Mouse monoclonal antibodies and polyclonal antibody on INTENDED USE colloidal gold particle. WH Accu TestTM PregnancyTest is a self-performing Material Provided:
immunoassay designed for the qualitative determination of
human chorionic gonadotropin (hCG) urine for early
Each WH Accu TestTM PregnancyTest strip individually WH ACCU TEST TM SUMMARY AND EXPLANATION One Step Pregnancy Test Strip Package Insert
Human chorionic gonadortoin (hCG) is a glycoprotein
Timer, sample container and disposable gloves.
hormone secreted by the developing placenta shortly after
No other equipment or reagents are needed.
fertilization. During normal pregnancy, hCG can be detected
in urine as early as 7 days following conception, doubling
every 1.3 to 2 days. At the time of the last missed menstrual
For Professional and In Vitro Diagnostic Use Only
STORAGE AND STABILITY
period, urine hCG levels of 100,000 to 200,000 mIU/ml seen
at the end of the first trimester. The presence of hCG soon
Self-performing Iimmunoassay for Qualitative Detection of
Store test strip at 4oC -30oC. The test strip is stable until the
after conception during early gestational growth make it an
Human Chorionic Gonadotropin (hCG) in Human Urine
ideal marker for the early gestational growth make it an ideal
marker for the early detection of pregnancy.
NOTE AND PRECAUTION PRINCIPLE
The test is intended for IN VITRO DIAGNOSTICS
The WH Accu TestTM PregnancyTest is rapid qualitative
Read directions for use carefully before performing this
one step assay for the detection of hCG in urine. The method
employs a unique combination of monoclonal dye conjugate
Do not use the test beyond the expiration date indicated
and polyclonal-solid phase antibodies phase antibodies to
selectively identify the hCG in the test samples with an
extremely high degree of sensitivity. In less than 5 minutes,
level of hCG as low as 25mIU/ml can be detected.
URINE SPECIMEN COLLECTION AND
As the test sample flows through the absorbent device, the
labeled antibody-dye conjugate binds to the hCG forming an
antibody-antigen complex. This complex binds to anti-hCG
For optional detection of early pregnancy, a first morning
antibody in the positive reaction zone (“T” area) and
urine specimen is preferred since it contains the highest
produces a pink-purple colored band when the hCG
concentration of hCG. However, randomly collected urine
concentration is greater than 25mIU/ml. In the absence of
specimens may be used. Collect the urine specimen in a
hCG, there is no line in the positive reaction zone. Unbound
clean container with preservatives. If testing is not immediate,
conjugate binds to the reagents in the control zone (“C” area),
the specimen should be stored refrigerated at 2-8oC for 24
producing a pink-purple band, demonstrating the reagents are
hours. In such cases bring the sample to room temperature
prior to testing. If testing is delayed more than 24 hours the
specimen is stable for 48 hours and should be thawed,
brought to room temperature and thoroughly mixed before
testing. Avoid repeated thawing and freezing.
REAGENTS NOTE: Handle all specimens for testing as if potentially
One hCG pregnancy test strip per foil pouch.
infectious. Proper precautions in handling should be
maintained according to good laboratory practice.
Ingredients: contains a combination of mouse monoclonal antibodies and polyclonal antibodies (sheep directed against human hemoglobin.
When the test is complete, you will see a pink-purple colored
ASSAY PROCEDURE LIMITATION OF THE PROCEDURE
band in the “C” area of the test device on negative samples
and an pink-purple colored band in the “T” and “C” area on
Test strip together with patient samples, controls should be
Occasionally specimens containing less than 25mIU/ml
positive samples. The appearance of the CONTROL band
brought to room temperature prior to testing.
indicates that the test device is performing properly and
In addition to pregnancy, hCG has been found in
Remove the strip from the foil wrapper. (bring the
patients with both gestational and non-gestational
container to the room temperature before opening to
avoid condensation of moisture in container). Label the
trophoblastic disease. Since the hCG has been found in
strip with patient or control identifications.
