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. hCG Combo Test ® 5 min. 3 min. Read results at 5 minutes for serum. Read results at 3 minutes for urine. Rev.
® hCG Combo Test CLIA Complexity: Waived for Urine Non-Waived for Serum INTENDED USE The OSOM ® hCG Combo Test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum 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.
Serum Serum specimens should be obtained aseptically in tubes without anticoagulants. Plasma specimens are not suitable and should not be used for the OSOM hCG Combo Test. Serum specimens may be stored at 2° – 8°C (35° – 46°F) for up to 48 hours before testing. However, if testing is delayed beyond 48 hours, the serum specimens (separated from the clot) should be frozen at -20°C (-4°F) or colder. Frozen specimens may be stored for up to 1 year.
LIMITATIONS IN hCG TESTING • T his assay is capable of detecting only whole molecule (intact) hCG, which is the predominant form of hCG in early pregnancy. It cannot detect the presence of hCG fragments or free subunits. • In later term pregnancies (generally beyond the first trimester), occasional urine samples can contain very high levels of hCG fragments. Therefore, for urine testing, the OSOM hCG Combo Test is most effective when used for the detection of pregnancy in its earlier stages.
• • • Detection of very low levels of hCG does not necessarily indicate pregnancy (5) as low levels of hCG can occur in apparently healthy, nonpregnant subjects. (14,15) Additionally, post-menopausal specimens may elicit weak positive results due to low hCG levels unrelated to pregnancy. In a normal pregnancy, hCG values double approximately every 48 hours. (16) Patients with very low levels of hCG should be sampled and tested again after 48 hours, or tested with an alternative method.
PERFORMANCE CHARACTERISTICS Analytical Sensitivity The OSOM hCG Combo Test will detect hCG in urine specimens with concentrations of 20 mIU/mL or more and in serum specimens with 10mIU/mL or more (calibrated against WHO 3rd IS 75/537). Specimens containing 1,000,000 mIU/mL (spiked with purified hCG) will also give positive results.
REFERENCES 1. Braunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Serum chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gynecol 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. Cole LA. Phantom hCG and Phantom Choriocarcinoma.
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.
