OraQuick HCV Rapid Test How to Run the Test. Overview Background Presentation Demo of the test You will practice running 2 tests We will not be testing.

OraQuick HCV Rapid TestHow to Run the Test

Overview

Background Presentation

Demo of the test

You will practice running 2 tests We will not be testing anyone in the room

Proficiency Test - You will run 2 tests without assistance Run, read, and document 2 tests Read results of 10 test images Pass/fail course, must get 100% to pass

Intro to OraQuick HCV Rapid Test

One-step test Visual interpretation Uses blood only Looks for HCV

antibodies Results in 20 to 40

minutes

Who can run the test?

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)

(continued...) 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 Inserts

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

Contains instructions

Test Accuracy

We’re going to talk about how well the test works

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

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

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 Test is Highly Sensitive…

We do not need to confirm negatives

We do, however, always need to do a follow-up test to find out if the client has HCV now

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! Negative, Positive Store controls at 36 to 46 degrees 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)

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: 36-86 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 developer solution and vial

Test device

Reusable test stand

Specimen collection

loop

Absorbent packetFlat pad

Result window

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 Demonstrate

Trainer Reads

Other Trainer preforms test

Participants follow along (Expanded Checklist)

Participants’ 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 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

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 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 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 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 HCV Test Proficiency

Follow the checklist!!!!

This is not a test of memorization

Run 2 tests using 2 different control 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