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
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 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 • Contains instructions • CLIA requires following the manufacturer’s instructionsto the letter!!
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: • Sensitivity • Specificity
Specificity • When a test finds something, it should be the right thing • Tests ability to detect a true negative
Specificity • 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
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 of the dolphins
Because Test is Highly Sensitive… • We do not need to confirm negatives • We do, however, always need to confirm reactive/ preliminary positives
2 Different Tests Stat-Pak 1stTest _ + + Negative, please come back and see us in 6 months OraQuick Test Reactive, 2ndTest _ + Both tests were reactive your next step is to see a doctor and we can help you with that Lab Testing
With Clients… • Emphasize that the test is extremely accurate • De-emphasize statistics and percentages • For example “This test is highly accurate”
Quality AssuranceRequirements • 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… Steady hand Good eye sight Organizational skills Adequate lighting • Full/bright light, task light • Do not use a flashlight
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?
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(ask State) • Store test: 35-80 degrees
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 redplastic 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 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
A D B C C C C C T T T T G H F E C C C C T T T T
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 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? • 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. 7:22pm T.K. 12/15/2011 End time: 7:12pm
Any questions? Proficiency tests coming next….
OraQuick HIV Test Proficiency: Words of Caution • Follow the checklist!!!! • This is not a test of memorization • Run five tests using five differentvials • 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