1. Urine Pregnancy Screening for Research Staff

2. All Rights Reserved, Duke Medicine 2007 These instructions refer to the QuickVue One-Step hCG Urine test kit Before testing a sample: Check product expiration, if expired discard kit. It is considered Best Practice to: Date and initial kit when opening.

3. All Rights Reserved, Duke Medicine 2007 Who can perform the test? Following demonstration of clinical competency, research staff may perform the QuickVue One-Step hCG Urine Test. Competency must include the performance of a known negative and positive sample. Competency must be documented annually for employees.

4. All Rights Reserved, Duke Medicine 2007 Quality Control: According to the QuickVue manufacturer, external controls should be tested with each new lot or shipment of test materials. If the study team purchases the kits from DOCR, DOCR will QC all kits for the study teams. If the study team purchases their own kits, they will need to QC the lot themselves according to the QuickVue manufacturer instructions. The QC results must be adequately documented. Study teams may use the QuickVue One-Step hCG QC and Results log sheet, or a similar template of their choosing.

5. All Rights Reserved, Duke Medicine 2007 Procedure: NOTE: Do not use if foil package appears to have been opened prior to testing. Draw up urine into the disposable dropper and dispense 3 drops into the large round Sample well. Read result at 3 minutes. Note: Some positive results may appear sooner. It is considered Best Practice to: Label the Test Device with patient History number or Subjects Study ID Number.

6. All Rights Reserved, Duke Medicine 2007 Interpretation of Results: Negative Result: Control: –A blue line appears in the square next to the letter “C” for “Control”. –Document the control reaction by recording “yes”. Patient: –There is no change in the square next to the letter “T” for “Test”. The blue line is the only line present. –Document the reaction by using either “NEG” or as a (–), minus sign. –Record in the patient result column as “NEG”.

7. All Rights Reserved, Duke Medicine 2007 Interpretation of Results: Positive Result: Control: –A blue line appears in the square next to the letter “C” for “Control”. –Document the control reaction by recording “yes”. Patient: –A pink line appears below the blue line in the square next to the letter “T” for “Test”. Document the reaction by using “POS” or as a (+), plus sign. –Record in patient result column as “POS”. NOTE: ANY shade of a pink line in the Result Window should be interpreted as a positive result.

8. All Rights Reserved, Duke Medicine 2007 Interpretation of Results: Invalid Result: If a blue line DOES NOT appear in the square next to the letter “C” for “Control”. Document the control reaction by using a “Invalid”. The test should be repeated using a new QuickVue One-Step hCG Test.

9. All Rights Reserved, Duke Medicine 2007 Reporting Results Most errors occur when recording the results incorrectly! Fill in date, time, patient’s name and history number. Record the reactions of both the control and patient test window on the QC Log Sheet. Write “POS” or “NEG” as the interpretation of the patient’s test result.

10. All Rights Reserved, Duke Medicine 2007 Reporting Results Templates Results may be reported on a template of the study team’s choosing. Here are two possible examples: 10

11. All Rights Reserved, Duke Medicine 2007 Completion of Training: Trainer must observe your performance of commercial controls with a known positive and negative hCG test before you can perform patient screening.

12. All Rights Reserved, Duke Medicine 2007 Standard Safe Work Practices No food, drink allowed in the screening area Area must have place for hand-washing Area must have Biohazard disposal Disposal is governed by the Medical Waste Management policy on the OESO website: http://www.safety.duke.edu/safetymanuals/university/VII_3MedWaste.pdf Work area must be maintained in a clean and sanitary condition Procedures involving body fluids are to be performed in a manner to minimize splashing, spraying, spattering, and droplet generation 12

13. All Rights Reserved, Duke Medicine 2007 Approved Trainers Ana Garcia-Turner, RPM Ophthalmology Barbara Kurth, RPM Radiology Bonnie Thiele, RPM, OB/GYN Catee Mullen, RPM Heart Center Deborah Hannah, RPM Dermatology Eang King, RPM CFM Holly Tiemann, DOCR Sharon Minda, RPM Psychiatry Terry Ainsworth, DOCR 13