HCG Pregnancy Rapid Test Strip (ESWT 1-0001)

• Product Name:

  HCG Pregnancy Rapid Test Strip (ESWT 1-0001)

• Category: Medical devices/Diagnostic Devices
• Package: STRIP 2.5/3/3.5/4MM
• Price: Get Latest Price

• Product Detials:Y. B. T. Pregnancy Test Card is an in vitro diagnostic (IVD) qualitative test for rapid detection of HCG in urine. This test is designed for self-testing use only. Format: Strip/cassette/Midstream Principle: Double antibody sandwich Sensitivity: 25mIU/ml >99.5% Specificity: >99.5% Strip Format: One foil pouch includes: 1. One pouched strip with desiccant 2. One piece of operating instruction. Cassette Format: One foil pouch includes: 1. One pouched cassette with desiccant 2. Blood dilluent in a dropper bottle, stored at 2-8 oC 3. One piece of operating instruction. Storage Requirements: The kit should be stored at the temperature 4-30oC, the sealed pouch for the duration of shelf life (24 minths) We can supply products with OEM package, print your own brand name or our brand name on each single pouch. Positive Urine Negative Urine Total y.b.t (+) 60 0 60 y.b.t (-) 0 60 60 Total 60 60 120 Diagnostic sensitivity: (60+0)/60=100% Diagnostic specificity: (0+60)/60=100% Relative accuracy: (60+60)/(60+60)=100% RECISION Intra-assay In the study, eleven replicate assays were performed with each of three specimens containing 0, 25, and 250 mIU/ml hCG. Correct negative and positive results were registered in 100% of the assays. Inter-assay The study involved the same three specimens containing 0, 25, and 250 mIU/ml hCG. The samples were analyzed in eleven independent assays with y.b.t. hCG Card originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays. STORAGE AND STABILITY Store Y.b.t. Preganacy Test Strip at temperature ranges 2 -30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze. LIMITATION 1. If a urine specimen is too diluted, it may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine should be obtained from the person and repeated the test. The hCG concentration less than 25 mIU/ml will be detected as negative. 2. A number of conditions other than pregnancy such as trophoblastic disease, proteinuria, hematuria, choriocarcinoma, ovarian and testicular teratomas can cause elevated levels of hCG. These diagnosis should be considered if appropriate to the clinical evidence. 3. Fertility drugs containing hCG may give false “pregnant” results. Other fertility therapies such as clomiphene citrate, pain killers and hormonal contraceptives (e.g. contraceptive pill) should not affect the results. 4. Immunologically interfering substances such as those used in antibody therapy treatments may invalidate the assay. 5. Samples containing very high levels of hCG ³ 600,000 mIU/ml may yield a test band with color internsity lighter than tha which is expected. When high dose “hook effect” is suspected it is recommended the test be repeated with a 1:10 dilution of the specimen with DI H2O. 6. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. INDEX OF SYMBOLS Do not re-use manufacture For In-Vitro Diagnostic use only Stored at Room Temperature Attention: See instruction for use Authorized Representative in the european Company Use by (Expiration date) Lot number REFERENCE 1. Cart, K. J.: J. Clin. Endocrinol.Metab., 1975, 40:537 2. Brauntein, G. D.: Am. J. Obstet. Gynecol., 1976, 126:678 3. Batzer, F. R.: Fertility & Sterility, 1980, 34:1 4. Engvall, E.: Method in Enzymology, 1980, 70:419 5. Wilcox, A. J.: N.England J. Med., 1988, 319:189 6. Dawood, M. Y.: Ob. Gyn., 1990, 126:678 QUESTIONS AND ANSWERS Q. How does the test work? A. When a woman gets pregnant, her body produces a pregnancy hormone called hCG (human Chorionic Gonadotropin) in her urine. y.b.t. â Midstream Pregnancy Test Stick detects the presence of the hormone from first day of missed period. Q. What do I do if the test is positive? A. You should see your doctor who will discuss your pregnancy with you and explain what steps you should take next. It is recommended that you retest three days later by using another y.b.t. â Preganacy Test Strip. The earlier you see your doctor, the better it is for your health can be showed less than 5 minutes and the health of your baby. Q. What do I do if the test is negative? A. A negative result means that no pregnancy hormone has been detected and you are probably not pregnant. If your period does not start within a week, you may have miscalculated the day your period was due. Retest by using another y.b.t. â Preganacy Test Strip. If the test still gives you a negative result and you still have not menstruated, you should see your doctor. Q. Do I have to test in the morning? A. No, y.b.t. â Preganacy Test Strip can be used at any time of the day from the day you period is due. Q. What if the test is allowed to run for more than 5 minutes? A. A negative (Not Pregnant) test result will not change after the test is finished. A positive (Pregnant) test result can be showed less than 5 minutes. Over time, some negative results might turn to a weak positive result because the test chemicals keep on reacting. Q. How accurate is the y.b.t. â Preganacy Test Strip? A. In laboratory studies, this test was shown to be over 99% accurate. Q. Can any medicines affect the result? A. Only medicines which contain hCG can give a false reading. HCG-containing drugs include: A.P.L., Pregnyl, Follutein and Profasi. Hormone therapies (such as Clomid, Serophene, or Pergonal), painkillers, or the contraceptive pill should not affect the test result. Q. Can I get a false or misleading result? A. This should not happen if you follow the instructions correctly. However, if you get the absorbent tip wet before using the test, if the test is out of the foil pouch for more than 24 hours before you conduct the test, if you don’t get enough urine on the absorbent tip, or if the test is not kept with the absorbent tip pointing down when immersed in urine, then you may not get a reliable result. Certain rare medical conditions can also cause a false result. If you repeatedly get unexpected results, you should check with you doctor. Q. How soon can I use y.b.t. â Preganacy Test Strip? A. This test can detect pregnancy hormone levels in your urine as early as the first day your period is late, and can be used on the day of your missed period as well as any day thereafter. Q. Does drinking alcohol affect the result? A. No. Q. What if I splash the test windows with urine? A. To minimize the possibility of splashing the widows, the test pad itself should be slid to the end of the splashguard to protect the windows. However, if the windows are thoroughly wet by urine, it is possible you might not obtain a correct result. If a purple band does not appear in the control window in 5 minutes, the test should be voided and you might use another y.b.t. â Preganacy Test Strip to retest. However, if you do get a band in the control window, you can rely on your result. Q. Does it matter if I touch the absorbent tip? A. No. If you conduct the test according to the instructions, it does not matter if you touch the absorbent tip. SAFEGUARD YOUR BABY’S HEALTH · Consult your doctor, and check with him or her regarding any medication you are currently taking. · Maintain a well-balanced diet. · Stop smoking. · Avoid alcohol. According to the Surgeon General, pregnant women should not drink alcohol because of the risk of birth defects. 0197