Item Brochure

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.
• The expected sensitivity of urine samples at a read time of 3 minutes is 20 mIU/mL
• The expected sensitivity of serum samples at a read time of 5 minutes is 10 mIU/mL
Note: Samples containing minute quantities of hCG (below 10 mIU/mL) may develop faint test bands.
% of samples containing varying amounts of hCG interpreted as positive
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 and serum specimens gives
negative results in the OSOM hCG Combo Test.
Interfering Substances
The following substances were added to urine and serum specimens containing 0 or 20 mIU/mL (urine)
or 10 mIU/mL (serum) hCG. The substances at the concentrations listed below were not found to affect
the performance of the test.
Urine
Acetaminophen 20 mg/dL
Acetoacetic acid 2000 mg/dL
Acetyl salicylic acid 20 mg/dL
Amitriptyline 100 mg/dL
Amphetamines 10 ug/mL
Ascorbic acid 20 mg/dL
Atropine 20 mg/dL
Benzoylecogonine 10 mg/dL
Bilirubin 2 mg/dL
Caffeine 20 mg/dL
Cannabinol 10 mg/dL
Chlorpromazine 5 mg/dL
Codeine 10 mg/dL
Desipramine 20 mg/dL
Diazepam 2 mg/dL
Ephedrine 20 mg/dL
Estradiol 25 ng/mL
Estriol 1 mg/dL
Hydroxybutyrate 2000 mg/dL
Ethanol 200 mg/dL
Gentisic acid 20 mg/dL
Glucose 2000 mg/dL
Hemoglobin 250 mg/dL
Human albumin 2000 mg/dL
Ibuprofen 40 mg/dL
Imipramine 100 mg/dL
Lithium 3.5 mg/dL
Mesoridazine 1mg/dL
Methadone 10 mg/dL
Morphine 6 ug/mL
Nortriptyline 100 mg/dL
Phenobarbital 15 mg/dL
Phenylpropanolamine 20 mg/dL
Pregnanediol 1500 ug/dL
Progesterone 40 ng/mL
Proteins 2000 mg/dL
Salicylic acid 20 mg/dL
Tetracycline 20 mg/dL
Thioridazine 2 mg/dL
Amitriptyline 100 mg/dL
Amphetamines 10 ug/mL
Benzoylecogonine 10 mg/dL
Bilirubin 30 mg/dL
Cannabinol 10 mg/dL
Chlorpromazine 5 mg/dL
Codeine 10 mg/dL
Desipramine 20 mg/dL
Diazepam 2 mg/dL
Estradiol 25 ng/mL
Estriol 1 mg/dL
Hemoglobin 500 mg/dL
Ibuprofen 40 mg/dL
Imipramine 100 mg/dL
Lithium 3.5 mg/dL
Mesoridazine 1 mg/dL
Methadone 10 mgldL
Morphine 6 ug/mL
Nortriptyline 100 mg/dL
Phenobarbital 15 mg/dL
Phenothiazine 2 mg/dL
Pregnanediol 1500 ug/dL
Progesterone 40 ng/mL
RF factor 40 IU/mL
Tetracycline 20 mg/dL
Thioridazine 2 mg/dL
Triglycerides 2000 g/dL
Serum
Urine
120%
100%
80%
60%
40%
20%
0%
0 5 10 20 30
Serum
0 2.5 5 10 20
120%
100%
80%
60%
40%
20%
0%