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INSTRUCTIONS: PREGNANCY TESTS: hCG Pregnancy Test Cassette
One Step dBest Pregnancy Test Strip
For Urine (Revised Jan. 30th, 2001)
Intended Use The dBest One Step hCG Urine Test is an immunoassay designed
for the qualitative determination of the human chorionic gonadotropin (hCG)
in urine for the early detection of pregnancy.Summary and Explanation of
the Test Human chorionic gonadotropin (hCG) is a glycopeptide hormone
produced by the placenta during pregnancy. The appearance and rapid
increase in the concentration of hCG in the mother urine makes it a good
marker for confirming pregnancy. The concentration of hCG in urine
increases steadily to a circulation peak of as much as 50,000 mIU/ml
between the eighth and eleventh weeks (1,2,3).
The dBest One Step hCG
Urine Test is a chromatographic immunoassay which uses specific antibodies
to selectively identify hCG in urine with a high degree of sensitivity.
Elevated levels of hCG as low as 20 mIU/ml can be detected within 3
Principles of the Test Urine is added to the test kit and allowed to
migrate through the absorbent device. The labeled antibody-dye conjugate
binds to the hCG in the specimen forming an antibody-antigen complex. This
complex binds to the anti-hCG antibody in the test zone and produces a
purple color band when the hCG concentration is equal to or greater than
20 mIU/ml. In the absence of hCG, no band is formed in the test zone. The
reaction mixture continues flowing through the absorbent device past the
test and control zones. Unbound conjugate binds to the reagents in the
control zone, producing a purple color band, demonstrating that the
reagents and the test kit are functioning correctly.
Reagents Used The test kit contains combination of goat/rabbit polyclonal
antibodies and mouse monoclonal antibodies in a protein buffer containing
Precautions (1) For in vitro diagnostic use only. (2) Do not use after the
expiration date imprinted on the test kit package. (3) Dispose of all
reaction devices in a proper biohazard container. (4) Patient specimens
may contain infectious agents and should be handled as potential
Test Kit Storage The test kit may be stored at room temperature 4-30oC
(40-86oF) for up to 18 months or until the expiration date. Optional
Liquid control reagents may have different storage requirements. Refer to
individual components for their specific requirements.
Urine Collection and Storage (1) First morning urine typically contains
the highest concentration of hCG and is therefore the best sample for
performing the urine test. However, any urine specimen may be used. (2)
Collect the urine specimen in a clean glass or plastic container. Do not
use preservatives. (3) If the specimen is not used immediately following
collection, but is to be used within 48 hours it should be refrigerated (2
to 8 oC), and brought back to room temperature (4 to 30 oC) before
testing. If the specimen is not going to be used for more than 48 hours,
it should be frozen at -20 degrees C. A frozen specimen should not be used
if stored longer than 2 weeks. Prior to testing, the frozen specimen must
be completely thawed, thoroughly mixed, and brought to room temperature.
Assay Procedure 1. Remove the test strip from its foil pouch. 2. Holding
the strip vertically, carefully dip it into the specimen. Do not immerse
the strip past the maximum line (Figure 1). 3. The strip can be removed
from the specimen when red-dye begins to migrate through the Result
Window. Interpret test results at 3 minutes. Do not interpret test results
after 3 minutes.
Interpretation of Results (1) NEGATIVE: If there is only one purple color
band in the result window, this indicates that the specimen does not
contain a detectable level of hCG and should be interpreted as a negative
result (Figure 2).
(2) POSITIVE: If there are two purple color bands in the result window,
this indicates that the specimen contains hCG and should be interpreted as
positive result (Figure 2).
(3) INVALID: If there is no purple color band in the result window, the
test result is invalid. The control band will not appear if an
insufficient volume of specimen is added into the test kit. Proper
procedures may not have been followed in performing the test or
deterioration of the test kit may have occurred. Repeat the test procedure
using a new test kit.
