FEMALES - menstrating: Follicular phase 3.5 - 12.5 mIU/mL Ovulation phase 4.7 - 21.5 mIU/mL Luteal phase 1.7 - 7.7 mIU/mL Postmenopause 25.8 - 134.8 mIU/mL MALES: 1.5 - 12.4 mIU/mL AGE MALE FEMALE 1 - 3 years 0.2-1.5 mIU/mL 1.2-5.7 mIU/mL 4 - 8 years 0.5-1.6 mIU/mL 0.8-3.0 mIU/mL Tanner I 0.7-3.1 mIU/mL 0.5-5.1 mIU/mL Tanner II 1.1-6.9 mIU/mL 2.4-8.7 mIU/mL Tanner III 1.8-6.2 mIU/mL 3.8-8.1 mIU/mL Tanner IV 1.8-4.8 mIU/mL 1.1-9.6 mIU/mL Tanner V 1.4-6.8 mIU/mL 2.0-7.6 mIU/mL

The assay is unaffected by icterus (bilirubin is less than 64 mg/dL), hemolysis (Hb is less than 1,000 gg/dL), lipemia (Intralipid is less than 1900 mg/dL) and biotin is less than 60 ng/mL. (criterion: recovery within plus or minus 10% of initial value). In patients receiving therapy with high biotin doses (i.e. is greater than 5 mg/day) no sample should be taken until at least 8 hours after the last biotin administration. No interference was observed from rheumatoid factors up to a concentration of 2250U/mL. No high dose hook effect at FSH concentrations of up to 2000 mIU/mL. In vitro tests were performed on 17 commonly used pharmaceuticals. No interference with the assay was found. As with all tests containing monoclonal antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or who have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to ruthenium can occur. FSH contains additives which minimize these effects. Extremely high titers of antibodies to streptavidin can occur in isolated cases and cause interference. For diagnostic purposes, the FSH findings should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.