Evaluation of simultaneous amplification testing and quantitative reverse transcription-polymerase chain reaction for quantitative detecting serum hepatitis B virus RNA
HUANG Chenlu1, XU Wei1, HU Qiankun1, ZHANG Xiaonan1, LI Qiang1, HUANG Yuxian1,2, CHEN Liang1
1. Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China; 2. Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China
Abstract The purpose of the current study is to evaluate the correlation and consistency of simultaneous amplification testing (SAT) and quantitative reverse transcription-polymerase chain reaction (qRT-PCR) for quantitative detecting serum hepatitis B virus RNA. 212 serum samples from Shanghai Public Health Clinical Center including 81 CHB patients with HBV DNA≥100 IU/mL, 76 CHB patients with HBV DNA 100 IU/mL and 55 patients without HBV infection were detected by SAT and qRT-PCR methods. In HBV DNA≥100 IU/mL CHB patients, 95.06% (77/81) samples were positive both in SAT and qRT-PCR method. SAT showed a relevantly good correlation and comparability with qRT-PCR (R2=0.803, CCC=0.882). Bland Altman analysis shows absolute bias was 0.1 log10 copies/mL and relative bias was 0.97%. The paired T test analysis of test results had no difference (t =1.617,P =0.110). In HBV DNA 100 IU/mL CHB patients, 98.68% (75/76) samples were positive in SAT method and 88.16% (67/76) samples were positive in qRT-PCR method. The statistical analysis of test results had difference (P<0.001). SAT showed a relevantly bad correlation and comparability with qRT-PCR (R2=0.326, CCC=0.438). Bland Altman analysis shows absolute bias was 0.5 log10 copies/mL and relative bias was 86%. The paired T test analysis of test results had difference (t =3.654,P<0.001). In 55 patients without HBV infection, all samples were negative in SAT method and qRT-PCR method. Correlation analysis shows strong correlation and consistency between SAT and qRT-PCR for CHB patients with HBV DNA≥100 IU/mL. Difference was found in the measurement of RNA using SAT and qRT-PCR for CHB patients with HBV RNA 100 IU/mL.