一步法HBV-DNA检测试剂的临床应用分析

The clinical application of ONE-STEP mothed HBV-DNA quantitative fluorescence diagnostic kit

目的比较一步法与煮沸法检测HBVDNA的结果，分析一步法临床推广价值。方法利用已知浓度的标准品检测其准确度，利用室内质控品评价其精密度，采用两种方法分三个批次进行平行检测临床标本62例，比较两种方法的灵敏度、检测结果的一致性及相关性。结果实测校准品与理论值对数据的偏差在可接受范围（0．08％〈0．3lgIU／mL），精密度满足临床需求（cv％=5．62％〈10％），两种方法阳性符合率为100％，阴性符合率为97．0％，总符合率为98．4％，两者检测结果线性关系良好，有显著相关（Y=0．7839X＋0．7101，R。一0．9163）。结论一步法试剂有操作简便，抗污染力强、定量准确、重复性好，成本低等优点，特别适合基层实验室推广应用。

Objective This paper compared the HBV DNA inspection results between one-step method and boiling method,and analyzed the clinical promotion value of one-step method. Methods This paper used a standard substance with known concentration to inspect the accuracy,and used laboratory quality control product to assess the degree of precision. Two kinds of methods were a- dopted to take parallel inspection for 62 cased of clinical specimens in 3 batches, Furthermore,this paper compared the sensitivity of the two methods, consistency and correlation of the test results. Results Deviation of the tested calibrators and theoretical value to the data was in an acceptable range（0.08〈0.31gIU/ml）. The degree of precision satisfied clinical requirements （CV%=5.62〈10%）,The positive coincidence rates of the two methods were 100 %, negative coincidence rates 97.0% and total coincidence rates 98.4~/oo. Linear relation of both testing results was good and it had significant correlation（Y= 0. 783 9X＋0. 710 1,R2=0. 916 3）. Conclusion One-step method reagent has advantages of simple and convenient operation,strong anti-pollution,accurate quantification, excellent repeatability and low cost. It is especially suitable for promotion and application in general laboratories.