Presentation on theme: "Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read"— Presentation transcript:
1Clearview COMPLETE HIV 1/2 Rapid Test How to Run and Read Purpose / Objectives of Slide: Title pageTalking Points: “This presentation is about testing with the Clearview COMPLETE Rapid Test.”Notes: Feel free to customize slide with trainer information
2Overview Background Presentation Demo of the test You will practice running 2 testsWe will not be testing anyone in the roomProficiency Test - You will run 5 tests without assistanceRun, read, and document 5 testsRead results of 12 test imagesPass / fail course, must get 100% to passPurpose / Objectives of Slide: Give overview and frameAdditional Talking Points: “We will cover the basics of this test, show how to run the test, and then you will get a chance to practice a couple times. After that you all will be given 5 tests and asked to run them perfectly. All paperwork will need to be 100%. Also one of the trainers will need to observe you running one of your 5 tests and ask you to correctly read 12 test images. We will cover what you need to pass in much greater detail later.”Notes: Do not cover the proficiency requirements in too much detail, just do some fore shadowing.
3What do you know about rapid HIV tests? Purpose / Objectives of Slide: Assess knowledge of classAdditional Talking Points: Brainstorm: “Before we get started, tell me what you know about rapid testing.”Notes: You can write up responses on a chart paper, or do this verbally
4Intro to Clearview COMPLETE Rapid Test One-step testVisual interpretationUses bloodLooks for HIV antibodiesResults within 15 minutesPurpose / Objectives of Slide: Brief overview of testAdditional Talking Points: “Note that Clearview Complete reactive results can be read as soon as line is visible. This is not true for all rapid HIV test”.Notes: Cover this slide quickly, used to foreshadow up coming materials
5In 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.ORAre working in an HIV testing site that meets these two criteria:Utilizes HIV counseling staff who are trained by OA or its agents andHas 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)Purpose / Objectives of Slide: To give participants an understanding of what this certification coversAdditional Talking Points: “Completion of this training will allow you to run a CLIA waived test. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy and reliability of patient test results. You will be acting as a lab, therefore, and you will be acting under these standards. You can only run HIV rapid tests. Traditionally these tests are run by trained lab staff. There is allowance in the laws that allows government funded HIV prevention programs to have lay persons (or non-lab staff) run HIV and Hep. C tests. These people must pass this training. There is also an allowance in the laws that allow for lay staff to do finger sticks.”Notes: This slide is not required. Participants often have misunderstood where and under what circumstances they are “Certified” to run tests.* QA requirements are specified in Section 1230 of Title 17 of the California Code of Regulations
6California State LawState law allows certified HIV test counselors to conduct finger sticks for the purpose of collecting blood samples for HIV and hepatitis C testingThis law does not allow you to do venipunctureObjective of slide: To inform about the law regarding counselors doing fingersticksTalking points: No additional talking pointsNotes: Read the slide
7Package Insert Contains instructions CLIA requires following the manufacturer’s instructions to the letter!!Purpose / Objectives of Slide: Introduce the package insert and give background for why they must follow manufacture instructions to the letterAdditional Talking Points: “When a manufacturer wants something approved, they write the instructions on how to run the product. The instructions include things like how long to run, how to store, and the temperature range in which the test must be run. Then the FDA takes the product and follows these instructions and looks to see if the test works when following the instructions. If the test performs correctly they approve the test and the instructions, or ‘Package Insert’. Then anyone using this product must follow these instructions. If the user does not follow the instructions, and the test does not perform properly, the user is responsible. Each box will have a copy of the Package Insert. I would recommend you read it before you start testing.”Notes: This slides helps participants understand why they must follow instructions so closely
