Sure-Vue Urine hCG (Pregnancy) Test

1. Sure-Vue Urine hCG (Pregnancy) Test This presentation was designed to provide an understanding of: - the correct test procedure for the Sure-Vue pregnancy test - quality control requirements for the test - limitations of the test - troubleshooting help - the availability of written procedures To advance slide, click anywhere on blank area of screen.

2. Sure-Vue Urine hCG (Pregnancy) Test This slide presentation is provided to you as an educational service by Loyola Medical Laboratories. This presentation should not be used or copied without the express permission of Loyola Medical Laboratories. To advance slide, click anywhere on blank area of screen.

3. Sure-Vue Urine hCG (pregnancy) Test If you have access to speakers, please turn them on; they will enhance the presentation. If not, the presentation will not be affected. To open presentation to full screen, click on the middle button in the upper most right corner of the box. To advance slide, click anywhere on blank area of screen. To end show, click on the box containing the “x” in the upper right hand corner of the screen.

4. Clinical Significance of the Urine Pregnancy Test The Sure-Vue Serum/Urine hCG kit is used to detect hCG (human chorionic gonadotropin) which is a hormone secreted by the developing placenta shortly after fertilization. The appearance and rapid rise in the concentration of hCG in the mother’s urine and serum make it an excellent marker for the presumptive diagnosis of pregnancy. The hCG hormone doubles approximately every 2.2 days during the 1st trimester. Detectable levels start at 5 mIU/ml during the first week of gestation and rise to 100,000 mIU/ml at 2-3 months. Since hCG levels of 25 mIU/ml have been observed as early as 10-12 days after conception, hCG may be detected using the Sure-Vue kit before a first missed menses.

5. Sure-Vue Urine Pregnancy Test The Sure-Vue pregnancy test packaging.

6. Sure-Vue Urine Pregnancy Test Sure-Vue individual test device Patient “T” (test) window (Indicates a positive patient result if pink line is present) “C” Control window (Pink line appears if device is functioning) Test well (where sample is placed)

7. Sure-Vue Urine Pregnancy Test Sample type, collection and storage information • Sample volume required: 4 drops of clear urine (no • particulate matter) • Collection- collect urine in clean, dry containers • Storage - specimens may be refrigerated up to 72 hrs. • If refrigerated, warm to room temperature before testing • First morning specimens are preferred • All specimens must have correct patient identification

8. Sure-Vue Urine Pregnancy Test Clinical Use All laboratory waived tests can be considered either screening tests or diagnostic tests. This indicates how the test result is utilized. If the test is used to “roughly” determine where the patient is at clinically, the test is considered a screening test. These tests require more accurate follow-up tests in the laboratory to determine how the patient will be managed. Diagnostic test results on the other hand, are more accurate and/or sensitive then screening tests and can be used to determine patient management. Diagnostic tests are as accurate as those performed in the laboratory. Results from the Sure-Vue pregnancy test can be considered diagnostic. No further laboratory confirmation is required.

9. Sure-Vue Urine Pregnancy Test Training requirements JCAHO regulations require that all staff members performing laboratory testing must have documented training before using the test for patient testing. You will be asked to sign a training checklist at the end of this presentation to document your training for JCAHO. This documentation should be given to your manager or clinical coordinator and maintained indefinitely for JCAHO and CLIA inspections.

10. Sure-Vue Urine Pregnancy Test Competency requirements All operators must demonstrate competency annually. Competency must be documented for each staff member and records must be maintained indefinitely for JCAHO. Annual competency can be achieved by: - documentation of the successful performance of quality controls - documented review of the written procedure, slide presentation and/or training checklist - demonstrating proficiency under direct observation

11. Sure-Vue Urine Pregnancy Test Quality Control Quality controls are materials that are formulated to “check” if a test system is performing correctly and that the person who is performing the test has proper technique. Manufacturers sometimes build in controls to be read along with the test and/or require “external” liquid type controls to be tested with their test to check it’s accuracy. These external controls have known values that are written on a insert sheet provided with the controls. For example, for the Sure-Vue pregnancy test two external controls are tested when each box of test devices is opened. One external control should read positive and one negative. If these controls do not read correctly, there may be something wrong with the test devices or with the tester’s technique.

12. Sure-Vue Urine Pregnancy Test Quality Control Requirements Required quality control for the Sure-Vue Urine pregnancy test consists of: - internal control (a pink control line in the “C” window) The presence of this internal control indicates that the test kit is functioning correctly. - external liquid controls each time a new box is opened qUAntify level 1 control = negative qUAntify level 2 control = positive Two controls (negative and positive) are required to be tested by federal law.

13. Sure-Vue Urine Pregnancy Test Sure-Vue Quality Control Internal control (pink vertical line) - must be present for result to be considered accurate. This checks that the test device is working correctly and that the correct volume of urine has been added.

14. Sure-Vue Urine Pregnancy Test Sure-Vue Quality Control The liquid controls that must be tested with each new box of pregnancy tests are the Hematronix qUAntify controls (level 1 and 2). Controls These controls are also used for checking quality control for the Bayer urinalysis strips and CLINITEK 50 automated urinalysis analyzer.

