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 )