Product Manual

Sensitivity- Serum Assay
Standard controls (calibrated to the WHO 3rd International Standard) ranging from
5 mIU/mL to 40 mIU/mL in serum tests were tested in 20 replicates. The results confirmed sensitivity of
25 mIU/mL.
Specificity
Thirty-six (36) urine specimens collected from menopausal women were studied. Specimens from
menopausal women are known to interfere frequently with pregnancy tests due to cross-reactivity
with other gonadotropin hormones. These specimens were assayed with OSOM Ultra hCG Combo
Test. All 36 specimens were found negative. The assay is free from interference with other commonly
known homologous hormones when tested at the levels specified below
(Table 3).
TABLE 3
Homologous
Hormones:
Urine Serum
hFSH 1000 mIU/mL 1000 mIU/mL
hLH 500 mIU/mL 500 mIU/mL
hTSH 1000 μIU/mL 1000 μIU/mL)
POTENTIALLY INTERFERING SUBSTANCES
Potentially interfering substances were prepared at the following concentrations in both urine and
serum which contain either 0 or 25 mIU/mL hCG. These samples were tested with the OSOM Ultra hCG
Combo. No interference was found (Table 4).
TABLE 4
Substance Added:
Concentration Added
in Urine in Serum
Drugs
Acetaminophen 20 mg/dL 20 mg/dL
Acetylsalicylic Acid 20 mg/dL 20 mg/dL
Ampicillin 20 mg/dL 20 mg/dL
Ascorbic Acid 20 mg/dL 20 mg/dL
Atropine 20 20 mg/dL 20 mg/dL
Caffeine 20 20 mg/dL 20 mg/dL
Gentisic Acid 20 mg/dL 20 mg/dL
Phenothiazine 20 mg/dL 20 mg/dL
Phenylpropanolamine 20 mg/dL 20 mg/dL
Salicylic Acid 20 mg/dL 20 mg/dL
Tetracycline 20 mg/dL 20 mg/dL
Urinary Analytes
Bilirubin 2 mg/dL 30 mg/dL
Glucose 2000 mg/dL 2000 mg/dL
Hemoglobin 25 mg/dL 250 mg/dL
Ketones 100 mg/dL -
Protein 2000 mg/dL 14000 mg/dL
Triglycerides - 2000 mg/dL
Homologous Hormones
hFSH 1000 mIU/mL 1000 mIU/mL
hLH 500 mIU/mL 1000 mIU/mL
hTSH 1000 μIU/mL 1000 μIU/mL