1. What is the purpose of the serastat blood cell separator, which is used in conjunction with the PIFA PlussPF4 assay? A. It is used to separate serum from the patient s plasma sample B. It is used to extract a measured volume of the liquid fraction from the patient s fresh whole blood C. It is used to dispense the patient s sample into the PIFA PlussPF4 MiniReactor D. Both A and C E. Both B and C 2. What type of blood collection tubes should be used for patient specimens when using PIFA PlussPF4? A. Orange top tubes or light green top tubes B. EDTA or Sodium Citrate tubes C. Red top tubes D. Gold or Red/Grey top tubes 3. How would a technician verify their PIFA PlussPF4 device is within expiration? A. Check for expiration on the PIFA PlussPF4 kit box B. PIFA PlussPF4 devices never expire C. Check for expiration on the PIFA PlussPF4 device D. Check for expiration on either the PIFA PlussPF4 Device or the kit box Page 1 of 13
4. A shipment of PIFA PlussPF4 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 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, it you call the manufacturer and explain the circumstances and they say it s alright to use them 5. Can controls from other test kits be used as controls for PIFA PlussPF4? A. Yes B. No 6. Since PIFA PlussPF4 is a screening device there is no need to ever run QC samples. A. True B. False Page 2 of 13
7. If a PIFA PlussPF4 device is run and the control window does not turn red can the results be accepted? A. Yes B. Possibly, if another technician verifies that all the proper test steps were followed C. No 8. What additional materials are needed, but not provided by the manufacturer, to run the PIFA PlussPF4 device? A. Nothing, the test system is complete and ready to use B. Transfer pipette capable of delivering one drop of sample C. Disinfectants and paper towels D. Pipettor capable of delivering 150uL & 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 an orange top tube and processed correctly. What is the next step? A. Remove a PIFA PlussPF4 test device from refrigeration and gather the materials needed for testing while it comes up to ambient temperature. B. Remove a PIFA PlussPF4 test device from refrigeration and run the sample on it right away because HIT can be very dangerous. C. Refrigerate the sample until it reaches 2-8 O C, then run immediately D. Arrange to get an additional blood sample because PIFA PlussPF4 should only be used to test patient samples that are collected in EDTA or Sodium Citrate collection tubes. Page 3 of 13
10. How long after the control window turns red are test results stable for? A. 30 minutes B. 45 minutes C. 5 minutes D. 60 minutes 11. What temperature should all the components, including the sample, be at before testing with a PIFA PlussPF4 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 can you tell that the serastat has completely separated the whole blood sample and it is time to dispense the specimen into the PIFA PlussPF4 device? A. Wait 8 minutes and immediately dispense the specimen into the PIFA PlussPF4 device B. A YELLOW front will move along the membrane that extends from the serastat, when it reaches the LOWER EDGE the sample is ready to be dispensed into the PIFA PlussPF4 device C. When the membrane extending from the serastat is dry, it is time to dispense the specimen into the PIFA PlussPF4 device D. None of the above Page 4 of 13
13. Does the manufacturer s package insert include Quality Control recommendations, sample preparation, test procedure, and a way to contact technical service if necessary? A. Yes B. No 14. How should PIFA PlussPF4 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. What is the correct sample size used for testing with the PIFA PlussPF4 device? A. One drop placed onto the serastat device for separation before being dispensed into the PIFA PlussPF4 device B. 150uL placed onto the serastat device for separation before being dispensed into the PIFA PlussPF4 device C. 30uL placed directly into the PIFA PlussPF4 device D. 150uL placed directly into the PIFA PlussPF4 device 16. Since PIFA PlussPF4 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 PlussPF4 is a simple and easy to use device with clearly written instructions B. Yes, even though PIFA PlussPF4 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 technicians personal level of comfort with new test procedures Page 5 of 13
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. The PIFA PlussPF4 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 Page 6 of 13
