OraQuick ADVANCE How to Run the Test

OraQuick ADVANCEHow to Run the Test

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 10 test images– Pass / fail course, must get 100% to pass

What Do You Know About Rapid HIV Tests?

Intro to OraQuick ADVANCE Rapid Test

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

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 testsOR

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

Package Insert

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

Contains instructions

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

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

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)

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

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

– 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%

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 Test is Highly Sensitive…

We do not need to confirm negatives

We do, however, always need to confirm reactive/ 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 flashlight

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 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

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 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 (ask State)

Store test: 35-80 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 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 list) Rapid testing log or lab slip Lab stickers HIV Testing Form

Always use blue or black ink only!

Introduction to the Test

• Control line• Test line• Flat pad

Trainers Demonstrate 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

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

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 HIV Test Proficiency:

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

Words of Caution