Clearview Stat-Pak HIV Rapid Test How to Run and Read

1. Clearview Stat-Pak HIV Rapid TestHow to Run and Read

2. 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 12 test images • Pass / fail course, must get 100% to pass

3. What do you know about rapid HIV tests?

4. Intro to ClearviewStat-Pak 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” • (Page 2) • 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 the details -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 23 of package insert 1 time Stat-Pak read (+) when client was (-) 9 times lab EIA tests read (+) when client was (-) Calculated specificity of Clearview Stat-Pak 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 12 of package insert Stat-Pak missed 2 positives EIA missed 0 positives (however EIA read 5 positives that were actually negatives) Calculated sensitivity of the Clearview Stat-Pak 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 the Test is Highly Sensitive… • We do not need to confirm negatives • We do, however, always need to confirm reactive and preliminary positives

17. 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

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

19. 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

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! • Controls can be negative, positive for HIV-1, or 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. 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

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 • 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

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 loops 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 Absorbent Material (Chux) Controls Buffer Solution Disposable Loops Test Device

35. Introduction tothe Test Device

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

37. 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

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

39. Reading Negative Results • HIV antibodies were not detected • Test result is interpreted as negative • Does not exclude possible infection with HIV

40. Reading Reactive Results • HIV antibodies have been detected • Test result is interpreted as reactive

41. Reading Invalid Results • There was a problem running the test • Cannot be interpreted • Repeat test with new device

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

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

44. Results

45. 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!!!!

46. 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

47. 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

48. 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

49. 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

50. 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?