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Urine Pregnancy Screening
CHAPTER
URINE
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POCT Program
Procedure:
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RESEARCH-ONLY PROCEDURE
Urine Pregnancy - CARDS Q.S. hCG
Urine Prenancy: Pregnancy testing using CARDS Q.S. hCG (subsidiary of Quidel)
PURPOSE
Study: A phase III international, multi-center, double blind, placebo-controlled study of
the safety, efficacy and tolerability of intravenous Antegren (natalizumab) in subjects with moderately to severely active Crohn’s disease.
IRB Reference Number: 3901
Sponsor Study ID: AN100226-CD301 &CD303
This method is approved for the above-mentioned study, and only trained approved users
may perform the procedure. Log sheets for controls will be maintained separately from
the test approved for the RWJMS POCT program. (Quick Vue)
PRINCIPLE
The CARDS Q.S. hCG Serum/Urine is a rapid and sensitive immunoassay for the qualitative detection of hCG in serum or urine. This test is intended for use as an aid in the detection of early pregnancy. The CARDS Q.S. hCG Serum/Urine is a lateral-flow immunoassay which uses a monoclonal antibody specific to the beta subunit of hCG for the
qualitative detection of human chorionic gonadotropin (HCG) in urine.
Urine is added to the sample well of the reaction unit. If hCG is present in the specimen
at a level of 20mlU/mL or greater, a pink vertical line will appear along with a blue horizontal line forming a plus + sign to indicate a positive result. If hCG is not present in the
sample, the Read Result window shows only the pre-printed blue horizontal line, forming
a minus sign to indicate a negative result.
As the sample moves through the test pack, a bar in the Control Window becomes blue.
A blue color in the Control Window indicates that the test is functionally active and is
also evidence that the test has been performed correctly.
CLINICAL SIGNIFICANCE
Human chorionic gonadotropin (hCG) is a glycoprotein hormone with two noncovalently bound subunits. The alpha subunit is similar to those of luteinizing hormone,
follicle-simulating hormone, and thyroid-stimulating hormone. The beta subunit of hCG
differs from the other pituitary glycoprotein hormones which results in its unique biochemical and immunological properties. hCG is synthesized by the placenta and is involved in maintaining the corpus luteum during pregnancy.
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In normal pregnancy, hCG can be detected as early as 6 days following conception with
concentrations doubling every 36 to 48 hours. For some patients, an hCG level of
25mIU/mL can be detected as early as two to three days before expected menses. By the
first day of missed menses, concentrations often exceed 100mlU/mL.
SPECIMEN REQUIREMENTS
 No special patient preparation is needed.
 Any voided urine collected in a clean container is suitable for testing. A preferred
specimen is a first morning urine, which contains the highest concentration of hCG.
 Specimens should be tested immediately. If necessary, specimens may be kept at room
temperature for 8 hours or stored at 2 to 8oC for up to 3 days. Do not freeze specimens.
REAGENTS AND MATERIALS SUPPLIED
Each CARDS Q.S. hCG Serum/Urine kit contains enough materials for 30 tests (Catalog
No. 0178) or 90 tests (Catalog No. 0179).
 Reaction Unit (30 or 90)
Each unit contains a murine monoclonal antibody and a caprine polyclonal antibody
to hCG.
 Disposable Dropper (30 or 90)
 Package insert (1)
MATERIALS REQUIRED BUT NOT PROVIDED
 Timer or watch that measures minutes and seconds
 Specimen collection containers
QUALITY CONTROL
External Quality Control Material
Quantametrix Control Urine Set Catalog #1440-04
Vendor: Quantametrix Corp. 10165 2005 Manhattan Beach Blvd., Redondo Beach, CA
90278
 Each kit contains one (1) Positive and one (1) Negative Human Urine Control
 The controls are liquid, ready to use, require no reconstitution or dilution
o
 The Urine Dipstick Controls should be stored at 2-8 C before initial use. When
stored at 2-8 oC, the controls are stable until the expiration date stated on the label.
 After initial use, Urine Dipstick Controls can be stored at room temperature. When
stored at room temperature (20-25 oC), the controls are stable for one month. Room
temperature expiration dating must be noted on the control bottle label.
External Controls: Process both Urine Dipstick controls as you would patient specimens. Record external QC results in the testing log.
Internal Quality Control
The CARDS Q.S hCG Serum/urine contains built-in control features. Document these
controls for each sample tested, on the testing log sheets.
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Internal Positive Procedural Control: A blue line in the Control Window is considered
an internal positive procedural control. If the test has been performed correctly and
the Reaction Unit is working properly, this indicator will appear.
 Internal Negative Procedural Control: A clear background in the Read Result Window is considered an internal negative procedural control. If the test has been performed correctly and the Reaction Unit is working properly the background will clear
to give a negative control result.
If the controls do not perform as expected, do not use the test results. Repeat the test or
contact Technical Assistance.

