TABLE 5.

LOD of the RealTime HCV assay based on clinical specimens representing genotypes 1 to 6^a

Sample dilution (IU/ml)	GT 1				GT 2				GT 3				GT 4				GT 5				GT 6
	No. of samples	No. of samples with positive measurements detectable at:		Hit rate (%)	No. of samples	No. of samples with positive measurements detectable at:		Hit rate (%)	No. of samples	No. of samples with positive measurements detectable at:		Hit rate (%)	No. of samples	No. of samples with positive measurements detectable at:		Hit rate (%)	No. of samples	No. of samples with positive measurements detectable at:		Hit rate (%)	No. of samples	No. of samples with positive measurements detectable at:		Hit rate (%)
		≥12 IU/ml	<12 and ≥12 IU/ml			≥12 IU/ml	<12 and ≥12 IU/ml			≥12 IU/ml	<12 and ≥12 IU/ml			≥12 IU/ml	<12 and ≥12 IU/ml			≥12 IU/ml	<12 and ≥12 IU/ml			≥12 IU/ml	<12 and ≥12 IU/ml
50	12	12	12	100	12	12	12	100	12	12	12	100	12	12	12	100	12	12	12	100	11	11	11	100
25	12	11	12	100	12	11	12	100	12	12	12	100	12	12	12	100	12	12	12	100	12	12	12	100
12.5	12	12	12	100	12	8	12	100	12	7	12	100	12	12	12	100	12	8	12	100	12	8	12	100
6.25	12	3	12	100	12	1	12	100	12	1	12	100	12		10	83	12		12	100	12	3	12	100
3.125	12		8	67	12		9	75	12	1	8	67	12		10	83	12	1	10	83	12		10	83

^aFor genotypes (GTs) 1 to 6, the LODs determined by probit analysis were 5.4 IU/ml, 5.2 IU/ml, 5.4 IU/ml, 9.0 IU/ml, 4.7 IU/ml, and 4.7 IU/ml, respectively.