Pregnancy Screening MCL Procedure
for Waived Applications
Sure VueŽ Urine hCG by Fisher Healthcare
The first morning specimen is preferred
for pregnancy screening since it is the most concentrated sample of the day.
Random samples are acceptable but are not the optimum. Have patient collect a
clean catch urine specimen by placing a clean, dry cup into stream after urinating
for a couple of seconds. It doesn't take too much-- about one-fourth of a cup.
If testing cannot be done within an hour
after voiding, refrigerate the specimen immediately. Testing may be done on a
urine sample that has been refrigerated for up to 72 hrs. Bring sample to room
temperature prior to testing. Remove the test device from the protective pouch.
- Hold a new disposable dropper vertically and dispense 3 FULL DROPS
of urine into the round sample well.
- Read result at 3 MINUTES.
- Positive Results: 2 colored lines appear, 1 colored line appears
at the Specimen Zone (T) and another line appears at the Control Zone (C).
- Negative Results: Only 1 line appears at the Control Zone (C).
- Invalid Results: If no line appears at the Control Zone (C) even if a colored line appears at
the Specimen Zone (T).
Invalid test #1
Invalid test #2
- Maintain the proper storage conditions by keeping the testing
device at room temperature and sealed in the foil pouch until just
- Do not use units that are expired or are unstable due to incorrect
- Follow the procedural instructions exactly.
- The internal positive control must be confirmed with EACH patient
before the result is accepted. A line appearing at the Control Zone (C)
confirms that test was performed correctly and that the testing device
- The internal negative control is confirmed by the absence
of interfering background in the result reading area. Confirm with EACH
patient before the result is accepted. The presence of a background that
interferes with the ability to read test results indicates the test was
performed incorrectly or that the reagents have deteriorated.
- Repeat test, if results are invalid or inconsistent with patient's
clinical findings. If results are invalid or inconsistent for the second
time, submit fresh specimen for laboratory confirmation.
- Repeated failures must be reported with a nursing service problem
- With EACH patient, confirm and document (on QC sheet provided)
that both internal positive and negative controls work. Document result in
- The laboratory assesses the quality of the test on an ongoing
basis. External quality control at the unit level is not necessary for