Microsoft word - 1155943102 unipath clearview fhc-102 ce insert_c 2009-3-31.doc

always appear in the control line region indicating that proper Clearview HCG is intended for the qualitative detection of volume of sample has been added and membrane wicking has human chorionic gonadotropin (hCG) in urine as an aid in the diagnosis of pregnancy. For professional in vitro diagnostic use Each Clearview HCG kit contains sufficient materials for 20 tests: hCG is a glycoprotein hormone produced by the blastocyst.1, 2 The device contains anti-hCG particles and anti-hCG coated on hCG normally begins to be detected in the urine from 7 days after conception. The sudden rapid rise in concentration of hCG in urine following conception makes it an excellent marker for • 20 Pouched devices: Each sealed foil pouch contains 1 Clearview HCG device, 1 disposable pipette and 1 desiccant Clearview HCG is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine Store at 2-30°C. Do not use after the expiry date. to aid in the early detection of pregnancy. The test uses two lines to indicate results. The test line utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The control line is composed of goat polyclonal antibodies and colloidal gold particles. The assay is conducted by adding a urine sample to the sample well of the 1. Do not open the foil pouch until ready to test. test device and observing the formation of colored lines. The 2. Do not use devices that have become wet, or if the foil sample migrates via capillary action along the membrane to 3. Properly dispose of all contaminated waste such as used Positive samples react with the specific antibody-hCG-colored 4. Do not use kit beyond expiration date printed on the outside conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will *NOTE: The intensity of the color in the test line region (T) may A urine sample collected at any time of the day is suitable, but a vary depending on the concentration of hCG present in the first morning sample is recommended.5 Urine samples must be sample. Therefore, any shade of color in the test line region (T) collected in a clean and dry container. Samples may be stored in the refrigerator (2-8°C) for up to 48 hours or frozen below -20°C. • NEGATIVE: One colored line appears in the control line region Samples must be allowed to reach room temperature (15-30°C) (C). No apparent colored line appears in the test line prior to testing. Urine samples exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear • INVALID: Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure Allow the device and urine sample to equilibrate to room and repeat the test with a new device. If the problem temperature (15-30°C) prior to testing. persists, discontinue using the kit immediately and contact 1. Remove the device from the sealed pouch and place on a 2. Using the plastic pipette supplied, insert the tip into the sample and squeeze the top bulb fully (A). DO NOT squeeze the bottom 1. Positive results from very early pregnancy may later prove bulb (B) when using the pipette. Release the top bulb to draw negative due to natural termination of the pregnancy.6 It is up the liquid. An exact quantity of sample (100 µL) will be therefore recommended that weak positive results are re-tested drawn into the lower part of the pipette. Excess sample will be 48-72 hours later with a first morning urine sample. 2. A negative result may be obtained if a urine sample is too 3. Remove the pipette from the sample. Squeeze the top bulb dilute. If pregnancy is still suspected, it is recommended the fully to dispense the sample carefully onto the sample well patient should be retested 48-72 hours later with a first (S). Use a new pipette for each test performed, even if using 3. Concentrations of hCG are generally lower in ectopic 4. Wait for the colored line(s) to appear. Read the result at 3 pregnancy than expected normal values for a given minutes. Do not interpret the result after 3 minutes. gestational age. Abnormal pregnancy cannot be distinguished from normal pregnancy by hCG levels alone.2,7 4. hCG remains elevated for a time after pregnancy. Pregnancy tests carried out less than 3 weeks after giving birth or 9 • POSITIVE:* Two distinct colored lines appear. One line should weeks after natural loss or termination may need further be in the control line region (C) and another line should be 5. A number of conditions other than pregnancy can cause elevated levels of urinary hCG e.g. menopause,4 trophoblastic disease and certain non-trophoblastic neoplasms.9 6. Occasionally, samples containing <25 mIU/mL hCG may test positive. Clearview HCG has been shown to be over 99% 7. Drugs containing hCG may interfere with Clearview HCG, and 8. False positive and false negative pregnancy tests may be observed in patients with abnormal bladder or kidney function e.g. enterocystoplasties and renal failure. 9. If the test result with Clearview HCG is not consistent with clinical evidence, further evaluation may be required. 10. Inconsistent results may be obtained if the urine sample Clearview HCG detects hCG at a concentration of 25 mIU/mL or Urine samples from healthy males and post-menopausal greater. The test has been standardized to the W.H.O. International females generally contain <10 mIU/mL hCG.10 Levels are Standard. The addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), generally <5 mIU/mL in pre-menopausal females. On the first and TSH (1,000 µIU/mL) to negative (0 mIU/mL hCG) and positive day of the first missed period, the levels of maternal urinary hCG (25 mIU/mL hCG) samples showed no cross-reactivity. are normally 50-250 mIU/mL. During the first trimester hCG levels peak at up to 200,000 mIU/mL in a typical pregnancy.3, 11 Clearview HCG has been shown to produce positive results with samples containing up to and including 500,000mIU/mL hCG, which is higher than the maximum level expected during a A multi-center clinical evaluation was conducted comparing the results obtained using Clearview HCG and another commercially available urine membrane hCG test. The urine study included 159 samples, and both assays identified 88 negative and 71 positive results. The results demonstrated a >99% overall accuracy of Clearview HCG when compared to the other urine membrane hCG test. The following potentially interfering substances were added to None of the substances at the concentration tested interfered in the assay. Further information can be obtained from your distributor, or call Inverness Medical Technical Support on: International: +44 (0)1234 835959 www.clearview.com

Source: http://www.merlin-medical.co.uk/fsn/Clearview_13072009/506788IFU%20-%20Clearview%20HCG.pdf