1.CE 0197 Mark. 2.For self-testing and in vitro diagnostic use only.
INTENDED USEAccu-Tell® One Step hCG Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy.
PRINCIPLEAccu-Tell® One Step hCG Pregnancy Test is a rapid qualitative one step assay for the detection of HCG in urine. The test utilizes a combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. The specimen migrates via capillary action along the membrane to react with the colored conjugate and observe the formation of colored lines. Positive specimens react with the specific antibody-HCG colored 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 always appear at the control line region if the test has been performed properly.
PERFORMANCE CHARACTERISTICSSensitivity and SpecificityThe Accu-Tell® One Step hCG Pregnancy detects hCG at a concentration of 25mlU/mL or greater. 300 know negative urine samples were equally divided into 6 groups.Each group of samples(50) were spiked with HCG to the concentration of 0mlU/ml, 10 mlU/ml, 15 mlU/ml, 25 mlU/ml, 50 mlU/ml and 5 IU/ml separately, calibration against WHO 3rd international standard. Each group of sample of samples were tested with Accu-Tell® One Step hCG Pregnancy Test. The results from this study gave 100% agreement with the expected results.
Interference TestingAccu-Tell® One Step hCG Pregnancy Test has been tested with commonly known drugs and hormones including LH(500mlU/ml),FSH(1,000mlU/ml),and TSH(1,000μlU/mL).At the levels tested, none of these substances interfered with the expected test results. For example: Acetaminophen 20mg/dl,Ace-tylsalicylic Acid 20mg/dl, Ascorbic Acid 20mg/dl,Atropine 20mg/dl,Caffeine 20mg/dl,Gentesic Acid 20mg/dl,Glucose2g/dl,Hemoglobin 20mg/dl, Ampicillin 20mg/dl,Tetracycline 20mg/dl.
Storage and StabilityThe test kit can be Stored at 4-30°C in the sealed pouch. It is stable through the expiration date printed on the pouch lable. Do not freeze.
HCG Pregnancy Rapid Test Strip
