Detection Limit

The detection limit was determined by spiking negative urine specimens with
intact hCG standard at 0, 25, 100mIU/mL and 1000mIU/mL. The hCG
standards were randomized and coded. Abbott AxSYM confirmed the
results. A total of 10 replicates for each standard were tested according to the
package insert. The specimens were tested with visual interpretations 5
minutes after specimen application. The results are presented in Table
below.

Table 1: Analytical Sensitivity Summary

Specimen hCG conc. #Tested #Negative(-) #Positive(+)
0mIU/mL 10 10 0
25mIU/mL 10 0 10
Urine
100mIU/mL 10 0 10
1000mIU/mL 10 0 10

Conclusion: As indicated in the table above: all specimens with hCG

concentration equal to or higher than 25mIU/mL show positive results, all
negative specimens with hCG showed negative results. Therefore, the
sensitivity concentration of the HCG One Step Pregnancy Test is determined
to be 25mIU/mL hCG.