OraQuick HIV and HCV Rapid Test Kit Proficiency Training

Overview

Background Presentation

Demo of the basic OraQuick rapid test

You will practice running 2 tests, 1 HIV and 1 HCV We will not be testing anyone in the room

Proficiency Test - You will run 3 of each test without assistance Run, read, and document 6 tests Read results of 10 test images Pass / fail course, must get 100% to pass

What Do You Know About Rapid Tests?

Introduction to the OraQuick Rapid Tests

One-step test Visual interpretation Uses blood HIV test can also use oral fluid Looks for HIV or HCV antibodies Results in 20 to 40 minutes

Who can run tests?

California Health and Safety Code Section 120917 allows non-medical personnel that have been trained as HIV test counselors to perform CLIA-waived HCV tests if they:

(Next Slide)

(continue……..) 1. Have been trained in HIV test counseling by OA or

its agents;

2. Work in a HIV testing site that is funded by OA or that uses staff trained by OA or its agents and has a QA plan approved by the local health department and has HIV testing staff that complies with state regulatory QA requirements.

3. Have been trained by OA or its agents in both HIV

and HCV test kit proficiency for finger-stick blood tests and in universal infection control precautions, consistent with best infection control practices.

Package Insert

CLIA requires following the manufacturer’s instructions to the letter!!

Contains instructions

HIV Subject Information Brochure

Contains information about the test that is relevant to the client

Package Insert says, “All subjects must receive the Subject Information Brochure”

Check in with your site to see how this is handled

No brochure for HCV test

Test Accuracy

We’re going to talk about how well the tests work

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

HIV SpecificityTest True Neg Tested Neg False Pos Specificity

EIA 1 467 442 25 94.7%

EIA RR 467 463 4 99.1%

OraQuick I 464 463 1 99.8%

OraQuick RR 464 463 1 99.8%

More specific than standard HIV test (EIA) Test is very accurate (but not perfect) Screening test is designed to be very sensitive. Due to this design, we sacrifice a little specificity. Must confirm preliminary positives (SOC, false+)

Draw blood and send to lab (conventional oral test is back up)

HCV 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

HIV Sensitivity

Rapid test is at least as sensitive as conventional HIV test (EIA) Same window period

RR = repeatedly reactive

Test True Pos Tested Pos False Neg Sensitivity

EIA 1 340 340 0 100%

EIA RR 340 340 0 100%

OraQuick 1 340 340 0 100%

OraQuick RR 340 340 0 100%

HCV 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 Two Tests are Highly Sensitive…

We do not need to confirm negatives

For both HIV and HCV, additional testing always needs to be done if a reaction is detected

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

_

Testing Process for HIV

+ +

_ +

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! 3 HIV controls - Negative, Positive for HIV-1,

Positive for HIV-2 2 HCV controls – Negative, Positive Store controls at 35 to 46 degrees F 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) Why?

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: HIV – 35 to 80 degrees

HCV – 36 to 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 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 doDo all steps in orderIf 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 HIV or

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 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….

OraQuick Test Proficiency:

Follow the checklist!!!!

This is not a test of memorization

Run 3 HIV and 3 HCV tests using 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