8Subject Information Notice Contains information about the test that is relevant to the clientPackage Insert says, “All subjects must receive the Subject Information Notice”Check in with your site to see how this is handledPurpose / Objectives of Slide: Introduce Subject Information Notice, understand why it must be handed outAdditional Talking Points: “The Subject Information Notice contains information about the test and basic HIV information. I would encourage you to read it. The Package Insert (manufacturer’s instructions) says it must be given to each person receiving a test, therefore its required. When you return to your site check in with your coordinator and find out how they handle this.”Notes: No additional notes
9Test 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 accurateThere are two components of test accuracy:SensitivitySpecificityPurpose / Objectives of Slide: Transition Slide, introduces the concepts of test accuracy, along with sensitivity and specificityAdditional Talking Points: No additional talking pointsNotes: No additional notes
10Specificity When a test finds something, it should be the right thing Tests ability to detect a true negativePurpose / Objectives of Slide: Introduce concept of specificityAdditional Talking Points: “When a manufacturer is developing a screening test, the goal is to make it so specific that when it finds something it is finding the right thing. In labs they often call it a test’s ability to detect a true negative.”Notes: Keep it simple
11Specificity Table 6 page 16 of package insert Study PopulationSamplesCOMPLETE NonreactiveEIA NonreactiveTrue NegativeLow-Risk691690687High-Risk776740735Total14671430142214311 time Clearview COMPLETE read (+) when client was (-)9 times lab EIA tests read (+) when client was (-)Calculated specificity of Clearview COMPLETEassay in these studies is 99.9%EIA was 99.3%Purpose / Objectives of Slide: Cover manufactures numbers around specificityAdditional Talking Points: “This is data about specificity that you will find on page 16 in the Package Insert. The manufacturer had 1467 samples. They ran the Clearview COMPLETE on all and found 1430 negatives and 37 reactives. One of those reactives was actually a negative. This means the test’s specificity was 99.9%. When they used an EIA, a traditional lab test, the EIA said 9 samples were reactive when they were actually negative. In a lab they run additional tests to rule out error before client hears the information. Even though the Clearview COMPLETE missed one, it is considered a highly specific test. The Clearview COMPLETE is more reliable than traditional lab tests.”Notes: The green “Low Risk” and “High Risk” rows confuse the issues. Only concentrate on the gray shaded row, and the True Negative column and the COMPLETE Nonreactive column. Keep in mind that no test, for the flu, pregnancy, or anything else is 100% accurate.
12SensitivityThe ability of a test to find what it’s looking for and not miss anything.Test’s ability to detect a true positivePurpose / Objectives of Slide: Introduce the concept of sensitivityAdditional Talking Points: “When a manufacturer is developing a screening test, the goal is to make it so sensitive that it does not miss anything! In labs they often call it a test’s ability to detect a true positive.”Notes: Keep this simple
13Sensitivity Table 1 page 9 of package insert Study PopulationSamplesCOMPLETE ReactiveEIA Repeatedly ReactiveWB reactiveTrue PositiveKnown Positive604600602High Risk776364135Total1380636643637638Clearview COMPLETE missed 2 positivesEIA missed 0 positives(however EIA read 5 positives that were actually negatives)Calculated sensitivity of the Clearview COMPLETEassay in these studies is 99.7%.Purpose / Objectives of Slide: Cover manufactures numbers around sensitivityAdditional Talking Points: “This is data about sensitivity that you will find on page 9 in the Package Insert. The manufacturer had 1380 samples. They ran the Clearview COMPLETE on all and found 636 reactives. Actually there were 638 reactives and the Clearview COMPLETE missed 2. This means the Clearview COMPLETE sensitivity was 99.7% (99.690%). When they used an EIA, the EIA didn’t miss any positives but said 5 samples were positive when they were actually negative. The test was too sensitive. In a lab they run additional tests to rule out error, before clients hear the information. Even though the Clearview COMPLETE missed 2 it is a highly sensitivity test.”Notes: The green “Known Positive” and “High Risk Positives” rows confuse the issues. Only concentrate on the gray shaded row - the True Positive column and the COMPLETE Reactive column.
