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OraQuick HCV Rapid Test How to Run the Test. Overview Background Presentation Demo of the test You will practice running 2 tests We will not be testing.

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Presentation on theme: "OraQuick HCV Rapid Test How to Run the Test. Overview Background Presentation Demo of the test You will practice running 2 tests We will not be testing."— Presentation transcript:

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 2 tests without assistance Run, read, and document 2 tests Read results of 10 test images Pass/fail course, must get 100% to pass

3 Intro to OraQuick HCV Rapid Test One-step test Visual interpretation Uses blood only Looks for HCV antibodies Results in 20 to 40 minutes

4 Who can run the test? California Health and Safety Code Section 120917 allows non-medical personnel that have been trained as HIV test counselors to perform CLIA- waived HCV tests if they: (Next Slide)

5 (continued...) 1. Have been trained in HIV test counseling by OA or its agents; 2. Work in a HIV testing site that is funded by OA or that uses staff trained by OA or its agents and has a QA plan approved by the local health department and has HIV testing staff that complies with state regulatory QA requirements. 3. Have been trained by OA or its agents in both HIV and HCV test kit proficiency for finger-stick blood tests and in universal infection control precautions, consistent with best infection control practices.

6 Package Inserts CLIA requires following the manufacturers instructions to the letter!! Contains instructions

7 Test Accuracy Were going to talk about how well the test works You do not need to memorize what Im saying - only need to know test is very accurate There are two components of test accuracy: Sensitivity Specificity

8 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 its looking for and not miss anything. Tests ability to detect a true positive

11 Sensitivity Total testsOraQuick reactive True positive Difference% Specificity 16607087231597.9 The tests 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 Todays 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 Demonstrate Trainer Reads Other Trainer preforms test Participants follow along (Expanded Checklist)

34 Participants 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 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

41 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 readers eyesight is adequate to run the test.

42 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 theyre present

43 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

44 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 its 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?

45 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.

46 Any questions? Proficiency tests coming next….

47 OraQuick HCV Test Proficiency Follow the checklist!!!! This is not a test of memorization Run 2 tests using 2 different control 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


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