Note: The instructions provided must be strictly followed in order to
achieve optimal test reactivity with the urine specimens.
Limitations of the Procedure 1. The dBest Urine hCG Pregnancy Test is for
in vitro diagnostic use only. 2. In addition to pregnancy, hCG has been
found in patients with both gestation and non-gestation trophoblastic
diseases. These conditions should be ruled out when interpreting hCG
levels to establish a pregnancy diagnosis. 3. Although the test is very
accurate in detecting pregnancy a low incidence of false results can
occur. Other clinically available tests are required if questionable
results are obtained. Consult with a physician if unexpected or
inconsistent results are obtained. 4. A normal pregnancy cannot be
distinguished from an ectopic pregnancy based solely on hCG levels. Also,
a spontaneous miscarriage may cause confusion in interpreting test
results. 5. As with all diagnostic tests, a definitive clinical diagnosis
should not be based on the results of a single test, but should only be
made by the physician after all clinical and laboratory findings have been
evaluated. 6. A negative result obtained from a urine specimen collected
from a mother in very early pregnancy may be due to an extremely low
concentration of hCG. In such cases, the test should be repeated on a
fresh specimen obtained two days later. 7. If a urine sample is too dilute
(i.e. low specific gravity), it may not contain a representative urinary
hCG concentration. If a negative result is obtained with a low specific
gravity specimen and pregnancy is still suspected, obtain a first morning
urine specimen and retest.
Expected Normal Values Urine hCG levels during pregnancy are estimated to
1. 10-30 mIU/ml 7-10 days post conception. 2. 37,000-50,000 mIU/ml 8-11
weeks after last menstrual period. 3. <5 mIU/ml Healthy men or
Standardization The dBest Pregnancy Urine Test will detect hCG
concentrations of 20 mIU/ml or greater (referenced to the World Health
Organization First International Standard).
Performance Characteristics Sensitivity The dBest Pregnancy Urine Test
will detect hCG in urine at concentrations of 20 mlU/ml or greater. This
sensitivity level has been confirmed with internal hCG standards in urine,
calibrated against the World Health Organization First International
Specificity The ability of the dBest Urine hCG Pregnancy Test to
specifically detect hCG was challenged through cross-reaction studies on
urine samples containing known quantities of structurally and
physiologically related hormones. Urine samples spiked with 500mIU/ml LH
(human Luteinizing Hormone), 1000 mIU/ml FSH (Follicle Stimulating
Hormone) and 1000 mIU/ml TSH (Thyroid Stimulating Hormone) show negative
Interference Data Potentially interfering drugs, protein and glucose were
supplemented to normal urine specimens devoid of hCG. Baseline urine
level, as well as 20 mIU/ml hCG standards were then analyzed and compared
with all samples containing a specific concentration of an interfering
Substances Acetaminophen, 20 mg/dl Acetylsalicylic acid, 20 mg/dl Ascorbic
acid, 20 mg/dl Atropine, 20 mg/dl Caffeine, 20 mg/dl Gentistic acid, 20
mg/dl Glucose, 2000 mg/dl Hemoglobin, 500 mg/dl Mestranol, 3 mg/dl
Penicillin, 40,000 U/dl Tetracycline, 20 mg/dl
Conclusion: All of the above substances have no interference with the
results of the “dBest” urine test kits.
Accuracy The dBest hCG Urine test compared with a commercially available
urine tests (Table).
A commercial hCG urine test Negative Positive Total dBest Negative 50 0 50
urine Positive 0 50 50 test Total 50 50 100
The conclusion is the dBest hCG Urine strip format is comparable with a
commercially available hCG urine test.
References 1. E.A. Lenton, LM. Neal, and Sulaiman. R. Fertil, Steril.,
Vol. 37 (1982), p773. 2. E. F. Batzer. Fertil, Steril., Vol. 34 (1980),
p1. 3. N. W. Tietz. Clinical Guide to Lab. Tests, 2nd ed., p128, 1990.
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