TABLE 2.

Improvement in performance of HCV TMA at two sites

Parameter	Value (no. of results) in:		P
	Multicenter evaluation	Registration studies
LoDa	9.5 IU/ml (288)	2.4 IU/ml (110)	>0.05e
Specificityb	95.5% (400)	99.4% (1,014)	<0.001
Run validityc	95.5% (22)	100% (16)	>0.05e
Specimen validityd	96.1% (1,881)	98.1% (1,340)	<0.001

^aLoD for multicenter evaluation at two sites based on 288 results obtained from testing of six replicates of a six-member dilution panel on four separate days at each site. LoD for registration studies based on 110 results obtained from 10 to 20 replicates of five-member dilution panels at two sites.

^bSpecificity for multicenter evaluation at two sites based on 400 results obtained by testing 200 unique seronegative specimens twice at each site. Specificity for registration studies at two sites based on 1,014 valid results obtained from testing of 1,014 unique seronegative specimens.

^cRun validity based on 22 assay runs performed at two sites in multicenter evaluation and 16 assay runs in registration studies.

^dSpecimen validity based on 1,881 specimen results obtained from two sites in multicenter evaluation and 1,340 specimens results from registration studies.

^eSample is too small to show statistical significance at the 0.05 level.