临床研究3种免核酸提取PCR试剂盒检测乙型肝炎患者血清中HBV DNA的比较

摘要

目的 比较3种免核酸提取PCR试剂盒检测乙型肝炎患者血清中乙型肝炎病毒(HBV) DNA的灵敏度和特异度,初步探讨其用于HBV DNA检测的临床价值.方法 用3种免核酸提取PCR试剂盒分别检测30例慢性乙型肝炎患者及30例阴性参比血清标本中的HBV DNA,以荧光定量PCR结果为标准,比较3种试剂检测灵敏度和特异度.结果 3种试剂盒的HBV DNA阳性检出率分别为93.3%(28/30)、96.7%(29/30)、100%(30/30);3种试剂检测HBV阴性的特异度均为100%;3种试剂检测灵敏度A公司为103 IU/mL,B、C公司均为102 IU/mL.结论 使用免核酸提取PCR试剂检测HBV快速、简便、高效,可用于临床HBV DNA快速检测.%Objective The sensitivity and specificity of three DNA extraction - free PCR kits for detecting HBV DNA were assessed for the feasibility in laboratory diagnosis of HBV. Methods Three DNA extraction - free PCR kits were used for HBV analysis in 30 serum samples of patients with chronic hepatitis B and 30 serum samples of negative reference. RT - PCR was applied as gold standard. Results The positive detection rates of the three kits were 93. 3% (28/30), 96.7%(29/30)andl00%(30/30), respectively; while specificities in 30 negative cases were 100% with all kits. The sensitivities of reagents from Company A, B and C were 10s , 102 and 102 IU/mL, respectively. Conclusion HBV DNA detection with DNA extraction - free PCR amplification kits is rapid, easy and efficient in screening of HBV infection.