Performance verification and comparison of TianLong automatic hypersensitive hepatitis B virus DNA quantification system with Roche CAP/CTM system

Table 1 Detail information of national standard materials

Art. No.	Standard Material No.	Batch No.	Standard material name	Reference Conc.
HS-0001	GBW (E) 090137	201511003	HBV DNA serum standard material	1.41 × 103 IU/mL
HS-0002	GBW (E) 090138	201512004	HBV DNA serum standard material	5.9 × 104 IU/mL
HS-0003	GBW (E) 090139	201511003	HBV DNA serum standard material	4.6 × 105 IU/mL

Table 2 Limit of detection test results

Sample Conc.	1st Batch of reagent			2nd Batch of reagent			3rd Batch of reagent			Average detection rate
(IU/ml)	NO.	NO. not	Detection	NO.	NO. not	Detection	NO.	NO. not	Detection
	detected	detected	rate	detected	detected	Rate	detected	detected	rate
2.5	10	15	40%	12	13	48%	11	14	44%	44.0%
5	21	4	84%	20	5	80%	22	3	88%	84.0%
10	25	0	100%	24	1	96%	25	0	100%	98.7%
15	25	0	100%	25	0	100%	25	0	100%	100.0%
30	25	0	100%	25	0	100%	25	0	100%	100.0%

Table 3 Limit of quantification test results

Sample Conc.	Test batch	Test result (Log10IU/mL)			Accurate rate
(IU/mL)		Avg. value	CV	No. ≤ ± 0.4	per batch	Average
10	1	0.79	40.57%	19	76.00%	65.33%
	2	0.59	47.58%	13	52.00%
	3	0.71	36.53%	17	68.00%
20	1	1.45	14.11%	21	84.00%	82.67%
	2	1.45	16.65%	20	80.00%
	3	1.36	20.55%	21	84.00%
30	1	1.49	6.09%	25	100.00%	100.00%
	2	1.40	8.51%	25	100.00%
	3	1.46	5.55%	25	100.00%

Table 4 Accuracy test results

National standard materials for Hepatitis B virus serum		Expected	mean ± SD,	Absolute value of Log10 IU/mL difference
Standard material No.	Reference Conc.	Log10 IU/mL	Log10 IU/mL
GBW (E) 090137	1.41 × 103 IU/mL	3.15	3.11 ± 0.02	0.04
GBW (E) 090138	5.9 × 104 IU/mL	4.77	4.80 ± 0.07	0.07
GBW (E) 090139	4.6 × 105 IU/mL	5.66	5.70 ± 0.05	0.05

Table 5 Precision and reproducibility test results

Sample Conc. (IU/mL)		1.0×107			1.0×104		1.0×102
Tested Results Log10 (IU/mL)			Mean Value	CV	Mean Value	CV	Mean Value	CV
Intra assay precision1			6.97	0.23%	4.06	1.10%	2.29	3.10%
Inter assay precision	1st Day2		6.94	0.91%	4.19	1.82%	2.26	3.79%
	2nd Day2		6.95	1.04%	4.31	1.49%	2.41	3.25%
	3rd Day2		7.08	0.64%	4.31	1.67%	2.39	3.72%
	4th Day2		7.10	0.81%	4.32	1.63%	2.42	3.47%
Reproducibility3			7.02	1.36%	4.28	2.08%	2.37	4.41%

¹n = 20;

²n = 15;

³n = 60 (15 tests/d × 4 d).

Table 6 Hepatitis B virus genotypes coverage test Ct value

Hepatitis B virus DNA	Average tested Ct value
genotypes	1st day	2nd day	3rd day	Negative
A	25.62	25.89	25.71	Undetected
B	25.58	25.78	25.78	Undetected
C	25.94	25.86	25.99	Undetected
D	22.61	22.78	22.78	Undetected
E	22.67	22.70	22.68	Undetected
F	22.68	22.72	22.71	Undetected
G	24.50	24.78	24.76	Undetected
H	24.81	24.80	24.85	Undetected