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INSTI HIV 1 Rapid Test How To Run and Read. Overview. Background Presentation D emo of the test You will practice running 2 tests We will not be testing anyone in the room Proficiency Test - You will run 5 tests without assistance R un, read, and document 5 tests

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INSTI HIV 1 Rapid Test How To Run and Read


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    Presentation Transcript
    1. INSTI HIV 1 Rapid TestHow To Run and Read

    2. Overview • Background Presentation • Demo of the test • Youwill 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 12 test images (?) • Pass / fail course, must get 100% to pass

    3. What do you know about rapid HIV tests?

    4. Intro to INSTI Rapid Test • Screening test • Visual interpretation • Looks for HIV antibodies • Uses blood • Results in 1 minute

    5. 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

    6. Package Insert • Contains instructions • CLIA requires following the manufacturer’s instructionsto the letter!!

    7. 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

    8. 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

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

    10. Specificity Not exact, but very accurate

    11. 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

    12. Sensitivity The test’s ability to detect true positives and not miss anything INSTI test

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

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

    15. Because the Test is Highly Sensitive… • We do not need to confirm negatives • We do, however, always need to confirm reactive and preliminary positives

    16. 2 Different Tests INSTI 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

    17. With Clients… • Emphasize that the test is extremely accurate • De-emphasize statistics and percentages • For example “This test is highly accurate”

    18. 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

    19. Components of Quality Assurance • Personal and logistical characteristics • External controls • Lab space • Universal precautions

    20. Must Have… Steady hand Good eye sight Organizational skills Adequate lighting • Full/bright light, task light • Do not use a flash light

    21. External Controls • Fluids made from inactivated human plasma • Biohazards – wear gloves! • Negative, Positive for HIV-1

    22. 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

    23. 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

    24. 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

    25. 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)

    26. Temperature Control • 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

    27. Lab Space • A space for undisturbed test processing • Your site is a lab • Separate from counseling area • No smoking, eating or drinking

    28. 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

    29. 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?

    30. Sharps: Handling & Disposal • 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

    31. 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.

    32. 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

    33. 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!

    34. Basic Materials 3 solutions Package insert Test device Pipette and lancet

    35. The Test Device Control spot Test spot THIS TAB DOWN

    36. How to Run INSTI Controls • Bring controls to room temperature • Mix controls by swirling • Collect 50ul (microliters) in clean pipette • Transfer control sample to Sample Diluent bottle (#1- a diluting agent) • Mix by inversion • Pour into center of membrane within 5 minutes (absorbs in 30 seconds) • Mix Color Developer (#2) by inverting • Check that Color Developer suspension is thoroughly mixed • Pour Color Developer into center of membrane (absorbs in 20 seconds) • Add Clarifying Solution (#3) to center of membrane, read result immediately while membrane is still wet • Do not read if 5 minutes have passed after adding Clarifying Solution

    37. 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

    38. Trainers Demonstrate • Trainer Reads • Other Trainer preforms test • Participants follow along (Expanded Checklist)

    39. Participants’ First Practice • No food or drink • Listen to detailed steps: • Only do what we tell you to do • The time it takes between introducing the fluids is important • Do all steps in order • If you finish step a quickly, wait for the next step, unless time-sensitive

    40. 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

    41. Negative Result Rarely a faint ring will appear around the test spot. This is still a negative result. THIS TAB DOWN

    42. 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 THIS TAB DOWN

    43. Indeterminate ResultAfter Clarifying Solution (#3) has been absorbed: control area is not shaded membrane displays “uniform tint” or “blue specks” THIS TAB DOWN THIS TAB DOWN THIS TAB DOWN THIS TAB DOWN

    44. What causes invalids? • Human error (e.g., no specimen) • Unknown • Manufacturer error • If you ever have an unusual result, do not deliver it

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

    46. Results (change to INSTI)

    47. 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!!!!

    48. 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

    49. 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

    50. 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 properly • The Test Spot tells us the test kit can detect HIV antibodies when they’re present