14Combining Specificity and Sensitivity An ideal test would find the right thing (specificity) and not miss anything (sensitivity)Purpose / Objectives of Slide: A simple explanation of specificity and sensitivityAdditional Talking Points: No further talking points.Notes: No additional notes
15A net that gets all the tuna and none of the dolphins Think of a Tuna net….Purpose / Objectives of Slide: A visual of the previous slideAdditional Talking Points: No further talking points neededNotes: No additional notesA net that gets all the tuna and none of the dolphins
16Because Test is Highly Sensitive… We do not need to confirm negativesWe do, however, always need to confirm reactive resultsPurpose / Objectives of Slide: Cover why we do not confirm negative samplesAdditional Talking Points: “Since the Clearview COMPLETE is so sensitive, 99.7%, it rarely misses anything and therefore we do not need to confirm negatives. If HIV antibodies are present they will most likely be picked up. If someone has recently been exposed they may not have a sufficient amount of antibodies for the test to detect. Therefore covering the window period with the client is very important. We always want to run additional tests for reactive results.”Notes: No additional notes
17Both tests were reactive 2 Different TestsClearview COMPLETE1st Test_+ +Negative,please come backand see us in 6 monthsOraQuick TestReactive, 2nd Test_+Both tests were reactiveyour next step is to seea doctor and we canhelp you with thatPurpose / Objectives of Slide: Illustration of the Rapid Testing Algorithm (RTA)Additional Talking Points: “This slide illustrates how a second rapid test is used to ‘verify’ a Clearview COMPLETE reactive result. The second rapid test is not a confirmatory test and therefore the second reactive result would still be called reactive when disclosed to the client (a confirmatory result, or positive diagnosis, can only come from a clinical laboratory where many tests would be run on the sample). A blood sample is taken and sent to a lab whenever a rapid test shows a reactive result. If only one rapid test is performed at a site, the client would be encouraged to return the following week to receive their confirmatory result. If the Rapid Testing Algorithm is used and a second rapid test from a different manufacturer is performed, the client is advised to see their doctor as their next step rather than return to the test site for the confirmatory result. The only time 2 Clearview COMPLETE tests are run on the same client is when the first test result is invalid. If the RTA is used, the second test must always be from a different manufacturer, such as the OraQuick ADVANCE Rapid Test. Please note that if the RTA is not used the second test would be a confirmatory test which is run at a lab. The client would be directed to return to the testing site a week later to receive their confirmatory result.”Notes: No additional notesLab Testing
18With Clients… Emphasize that the test is extremely accurate De-emphasize statistics and percentagesFor example “This test is highly accurate”Purpose / Objectives of Slide: Covers what to say to clients about specificity and sensitivityAdditional Talking Points: “Best practice is not to share numbers with client. Clients may fixate in the 0.1% degree of error. Just assure them that the test is highly accurate. For reactive samples you run additional tests and you also cover the window period.”Notes: No additional notes
19Quality Assurance Requirements QA are practices and procedures which ensure that every client receives an accurate test resultQA reduces human error asmuch as possiblePurpose / Objectives of Slide: Introduce the concept of Quality AssuranceAdditional Talking Points: “We will cover many aspects of quality assurance. The goal is to remove error, especially human error.”Notes: No additional notes
20Components of Quality Assurance Personal and logistical characteristicsExternal controlsLab spaceUniversal precautionsPurpose / Objectives of Slide: Introduces components of quality assuranceAdditional Talking Points: “Now we will talk about what quality assurance means. Many things need to be in place in order to assure the integrity of rapid test results. Some of them involve the abilities and attributes of the testing operator, or technician, and other things involve the physical space and testing environment. These are the quality assurance components we will be addressing in the next few slides.”Notes: Read the slide
21Must Have… Steady hand Good eye sight Organizational skills Adequate lightingPurpose / Objectives of Slide: Examples of areas where quality assurance is very importantAdditional Talking Points: “Quality Assurance is having good eye sight for all steps of running and reading the test, having adequate lighting for reading the test results, and having good organizational skills. An uncluttered, organized space is very important, as are skills for keeping order and insuring the accuracy and integrity of the testing process. Lighting should be diffused lighting such as from ceiling lights or from a task or desk lamp. A spotlight, such as a flashlight should not be used as a lighting source. It could cause an incorrect interpretation of the test result. More Quality Assurance details will be covered in upcoming slides.”Notes: No additional notesFull/bright light, task lightDo not use a flash light
22External Controls fluids made from human plasma Biohazards – wear gloves!Negative, Positive for HIV-1, Positive for HIV-2Purpose / Objectives of Slide: Explain what external controls areAdditional Talking Points: “Controls are made from de-neutered HIV virus. They need to be stored in a refrigerator between 36 and 46 degrees Fahrenheit and have a 24 month shelf life from the date they were manufactured. They are considered to be a bio hazard and gloves need to be worn when handling them.”Notes: No additional notes
23External Controls are Used for: Training, we will use them todayDetermining if test is working properlyDetermining if lighting is adequateDetermining if the test reader has sufficienteye sitePurpose / Objectives of Slide: Explain what external controls are used forAdditional Talking Points: “When running controls you always know what the result should be. If the result is different from what it should be, this could be an indication that there is something wrong with the test device or that there was an error in the way the operator ran the test. Also, if when running a positive control the result appears to be negative, that could be an indication that the lighting is insufficient for running this test in those lighting conditions. Running controls is also a good way of determining whether a person’s eye sight is good enough to accurately read results in a variety of lighting conditions.”Notes: No additional notes
24HIV 1 vs HIV 2 Two different strains Both are transmitted the same way HIV-2 is less infectiousHIV 2 progresses more slowlyHIV 2 found in West Africa and is rarely found elsewherePurpose / Objectives of Slide: Clears up confusion and explain the difference between HIV 1 and HIV 2Additional Talking Points: “HIV 1 is the most common form of HIV that we see in the United States and in most of the world. The HIV 2 strain is almost only found in West Africa. It is rare that there would be an HIV 2 infection found in California but the Stat-Pak HIV test automatically tests for both. A reactive result with a Stat-Pak test would not indicate in any way if the antibodies detected developed because of HIV 1 or HIV 2.”Notes: The question about the difference between HIV 1 and HIV 2 always comes up in trainings, which is why this slide was included.
