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Clearview Stat-Pak HIV Rapid Test How to Run and Read - PowerPoint PPT Presentation


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Clearview Stat-Pak HIV Rapid Test How to Run and Read. Overview. Background Presentation D emo 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

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Presentation Transcript
overview
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 12 test images
    • Pass / fail course, must get 100% to pass
intro to clearview stat pak rapid test
Intro to ClearviewStat-Pak Rapid Test
  • One-step test
  • Visual interpretation
  • Uses blood
  • Looks for HIV antibodies
  • Results within 15 minutes
in california
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
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
Package Insert
  • Contains instructions
  • CLIA requires following the manufacturer’s instructionsto the letter!!
subject information notice
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
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
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
SpecificityTable 6 page 23 of package insert

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
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
SensitivityTable 1 page 12 of package insert

Stat-Pak missed 2 positives

EIA 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%.

combining specificity and sensitivity
Combining Specificity and Sensitivity

An ideal test would find the right thing (specificity)

and not miss anything

(sensitivity)

slide15

Think of a Tuna net….

A net that gets all the tuna and none of the dolphins

because the test is highly sensitive
Because the Test is Highly Sensitive…
  • We do not need to confirm negatives
  • We do, however, always need to confirm reactive and preliminary positives
2 different tests
2 Different Tests

Stat-Pak

1stTest

_

+ +

Negative,

please come back

and see us in 6 months

OraQuick Test

Reactive, 2ndTest

_

+

Both tests were reactive

your next step is to see

a doctor and we can

help you with that

Lab Testing

with clients
With Clients…
  • Emphasize that the

test is extremely accurate

  • De-emphasize statistics and percentages
  • For example “This test is highly accurate”
quality assurance requirements
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
Components of Quality Assurance
  • Personal and logistical characteristics
  • External controls
  • Lab space
  • Universal precautions
must have
Must Have…

Steady hand

Good eye sight

Organizational skills

Adequate lighting

  • Full/bright light, task light
  • Do not use a flash light
external controls
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
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
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
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)

temperature control
Temperature Control
  • 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
slide27

Lab Space

  • A space for undisturbed test processing
    • Your site is a lab
    • Separate from counseling area
    • No smoking, eating or drinking
universal precautions
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
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 d isposal
Sharps: Handling & Disposal
  • Sharps are medical instruments that are used to puncture the skin (syringes, lancets, needles)
  • Dispose of sharps immediately,

in a hard redplastic bio bin!

  • Do NOT dispose of sharps

in a red bio hazard bag

biohazard bags handling disposal
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 t raining
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
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
Basic Materials

Absorbent Material

(Chux)

Controls

Buffer Solution

Disposable Loops

Test Device

trainers demonstrate
Trainers Demonstrate
  • One Trainer Reads
  • Other Trainer preforms test
  • Participants follow along

(Expanded Checklist)

participants first practice
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 step quickly, wait for the next step
reading time
Reading Time
  • Negative results in 15-20 minutes
  • Reactive results as soon as clear

test line and control line develop

reading negative results
Reading Negative Results
  • HIV antibodies were not detected
  • Test result is interpreted as negative
  • Does not exclude possible infection with HIV
reading reactive results
Reading Reactive Results
  • HIV antibodies have been detected
  • Test result is interpreted as reactive
reading invalid results
Reading Invalid Results
  • There was a problem running the test
  • Cannot be interpreted
  • Repeat test with new device
what causes i nvalids
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
What does it mean if a client has an invalid test result?What does the darkness of the lines mean?

NOTHING

participants second practice
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
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
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
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
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 a sks to see the test k it what w ould y ou d o
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 c orrect a written m istake
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
Any questions?

Proficiency tests coming next….

stat pak hiv test proficiency
Stat-Pak HIV Test Proficiency:

Words of Caution

  • Follow the checklist!!!!
  • This is not a test of memorization
  • Run five tests using five differentvials
  • 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
additional resources
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 )