OneStep hCG Strip Test;
Atlas Link
InstaStrip hCG
OneStep hCG Pregnancy Test
Catalog No. 113043 - 3mm
Catalog No. 113044 - 4mm
Catalog No. 113045 - 5mm
InstaStrip OneStep hCG Pregnancy Test
For the rapid determination of human chorionic gonadotropin (hCG)
in urine. The test strip is used to obtain a visual qualitative result.
protein matrix with a 0.1% sodium azide.
STORAGE AND STABILITY
OneStep test strip can be stored at room temperature (below 25°C)
and stable until expiration date on the label. Do not store the test strip
at hot room temperature (30 - 45°C) for a long period of time.
PRECAUTIONS
1.
2.
For In Vitro diagnostic use only.
Warning: the reagents in this kit contain sodium azide which may react
with lead or copper plumbing to form potentially
explosive metal azides. When disposing of such reagents, always flush
with large volumes of water to prevent azide build-up.
INTRODUCTION
Human chorionic gonadotropin (hCG) is a glycoprotein hormone
secreted by the developing placenta shortly after fertilization. In
normal pregnancy, hCG can be detected in serum as early as 7 days
following conception1-2, doubling every 1.3 to 2 days and reading
100 mlU/ml at the first missed menstrual period.3 The appearance of
hCG soon after conception and its subsequent rise in concentration
during early gestational growth make it an excellent marker for the
early detection of pregnancy.
OneStep Dipstick Pregnancy Test is a qualitative, sandwich dye
conjugate immunoassay for the determination of human hCG in
urine.4,5 The method employs a unique combination of monoclonal
and polyclonal antibodies to selectively identify hCG in test samples
with a high degree of sensitivity. In less than 5 minutes, elevated
levels of hCG as low as 25 mlU/mL can be detected.
SPECIMEN COLLECTION
The urine specimen must be collected in a clean dry container either
plastic or glass, without preservative. Specimens collected at any
time may be used, however the first morning urine generally contains
the highest concentration of hormone.
Urine specimens may be refrigerated (2 - 8°C) and stored up to 72
hours prior to assay. If samples are refrigerated, they must be
equilibrated to room temperature before testing. Urine samples
exhibiting visible precipitates should be filtered, centrifuged, or
allowed to settle and clear aliquots obtained for testing.
MATERIAL REQUIRED BUT NOT
PROVIDED
PRINCIPLE
Specimen collection containers. Clock or timer.
As the test sample diffuses through the absorbent test strip, 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 positive reaction zone and produces a pink-rose
color band when hCG concentration is greater than 25 mlU/mL. In
the absence of hCG, there is no line in the positive reaction zone. The
reaction mixture continues flowing through the absorbent device past
the positive reaction zone and negative zone. Unbound conjugate
binds to the reagents in the negative control zone, producing a pinkrose color band, demonstrating that the reagents and test strip are
functioning correctly.
ASSAY PROCEDURE
1. Remove the test strip from its foil wrapper by
tearing along the "splice".
2. Fill a test tube or a urine cup with urine sample
and hold the strip in a vertical position. The urine
level should not be higher than the "max level"
indicated on the strip.
3. Place the test strip into the tube or container
containing the sample. The strip must be placed in
the tube or container so that the words "dip" and
"read" are in an upright position.
4. Read results after 5 minutes.
REAGENTS
OneStep Pregnancy Test Strip:
Test strip contains polyclonal antibody coated membrane and a pad
contains mouse monoclonal IgG (antibody) dye conjugate in protein
matrix with 0.1% sodium azide.
INTERPRETATION OF RESULTS
MATERIALS SUPPLIED
Test strip:
The test strip contains polyclonal anti hCG coated membrane and a
pad contains the monoclonal antibody (anti-hCG) dye conjugate in
1.
2.
In 5 minutes, a color band will appear closest to the top
indicating that the test is complete.(single color band).
The closest band to the bottom shows the test results. If
there is any color band close to the bottom (two color
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, info@atlaslink-inc.com
OneStep hCG Test
bands), you are pregnant. If there is no color band, or single
colorband to the top you are not pregnant.
A study was performed using urine specimens from 20
postmenopausal women. These specimens were chosen because urine
from postmenopausal women frequently interferes with pregnancy
tests due to cross reactivity with other gonadotropin hormones. All 20
urine specimens were negative when tested with OneStep hCG Strip.
Potentially interfering substances were added to urine which had
hCG levels of 0 and 25 mIU/mL. In each case, no interference with
the expected OneStep Dipstick Pregnancy Test results were observed.
Standardization
The OneStep hCG Strip has been standardized to World Health
Organization First International Reference Preparation (IRP 75-537).
Accuracy
QUALITY CONTROL
Each test strip has its own built-in quality control indicator. If after
performing the test and no line is visible on test strip, you may have
placed the strip into the tube or container incorrectly or the test strip
may have deteriorated. Repeat the assay using a new strip.
AFTER TESTING
Flush the remaining urine sample down the toilet. Discard
remaining components in the waste.
PERFORMANCE CHARACTERISTICS
Sensitivity and specificity
OneStep hCG Pregnancy Test detects Urinary hCG concentrations
greater than 25 mIU/ml as indicated by the development of two lines
on the test strip.
Urine from healthy men and non-pregnant women will normally
show undetectable levels of hCG when tested on OneStep Dipstick
Pregnancy Test. The test will yield a positive result on the first day of
missed menstrual period.
Specificity of the OneStep Strip was determined from cross reaction
studies with known amounts of Luteinizing Hormone (hLH), Follicle
Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone
(hTSH), 500 mlU/ml hLH, 1000 mIU/ml hFSH and 1000 mlU/ml
hTSH. All gave negative results.
Menopausal Urines:
A study was performed using a total of 150 positive and negative
urine specimens. These specimens were assayed with OneStep hCG
Strip and our Visual Pregnancy Test and it showed identical results.
Interference Testing:
The following substances were added in hCG free and 25 mlU/ml
hCG spiked urine samples. None of the substances at concentration
tested interfered in the assay.
Acetaminophen
Acetylsalicylic Acid
Ascorbic Acid
Atropine
20 mg/dl
20 mg/dl
20 mg/dl
20 mg/dl
Caffeine
20 mg/dl
Gentesic Acid 20 mg/dl
Glucose
2 g/dl
Hemoglobin
1 mg/dl
REFERENCES:
1. Catt, K.J., Dufan, M.L., and Vaitukaitis, J.L., J.
Clin.Endocrinol. Metab., Vol. 40, 537, (1975).
2. Lenton, E.A., Neal, L.M., Sulaiman, R., Fertility & Sterility,
Vol. 37, 773, (1982).
3. Batzer, F.R., Fertility & Sterility, Vol. 34, 1, (1980).
4. Engvall, E., Method in Enzymology, Vol. 70,
pp. 419-439, (1980).
5. Uotila, M., Ruoslahti, E., and Engvall, E., .J. Immunol.
Methods. Vol. 42, 11, (1981).
6. Dawood, M.Y., Saxeba, B.B., and Landesman,
R., Ob. Gyn., Vol. 126, 678, (1976).
Date Revised 12/97
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, info@atlaslink-inc.com