25When to Run External Controls New operatorNew test kit lot or shipmentTwo invalid results in a rowOut of temperature range in testing area orin storage areaEvery 40 tests or once a month(whichever comes first)Purpose / Objectives of Slide: Describes protocols around external controlsAdditional Talking Points: “Your supervisor will take care of protocols, but you need to understand these things – you will be the one who notices if or when the temperature is out of range, when lighting is poor, etc.”Notes: No additional notes
26How to Run Controls Use Accessory Kit (#92115) Use a fresh pipette, collect control from vialTransfer control to a fresh weigh boatCollect control from weight boat using sampling tip of devicePurpose / Objectives of Slide: Describes materials needed and steps in running controlsAdditional Talking Points: “Squeeze the pipette bulb fully and then dip the tip into the control fluid inside the control vial. Release the pressure on the pipette bulb and allow the control fluid to flow inside the pipette. Then hold the pipette over the weigh boat and once again squeeze the pipette bulb until all of the control fluid has been transferred into the weigh boat. The amount of control fluid in the weigh boat does not have to be measured as long as the pipette bulb was squeezed fully and then released when extracting control fluid from the vial. When you introduce the sample tip of the testing device into the control fluid in the weigh boat, the correct amount of fluid will be drawn up into the testing device. The same thing happens when introducing the testing device’s sample tip to the drop of blood from a finger stick.”Notes: No additional notes
27How to Run ControlsPurpose / Objectives of Slide: Illustrates steps in running controlsAdditional Talking Points: No additional talking pointsNotes: No additional notes
28Temperature Control Perform test, 64-86 degrees If testing temperature is out of required temperature range stop testingIf out of temp range, run controls before proceedingStore test: degreesPurpose / Objectives of Slide: Important QA information all testers need to knowAdditional Talking Points: “If testing temperature is out of required temperature range stop testing – state policy (stricter than manufacturer’s guidelines).”Notes: No additional notes
29Lab Space A space for undisturbed test processing Your site is a lab Separate from counseling areaNo smoking, eating or drinkingPurpose / Objectives of Slide: Clarify that any space where a test is being run is considered a labAdditional Talking Points: “It is important that you think of any testing area as being a laboratory. And because of that, it is important that this space is separate from where your client will be counseled and in an area where there will be no smoking, food, or any other contaminants that might otherwise affect the integrity of the test. It should also be a place that will only be accessed by you and other test counselors who are running tests, or phlebotomists, and not by the general public or unrelated staff. Your site is a lab, an RV can be a lab, a room in a venue-based site can be a lab. Wherever you run and read a test will be a lab for as long as you are testing.”Notes: No additional notes
30Universal Precautions The universal practice of avoiding contact with patients' bodily fluids, (blood) by means of the wearing of nonporous articles such as medical glovesPurpose / Objectives of Slide: Introduce Universal PrecautionsAdditional Talking Points: “Universal Precautions is the concept that all body fluids, (blood, nasal secretions, feces) are perceived as harmful and should be handled in a way that prevents infection. Universal Precautions are in place to protect both you and your clients from possible exposure to contaminants. Even a pen can become a possible contaminant if handled with the same gloves that previously came in contact with body fluids or control samples. Being aware of what you touch with and without gloves is important. And being aware of the gloves themselves when removing them is also very important. The next slide describes when to wear gloves and how to remove your gloves safely.”Notes: No additional notes
