1. How would a technician verify their PIFA HPF4 device is within expiration? A. Check for expiration on the PIFA HPF4 kit box B. PIFA HPF4 devices never expire C. Check for expiration on the PIFA HPF4 device D. Check for expiration on either the device or the kit box 2. A blood sample was drawn and allowed to clot as per the tube manufacturer s recommendation. The tube was centrifuged. The serum has been sitting on the clot for 90 minutes. Is this sample acceptable for testing in a PIFA HPF4 device? A. Yes, the sample is perfectly fine to use. B. It can be used, but it should be tested in duplicate since it was in the collection tube for a pretty long time. C. No, patient specimens used in the PIFA HPF4 Assay should not stand on the clot for longer than 60 minutes after centrifugation. 3. The Control window of the PIFA HPF4 device turned red and the Test window looks wet but white, did something go wrong if it just looks wet? A. No, both the reagent and the sample are aqueous so as the reagent/sample mixture flows through the device it may look like a wet white in the test window. B. Yes, something definitely went wrong. The test is invalid and should be run again. Page 1 of 11
4. A shipment of PIFA HPF4 devices was supposed to be delivered to your facility yesterday. It was finally located and as it turns out, the shipping container was erroneously left on the unheated loading dock overnight with consistent temperatures of 15 O F. Can the devices be used? A. No, they should be disposed of and new devices need to be ordered. The devices could have frozen. B. Yes, but only if two devices are run using positive and negative QC controls and the units are proven to still work correctly. C. Yes, if the lab supervisor says it is OK. D. Possibly, if you call the manufacturer and explain the circumstances and they say it is alright to use them. 5. Properly prepared serum that has been removed from the clot, but cannot be tested immediately may be stored at -20 O C. A. True B. False 6. If there are currently two kits of PIFA HPF4 devices in the lab, can the lots be mixed if both lots have met QC testing requirements? A. Yes B. No Page 2 of 11
7. What is the correct sample size used for testing with the PIFA HPF4 device? A. One drop B. 50uL C. 30uL D. None of the above 8. What additional materials are needed, but not provided by the manufacturer, to run the PIFA HPF4 device? A. Nothing, the test system is complete and ready to use. B. Transfer pipettor capable of delivering one drop of sample C. Disinfectants and paper towels D. Pipettor capable of delivering 30uL & a timing device 9. A physician has written orders for a patient to have several tests completed by your lab, including screening for possible HIT. The patient s blood sample is received in a light blue top tube and processed correctly. What is the next step? A. Remove a PIFA HPF4 test device from refrigeration and gather the materials needed for testing while it comes up to ambient temperature. B. Remove a PIFA HPF4 test device from refrigeration and run the sample on it right away because HIT can be very dangerous. C. Arrange to get an additional blood sample because PIFA HPF4 should only be used to test patient samples that are collected in collection tubes with a red top, plain glass or plastic with clot activator. D. Remove a PIFA HPF4 test device from refrigeration and gather the materials needed for testing while it comes up to ambient temperature. Page 3 of 11
10. Can icteric, lipemic, or hemolyzed samples be used for testing on PIFA HPF4? A. Yes B. No C. Sometimes, depending on how icteric, lipemic or hemolyzed the sample is 11. What temperature should all the components, including the sample, be at before testing with a PIFA HPF4 device? A. The devices can be used right out of the refrigerator, and the sample is fine to use between 2-27 O C B. All components, including the sample, should be used before their temperature reaches above 8 O C C. All components, including the sample, should be brought to ambient temperature (18-27 O C) D. All components, including the sample, should be brought to a temperature above 27 O C 12. How long are test results stable after the control window turns red? A. 30 minutes B. 45 minutes C. 5 minutes D. 60 minutes Page 4 of 11
13. Since PIFA HPF4 is a screening device and it comes with instructions, do I need to be trained before running patients samples in the device? A. No, PIFA HPF4 is a simple and easy to use device with clearly written instructions B. Yes, even though PIFA HPF4 is a simple and easy to use device with clearly written instructions, technicians should always undergo formal training before using a new test system. C. Possibly, depending on the technician s personal level of comfort with new test procedures. 14. How should PIFA HPF4 devices be stored after they are received at your facility? A. At room temperature B. -20 O C or below C. 2-8 O C D. 40 O C or above 15. Since PIFA HPF4 is a screening device there is no need to ever run QC samples. A. True B. False 16. Does the manufacturer have instructions that pertain to the temperature to which the device should be brought to before testing is initiated? A. Yes B. No Page 5 of 11
