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

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Presentation Transcript
  • 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
  • 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%

  • 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



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




+ +


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

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

  • 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



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?


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: <>
  • The California Quality Assurance Guidelines are available on the Office of AIDS website at: STATE )