31Gloves Wear them when handling blood or blood products TODAY – whenever you touch the control fluid vials!!!!How often doyou change them?How do you remove them?Purpose / Objectives of Slide: Instructions on how to remove glovesAdditional Talking Points: “Today (and always) whenever handling control fluids you must be wearing gloves. Change gloves for every client, every test. Here are instructions on how to remove your gloves, ”1. Hold one hand out with its palm facing up.2. With your other hand pinch a portion of that glove between that wrist and the palm and pull glove off so that it turns inside out as you remove it.3. You are now holding an inside-out glove in your remaining gloved hand.4. Crumble the removed glove into the palm of your gloved hand and hold it there.5. Take your ungloved index finger and slide it under the remaining glove, between the skin and the glove of the gloved hand.6. Use that finger to pull the glove down over the palm of your hand, turning that glove inside out and over the removed glove as you go.7. You now have a glove inside of a glove, both inside out. Dispose of gloves in a bio hazard bag.Notes: No additional notes
32Sharps: 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 sharpsin a red bio hazard bagPurpose / Objectives of Slide: To review what sharps are and how to dispose of themAdditional Talking Points: “Sharps are items that are sharp and/or are metallic which have been used to break the skin, for example needles or lancets. Used sharps can puncture someone’s skin and transmit diseases and therefore should be perceived as dangerous. Sharps must be disposed of in a red, hard plastic, sharps container with a lid. Never reach into a sharps container and never fill past the full line on the outside of the container.Notes: No additional notes
33Biohazard Bags Handling & Disposal Bandages, used cotton and gauze, and gloves with body fluids on them are bio hazardous wasteBy law, if fluid cannot be squeezed out of the cotton, gauze, etc., the waste item can be disposed of in regular trash.Purpose / Objectives of Slide: To introduce the biohazard waste bags and cover where to dispose of gloves, bandages, and gauzeAdditional Talking Points: “Red plastic biohazard bags are to be used to dispose of all non-sharps materials that have been exposed to blood or body fluids. This can include bandages, cotton, and gauze. As it stands today, in California these items may legally be disposed of in everyday trash containers if they are not soaked with blood or fluids, as would be the case with cotton or gauze after the first drop of blood is wiped away after a finger stick. Check with your site to find out where you are instructed to dispose of non-sharps bio hazardous waste.”Notes: No additional notes
34For Today’s Training Place used test kits in the sharps container Place gloves and all other trash in the brown paper bagsPurpose / Objectives of Slide: An illustration of where participants are instructed to dispose of training wasteAdditional Talking Points: “For the duration of the training the hard red plastic sharps containers will not have lids on them. We will not be using sharps and will be using these containers to dispose of used test kits. All other materials, gloves, left over lab stickers, etc., will be disposed of in brown paper bags.”Notes: No additional notes
35These forms help make sure samples are not mixed up Paperwork NeededExpanded ChecklistShort Checklist (Competency Assessment Test)Rapid testing log or lab slipLab stickersHIV Testing FormThese forms help make sure samples are not mixed upPurpose / Objectives of Slide: Introduce forms/paperwork that are required in this training and at test sitesAdditional Talking Points: “These are the forms that will be used when you start running tests, both here and at your site. They must be filled out correctly in order to pass this training and with every client you test at your site. We will talk about how to properly correct mistakes a little later.”Notes: No additional notes
36Test MaterialsPurpose / Objectives of Slide: Gathering Test Kit MaterialsAdditional Talking Points: “This slide illustrates the items that come with the Clearview COMPLETE test packet. In addition to the items you see here you must also have an absorbent pad, or chux, alcohol wipes, and gauze pads or cotton.Notes: Stress the importance of checking the test kit before it is used, that it is unopened and contains the absorbent desiccant packet. Mention that any bio hazardous fluid or material must be kept on the chux, such as control vials.
