INSTI HIV 1 Rapid TestHow To Run and Read

Overview Background Presentation

Demo of the test

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 images (?)Pass / fail course, must get 100% to pass

What do you know about rapid HIV tests?

Intro to INSTI Rapid Test

Screening test Visual interpretation Looks for HIV antibodies Uses blood Results in 1 minute

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

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”

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

SpecificityTotal True

negativesINSTI

negativesDifference % Specific

1408 1382 1375 7 99.5%

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

SensitivityTotal Confirmed

positivesINSTI

reactivesDifference % Specific

3507 820 817 3 99.6

INSTI test

The test’s ability to detect true positives and not miss anything

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

INSTI1st 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

inactivated human plasma

Biohazards – wear gloves!

Negative, Positive for HIV-1

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

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, 59 to 86 degrees

If testing temperature is out of required temperature range stop testing

If out of temp range, run controls before proceeding

Store test: 59-86 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 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 pipettes 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

3 solutions

Test device

Pipette and lancet

Package insert

The Test Device

Control spot

Test spot

THIS TAB DOWN

How to Run INSTI Controls1. Bring controls to room temperature2. Mix controls by swirling3. Collect 50ul (microliters) in clean pipette4. Transfer control sample to Sample Diluent bottle (#1- a diluting

agent)5. Mix by inversion6. Pour into center of membrane within 5 minutes (absorbs in 30

seconds)7. Mix Color Developer (#2) by inverting8. Check that Color Developer suspension is thoroughly mixed9. Pour Color Developer into center of membrane (absorbs in 20

seconds)10. Add Clarifying Solution (#3) to center of membrane, read result

immediately while membrane is still wet11. Do not read if 5 minutes have passed after adding Clarifying Solution

Why INSTI is a 1-Minute Test

30 seconds for the first step

20 seconds for the second step

10 seconds or less for the third step

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 doThe time it takes between introducing

the fluids is importantDo all steps in orderIf you finish step a quickly, wait for the

next step, unless time-sensitive

Negative Result

After Clarifying Solution (#3) has been absorbed,

control spot is shaded, test spot

is not

Light or dark, still negative

THIS TAB DOWN THIS TAB DOWN

THIS TAB DOWN

Negative Result

Rarely a faint ring will appear around the test spot. This is still a negative result.

THIS TAB DOWN

Reactive Result After Clarifying

Solution (#3) has been absorbed, control spot is shaded, test spot is also shaded

Test spot must be completely shaded, light or dark

Indeterminate Result After Clarifying Solution (#3) has been absorbed:

control area is not shaded

THIS TAB DOWN THIS TAB DOWN THIS TAB DOWN THIS TAB DOWN

membrane displays “uniform tint” or “blue specks”

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 spots mean?

NOTHING

Results (change to INSTI)

Participants’ Second Practice

Pair upOne person run a test at their own pace, using

the short checklistPartner 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 Control Spot

Internal control tells us: Specimen was adequately applied Proper absorption of solutions

Internal & external controls are standard lab practice – not a sign of test kit unreliability

Test Spot

It works with the external control fluids to:

tell us if the result is reactive or non-reactive

tell us if reader can see spots

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 (control spot) & the external controls (control fluids) both tell us the test kit is working, why do we need both?

Because they tell us something different!The Control Spot tells us test kit is working

properlyThe Test Spot 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”A light test spot verifies lighting is OKVerifies test kit detecting small amount of antibodyDarkness of test spot 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

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 controls

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

INSTI HIV Test Proficiency:Words of Caution

Additional Resources

The current package insert (including instructions for operation) for the BioLytical INSTI HIV1Rapid test

http://www.biolyticalus.com/instructions.html

The California Quality Assurance Guidelines are available on the Office of AIDS website at: http://www.cdph.ca.gov/aids