Basic Study
Copyright ©The Author(s) 2017.
World J Gastroenterol. Oct 7, 2017; 23(37): 6845-6853
Published online Oct 7, 2017. doi: 10.3748/wjg.v23.i37.6845
Table 1 Detail information of national standard materials
Art. No.Standard Material No.Batch No.Standard material nameReference Conc.
HS-0001GBW (E) 090137201511003HBV DNA serum standard material1.41 × 103 IU/mL
HS-0002GBW (E) 090138201512004HBV DNA serum standard material5.9 × 104 IU/mL
HS-0003GBW (E) 090139201511003HBV DNA serum standard material4.6 × 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. notDetectionNO.NO. notDetectionNO.NO. notDetection
detecteddetectedratedetecteddetectedRatedetecteddetectedrate
2.5101540%121348%111444%44.0%
521484%20580%22388%84.0%
10250100%24196%250100%98.7%
15250100%250100%250100%100.0%
30250100%250100%250100%100.0%
Table 3 Limit of quantification test results
Sample Conc.Test batchTest result (Log10IU/mL)
Accurate rate
(IU/mL)Avg. valueCVNo. ≤ ± 0.4per batchAverage
1010.7940.57%1976.00%65.33%
20.5947.58%1352.00%
30.7136.53%1768.00%
2011.4514.11%2184.00%82.67%
21.4516.65%2080.00%
31.3620.55%2184.00%
3011.496.09%25100.00%100.00%
21.408.51%25100.00%
31.465.55%25100.00%
Table 4 Accuracy test results
National standard materials for Hepatitis B virus serumExpectedmean ± SD,Absolute value of Log10 IU/mL difference
Standard material No.Reference Conc.Log10 IU/mLLog10 IU/mL
GBW (E) 0901371.41 × 103 IU/mL3.153.11 ± 0.020.04
GBW (E) 0901385.9 × 104 IU/mL4.774.80 ± 0.070.07
GBW (E) 0901394.6 × 105 IU/mL5.665.70 ± 0.050.05
Table 5 Precision and reproducibility test results
Sample Conc. (IU/mL)1.0×1071.0×1041.0×102
Tested Results Log10 (IU/mL)Mean ValueCVMean ValueCVMean ValueCV
Intra assay precision16.970.23%4.061.10%2.293.10%
Inter assay precision1st Day26.940.91%4.191.82%2.263.79%
2nd Day26.951.04%4.311.49%2.413.25%
3rd Day27.080.64%4.311.67%2.393.72%
4th Day27.100.81%4.321.63%2.423.47%
Reproducibility37.021.36%4.282.08%2.374.41%
Table 6 Hepatitis B virus genotypes coverage test Ct value
Hepatitis B virus DNAAverage tested Ct value
genotypes1st day2nd day3rd dayNegative
A25.6225.8925.71Undetected
B25.5825.7825.78Undetected
C25.9425.8625.99Undetected
D22.6122.7822.78Undetected
E22.6722.7022.68Undetected
F22.6822.7222.71Undetected
G24.5024.7824.76Undetected
H24.8124.8024.85Undetected