Presentation on theme: "Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read."— Presentation transcript:
Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read
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 12 test images Pass / fail course, must get 100% to pass
What do you know about rapid HIV tests?
Intro to Clearview COMPLETE Rapid Test One-step test Visual interpretation Uses blood Looks for HIV antibodies Results within 15 minutes
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
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
Package Insert CLIA requires following the manufacturers instructions to the letter!! Contains instructions
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
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
When a test finds something, it should be the right thing Tests ability to detect a true negative
Specificity Table 6 page 16 of package insert Study Population Samples COMPLETE Nonreactive EIA NonreactiveTrue Negative Low-Risk High-Risk Total 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%
Sensitivity The ability of a test to find what its looking for and not miss anything. Tests ability to detect a true positive
Sensitivity Table 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%. Study PopulationSamples COMPLETE Reactive EIA Repeatedly Reactive WB reactive True Positive Known Positive High Risk Total
Combining Specificity and Sensitivity An ideal test would find the right thing (specificity) and not miss anything (sensitivity)
A net that gets all the tuna and none of the dolphins Think of a Tuna net….
Because Test is Highly Sensitive… We do not need to confirm negatives We do, however, always need to confirm reactive results
Clearview COMPLETE 1 st Test Negative, please come back and see us in 6 months Lab Testing OraQuick Test Reactive, 2 nd Test Both tests were reactive your next step is to see a doctor and we can help you with that _ 2 Different Tests + _ +
With Clients… Emphasize that the test is extremely accurate De-emphasize statistics and percentages For example This test is highly accurate
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
Components of Quality Assurance Personal and logistical characteristics External controls Lab space Universal precautions
Must Have… Good eye sight Organizational skills Full/bright light, task light Do not use a flash light Steady hand Adequate lighting
External Controls fluids made from human plasma Biohazards – wear gloves! Negative, Positive for HIV-1, Positive for HIV-2
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
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
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)
How to Run Controls Use Accessory Kit (#92115) 1.Use a fresh pipette, collect control from vial 2.Transfer control to a fresh weigh boat 3.Collect control from weight boat using sampling tip of device
How to Run Controls
Perform test, degrees If testing temperature is out of required temperature range stop testing If out of temp range, run controls before proceeding Store test: degrees Temperature Control
Lab Space A space for undisturbed test processing Your site is a lab Separate from counseling area No smoking, eating or drinking
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
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?
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
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.
For Todays Training Place used test kits in the sharps container Place gloves and all other trash in the brown paper bags
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
Testing Device Control area Test area Blue line Test stand Buffer cap
Remove Buffer Cap Remove buffer cap from test device Place buffer cap in stand
Collect Blood Sample After performing finger stick, wipe away first drop of blood. Touch devices blood sample tip to second drop of blood Blood will travel into the sample tip
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)
Confirm Device is Fully Seated If you do not see pink/purple flow within 3 minutes, Push Again! (then start timer)
Trainers Demonstration Trainer Reads Other Trainer preforms test Participants follow along (Expanded Checklist)
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
Reading Time Negative results in minutes Reactive results as soon as clear test line and control line develop
What causes invalids? Human error (e.g., no specimen) Unknown Manufacturer error If you ever have an unusual result, do not deliver it
What does it mean if a client has an invalid test result? What does the darkness of the lines mean? NOTHING
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!!!!
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
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 reader can see lines tell us if there is proper lighting tell us if the readers eyesight is adequate to run the test
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 theyre present
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
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?
How do You Correct a Written Mistake? 7:22pm T.K. 12/15/2011 End time: 7:12pm 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
Any questions? Proficiency tests coming next….
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 Clearview COMPLETE Proficiency Words of Caution
Additional Resources The current package insert (including instructions for operation) for the Clearview COMPLETE Clearview COMPLETE test is on the Alere website at: hiv-12/index.jsp The California Quality Assurance Guidelines are available on the Office of AIDS website at: (ASK STATE )