37Testing Device Control area Test area Blue line Test stand Buffer cap -Purpose / Objectives of Slide: A visual of what the Clearview COMPLETE testing device looks likeAdditional Talking Points: “This is what the Clearview COMPLETE testing device looks like. This test device is much different than other test devices in that it does not have labeled control and test areas as with Stat-Pak and OraQuick devices. The areas shown in red in this slide are the places where lines would need to appear in order for the test to be considered valid. You will see a variety of how test results appear in following slides.Important: Notice the ‘buffer cap’ which sits inside the test stand. During a test, the test stand holds both the test device and the buffer cap. The test device passes into the stand and punctures the buffer cap and is inserted all the way in to it. There it rests until results are ready.Important: Notice the blue line. The test stand is a frosted plastic object with a clear area at the top of the stand. If the test device has been inserted correctly into the buffer cap, the blue line on the test device should show clearly through the clear area of the test stand. If it does not, it needs to be pushed down further. The following slides will illustrate how the device is used to collect a finger stick blood sample and to run a test.”Notes: No additional notes
38Remove Buffer Cap Remove buffer cap from test device Place buffer cap in standPurpose / Objectives of Slide: Illustrates how to remove the buffer capAdditional Talking Points: “The Clearview COMPLETE comes in 3 pieces – the stand and the test device with buffer cap. The buffer cap is stored inside the test device and has to be removed and inserted into the stand before using. The stand is separate and serves to hold the buffer cap and the test device while the test is running.”Notes: No additional notes
39Collect Blood SampleAfter performing finger stick, wipe away first drop of blood.Touch device’s blood sample tip to second drop of bloodBlood will travel into the sample tipPurpose / Objectives of Slide: To show how the test device collects the sampleAdditional Talking Points: “The ‘blood sample tip’ is similar to a pipette in the way that it draws the sample up into it just by touching the tip to the sample. It only draws the sample into the tip and not all of the way into the test device. That will only happen when the tip makes contact with the buffer solution inside the buffer cap.”Notes: No additional notes
40Push Device Tip into Buffer Cap You will feel 3 snaps:Snap 1: through foilSnap 2: into capSnap 3: fully seated(blue line is visible throughclear area of the stand)Purpose / Objectives of Slide: Shows how to insert the test device into the stand and buffer capAdditional Talking Points: “After collecting the sample, insert the test device into the stand and feel it touch the foil cap. Push it through the foil cap and all the way down as far as it will go until the blue line is visible through the clear area of the stand. Notice how the two arrows in the illustration show how in step 3 the test device is fully seated in the buffer cap and the blue line is visible through the clear area near the top of the stand.”Notes: This could be done in one continuous motion. However, when done slowly you will probably hear 3 separate clicks.
41Confirm Device is Fully Seated If you do not see pink/purple flow within 3 minutes, Push Again! (then start timer)Purpose / Objectives of Slide: To illustrate how the test device should be seated to run a test properlyAdditional Talking Points: “If the test device has been inserted properly the blue line should be visible in the clear area of the stand and the test window should start showing a pinkish-purplish color as the sample and buffer solution both travel up into the test device. After the test device has been seated properly inside the stand and buffer cap the test begins to run and the time and temperature should be logged down in their proper places. If three minutes has passed and the test window shows no sign of color, this means the test device is not seated properly in the buffer cap and needs to be pushed down further. If this happens don’t forget to adjust the test’s start time.Notes: No additional notes
42Trainers Demonstration Trainer ReadsOther Trainer preforms testParticipants follow along (Expanded Checklist)Purpose / Objectives of Slide: Introduce trainers’ demo of how to run the testAdditional Talking Points: “Now we are going to run a test as you watch and follow along on the expanded checklist. When you run your practice and final tests you will follow the short checklist.”Notes: Trainers do demo of running test using expanded checklist
43Participants’ First Practice No food or drinkListen to detailed steps:Only do what we tell you to doDo all steps in orderIf you finish step quickly, wait for the next stepPurpose / Objectives of Slide: Participant’s first practice testAdditional Talking Points: “Now you will run your first practice test. I will be using the expanded checklist and will read the instructions to you and you will follow the steps exactly as I read them. Follow along referring to the short checklist. Do not do anything until I tell you to do it and do exactly what I tell you to do, only! We all need to be on the same step at the same time. When we get to the step where you have to take a sample from the vial, we will bring the vial over to you. In about 15 or 20 minutes you will do a second practice test on your own following the short checklist.”Notes: Remind participants that they will get to use the short checklist on their proficiency test and that they must use it! Read long checklist as participants run tests – they follow along with the shorter version. Go around the room with control fluid (2 vials) – let people pick a vial. Have two trainers start at opposite ends, each with a negative and positive vial, and meet in the middle.