17. Is the one minute incubation time noted in the directions really critical to the proper functioning of the test? A. Not really, most of the reaction is finished in the first 5 seconds of incubation time. Waiting 60 seconds just gives the technician a chance to recap the sample tube and place it in a rack. B. More incubation time is even better. That way if the sample is border-line it gets a longer time for the rate reaction to work. C. No, it s just that most timers can be set for one minute so it works for almost any lab. D. Yes, the one minute incubation time is critical because the test is based on a rate reaction. 18. How often does the manufacturer recommend running positive and negative QC controls? A. Every 6 months as part of the normal proficiency testing protocol B. During the initial use of a new lot of devices C. Once a day D. During the initial use of a new lot of devices and after running 100 tests of the same lot of devices 19. Can serum that has been drawn in a red top tube, allowed to clot and centrifuged as per the manufacturers recommendation, then removed from the clot 120 minutes later, be stored at 2-8 O C if it cannot be tested on PIFA HPF4 immediately? A. No B. Yes Page 6 of 11
20. A PIFA HPF4 device was brought to room temperature, but was not used during the 8 hour shift. Can it be place back in the refrigerator and used later or should it be discarded? A. Yes, it can be repeatedly warmed to room temperature and placed back into refrigeration as often as needed until the device reaches its expiration date. B. No, it should be immediately discarded. C. Yes, if the device was not removed from the sealed pouch while it equilibrated to ambient temperature, it can be place back in refrigeration as many times as necessary until the device reaches its expiration date. D. Yes, if the device was not removed from the sealed pouch while it equilibrated to ambient temperature, it can be place back in refrigeration. This removal from and return to refrigeration protocol of the pouched devices can occur up to 4 times, for a maximum room temperature exposure of 32 hours per pouched device. 21. If a PIFA HPF4 device is run and the control window does not turn red can the results be accepted? A. Yes B. No C. Possibly, if another technician verifies that all the proper test steps were followed D. Yes, but the results should only be verbally reported and should not be entered into LIS until a second device is run 22. Patient samples should be collected in gel serum separator (SST) tubes. A. True B. False Page 7 of 11
23. Is it acceptable for another technician to verbally tell you how to use the PIFA HPF4 device if the instructions are not available and you have never used it before? A. Yes, but only if you are an experienced lab technician. B. Yes, but only if the lab supervisor is advised first. C. No, every technician should be formally trained, with that training being documented, prior to running this assay. D. Yes, if the manufacturer s web site is accessed and the FAQ sheet is printed out. 24. If a PIFA HPF4 device is brought to room temperature and the pouch is opened, can it be placed back in the refrigerator and used at a later date? A. Yes, it can be placed back in refrigeration. This removal from and return to refrigeration protocol of the pouched devices can occur up to 4 times, for a maximum room temperature exposure of 32 hours per pouched device. B. Yes, it can be repeatedly warmed to room temperature and placed back into refrigeration as often as needed until the device reaches its expiration date as long as the pouch is resealed before placing the device back in refrigeration. C. No, the device should be used immediately or discarded. D. Yes, it can be used later as long as it is left at ambient temperature until it is used. 25. The last time a PIFA HPF4 test was run, the negative result was a vibrant blue color in the test window, but this time the color is a little pale. Does that make the test invalid or positive? A. Yes, every time a negative sample is run the results should look exactly the same B. No, the color in the test window is sample dependent, so the intensity of the blue color in the test window may vary from a pale blue to a vibrant blue. Any blue color in the test window should be interpreted as a negative result. Page 8 of 11
26. How long can a refrigerated serum sample be stored in 2-8 O C before testing on PIFA HPF4? A. 8 hours B. Up to 24 hours C. The sample can t be used, it should only be stored in -20 O C or below D. No longer than 72 hours 27. The control window took five minutes to turn red does that make the test invalid? A. Yes, PIFA HPF4 is a screening device so by definition it should give results very quickly B. No, flow rate is sample dependent so the time interval for a red color to develop in the control window varies, ranging from 1 to 10 minutes C. No, as long as the red color appears within 10 minutes the test is considered valid D. Both B & C 28. If the device is not slid from side to side vigorously after introducing the sample into the device, will the test be valid? A. No, vigorous mixing insures that the patient sample is mixed properly with the reagent. Improper mixing could produce false negative results B. Yes, as long as the patient sample is introduced into the device the test will work C. Yes, as long as the control window turns red within 10 minutes D. Both B & C Page 9 of 11
29. The PIFA HPF4 assay should be used in a well-lit part of the lab and insulated from a cold lab bench if the bench tends to be colder than ambient temperatures. A. True B. False 30. Draw a line from the test & control interpretation on the left to the matching result on the right. TEST Window CONTROL Window RESULT A) ANY Blue NO Red 1) NPositive/ReactiveN B) NO Blue NO Red 2) NInvalidN C) NO Blue ANY Red 3) NNegative/NonreactiveN D) ANY Blue ANY Red 4) NInvalidN Page 10 of 11
1) D 2) C 3) A 4) A 5) B 6) A 7) C 8) D 9) C 10) C 11) C 12) D 13) B 14) C 15) B 16) A 17) D 18) D 19) A 20) D 21) B 22) B 23) C 24) C 25) B 26) D 27) D 28) A 29) A 30) A-2 B-4 C-1 D-3 Page 11 of 11