Urine hCG Testing
Document #9/version #05
Effective Date: 05/25/04
URINE HCG TESTING
Purpose
Consult™ Diagnostics card pregnancy test is a rapid chromatographic
immunoassay for the qualitative detection of human chorionic
gonadotropic (hCG) in urine to aid in the early detection of pregnancy.
Principle
Human chorionic gonadotropic (hCG) is a glycoprotein hormone produced
by the developing placenta shortly after fertilization. In normal
pregnancy, hCG can be detected as early as 7 to 10 days after conception.
The test utilizes a combination of monoclonal and polyclonal antibody
reagents to selectively detect elevated levels of hCG. The assay is
conducted dispensing urine specimen onto test card and observing the
formation of colored lines in the result area. The specimen migrates via
capillary action along the membrane and reacts with the colored
conjugate. Positive hCG specimens react with the specific antibody –hCG
– colored conjugate and form a colored line at the test line region of the
membrane. Absence of this colored line suggests a negative result. To
serve as a positive procedural control, a colored line in the control line
region will always appear regardless of the presence or absence of hCG.
Sample
Urine specimens must be collected in a clean, dry container, without
preservatives. Specimens collected at any time may be used. However,
the first morning urine generally contains the highest concentration of
hCG and is therefore the most suitable. If testing is to be delayed more
than a few hours, the urine can be stored at 2-8ºC for up to 48 hours or
frozen (-20ºC) but must be brought to room temperature prior to testing.
DO NOT USE SERUM.
Materials
Equipment
 NA
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
Quality
Control
Reagents
Consult Diagnostics
Hcg test card
Positive and negative
control material
Supplies
 Timer or watch
 PPE
Internal Controls  A positive procedural control is built into the test card. A red control
line will always appear if the test is performed correctly and if the strip
is working properly. An absence of this control line indicates incorrect
procedure or deterioration of the strip.
 A clear background is a negative procedural control. If background
color appears in the result area which interferes with the ability to read
the test results, the result may be invalid.
 If control line fails to appear with a repeat assay, do not report patient
result.
Columbus County Health Department Laboratory, Whiteville NC 28472
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Urine hCG Testing
Document #9/version #05
Effective Date: 05/25/04
External Controls - External Controls are tested with each week of patient
testing and each new test kit. Test controls the same as patients. Kova
Trol 1 and 3 QC materials are used. Control results are logged onto the
hCG QC logsheet. If controls do not react appropriately, repeat the
assay(s). If still unacceptable, new QC should be used. If not acceptable,
a new lot number of test devices should be used if available.
Test
Procedure
Step
1
2
3
4
5
Action
Bring specimen to room temperature if needed.
Remove the test device from the sealed pouch and use as soon
as possible.
Squeeze the bulb of the pipette and draw up enough sample in
pipette to dispense three full drops of urine into the round well
marked by an S.
Place the test card on a non-absorbent flat surface. Set timer
for 3 minutes.
Read at 3 MINUTES.
Interpretation
If there is
One red line in the control
region and no apparent red or
pink line in the test region.
Two distinct red lines appear,
one in the control region and
one in the test region.
No red line appears in the
control region.
Then
 Record result as negative.
 Record result as positive.
 Test is invalid.
 Repeat test using a new test.
Result Reporting
Log all results on the lab log and enter results onto EMR.
Expected
Values
There are no critical values or panic values.
Limitations

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Do not interpret results after 5 minutes. Positive test results may be
interpreted as soon as color develops on the test band and control
band.
False negative results may occur when the levels of hCG are below the
sensitivity level of the test. When pregnancy is still suspected, a first
morning urine specimen should be collected 48 hours later and
retested.
Very low levels of hCG (less than 50 mIU/mL) are present in urine
specimens shortly after implantation. However, because a significant
Columbus County Health Department Laboratory, Whiteville NC 28472
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Urine hCG Testing
Document #9/version #05
Effective Date: 05/25/04
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References
number of first trimester pregnancies terminate for natural reasons, a
test result that is weekly positive should be confirmed by retesting
with a first morning specimen collected 48 hours later.
A number or conditions other than pregnancy, including trophoblastic
disease and non-trophoblastic neoplasms including testicular tumors,
prostate cancer, breast cancer, and lung cancer, cause elevated levels
of hCG. Therefore, the presence of hCG in urine should not be used to
diagnose pregnancy unless these conditions have been ruled out.
This test provides a presumptive diagnosis for pregnancy. A
confirmed diagnosis should only be made by a physician after all
clinical and laboratory findings have been evaluated.

Manufacturer’s package insert for Consult™ Diagnostics Urine Hcg
Detector.
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Document #1. Urine Collection Procedure.
Policy #2. Specimen Rejection Policy.
Policy #14, EMR Policy.
Related Documents
Author
Karen H. Wall, BSMT (ASCP), Technical Consultant
Approval
Signature
_____________________________
Name
Columbus County Health Department Laboratory, Whiteville NC 28472
_____________
Date
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