Urine Pregnancy Screening for Research Staff

Urine Pregnancy Screening for Research Staff

All Rights Reserved, Duke Medicine 2007

Before testing sample

• Date and initial kit when opening.

• Check product expiration, if expired discard kit.


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.


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.


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.


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”.


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.


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.


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.


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.


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

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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

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Documents

Urine Pregnancy Screening for Research Staff