1. Urine Pregnancy Screening for Research Staff

2. Before testing sample Date and initial kit when opening.
Check product expiration, if expired discard kit.

3. 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.
CLIA-Waived test. Can be performed in any specimen-handling area.

4. Quality Control:
Perform commercial quality control at each location during monthly maintenance.
These results are documented on the QuickVue+ One-Step hCG QC log sheet.

5. Procedure:
NOTE: Do not use if foil package appears to have been opened prior to testing.
Label the Test Device with patient History number or Subjects Study ID Number.
Allow the urine to come to room temperature and mix thoroughly.
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.

6. Interpretation of Results:
Negative Result:
Control:
A blue line appears in the small square labeled “Control Window”.
Document the control reaction by recording “yes”.
Patient:
There is no change in the in the large square labeled “Read Result Window”. 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. Interpretation of Results:
Positive Result:
Control:
A blue line appears in the small square labeled “Control Window”.
Document the control reaction by recording “yes”.
Patient:
A pink line appears across the blue line to form a plus sign (+) in the large square labeled “Read Result Window”.
Document the reaction by using “POS” or as a (+), plus sign.
Record in patient result column as “POS”.
NOTE: ANY shade of a pink vertical line in the Read Result Window should be interpreted as a positive result.

8. Interpretation of Results:
Invalid Result:
If a vertical blue line DOES NOT appear in the small square labeled “Control Window”.
Document the control reaction by using a “Invalid”.
The test should be repeated using a new QuickVue+ One-Step hCG Test.

9. 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. Completion of Training:
Trainer must observe your performance of commercial controls with a known positive and negative hCG test before you can perform patient testing.

11. Standard Safe Work Practices
No food, drink allowed in the testing area
Area must have place for hand-washing
Area must have Biohazard disposal
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. 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