patients with both gestational and non-gestational
Immerse the strip into the urine with the arrow end
neoplasms is similar to that found pregnancy, these
pointing toward the urine. Do not cover the urine over
conditions, which include choriocarcinoma and
the MAX (maximum) line. You may take the strip out
after minimum of 15 seconds in the urine and lay the
WH Accu TestTM PregnancyTest strip is an extremely
hydatichiform mole, should be ruled out before a
strip flatly on non-absorptive clean surface.
rapid test used to detect the presence of hCG in urine
Read the results at 5 minutes. DO NOT INTERPRET
qualitatively at levels as low as 25mIU/ml.
A normal pregnancy can not be distinguished from an
ectopic pregnancy based on hCG levels alone. Also,
spontaneous miscarriage may cause confusion in
Test accuracy was assessed by comparing commercial
available of 90 patients with a clinical diagnosis of non-
A very early pregnancy containing an extremely low
pregnant, and 70 diagnosed pregnant. WH Accu Test
concentration of hCG can give a negative result. In this
Pregnancy showed 100% correlation with both BD and the
case, another specimen should be obtained at least 48
hCG levels may remain detectable for several weeks
after normal delivery, delivery by cesarean section,
spontaneous abortion or therapeutic abortion.
INTERPRETATION OF RESULTS
A study was performed using urine specimens from 20
postmenopausal women. These specimens were chosen
REFERENCE 1. Negative
because urine from menopausal women frequently interferes
Only one pink-purple colored band appears in the control
with the pregnancy tests due to cross reactivity with other
Batzer, F.R. Fertility & Sterility, Vol 34, 1 1980
gonadotropin hormones. All 20 urine specimens were
Catt, K.J. Dufan, M.L. and vaitukaitis, J.L. J.
negative when tested with the WH Accu Test Pregnancy test.
Potentially interfering substances were added to urine, which
Clin. Endocrinol Metab., Vol.40,537, 1975
had hCG levels of 0 and 25mIU/ml. In this case, no
Braunstein, G.D., Rasor, J., Alder, D., Danzer H.,
interference with the WH Accu Test Pregnancy test.
Wade, M.E. Am. J. Obster. Gynecol., Vo. 126, 678, 1976
Lenton, E.A., Neal L.M., Sulaiman, R. Fertility and Sterility,
In addition to the control band, a clearly distinguishable
pink-purple colored band also appears in the test area (T).
Batzer, F.R. Fertility & Sterility, Vol, 34, 1 1980
Dawood, M.Y., Sexeba, B.B., and Lanesman, R.Ob. Gyn.
Braustein, G.D., et Al.AM. Inter.Med.Vol.78,pp.419-439,
As long as there is no distinct pink-purple colored band
Uotila, M., Ruoslahti, E. And Engvall, H.J. Immunol.
visible in control area, the test is invalid. It is recommended
that in this case the test be repeated or fresh specimen be
C. Galfre, S.C. Howe, C. Milstein, G.N. Butcher, and J.C.
M.N. Iscove and F. Melchers, J. Exp Med. 147, 923, 1978
P.L., Ey, et. Al., Immunochemistry 15, 429, 1978
QUALITY CONTROL HOMOLGOUS HORMONES
After additional of the sample these colored bands migrate
along the membrane at the leading edge of the dye conjugate
and are “removed” from the test device completely.
Unter den Wolken kann die Freiheit nicht grenzenlos sein Bern, 30.05.2006 (GS-UVEK) - Bundespräsident Moritz Leuenberger zum 1. Schweizerischen Luftfahrtkongress vom 30. Mai 2006 am Flughafen Zürich 1. Grenzen der Luftfahrt In der langen Geschichte der Menschen blieb das Fliegen bis vor kurzem den Göttern vorbehalten, die ihre Allmacht hoch über den Wolken auslebten. Für die Mens
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