1. OraQuick HCV Rapid Test How to Run the Test

2. Overview  Background Presentation  Demo 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  Run, read, and document 5 tests  Read results of 10 test images  Pass/fail course, must get 100% to pass

3. What Do You Know About Rapid Tests?

4. Intro to OraQuick HCV Rapid Test  One-step test  Visual interpretation  Uses blood  Looks for HCV antibodies  Results in 20 to 40 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. Package Insert  CLIA requires following the manufacturer’s instructions to the letter!!  Contains instructions

7. 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

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

9. Specificity Total testsOraQuick negative True negative Difference% Specificity 16609239371498.5 Not exact, but very accurate

10. 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

11. Sensitivity Total testsOraQuick reactive True positive Difference% Specificity 16607087231597.9 The test’s ability to detect true positives and not miss anything HCV test

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

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

14. Because the Test is Highly Sensitive…  We do not need to confirm negatives  We do, however, always need to do a follow- up test to find out if the client has HCV now

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

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

17. 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

18. Components of Quality Assurance  Personal and logistical characteristics  External controls  Lab space  Universal precautions

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

20. External Controls  Fluids made from human plasma  Biohazards – wear gloves!  Negative, Positive  Store controls at 36 to 46 degrees  Expire 56 days after opening

21. 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

22. 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)

23.  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: 36-86 degrees Temperature Control

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

25. Universal Precautions T he universal practice of avoiding contact with patients' bodily fluids, (blood) by means of the wearing of nonporous articles such as medical gloves

26. 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?

27. 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

28. 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.

29. 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

30. 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!

31. Test developer solution and vial Test device Reusable test stand Specimen collection loop Absorbent packet Flat pad Result window

32. 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

33. Trainers Demo  Trainer Reads  Other Trainer preforms test  Participants follow along (Expanded Checklist)

34. 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

35. 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

36. OraQuick Test Results  Two lines:  “C” - Control line  “T” - Test line  Negative result  Reactive result  Invalid result

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

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

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

40. 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!!!!

41. 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

42. 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.

43. 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 HCV antibodies when they’re present

44. 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

45. 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?

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

47. Any questions? Proficiency tests coming next….

48. OraQuick HCV Test Proficiency  Follow the checklist!!!!  This is not a test of memorization  Run five tests using five 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 ‾and you catch it, you can fix it. ‾and I catch it, you will have to come back another day Words of Caution