Performance of Quality Control
 Quality control must be performed at minimum:

Internal: With each test performed.

External: Once each day that tests are being performed. Kits are validated by the
RWJMS/UMG POCT program, but that validation does not substitute for external
QC being performed at the POCT site each day of testing.
 Record unit lot number and expiration date, control lot numbers and expiration date,
results and operator initials in the Result Log. New sheets are started at the beginning
of the month. The POCT site coordinator for this test must check that the log is being
filled out properly and sign off weekly. The site coordinator must send completed
logs (or a copy) to the RWJMS POCT coordinator or administrative office monthly.
 Any quality control failures require investigation of controls, reagent and technical
procedures. The problem must be corrected and documented on the testing log. The
external controls must be successfully run before reporting any patient results.
PROFICENY TESTING
The RWJMS Point of Care Testing program subscribes to the CAP Clinical Microscopy
Survey. Three challenges are sent per year, two samples per challenge. Unit personnel
will randomly be chosen to participate in the proficiency challenge.
TESTING PROCEDURE
1. Identify the patient (or quality control or proficiency test) sample.
2. Remove the Reaction Unit from the foil pouch and place on a clean, dry level surface
3. Write the name of the patient on the cassette with pen.
4. Don disposable gloves.
5. Using one of the disposable pipets supplied, add 4 drops of urine to the sample well.
The test unit should not be manipulated or jarred again until the assay is complete and
ready for interpretation. Shortly after the sample is added, a pink to purple color will
be seen moving across the Reaction Unit’s Windows. The Read Result Window contains a pre-printed horizontal blue line on the membrane.
6. Wait three minutes and read.
7. Record the results on the result log and on the patient’s chart.
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Interpretation
Positive
The appearance of any pink-to-blue plus + sign in the large square
Read Result window along with a blue procedural control line in the
small square Control Window.
Negative
The appearance of a blue minus sign – in the large square Read Result Window along with a blue line in the small square Control Window.
Invalid Result If no blue procedural control line appears in the small square Control
Window or background color in the large square Read Result Window. The test is invalid and the specimen must be retested with a
new cassette. THIS STILL NEEDS TO BE CLARIFIED.
EXPECTED VALUES:
Negative if the person is not pregnant. Positive if the person is pregnant.
PROCEDURAL NOTES
A specimen with a low level of hCG may show color development over time. If a negative result is obtained but pregnancy is suspected, a repeat specimen should be collected
after 48 to 72 hours and retested.
For assistance contact the following:
1. Your CRC clinical protocol coordinator,
2. Sponsor company,
3. Manufacturer’s Technical Assistance Line, at 800-874-1517, and
4. The RWJMS POCT coordinator or administrative office.
Record all contacts on the test log sheet.
LIMITATIONS OF THE PROCEDURE
The lower limit of detection of hCG in urine is 20mIU/ml.
No chemical or biological compounds were found to interfere in the assay. Elevated hCG
concentrations unrelated to pregnancy have been reported. Conditions other than normal
pregnancy may be associated with detectable hCG, including ectopic pregnancy or molar
pregnancy. hCG may remain detectable for a few days to several weeks after delivery,
abortion, or hCG injection.
REFERENCES
1. Recommendations for the Prevention of HIV Transmission in Health Care
Settings, Morbidity and Mortality Weekly Report, Centers for Disease Control, August 21, 1987.
2. Rasor, J.L. and Braunstein, G.D., Obstet. Gynecol., 50, 553-558 (1977).
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3. Edmonds, D.K., Lindsay, K.S., Miller, J.F., Williamson, E. and Wood, R.J.,
Fertility and Sterility, 38, 447-453 (1982).
4. Braunstein, G.D., Vaitukaitis, J.L., Carbone, P.P., and Ross, G.T., Ann. Intern. Med., 78, 39-45 (1973).
5. Lenton, E.A., Neal, L.M. and Sulaiman, R., Fertility and Sterility, 37, 773778 (1982).
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