To evaluate the clinical utility of a novel quantitative assay named hepatitis B virus (HBV) simultaneous amplification and testing (SAT) using a kit for HBV RNA detection (RNA probes).

HBV RNA was detected in 170 serum samples of chronic hepatitis B patients and 30 serum samples of patients without HBV infection collected by simple random sampling method from June 2017 to June 2018 in Huashan Hospital, Fudan University, Shanghai using HBV SAT and reverse transcription polymerase chain reaction (PCR) method. The sensitivity, specificity, kappa value and quantitative correlation of the two methods were analyzed and compared.The detection rates of HBV RNA from samples with different HBV DNA concentrations of the two methods were analyzed and compared. Statistical analysis was performed by chi-square test.

Based on the clinical diagnosis, the detection sensitivity, specificity, kappa value of HBV SAT were 97.06%(165/170), 100.00%(30/30) and 0.908, respectively, while the reverse transcription PCR were 92.94%(158/170), 100.00%(30/30) and 0.798, respectively. Among samples with lower concentration of HBV DNA (HBV DNA<100 IU/mL), the detection rates of HBV SAT and reverse transcription PCR were 77.27%(17/22) and 59.09%(13/22), respectively. The linear correlation coefficient of the two methods wasr=0.987 8.

Quantitation results of HBV RNA by HBV SAT and reverse transcription PCR method are consistent. HBV SAT is a rapid and accurate method for HBV RNA quantitative detection, which has a slightly higher detection rate than reverse transcription PCR in samples with low concentration of HBV DNA.

Hepatitis B virus; RNA; Quantitative detection