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One Step Pregnancy Test Strip (Urine)
A rapid, one step test for the qualitative detection
of human chorionic gonadotropin (hCG) in urine. For professional
in vitro diagnostic use only.
Order at least 4 tests for
value pricing of $ 4.05 each 
INTENDED USE
The hCG One Step Pregnancy Test Strip (Urine) is a rapid chromatographic
immunoassay for the qualitative detection of human chorionic gonadotropin
(hCG) in urine to aid in the early detection of pregnancy.
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SUMMARY
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced
by the developing placenta shortly after fertilization. In normal
pregnancy, hCG can be detected in both urine and serum as early
as 7 to 10 days after conception (1-4). hCG levels continue to rise
very rapidly, frequently exceeding 100 mIU/mL by the first missed
menstrual period (2-4), and peaking in the 100,000-200,000 mIU/mL
range about 10-12 weeks into pregnancy. The appearance of hCG in
both urine and serum soon after conception, and its subsequent rapid
rise in concentration during early gestational growth, make it an
excellent marker for the early detection of pregnancy.
The hCG One Step Pregnancy Test Strip (Urine) is a rapid test
that qualitatively detects the presence of hCG in urine specimen
at the sensitivity of 25 mIU/mL. The test utilizes a combination
of monoclonal and polyclonal antibodies to selectively detect elevated
levels of hCG in urine. At the level of claimed sensitivity, the
hCG One Step Pregnancy Test Strip (Urine) shows no cross-reactivity
interference from the structurally related glycoprotein hormones
hFSH, hLH and hTSH at high physiological levels.
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TEST PRINCIPLE
The hCG One Step Pregnancy Test Strip (Urine) is a rapid chromatographic
immunoassay for the qualitative detection of human chorionic gonadotropin
(hCG) in urine to aid in the early detection of pregnancy. The test
utilizes a combination of antibodies including a monoclonal hCG
antibody to selectively detect elevated levels of hCG. The assay
is conducted by immersing the test strip in a urine specimen and
observing the formation of colored lines. The specimen migrates
via capillary action along the membrane to react with the colored
conjugate.
Positive specimens react with the specific antibody-hCGcolored
conjugate to 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 procedural control, a colored line will always appear
at the control line region if the test has been performed properly.
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STORAGE AND STABILITY
Store as packaged in the sealed pouch at 4-30°C. The test strip
is stable through the expiration date printed on the sealed pouch.
The test strip must remain in the sealed pouch until use. DO NOT
FREEZE. Do not use beyond the expiration date.
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PRECAUTIONS
• For professional in vitro diagnostic use only. Do not use
after the expiration date.
• The test strip should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous
and handled in the same manner as an infectious agent.
• The test strip should be discarded in a proper biohazard
container after testing.
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REAGENTS AND MATERIALS SUPPLIED
• Test strips
• Package insert
Positive specimens react with the specific antibody-hCGcolored conjugate
to 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 procedural control, a colored line will always appear at the
control line region if the test has been performed properly.
REAGENTS
The test strip contains anti-hCG particles and anti-hCG coated on
the membrane.
Materials Required But Not Provided
• Specimen collection container
• Timer
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SPECIMEN COLLECTION AND HANDLING
Urine Assay
A urine specimen must be collected in a clean and dry container.
A first morning urine specimen is preferred since it generally contains
the highest concentration of hCG; however, urine specimens collected
at any time of the day may be used. Urine specimens exhibiting visible
precipitates should be centrifuged, filtered, or allowed to settle
to obtain a clear specimen for testing.
Note: A low hCG concentration might result in a weak line appearing
in the test region (T) after an extended period of time; therefore,
do not interpret the result after 10 minutes.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 48 hours prior
to testing. For prolonged storage, specimens may be frozen and stored
below -20°C. Frozen specimens should be thawed and mixed before
testing.
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TEST PROCEDURE
Allow the test strip, urine specimen and/or controls to equilibrate
to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test strip from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the urine specimen, immerse the test
strip vertically in the urine specimen for at least 5 seconds. Do
not pass the maximum line (MAX) on the test strip when immersing
the strip. See the illustration below.
