INTENDED USE These tests are for the ultra early detection of human chronic gonadotropin (HCG) in urine specimens. INTRODUCTION HCG is a hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration in urine. HCG appears in urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an excellent indicator for the detection of pregnancy. INTERPRETATION OF RESULTS Negative: Only one colored band appears on the control region. No colored band in the test region. Positive: In addition to the control band, a distinct colored band also appears in the test region. Invalid: If no bands appear, or a test band appear without a control band, the test should be repeated using a new device. LIMITATION 1. The HCG strip is a qualitative test and is not intended for any use other than for the early detection of pregnancy. 2. In addition to the normal elevations of HCG produced in pregnancy, a number of conditions including trophoblastic disease, proteinuria, hematuria, choriocarcinoma, ovarian and testicular teratomas cause elevated levels of HCG. These diagnoses should be considered if appropriate to the clinical evidence. 3. 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 a doctor after all clinical and laboratory findings have been evaluated. Sensitivity: The sensitivity of this test has been set at 10 mIU/ml. A urine specimen contains HCG concentrations equal to or greater than 10mIU/ml HCG gives a positive result. Accuracy: A study was performed using a total of 66 randomly selected urine specimens. These specimens were compared with a similar commercial available qualitative visual pregnency test. The results indicated a complete agreement (36 positive specimens and 30 negative specimens).
- CE marked and FDA cleared for peace of mind
- Sensitivity is 10mIU and accuracy is 99%
- Easy to use and clear to read the results
- Can be used up to 6 days earlier than a standard pregnancy test kit
- Economic 2.5mm strips, work just as well as more expensive alternatives