44Reading Time Negative results in 15-20 minutes Reactive results as soon as cleartest line and control line developPurpose / Objectives of Slide: Explanation of how much time has to pass before an accurate result can be readAdditional Talking Points: “From one rapid test brand to another the times it takes for them to process will vary. With Clearview COMPLETE a negative result can be read at 15 minutes but no later than 20 minutes after the device was introduced into the buffer cap and that time was logged down. However, a reactive result can be read as soon as both Control and Test lines appear in their designated areas (but no later than 20 minutes).”Note: Warn participants to use the same clock for reading beginning time and end time
45Results Interpretation Purpose / Objectives of Slide: A visual example of all possible resultsAdditional Talking Points: “This slide illustrates the three possible results and their variations in relation to their control and test areas. The upper part of the test window is always the control area and the lower part of the window is always the test area when the test device is positioned with the sample tip facing down, as it should always be when running tests. As with most rapid tests, when the control line is in its proper area and there is no other line, the result is called negative. Also, if 2 lines appear, and both in their proper control and test areas, the result is called reactive. If after 15 minutes there are no lines, or lines appear outside of their designated areas, the result is considered invalid.Notes: No additional notes
46What causes invalids? Human error (e.g., no specimen) Unknown Manufacturer errorIf you ever have an unusual result, do not deliver itPurpose / Objectives of Slide: Discussion of why invalid results might happenAdditional Talking Points: “You cannot usually tell why an invalid result occurred. Sometimes if no lines are present at all it can be because there was insufficient or no sample introduced into the sample tip and buffer cap. It could also be because the buffer cap wasn’t punctured sufficiently and the sample/buffer solution didn’t draw up into the testing device. If this is the case, this should be apparent within 3 minutes and the test device should be pushed fully down into the buffer cap after which time the testing process should begin and you will notice the fluid travel up into the test device. If you get an invalid result, rerun the test. If you get 2 invalid results in a row, that is an indication that you need to stop and run controls to see if there might be something wrong with the test kit lot.”Notes: No additional notes
47What does it mean if a client has an invalid test result What does it mean if a client has an invalid test result? What does the darkness of the lines mean?Purpose / Objectives of Slide: The meaning of faint or partial lines and of invalid test resultsAdditional Talking Points: “In regard to the client being tested, if a test result is invalid, it most likely had nothing to do with the client’s sample and therefore says nothing about the client’s HIV status. Sometimes the lines are lighter and sometimes they are darker. This also means nothing. A line is a line is a line. Dark or light, partial or whole, it’s still a line.”Notes: No additional notesNOTHING
48ResultsPurpose / Objectives of Slide: Practice reading of 12 Clearview COMPLETE test resultsAdditional Talking Points: “Together we will identify how each of these Clearview COMPLETE tests read.”Notes: Have participants call out what each result is
49Participants’ Second Practice Pair upOne person run a test at their own pace, using the short checklistPartner observe them and help only as needed (e.g., if you see any steps that were missed, say something)SwitchUse the checklist!!!!Purpose / Objectives of Slide: Opportunity for participants to practice on their own using the short checklistAdditional Talking Points: “This is your last practice test before the 5 proficiency tests. This time I will not read the instructions to you. Instead, you will follow the short checklist yourself, step by step. You will pair up with a neighbor and one person will perform the test while the other person watches. The person watching can point out errors as you go but otherwise should remain silent. When it is time to affix a client number sticker to the HIV Testing Form, make sure you do not cover the one from the first test. At the end of the day we should see 7 different stickers on the HIV Testing Form form and 7 different stickers on the lab log. As with your first practice test let us know when you are ready for the control sample and we will bring the vial over for you to dip your pipette in to. As soon as you are finished and your test is processing, switch roles and continue with the other person beginning their second practice test. When it is time to log your results, check your paperwork carefully and make sure that it is correct (including the am’s and pm’s).”Notes: Have two trainers take a positive and a negative vial each and pass around – meet in the middle. Walk around to observe and answer questions. Ask participants what result they got the first time and give them a different vial this time.
