Ora Quick HIV and HCV Rapid Test Kit

  • Slides: 53
Download presentation
Ora. Quick HIV and HCV Rapid Test Kit Proficiency Training

Ora. Quick HIV and HCV Rapid Test Kit Proficiency Training

Overview § Background Presentation § Demo of the basic Ora. Quick rapid test §

Overview § Background Presentation § Demo of the basic Ora. Quick 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?

What Do You Know About Rapid Tests?

Introduction to the Ora. Quick Rapid Tests § § § One-step test Visual interpretation

Introduction to the Ora. Quick 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

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 CLIAwaived HCV tests if they: (Next Slide)

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

(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 § Contains instructions § CLIA requires following the manufacturer’s instructions to the

Package Insert § Contains instructions § CLIA requires following the manufacturer’s instructions to the letter!!

HIV Subject Information Brochure § Contains information about the test that is relevant to

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 §

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 §

Specificity § When a test finds something, it should be the right thing § Tests ability to detect a true negative

HIV Specificity Test True Neg Tested Neg False Pos Specificity EIA 1 467 442

HIV Specificity Test True Neg Tested Neg False Pos Specificity EIA 1 467 442 25 94. 7% EIA RR 467 463 4 99. 1% Ora. Quick I 464 463 1 99. 8% Ora. Quick 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 Ora. Quick negative True negative Difference % Specificity 1660 923

HCV Specificity Total tests Ora. Quick 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

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 Test True Pos Tested Pos False Neg Sensitivity EIA 1 340 0

HIV Sensitivity Test True Pos Tested Pos False Neg Sensitivity EIA 1 340 0 100% EIA RR 340 0 100% Ora. Quick 1 340 0 100% Ora. Quick RR 340 0 100% § Rapid test is at least as sensitive as conventional HIV test (EIA) § Same window period § RR = repeatedly reactive

HCV Sensitivity Total tests Ora. Quick reactive True positive Difference % Specificity 1660 708

HCV Sensitivity Total tests Ora. Quick reactive True positive Difference % Specificity 1660 708 723 15 97. 9 HCV 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

Combining Specificity and Sensitivity An ideal test would find the right thing (specificity) and not miss anything (sensitivity)

Think of a Tuna net…. A net that gets all the tuna and none

Think of a Tuna net…. A net that gets all the tuna and none of the dolphins

Because the Two Tests are Highly Sensitive… § We do not need to confirm

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

Testing Process for HIV Stat-Pak 1 st Test _ Negative, please come back and

Testing Process for HIV Stat-Pak 1 st Test _ Negative, please come back and see us in 6 months + ++ Ora. Quick Test Reactive, 2 nd Test _ Lab Testing Both tests were reactive your next step is to see a doctor and we can help you with that

 Testing Process for HCV Ora. Quick Test Negative Reactive Client referred to follow-up

Testing Process for HCV Ora. Quick Test Negative Reactive Client referred to follow-up HCV nucleic acid testing

With Clients… § Emphasize that the test is extremely accurate § De-emphasize statistics and

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

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

Components of Quality Assurance § Personal and logistical characteristics § External controls § Lab space § Universal precautions

Must Have… Steady hand Good eye sight Organizational skills Adequate lighting Ø Full/bright light,

Must Have… Steady hand Good eye sight Organizational skills Adequate lighting Ø Full/bright light, task light Ø Do not use a flashlight

External Controls § Fluids made from human plasma § Biohazards – wear gloves! §

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

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

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?

Temperature Control § Perform test, 59 -99 degrees § If testing temperature is out

Temperature Control § 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

Lab Space A space for undisturbed test processing § Your site is a lab

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

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

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

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

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 § Place gloves and all test

For Today’s Training § Place loops and used § Place gloves and all test kits in the sharps other trash in the container brown paper bag

Paperwork Needed § Expanded Checklist § Short Checklist (Competency Assessment Test list) § Rapid

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

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

Trainers Demo § Trainer Reads § Other Trainer preforms test § Participants follow along (Expanded Checklist)

Participants’ First Practice § No food or drink § Listen to detailed steps: ØOnly

Participants’ First Practice § No food or drink § Listen to detailed steps: ØOnly do what we tell you to do ØDo all steps in order ØIf you finish a step quickly, wait for the next step

Reading Time § Results in 20 -40 minutes § If a reactive result appears

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

Ora. Quick Test Results § Two lines: § “C” - Control line § “T”

Ora. Quick 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 §

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

What does it mean if a client has an invalid test result? What does the darkness of the lines mean? NOTHING

A B D C C C T T G F E H C C

A B D C C C T T G F E H C C T T

Participants’ Second Practice § Pair up § One person run a test at their

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 The “C” Line § The control line is the “C” line § Internal control tells us: Ø Specimen was adequately applied Ø Proper hydration Ø 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

Test Line The “T” Line § The “T” line is the “test line”. It works with the external control fluids to: Ø tell us if the result is reactive or non-reactive. Ø tell us if the reader can see lines. Ø tell us if there is proper lighting. Ø 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

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! Ø“C” line tells us test kit is working properly Ø“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?

Results of Practice Test § Did you get the correct result? § Any questions? § The control fluid that we use provides a “challenge sample” Ø Light control line verifies lighting is OK Ø Verifies test kit detecting small amount of antibody Ø 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? §

If a Client Asks to See the Test Kit, What Would You Do? § Say “No” – Why? Ø Could compromise confidentiality Ø Only trained personnel may read the test Ø Test is disposed of in biohazard bag as soon as it’s read Ø 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? § Use blue or black ink only

How Do You Correct a Written Mistake? § 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. 7: 22 pm T. K. 12/15/2011 End time: 7: 12 pm

Any questions? Proficiency tests coming next….

Any questions? Proficiency tests coming next….

Ora. Quick Test Proficiency: Words of Caution § Follow the checklist!!!! § This is

Ora. Quick Test Proficiency: Words of Caution § 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 Ø and you catch it, you can fix it. Ø and I catch it, you will have to come back another day