3. Place the test strip on a non-absorbent flat surface, start
the timer and wait for the red line(s) to appear. The result should
be read at 3 minutes. It is important that the background is clear
before the result is read.
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INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: Two distinct red lines appear. One line should be in the
control region (C) and another line should be in the test region
(T).
NEGATIVE: One red line appears in the control region (C). No apparent
red or pink line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test strip. If the problem persists, discontinue using the
test kit immediately and contact your local distributor.
NOTE: The intensity of the red color in the test line region (T)
will vary depending on the concentration of hCG present in the specimen.
However, neither the quantitative value nor the rate of increase
in hCG can be determined by this qualitative test.
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QUALITY CONTROL
Internal procedural controls are included in the test. A red line
appearing in the control region (C) is the internal procedural control.
It confirms sufficient specimen volume and correct procedural technique.
A clear background is an internal negative background control. If
the test is working properly, the background in the result area
should be white to light pink and not interfere with the ability
to read the test result.
It is recommended that a positive hCG control (containing 25-250
mIU/mL hCG) and a negative hCG control (containing "0"
mIU/mL hCG) be evaluated to verify proper test performance when
a new shipment of test strips is received.
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LIMITATIONS
1. Very dilute urine specimens, as indicated by a low specific
gravity, may not contain representative levels of hCG. If pregnancy
is still suspected, a first morning
urine specimen should be collected 48 hours later and tested.
2. 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 tested.
3. Very low levels of hCG (less than 50 mIU/mL) are present in
urine specimen shortly after implantation. However, because a significant
number of first trimester pregnancies terminate for natural reasons
(5), a test result that is weakly positive should be confirmed by
retesting with a first morning urine specimen collected 48 hours
later.
4. A number of conditions other than pregnancy, including trophoblastic
disease and certain nontrophoblastic neoplasms including testicular
tumors, prostate cancer, breast cancer, and lung cancer, cause elevated
levels of hCG (6-7). Therefore, the presence of Interfering hCG
in urine should not be used to diagnose pregnancy unless these conditions
have been ruled out.
Substances
The following potentially interfering substances were added to hCG
negative and positive specimens:.
Acetaminophen 20 mg/mL, Acetylsalicylic Acid
20 mg/mL Gentisic Acid 20 mg/mL, 20 mg/mL Ascorbic Acid, 20 mg/mL
Atropine , Bilirubin 2 mg/dL, 20 mg/mL Caffeine, Glucose 2 g/dL
Hemoglobin 1 mg/dL
5. This test provides a presumptive diagnosis for pregnancy. A
confirmed pregnancy diagnosis should only be made by a physician
after all clinical and laboratory findings have been evaluated.
None of the substances at the concentration tested interfered in
the assay.
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EXPECTED RESULTS
Negative results are expected in healthy non-pregnant women and
healthy men. Healthy pregnant women have hCG present in their urine
and serum specimens. The amount of hCG will vary greatly with gestational
age and between individuals.
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PERFORMANCE CHARACTERISTICS
Accuracy
A multi-center clinical evaluation was conducted comparing the results
obtained using the hCG One Step Pregnancy Test Strip (Urine) to
another commercially available urine membrane hCG test. The study
included 150 urine specimens: both assays identified 72 negative
and 78 positive results. The results demonstrated 100% overall agreement
(for an accuracy of > 99%) of the hCG Pregnancy Test Strip (Urine)
when compared to the other urine membrane hCG test.
Sensitivity and Specificity
The hCG One Step Pregnancy Test Strip (Urine) detects hCG at a concentration
of 25 mIU/mL or greater. The test has been standardized to the W.H.O.
Third International Standard. The addition of LH (300 mIU/mL), FSH
(1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mL
hCG) and positive (25 mIU/mL hCG) specimens showed no cross-reactivity.
Reference hCG Method
------------------------------------------ Positive ----
Negative
One Step Method Positive
78
0
Negaitive 0
72
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