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PERFORMANCE CHARACTERISTICS

Sensitivity

Urine specimens containing as low as 25 mIU/mL hCG (calibrated against WHO 3rd

IS 75/537) will yield positive results when tested with the OSOM hCG-Urine Test.

Interference Testing

The following substances were tested individually in hCG-free urine and urine containing

25 mIU/mL hCG. None of the substances, at the levels tested, affected expected results:

hLH (500 mIU/mL), hFSH (1,000 mIU/mL), hTSH (1,000 µIU/mL), Estriol (2 mg/dL),

Pregnanediol (2 mg/dL), Acetaminophen (20 mg/dL), Acetoacetic Acid (1,000 mg/dL),

Acetone (1,000 mg/dL), Acetylsalicylic Acid (20 mg/dL), Albumin (2,000 mg/dL),

Ampicillin (20 mg/dL), Ascorbic Acid (20 mg/dL), Atropine (20 mg/dL), Bilirubin (2 mg/dL),

Caffeine (20 mg/dL), Gentisic Acid (20 mg/dL), Glucose (2,000 mg/dL), Hemoglobin

(1,000 mg/dL), Hydroxybutyric Acid (100 mg/dL), Phenothiazine (20 mg/dL),

Phenylpropanolamine (20 mg/dL), Salicylic Acid (20 mg/dL), Tetracycline (20 mg/dL).

Accuracy

A total of 40 urine specimens were evaluated in a clinical study in which test results

of the OSOM hCG-Urine Test were compared to results obtained with a commercially

available visual test for hCG.

The OSOM hCG-Urine Test, when compared to a commercially available visual test

for hCG, results in a sensitivity of 100% and speciﬁcity of 100%.

An evaluation of the OSOM hCG-Urine Test was conducted at three physician’s ofﬁces.

Each site tested the randomly coded panel consisting of negative, low positive and

moderate positive samples for three days. The results obtained had 100% agreement

with the expected results.

Comparative Test

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OSOM hCG-Urine Test