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One-Step Pregnancy Test
Device (Urine)
Package Insert
(Catalog Number: APT-121)
A rapid, sensitive, One-Step test for the qualitative detection
of human chorionic gonadotropin (hCG) in urine. For professional
in vitro diagnostic use only.
INTENDED USE
The AZOG hCG One-Step Pregnancy Test Device (Urine) is a rapid and
sensitive chromatographic immunoassay for the qualitative detection
of human chorionic gonadotropin (hCG) in urine for the early detection
of pregnancy.
SUMMARY
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced
by the developing placenta shortly after implantation. In normal
pregnancy, hCG can be detected in both urine and serum as early
as 7 to 10 days following conception (1-4). hCG levels continue
to increase rapidly during pregnancy and normally reach levels in
excess of 100,000 mIU/mL during the first trimester (2-4). The appearance
of hCG in both urine and serum soon after conception, and subsequent
rapid increase in concentration during early stages of pregnancy,
make it an excellent marker for the early detection of pregnancy.
The AZOG hCG One-Step Pregnancy Test Device (Urine) is a rapid test
that qualitatively detects the presence of hCG in urine specimen
at the level of 25 mIU/mL or greater. The test uses a combination
of monoclonal and polyclonal antibodies in a novel single-step technology
to accurately detect elevated levels of hCG in urine. At the level
of claimed sensitivity, structurally related glycoprotein hormones
hFSH, hLH and hTSH were tested in the AZOG hCG One-Step Pregnancy
Test Device (Urine) at levels ranging from 1,000 mIU/mL to 1,000
mIU/mL and no cross-reactivity interference was observed.
PRINCIPLE
The AZOG hCG One-Step Pregnancy Test Device (Urine) is a rapid and
sensitive chromatographic immunoassay for the qualitative detection
of human chorionic gonadotropin (hCG) in urine for the early detection
of pregnancy. The test uses a specific, monoclonal hCG antibody
to accurately detect hCG. The assay is conducted by briefly dipping
the test Device in a urine specimen and observing the formation
of colored lines. The specimen migrates by capillary action along
the membrane to react with the colored conjugate.
Positive specimens react with the specific anti-hCG-colored conjugate
to form a reddish line at the test line region (T) of the membrane.
Absence of this reddish line suggests a negative result. To assure
reagent integrity as well as correct testing procedures, a reddish
line will always appear at the control line region (C).
REAGENTS
The test Device contains gold-colloid anti-hCG conjugate and goat
polyclonal anti-hCG coated on the membrane.
PRECAUTIONS ·
Kit contents are for professional in vitro diagnostic use only.
Do not use kit contents after the expiration date.
· Do not remove test Device from pouch until ready to perform test.
· Use caution in handling patient specimens.
· Dispose of all components in proper biohazard container after
testing.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at
15-30°C, out of direct sunlight. DO NOT FREEZE.
The test Device is stable until the expiration date printed on the
sealed pouch.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
Collect urine specimen in a clean and dry container. First morning
urine specimen generally contains the highest concentration of hCG;
however, urine specimens collected at any time of the day may be
used in the test. Turbid urine specimens should be clarified by
centrifugation, filtration, or by allowing particulates to settle
out.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 72 hours prior
to testing. For longer storage, specimens may be frozen at -20°C.
Frozen specimens should be thawed and mixed before testing.
PROCEDURE
Materials Provided · Test Devices in desiccated pouches
· Disposable specimen droppers
· Package insert Materials Required But Not Provided · Specimen
collection container
· Timer
DIRECTIONS FOR USE
Allow the test Device, urine specimen and/or
controls to equilibrate at room temperature (15-30°C) before testing.
1. Open sealed pouch at notch. Remove the test device and use it
as soon as possible.
2. Place the test device on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 100ml)
to the specimen well (S) of the test device, and then start the
timer. Avoid trapping air bubbles in the specimen well (S). See
the illustration below.
3. Wait for the red line(s) to appear. Read results at 3 minutes.
It is important that the background is clear before the result is
read.
Note: A specimen with 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.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: The appearance of
a reddish Test Line and a reddish Control Line.
NEGATIVE: The appearance of a reddish Control Line
only.
INVALID: Control line fails to appear. The most
likely reasons for control line failure are insufficient specimen
volume or incorrect procedural techniques. Review the procedure and
repeat the test with a new test Device. 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.
