The clinical evaluation of a new diagnostic kit for hepatitis B virus YMDD mutation DNA detection / 中国医师杂志

ABSTRACT

Objective To evaluate the clinical application of a novel hepatitis B virus YMDD mutation DNA diagnostic kit (magnetic beads method kit).Methods A total of 324 HBV clinical serum samples was tested with the magnetic beads method kit and another kind of fluorescence diagnostic kit (boiling method).Accuracy, specificity, and sensitivity were compared.Results The consistency of positive detection rate of two kits was 100％ (95％ CI 98.0％ ～ 100％), negative consistency was 97.12％ (95％ CI 92.8％ ～99.2％) and the total consistency was 98.76％ (95％ CI 96.9％ ～99.7％).Four cases of discrepant samples were confirmed by sequencing, and statistical analysis performed by Kappa test (Kappa =0.975) shows good consistency between the two methods.Conclusions The magnetic beads method kit has good consistency compared to the regular boiling method kit, and the polymerase chain reaction (PCR) detection system contains an internal positive control (internal control) to avoid a false negative resuit, which is more suitable for clinical diagnosis.