HCG Pregnancy cassette test

HCG Pregnancy cassette test - The Pregnancy Cassette 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. SUMMARY: 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 conception.The concentration of hCG continues to rise rapidly, frequently exceeding 100 mIU/mL by the fi rst missed menstrual period and peaking in the 30-200,000 mIU/mL range by 10-12 weeks into pregnancy. 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. The hCG Pregnancy Test is a rapid test to detect the presence of hCG in urine specimens in a qualitative format sensitive to 20mIU/mL. The test utilizes monoclonal antibody reagents to selectively detect elevated levels of hCG in urine specimens. The immunological specifi city of the test strip virtually eliminates cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at physiological levels. PRINCIPLE: The hCG Pregnancy Test is a chromatographic immunoassay (CIA) for the rapid qualitative determination of hCG in urine. The membrane is pre-coated with anti-alpha hCG capture antibody on the test region and goat anti-mouse on the control region. During testing, the urine specimen is allowed to react with the colored conjugate (mouse antihCG monoclonal antibody-colloidal gold conjugate), which has been pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive result, a red-colored line with the specifi c antibody-hCGcolored conjugate complex will form in the test region of the membrane. Absence of this red-colored line in the test region indicates a negative result. Regardless of the presence of hCG, as the mixture continues to move across the membrane to the immobilized goat anti-mouse, a red-colored line at the control region will always appear. The presence of this red-colored line serves as: 1) verifi cation that suffi cient volume is added. 2) that proper fl ow is abtained, and 3) as a control for the reagents. REAGENTS AND MATERIALS SUPPLIED Individually wrapped test strip. One test which contains 1~2 μg anti-hCG capture antibody coated on the test region of membrane, 1~2 μg goat anti-mouse IgG on the control region of membrane, and colloidal gold particles coated with anti-hCG monoclonal antibody One test instruction SPECIMEN COLLECTION AND STORAGE: The urine specimen must be collected in a clean, dry container, either plastic or glass. Specimens collected at any time of day may be used; however, the fi rst morning urine generally contains the highest concentration of hormone. Urine specimens may be refrigerated (2-8 °C) and stored up to 72 hours prior to testing. If samples are refrigerated, they must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be fi ltered, centrifuged or allowed to settle and clear aliquots are obtained for testing. TEST PROCEDURE: Review “Specimen Collection” instructions. Test strip, patient’s samples, and controls should be brought to room temperature prior to testing. Do not open pouches until ready to perform the assay. · Remove the test strip from its protective pouch (bring the test to room temperature before opening the pouch to avoid condensation of moisture on the membrane). 1. Immerse the test strip in the urine sample with the arrow end pointing toward the urine. Do not immerse the strip above the printed MAX line. After a minimum of 15 seconds, remove the test strip from the urine and lay fl at on a non-absorptive clean surface. Alternatively, the test strip may be left in the test sample, as long as the strip is not immersed above the MAX line. A separate test strip must be for each sample or control. 2. Wait for red-colored lines to appear. Depending on the concentration of hCG, positive results may be observed as soon as 60 seconds. However, to confi rm negative results with urine samples the complete reaction line of 5 minutes is required. Do not interpret results after 10 minutes. INTERPRETATION OF RESULTS: POSITIVE - Two distinct red-colored lines appear, one in the patient test region and one in control region. NEGATIVE - Only one red-colored line appears in the control region. No apparent red line appears in the patient test region. INVALID - The test is invalid if the control line is not visible at fi ve minutes. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device. NOTE: Negative test results in patients suspected to be pregnant should be re-tested with a sample obtained 48 hours later, or by performing a quantitative assay. When testing with a urine specimen, the fi rst morning specimen should contain the highest concentration of hCG. The shade of red in the test region (T) will vary depending on the concentration of hCG present. However, neither the quantitative value nor the rate of in hCG can be determined by a quantitative test.