Performance Comparison And Application Of HBV-DNA Detection Reagents

Objective Evaluate and compare the performance of two different HBV-DNA reagent kits to provide rapid and accurate results for clinical detection.Methods Performance verification was performed from accuracy,precision,limit of quantification,the sensitivity of the two different HBV-DNA reagent kits.To evaluate the differences between the two kinds of reagents,the different types of clinical samples was further selected for detect and analysis through the correlation and consistency.Results(1)The accuracy of intra-assay and inter-assay of two kinds of kits was analyzed,and the results indicated that the detection accuracy of high concentration samples was better than that of the low concentration.There was no significant difference was found in the results of the two regents for the HBV-DNA detection.The positive rate of HBV-DNA quantitation limit of detection was 100%by A reagent,the positive rate of B reagent was 88%,the deviation of the two reagents was within the range of 0.5.The linear range validation of the two reagents was satisfied with the relevant requirements.The interference test of two reagents showed that severe hemolysis and lipid blood samples could affect the detection of low viral load HBV-DNA,but HBV-DNA detection of the low load specimens was not affected by slight hemolysis and lipid blood samples.However the differences between the three storage time was not significant at the immediate detection,3 days at room temperature and 7 days at 4 degrees.(2)The detection of 100 clinical samples was analyzed for correlation and consistency used by the two reagents,the results indicated that the detection rate of A reagent(43.06%)is slightly higher than that of B reagent(40.28%)in the low concentration of viral load,both reagents and control reagents had better correlation and consistency in the detection of HBV-DNA.The detection of hepatitis HBV samples combined with HCV infection was also performed with the two reagents,and the results indicated that the results were reliable in detecting hepatitis patients with mixed infection in clinical practice(r~2=0.952).The clinical specimens of patients with hepatocellular carcinoma were detected and analyzed.The results showed that the correlation and consistency of the two reagents were good.Conclusion Both of the selected HBV-DNA test reagents met the experimental requirements.That A reagent and B reagent have comparable abilities and are equivalent in the detection of low viral load samples in the clinic detection.