15. Sure-Vue Urine Pregnancy Test Performing Quality Control When each new box is opened for the first time, two levels of liquid controls (negative and positive) must be tested and documented on a QC (quality control) log. Each day that patient testing is performed, the lot number, expiration date, presence of control line, and tester’s initials must be documented on the Sure-Vue QC log for the first patient performed that day. This provides legal proof that kits were not expired and were functioning on the day when patient test was performed.

16. Sure-Vue Urine Pregnancy Test Hands-on exercise For this hands-on training exercise, you will need: • Three Sure-Vue test devices from the box • qUAntify Level 1 and Level 2 urine controls • A black waterproof marker • A blank Sure-Vue quality control log • A patient urine (clear with no particulate matter) (if a real • one is not available, put some water in a cup) • quality control insert sheet from the quality control box • a Sure-Vue training checklist Take a minute to check that you have all the supplies needed before proceeding.

17. Sure-Vue Urine Pregnancy Test Hands-on exercise

18. Sure-Vue Urine Pregnancy Test Performing quality control for each box To perform quality control testing with each box: 1. Obtain two Sure-Vue test devices in their foil envelopes. 2. Open the foil packets and remove the test devices. The plastic pipettes can be discarded or used for another purpose. 3. Label each test device with “Level 1” or “Level 2” with the waterproof marker in the space provided. Check the insert sheet in the QC box to see which level control should be positive and which should be negative.

19. Sure-Vue Urine Pregnancy Test 4. Mix the qUAntify Level 1 control, open cap and drop 4 drops of control into the test well of the first test device. 5. Mix the qUAntify Level 2 control, open cap and drop 4 drops of control into the test well of the second test device marked level 2. 6. Set a timer for 4 minutes.

20. Sure-Vue Urine Pregnancy Test 7. After the 4 minutes has passed, check the test devices for the following: Level 1 - Negative control - in the “C” box there should be a pink vertical line - in the “T” box there should be NO line Level 2 - Positive control - in the “C” box there should be a pink vertical line - in the “T” box there should be a pink vertical line See examples on the next two slides.

21. Sure-Vue Urine Pregnancy Test The negative control result should look like this: Level 1 Negative C (Control) line present + no pink line in the T (test) window.

22. Sure-Vue Urine Pregnancy Test The positive control result should look like this: Level 2 Positive C (Control) line present + pink line in the T (test) window. Note: ANY line (whether heavy or faint) in the T window should be considered positive.

23. Sure-Vue Urine Pregnancy Test Don’t be too quick…. Too slow….. Or forgetful! To be accurate, the results should be read at 4 minutes and within 15 minutes after starting the test!

24. Sure-Vue Urine Pregnancy Test Patient testing cannot be performed using the test devices in the box until liquid controls read properly: Negative control = negative Positive control = positive If the controls do not read correctly, consult the troubleshooting section of the Sure-Vue pregnancy procedure for help. This is found in the Laboratory Procedure Manual - Waived Tests.

25. Sure-Vue Urine Pregnancy Test Troubleshooting problems If no pink line appears in the “C” (control) window, the result is not valid. Sometimes, the liquid does not travel across the membrane correctly due to particulate matter in the urine or inadequate volume. This can be corrected by adding 4 more drops of urine and waiting four more minutes. If the control line still does not appear, the result must be considered invalid and a new test device should be used.

26. Sure-Vue Urine Pregnancy Test Documenting your Level 1 and Level 2 controls: 1. Using your Sure-Vue QC (quality control) log, write the date down in the left hand column. 2. Under the column that says “Each new Box of Test Devices”, check off the Negative control column if the negative control read negative. 3. Under the same column, check off the Positive control column if the positive control read positive.

27. Sure-Vue Urine Pregnancy Test Documenting your positive and negative controls when each new box is opened.

28. Sure-Vue Urine Pregnancy Test Opened and Controls tested 5/22/01 Don’t forget….... Don’t waste the time of others! Since you are opening a new box of pregnancy tests for the first time, remember to write the date the box was opened and controls were tested on the top of the box so that other staff members will know that this box has already been tested!

29. Sure-Vue Urine Pregnancy Test Performing patient testing To perform patient testing: 1. Obtain a Sure-Vue test device. 2. Open the foil packet and remove the test device and plastic pipette. 3. Label the test device with a patient’s name or medical record number with the waterproof marker. 4. Look at the patient’s urine to make sure that the urine is clear with no particulate matter.

30. Sure-Vue Urine Pregnancy Test 5. If the patient’s urine has a lot of particulate matter, you should do one three things: 1) let the urine settle until a clear layer is available, 2) centrifuge the urine to remove the particulate matter, or 3) filter the urine to remove the particulate matter. 6. Using the plastic pipette included in the foil packet, draw up some clear patient urine and drop 4 drops into the test well of the device. 7. Set a timer for 4 minutes.