50Internal Control – The “C” Line The control line is the “C” lineInternal control tells us:Specimen was adequately appliedProper hydrationMigration of reagents past the “T” zone.Internal & external controls are standard lab practice – not a sign of test kit unreliabilityPurpose / Objectives of Slide: Describes the Internal ControlAdditional Talking Points: “The ‘C’ line is an internal control. Regardless of how all other conditions seem to be, if a ‘C’ line doesn’t appear when running a test, there is something wrong. It could be the test device – use another one. Maybe not enough specimen was introduced (or none at all) or the sample tip was not seated fully into the buffer cap. If a ‘C’ line is visible, the test device is operating properly and there has been a sufficient amount of both specimen and buffer introduced into the test device.”Notes: No additional notes
51Test Line – The “T” LineThe “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 linestell us if there is proper lightingtell us if the reader’s eyesight is adequate to run the testPurpose / Objectives of Slide: Describes the “T” lineAdditional Talking Points: “Provided that the ‘C’ line is visible and in its proper area, the ‘T’ line lets us know whether the result is reactive or negative. It also lets us know if lighting conditions are adequate enough to run tests in that environment and if the reader’s eye site is good enough to detect lines when they are present.”Notes: No additional notes
52Controls 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 presentPurpose / Objectives of Slide: Importance of “C” and “T” linesAdditional Talking Points: “The two lines tell us different things. One, the ‘C’ line, tells us that the test kit is working properly and that fluid has migrated past the ‘T’ area and has reached the ‘C’ area. The other one tells us whether or not antibodies are present and if testing conditions, and our eye site, allow us to detect that line when antibodies are there (T line).”Notes: No additional notes
53Results 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 OKVerifies test kit detecting small amount of antibodyDarkness of line NOT related to viral load, disease progression, or anything else about the clientPurpose / Objectives of Slide: Inspection of result linesAdditional Talking Points: “Now that you have run 2 tests you have noticed how the lines can vary from one test to the next. The control samples that are used are formulated to make this test-reading experience challenging. Remember that the size or intensity of a line doesn’t mean anything but notice how important good lighting and following proper procedures will be wherever you might be testing. Whenever in doubt of how to read a test result due to faint lines it is helpful to get a second set of eyes to look at it, another trained test operator.”Notes: No additional notes
54If a Client Asks to See the Test Kit, What Would You Do? Say “No” – Why?Could compromise confidentialityOnly trained personnel may read the testTest is disposed of in biohazard bag as soon as it’s readThink about the picture with the pink background – if you have a light line would you be able to see it on this test?Purpose / Objectives of Slide: Addresses what to do if clients ask to see the test deviceAdditional Talking Points: No additional talking points needed.Notes: Read slide
55How do You Correct a Written Mistake? A single crossed-out line, corrected entry written clearly above, include date and initials of the individual making the changeAt no time should an original entry be obliterated or otherwise made illegible by a change on the record7:22pm T.K. 12/15/2011End time: 7:12pmPurpose / Objectives of Slide: Instructions on how to correct a written mistake on a form and what to write withAdditional Talking Points: “As with so many of the things we talked about today there is only one way to correct a mistake on a form, as shown on this slide. A lab log or lab slip is a medical record and can not be altered in any way that might make it appear to be falsified or forged. All other forms linked to a client with identifying numbers or dates should be corrected in the same manner. Never use ‘White Out’! And never try to modify a number to make it look like another number. The illustration in the slide is the only acceptable way to correct a mistake. When recording information or logging results do not use a pencil. Only use a pen with blue or black ink.”Notes: No additional notes
56Proficiency tests coming next…. Purpose / Objectives of Slide: Give participants a chance to ask any final questionsAdditional Talking Points: “Any question before you start your proficiency?”Notes: No additional notesAny questions?Proficiency tests coming next….
57Clearview COMPLETE Proficiency Words of CautionFollow the checklist!!!!This is not a test of memorizationRun five tests using five different vialsPut your name on the top of your paper(s)Take your time, double & triple checking your workIf you make a mistake on your paperworkand you catch it, you can fix it.and I catch it, you will have to come back another dayPurpose / Objectives of Slide: To frame the proficiency pieceAdditional Talking Points: “Please follow the checklist. Write your your name on the lab log, HIV Testing Form, and any other paperwork. Take your time, and check your paperwork. If you catch a mistake you can fix it, if we find an error in your paperwork you will not pass. Remember to keep your workspace clear of anything you are not using on the current test you are running, including stickers from previous tests. Also remember to log in the appropriate column the letter/number of the control vial used for each test and do not use the same control fluid twice. At the end of running five tests you should have used 5 different controls and should have 5 different letter/numbers logged down. Do NOT throw away any test devices after you have logged down the results. We will do that after we have read them and matched them to your lab log. Once you fully seat the test device into the stand/buffer cap you cannot disturb the test, so make sure that you position your very first test on a space on your chuck where it will not be in your way as you continue to run the next 4 tests. Be organized and be sure to match the client sticker on the test to the client sticker on the lab log before logging results. Don’t rely on the pattern in which you arranged your test devices on your chuck when logging results.”Notes: No additional notes
58Additional ResourcesThe current package insert (including instructions for operation) for the Clearview COMPLETEClearview COMPLETE test is on the Alere website at:The California Quality Assurance Guidelines are available on the Office of AIDS website at: (ASK STATE )Purpose / Objectives of Slide: To provide additional resourcesAdditional Talking Points: “If you would like more information here are some places where you can get more information on the Clearview COMPLETE.”Notes: No additional notes