HCG TEST STRIP :

OneStep hCG home pregnancy test Strip 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.INTRODUCTION to home pregnancy test 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.
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.

PRINCIPLE 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 pink-rose color band, demonstrating that the reagents and test strip are functioning correctly.

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.

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 protein matrix with a 0.1% sodium azide.

STORAGE AND STABILITY OneStep test strip can be stored at room temperature (below 25œC) and stable until expiration date on the label. Do not store the test strip at hot room temperature (30 - 45œC) for a long period of time.

PRECAUTIONS :

1. For In Vitro diagnostic use only. 2. 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.

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 - 8œC) 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 Specimen collection containers. Clock or timer.

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.

INTERPRETATION OF RESULTS :

1. In 5 minutes, a color band will appear closest to the top indicating that the test is complete.(single color band). 2. The closest band to the bottom shows the test results. If there is any color band close to the bottom (two color bands), you are pregnant. If there is no color band, or single colorband to the top you are not pregnant.

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 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 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 20 mg/dl Caffeine 20 mg/dl Acetylsalicylic Acid 20 mg/dl Gentesic Acid 20 mg/dl Ascorbic Acid 20 mg/dl Glucose 2 g/dl Atropine 20 mg/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).