QUALITY CONTROL
The test contains built-in control features. A reddish line appearing
in the control region (C) indicates that sufficient specimen volume
was absorbed and capillary flow occurred. A clear background is also
required. Good laboratory practice recommends the use of external
controls to assure that the assay is performing properly.
LIMITATION
1. Very dilute urine specimens (indicated by a low specific gravity),
may not contain representative levels of hCG. When 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,
first morning urine should be collected 48 hours later and tested.
3. In general, hCG level of 50 mIU/mL is present in urine specimen
shortly after implantation. However, because a significant number
of first trimester pregnancies terminate naturally (5), a test result
that is weakly positive should be confirmed by retesting with a first
morning urine specimen collected 48 hours later.
4. Conditions other than normal pregnancy, including, for example,
trophoblastic disease and certain non-trophoblastic neoplasms including
testicular tumors, prostate cancer, breast cancer, and lung cancer,
cause elevated levels of hCG (6-7). These conditions should be ruled
out when diagnosing pregnancy.
5. This test provides a presumptive diagnosis for pregnancy. Test
results must always be evaluated with other data available to the
physician.
EXPECTED VALUES
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.
The AZOG hCG One-Step Pregnancy Test Device (Urine) has a sensitivity
of 25 mIU/mL, and is capable of detecting pregnancy by the first day
of missed menses.
PERFORMANCE CHARACTERISTICS
Accuracy
A clinical evaluation was conducted comparing the results obtained
using the AZOG hCG One-Step Pregnancy Test Device (Urine) to another
commercially available urine membrane hCG test. The study included
150 urine specimens and both assays identified 76 negative and 74
positive results. The AZOG hCG Pregnancy Test Device (Urine) demonstrated
100% concordance (for an accuracy of > 99%) with the other commercially
available urine membrane hCG test.
Reference hCG Method
|
|
Positive |
Negative |
|
AZOG |
Positive |
74 |
0 |
|
Method |
Negative |
0 |
76 |
Sensitivity and Specificity
The AZOG hCG One-Step Pregnancy Test
Device (Urine) detects hCG at a concentration of 25 mIU/mL and greater.
The test has been standardized to the W.H.O. Third International Standard.
The addition of LH (1000 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000
mIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) urine
showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances
were added to hCG negative and positive specimens.
|
Acetaminophen |
20 mg/mL |
Ethanol |
1% |
|
Acetylsalicylic Acid |
20 mg/mL |
EDTA |
80 mg/dL |
|
Albumin (human) |
2 g/dL |
Ephedrine |
20 mg/dL |
|
Ascorbic Acid |
20 mg/mL |
Gentisic Acid |
20 mg/mL |
|
Atropine |
20 mg/mL |
Glucose |
2 g/dL |
|
Bilirubin |
2 mg/dL |
Hemoglobin |
1 mg/dL |
|
Caffeine |
20 mg/mL |
Pregnanediol |
1.5 mg/dL |
|
Estriol |
17-Beta 1.4 mg/dL |
Salicylic Acid |
20 mg/dL |
None of the substances at the concentration
tested interfered in the assay.
BIBLIOGRAPHY
1. Batzer FR. “Hormonal evaluation of early pregnancy”, Fertil. Steril.
1980; 34(1): 1-13
2. Catt KJ, ML Dufau, JL Vaitukaitis “Appearance of hCG in pregnancy
plasma following the initiation of implantation of the blastocyte”,
J. Clin. Endocrinol. Metab. 1975; 40(3): 537-540
3. Braunstein GD, J Rasor, H. Danzer, D Adler, ME Wade “Serum human
chorionic gonadotropin levels throughout normal pregnancy”, Am. J.
Obstet. Gynecol. 1976; 126(6): 678-681
4. Lenton EA, LM Neal, R Sulaiman “Plasma concentration of human chorionic
gonadotropin from the time of implantation until the second week of
pregnancy”, Fertil. Steril. 1982; 37(6): 773-778
5. Steier JA, P Bergsjo, OL Myking “Human chorionic gonadotropin in
maternal plasma after induced abortion, spontaneous abortion and removed
ectopic pregnancy”, Obstet. Gynecol. 1984; 64(3): 391-394
6. Dawood MY, BB Saxena, R Landesman “Human chorionic gonadotropin
and its subunits in hydatidiform mole and choriocarcinoma”, Obstet.
Gynecol. 1977; 50(2): 172-181
7. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopic production
of human chorionic gonadotropin by neoplasms”, Ann. Intern Med. 1973;
78(1): 39-45 |
