read 5 positives that were actually negatives)
Calculated sensitivity of the Clearview Stat-Pak assay in these studies is 99.7%.
Study Population Samples STAT-PAK Reactive
EIA Repeatedly Reactive
WB Reactive True Positive
Known Positive 613 609 611 611 611
High Risk 776 36 41 35 36
Total 1389 645 652 646 647
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 confirm reactive and preliminary positives
Stat-Pak1st Test
Negative, please come back
and see us in 6 months
Lab Testing
OraQuick Test Reactive, 2nd Test
Both tests were reactive your next step is to see a doctor and we can
help you with that
_
2 Different Tests
+ +
_ +
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 flash light
Steady hand
Adequate lighting
External Controls
Fluids made from human plasma Biohazards – wear gloves! Controls can be negative, positive for HIV-1,
or positive for HIV-2
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 test kit lot or shipment
Two invalid results in a row
Out of temperature range in testing area or in storage area
Every 40 tests or once a month (whichever comes first)
Perform test, 64-86 degrees
If testing temperature is out of required temperature range stop testing
If out of temp range, run controls before proceeding
Store test: 46-86 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
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 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) Rapid testing log or lab slip Lab stickers HIV Testing Form
Always use blue or black ink only!
Basic Materials
Disposable Loops
Buffer Solution
Controls
Test Device
Absorbent Material(Chux)
Introduction tothe Test Device
Trainers Demonstrate One 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 doDo all steps in orderIf you finish step quickly, wait for the
next step
Reading Time
Negative results in 15-20 minutes
Reactive results as soon as clear test line and control line develop
Reading Negative Results
HIV antibodies were not detectedTest result is interpreted as negativeDoes not exclude possible infection with HIV
Reading Reactive Results
HIV antibodies have been detectedTest result is interpreted as reactive
Reading Invalid Results
There was a problem running the testCannot be interpretedRepeat test with new device
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
Results
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 OKVerifies test kit detecting small amount of antibodyDarkness 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….
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
Stat-Pak HIV Test Proficiency:Words of Caution
Additional Resources
• The current package insert (including instructions for operation) for the Clearview HIV 1 / 2 Stat-Pak
• Clearview HIV 1 / 2 Stat-Pak test is on the Alere website at: <http://www.alere.com/EN_US/products/clearview-hiv-12-stat-pak/index.jsp>
• The California Quality Assurance Guidelines are available on the Office of AIDS website at: http://www.cdph.ca.gov/aids (ASK STATE )