Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read

1. ClearviewCOMPLETE HIV 1/2 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 Clearview COMPLETE Rapid Test • One-step test • Visual interpretation • Uses blood • Looks for HIV antibodies • Results within 15 minutes

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. California State Law • State law allows certified HIV test counselors to conduct finger sticks for the purpose of collecting blood samples for HIV and hepatitis C testing • This law does not allow you to do venipuncture

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

8. 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

9. 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

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

11. SpecificityTable 6 page 16 of package insert 1 time Clearview COMPLETE read (+) when client was (-) 9 times lab EIA tests read (+) when client was (-) Calculated specificity of Clearview COMPLETE assay in these studies is 99.9% EIA was 99.3%

12. 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

13. SensitivityTable 1 page 9 of package insert Clearview COMPLETE missed 2 positives EIA missed 0 positives (however EIA read 5 positives that were actually negatives) Calculated sensitivity of the Clearview COMPLETE assay in these studies is 99.7%.

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

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

16. Because Test is Highly Sensitive… • We do not need to confirm negatives • We do, however, always need to confirm reactive results

17. 2 Different Tests ClearviewCOMPLETE 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

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

19. 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

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

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

22. External Controls • fluids made from human plasma • Biohazards – wear gloves! • Negative, Positive for HIV-1, Positive for HIV-2

23. 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

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. How to Run Controls Use Accessory Kit (#92115) • Use a fresh pipette, collect control from vial • Transfer control to a fresh weigh boat • Collect control from weight boat using sampling tip of device

27. How to Run Controls

28. Temperature Control • Perform test, • 64-86 degrees • If testing temperature is out of required temperature range stop testing • If out of temp range, run controls before proceeding • Store test: 46-86 degrees

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

30. 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

31. 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?

32. 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

33. 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.

34. For Today’s Training • Place used test kits in the sharps container • Place gloves and all other trash in the brown paper bags

35. Paperwork Needed • Expanded Checklist • Short Checklist (Competency Assessment Test) • Rapid testing log or lab slip • Lab stickers • HIV Testing Form • These forms help make sure samples are not mixed up

36. Test Materials

37. TestingDevice • Control area • Test area • Blue line • Test stand • Buffer cap

38. Remove Buffer Cap • Remove buffer cap from test device • Place buffer cap in stand

39. Collect Blood Sample • After performing finger stick, wipe away first drop of blood. • Touch device’s blood sample tip to second drop of blood • Blood will travel into the sample tip

40. Push Device Tip into Buffer Cap • You will feel 3 snaps: • Snap 1: through foil • Snap 2: into cap • Snap 3: fully seated (blue line is visible through clear area of the stand)

41. Confirm Device is Fully Seated If you do not see pink/purple flow within 3 minutes, Push Again! (then start timer)

42. Trainers Demonstration • Trainer Reads • Other Trainer preforms test • Participants follow along (Expanded Checklist)

43. 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 step quickly, wait for the next step

44. Reading Time • Negative results in 15-20 minutes • Reactive results as soon as clear • test line and control line develop

45. Results Interpretation

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

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

48. Results

49. 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!!!!

50. 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