1.

1 Cross-reactivity
Some related compounds were spiked into negative urine pools (Abbott
AxSYM confirmed) and positive urine pools (Abbott AxSYM confirmed) at
the concentrations listed. The specimens were tested in triplicate with 3 lots
of test midstreams. Visual interpretations were made at 5 minutes and 10
minutes after specimen application. The results are presented in Table
below.

Table 1: Non Cross-Reacting Compounds

hCG10426 hCG10427 hCG10428
Analytes Concentration 0mIU/mL 25mIU/mL 0mIU/mL 25mIU/mL 0mIU/mL 25mIU/mL
hCG hCG hCG hCG hCG hCG
LH 300mIU/mL - + - + - +
FSH 1000mIU/mL - + - + - +
TSH 1000µIU/mL - + - + - +

Conclusion: The related compounds do not interference with the test at

levels equal to or below than the concentrations listed.
 1.2 Interfering Substances
Analytes were spiked individually, at the concentrations indicated, in a male
urine pool containing 0 and 25 (cut-off value) mIU/mL hCG (sigma). The
samples were tested in triplicate. The samples were rated either positive or
negative at 5 and 10 minutes. The results are presented in Table 1 below.

Table 1: Interfering Substances

Analyte Conc. Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3
(3 Minutes) (10 Minutes)
0 25 0 25 0 25 0 25 0 25 0 25
Acetoaminophen 20 mg/dL - + - + - + - + - + - +
Acetoacetic Acid 2000mg/dL - + - + - + - + - + - +
Ascorbic Acid 20 mg/dL - + - + - + - + - + - +
B-hydroxybutyrate 2000mg/dL - + - + - + - + - + - +
Caffeine 20 mg/dL - + - + - + - + - + - +
Ephedrine 20 mg/dL - + - + - + - + - + - +
Gentisic Acid 20 mg/dL - + - + - + - + - + - +
Phenylpropanolamine 20 mg/dL - + - + - + - + - + - +
Salicylic Acid 20 mg/dL - + - + - + - + - + - +
Phenothiazine 20 mg/dL - + - + - + - + - + - +
EDTA 20 mg/dL - + - + - + - + - + - +
Acetylsalicylic Acid 20 mg/dL - + - + - + - + - + - +
Benzoylecgonine 10 mg/dL - + - + - + - + - + - +
Cannabinol 10 mg/dL - + - + - + - + - + - +
Codeine 10 mg/dL - + - + - + - + - + - +
Methadone 10 mg/dL - + - + - + - + - + - +
Ethanol 1.0 % - + - + - + - + - + - +
Methanol 10 % - + - + - + - + - + - +
Albumin 2000mg/dL - + - + - + - + - + - +
Atropine 20 mg/dL - + - + - + - + - + - +
Glucose 2000mg/dL - + - + - + - + - + - +
Bilirubin 1000mg/dL - + - + - + - + - + - +
Hemoglobin 1000mg/dL - + - + - + - + - + - +

Conclusion: None of the substances tested interfered with the expected results in the
three or ten minutes read times.