20. If a PIFA PlussPF4 device is 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. Can icteric, lipemic, or hemolyzed samples be used for testing on PIFA PlussPF4? A. Yes B. No C. Sometimes, depending on how icteric, lipemic or hemolyzed the sample is D. Yes, but the results should only be verbally reported and should not be entered into LIS until a second device is run Page 7 of 13
22. How long should it take for a measured volume of the liquid fraction to be extracted from a fresh whole blood sample when using serastat? A. Most samples will separate within 5 minutes; occasionally separation may take up to 8 minutes B. thirty seconds or less C. At least 10 minutes D. Samples will separate within 5 minutes 23. Is it acceptable for another technician to verbally tell you how to use the PIFA PlussPF4 test system 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, and that training should be documented, prior to running this assay D. Yes if the manufacturer s web site is accessed and the FAQ sheet is printed out 24. Last time a PIFA PlussPF4 test was run the negative result was a pale green color in the Test window, but this time the color is a very vibrant greenish blue, does that mean something went wrong and the test is invalid? 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 dependant, so the intensity of the blue-green color in the test window may vary from a pale green to a vibrant blue-green. Any green or blue color in the test window should be interpreted as a negative result. Page 8 of 13
25. If a PIFA PlussPF4 test system 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 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. 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 26. How far does the clear plastic sleeve of the serastat have to slide over the sample well before inserting the serastat into the PIFA PlussPF4 device? A. Until exactly 4 millimeters of the membrane is showing B. The clear plastic sleeve should never be moved it is there to guard against biological hazards C. Until the sample well is covered no farther D. Until the top edge of the sleeve is flush with the top edge of the serastat 27. PIFA PlussPF4 is a functional test A. True B. False Page 9 of 13
28. If the device is not slid from side to side vigorously after introducing the serastat into the PIFA PlussPF4 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 29. Draw a line from the test & control interpretation on the left to the matching result on the right TEST Window CONTROL Window RESULT ANY Blue-Green No Red Positive/Reactive ANY Blue-Green Any Red Invalid ANY Yellow Any Red Negative/Nonreactive Any Yellow No Red Invalid Page 10 of 13
30. The control window took five minutes to turn red does that make the test invalid? A. Yes, PIFA PlussPF4 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 31. How long can a refrigerated, properly collected anti-coagulated whole blood sample be stored in 2-8 O C before testing on PIFA PlussPF4? 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 32. Does the serastat blood cell separator have to be used every time a sample is tested on a PIFA PlussPF4 device? A. Not really, if the membrane extending from the serastat is damaged or the serastat is somehow lost, just go ahead and place your whole blood sample directly into the PIFA PlussPF4 device B. It only needs to be used if the patient sample has been refrigerated for more than 24 hours C. Yes, the serastat and PIFA PlussPF4 devices are always used together D. It should be, but can be omitted if there is a shift change coming up Page 11 of 13
33. What is the proper way to dispense a patient sample into the PIFA PlussPF4 device? A. Remove 150uL patient sample from the collection tube and place it directly into the slot at the top of the tower portion of the PIFA PlussPF4 device B. Orient the serastat so that the yellow membrane is in a downward position and the sample well is facing AWAY from you, carefully insert the serastat into the slot in the tower portion of the PIFA PlussPF4 device, and push until the serastat reaches a seated position C. Orient the serastat so that the yellow membrane is in a downward position and the sample well is facing TOWARD you, carefully insert the serastat into the slot in the tower portion of the PIFA PlussPF4 device, and push until the serastat reaches a seated position Page 12 of 13
Answer Key 1 E 21 B 2 B 22 A 3 D 23 C 4 A 24 B 5 B 25 C 6 B 26 D 7 C 27 B 8 D 28 A 9 D 29 ANY Blue-Green No Red Positive/Reactive 10 A ANY Blue-Green Any Red Invalid 11 C ANY Yellow Any Red Negative/Nonreactive 12 B Any Yellow No Red Invalid 13 A 14 C 30 D 15 B 31 B 16 B 32 C 17 D 33 B 18 D 19 A 20 D Page 13 of 13