Do not overfill. Squeeze the bulb of the pipette and draw up enough sample to fill the barrel to the line indicated on the pipette. Expel entire contents of the barrel into the sample well of the test device. No drop counting required. 3 min. CardPregnancy Pregnancy Card TestTest ® Read results at 3 minutes. Rev.
® Card Pregnancy Test CLIA Complexity: Waived INTENDED USE The OSOM ® Card Pregnancy Test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early determination of pregnancy. This test is for professional use in physicians’ offices and clinical laboratories. SUMMARY AND EXPLANATION Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta.
QUALITY CONTROL Internal Quality Control Several procedural controls are incorporated into each OSOM Card Pregnancy Test for routine quality checks. The same labeled conjugate antibody results in the appearance of both the test and the control bands.
sample to barrel to indicated pipette. Test procedure Patient specimens and control material must be brought to room temperature (15° – 30°C; 59° – 86°F) prior to testing. Do not ov Squeeze the bulb • Remove the Test Device and the pipette from the of the pipette and pouch. Place the Device on a flat surface. draw up enough sample to fill the barrel the line • Squeeze the bulb of theto pipette and insert the barrel on the into the patientindicated sample.
EXPECTED VALUES hCG is not normally detected in the urine and serum specimens of healthy men and non-pregnant women. In normal pregnancy, 20 mIU/mL hCG is reported to be present in both urine and serum 2 to 3 days before the first missed menstrual period. (15,16) The levels of hCG continue to increase up to 200,000 mIU/mL at the end of the first trimester. Agreement Urine specimens from 634 individuals were evaluated with the OSOM Card Pregnancy Test and the QuickVue ® + One-Step hCG-Combo Test.
Cross Reactivity The addition of luteinizing hormone (300 mIU/mL of LH), follicle stimulating hormone (1000 mIU/mL of FSH), or thyroid stimulating hormone (1000 µIU/mL of TSH) to negative urine specimens gives negative results in the OSOM Card Pregnancy Test. Interfering Substances The following substances were added to urine specimens containing 0 or 20 mIU/mL hCG. The substances at the concentrations listed below were not found to affect the performance of the test.
REFERENCES 1. Braunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Serum chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gyneco/1976; 126:678 – 681. 2. Kadar N, Devore G, Romero R. Discriminatory hCG Zone: Its Use in the Sonographic Evaluation for Ectopic Pregnancy. Obstet Gyneco/1981;58:156 – 61. 3. Kadar N, Caldwell BV, Romero R. A Method of Screening for Ectopic Pregnancy and Its Indications. Obstet Gyneco/1981;58:162 – 6. 4. Hussa RO.
Key to component Labeling Use by YYYY-MM Batch code Catalog number Contents sufficient for tests In vitro diagnostic medical device Temperature limitation Manufacturer/Manufactured by Consult instructions for use Authorized representative in the European Community Caution, consult accompanying documents.
