Wh accu test tm

Mouse monoclonal antibodies and polyclonal antibody on
INTENDED USE
colloidal gold particle.
WH Accu TestTM Pregnancy Test is a self-performing
Material Provided:
immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) urine for early Each WH Accu TestTM Pregnancy Test 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 Pregnancy Test 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 PREPARATION
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. PERFORMANCE CHARACTERISTICS
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 Sensitivity:
after minimum of 15 seconds in the urine and lay the WH Accu TestTM Pregnancy Test 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,
Accuracy:
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 Specificity:
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 2. Positive
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, 3. Invalid:
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.

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