中文摘要：

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10^3IU／mL，B、C公司均为10^2IU／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。

英文摘要：

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） and 100% （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 103 , 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.