31. Sure-Vue Urine Pregnancy Test Read at 4 minutes but before 15 minutes have passed. Results read after 15 minutes ARE INVALID. Negative Positive

32. Sure-Vue Urine Pregnancy Test Remember: ANY line (whether heavy or faint) in the T window should be considered positive. If no pink line appears in the “C” (control) window, the result is not valid. Sometimes, the liquid does not travel across the membrane correctly due to particulate matter in the urine or inadequate volume. This can be corrected by adding 4 more drops of clear urine and waiting four more minutes.

33. Sure-Vue Urine Pregnancy Test Documenting patient results Per federal regulations and JCAHO standards, patient results must be documented in the patient’s medical record along with the tester’s intials. Documentation should be performed per your area’s protocol. The following options are available: 1. If your area is considered an outpatient or satellite facility, you may use the “Laboratory Waived Testing Outpatient Result Form (see example). The presence of the control line and the patient result is documented on this form.

35. Sure-Vue Urine Pregnancy Test 2. If you are performing pregnancy testing on a hospital unit, you may document the results in the nursing notes or on a flowsheet, along with your initials. 3. In addition, each day that patient testing is performed, the lot number, expiration date, presence of control line, and tester’s initials must be documented on the Sure-Vue QC log for the first patient performed that day. This provides legal proof that kits were not expired and were functioning on the day when patient test was performed. See example on next page.

36. Sure-Vue Urine Pregnancy Test Documenting the first pregnancy test of the day:

37. Sure-Vue Urine Pregnancy Test Limitations of the test Even though this kit is a serum/urine kit, ONLY URINE can be used under a waived or PPM license. Serum (spun down whole blood) can only be used in the laboratory. This test cannot be used with whole blood under any circumstances. The sensitivity of this test is 25 mIU/L which can show a positive result as early as 10-12 days after conception. Elevated levels of hCG may also be found in trophoblastic disease, choriocarcinoma, embryonal cell carcinoma and islet cell tumors.

38. Sure-Vue Urine Pregnancy Test Limitations of the test If the patient has clinical signs of pregnancy but the test reads negative, the following should be considered: - Low specific gravity of the urine (sample is too dilute); collecting a first morning specimen is preferred. - Inadequate urine volume; make sure that control line appears. Detectable levels of hCG may remain several weeks following normal pregnancy, delivery by C section, or spontaneous or therapeutic abortion. Ectopic pregnancies may produce very low levels of hCG. If this is suspected, a quantitative hCG should be ordered.

39. Sure-Vue Urine Pregnancy Test Limitations of the test This test provides a presumptive diagnosis for pregnancy only. Physicians should evaluate all clinical and laboratory findings before making a definitive diagnosis.

40. Where to get Technical Help The Laboratory Procedure Manual for Waived Testing For any information about waived testing procedures performed at your facility, you should consult the “Laboratory Procedure Manual - Waived Tests”. This is a large, royal blue binder given to all sites who perform waived testing.

41. Where to get Technical Help The Laboratory Procedure Manual for Waived Testing The Waived Testing Procedure manual contains: • Written procedures for each test • JCAHO regulations • Required quality assurance for all tests • Training checklists for all tests • Sample competency logs for maintaining annual competency • Helpful articles about CLIA and JCAHO regulations • Master quality control logs for all tests • Troubleshooting help • Supply and ordering information

42. Sure-Vue Urine Pregnancy Test Review Questions True or False answers To see the answer, mouse click under the question. 1. The Sure-Vue test must be read after 4 min. but before 15 min. True 2. A patient or control is still valid if no control line appears. False 3. If the patient appears clinically pregnant but the test is negative, the test should be repeated within 48 hours. True

43. Sure-Vue Urine Pregnancy Test Review Questions True or False answers To see the answer, mouse click under the question. 4. A negative result may be due to a low specific gravity (too dilute). True 5. A first morning specimen is preferred for pregnancy testing. True 6. Two liquid controls (positive and negative) must be tested each time a new box of test devices is opened. True

44. Sure-Vue Urine Pregnancy Test Review Questions True or False answers To see the answer, mouse click under the question 7. The Sure-Vue test devices must be stored in the refrigerator. False 8. If cold, the foil envelope must be warmed to room temperature prior to opening. True 9. hCG levels may be detected as early as 2 days after conception. False

45. Sure-Vue Urine Pregnancy Test Please take a minute now to find the Sure-Vue Training Checklist. A copy can be found in the Waived Testing Procedure Manual. This training checklist lists all the important facts that you should know about the Sure-Vue pregnancy test. When you finish this presentation, please read the list and check that you understand all the information included. When you are finished, print your name, date the list, sign where requested and give this list to the manager or coordinator at your site to keep for JCAHO inspections.

46. Sure-Vue Training checklist with documentation on back.

47. This concludes the Sure-Vue pregnancy test training presentation. Please refer any questions or problems to: Geri Augustine BS MT(ASCP) CLS(NCA) Technical Specialist - Near Patient Testing. Loyola Medical Laboratories Loyola University Medical Center (708) 216 -8044 or x68044 To end show, close the box with the X in the upper right hand corner.