Comparison of real-time polymerase chain reaction with the COBAS Amplicor test for quantitation of hepatitis B virus DNA in serum samples

Table 1 Sensitivity of the Fosun real-time PCR HBV DNA assay and results of interassay testing

NICPBP references	Reference range (copies/mL)	Results (copies/mL)			Mean (log 10 copies/mL)	SD (log 10 copies/mL)	CV (%)
		Run 1	Run 2	Run 3
L0	7.76 × 107 - 6.17 × 108	1.65 × 108	1.84 × 108	1.52 × 108	8.22	0.04	0.5
L1	1.48 × 107 - 1.18 × 108	9.21 × 107	1.01 × 108	9.23 × 107	7.98	0.02	0.3
L2	1.59 × 106 - 1.26 × 107	8.54 × 106	9.00 × 106	9.20 × 106	6.95	0.02	0.3
L3	1.66 × 105 - 1.32 × 106	7.06 × 105	6.13 × 105	9.55 × 105	5.87	0.10	1.7
L4	1.82 × 104 - 1.48 × 105	8.60 × 104	3.84 × 104	6.30 × 104	4.77	0.18	3.8
L5	1.51 × 103 - 1.23 × 104	1.07 × 104	6.20 × 103	8.82 × 103	3.92	0.12	3.1
L6	< 1000	524	442	581	2.71	0.06	2.2

Table 2 Intra-assay variation of the Fosun real-time PCR HBV DNA assay

No. of samples	Replicates	Mean of HBV DNA	SD	CV (%)
		level (log10 copies/mL)
3768	12	3.97	0.32	8.1
3785	12	6.00	0.12	2.0
3770	12	7.84	0.11	1.4