CAJ | 학술논문

目的：比较马鞍山国声生物技术有限公司研制的降钙素原（PCT）定量检测试剂盒（免疫层析法）与已批准上市的同类产品检测结果的符合率和定量检测的等效性，判断其研制产品是否符合临床使用要求。方法选取2014年3～4月收集的各类临床标本122例，分别用两种方法进行检测，比较两种试剂盒的检测结果。统计软件采用 Bland‐Altman 方法分析、回归分析、组内相关分析及 Pearson 积距相关分析，分析两种检测方法的一致性。结果 cut off 值为0．5 ng／mL 时，两种试剂盒分析的一致性为99．18％；cut off 值为2 ng／mL 时，两种试剂盒分析的一致性为95．08％。一致性限度值为（0．2057，0．0884），小于专业界值±0．5。 Pearson 相关系数为0．9795， Spearman 相关系数为0．9721，两种试剂盒的检测结果显著相关（P＜0．01）。结论两种试剂盒具有等效性。
목적：비교마안산국성생물기술유한공사연제적강개소원（PCT）정량검측시제합（면역층석법）여이비준상시적동류산품검측결과적부합솔화정량검측적등효성，판단기연제산품시부부합림상사용요구。방법선취2014년3～4월수집적각류림상표본122례，분별용량충방법진행검측，비교량충시제합적검측결과。통계연건채용 Bland‐Altman 방법분석、회귀분석、조내상관분석급 Pearson 적거상관분석，분석량충검측방법적일치성。결과 cut off 치위0．5 ng／mL 시，량충시제합분석적일치성위99．18％；cut off 치위2 ng／mL 시，량충시제합분석적일치성위95．08％。일치성한도치위（0．2057，0．0884），소우전업계치±0．5。 Pearson 상관계수위0．9795， Spearman 상관계수위0．9721，량충시제합적검측결과현저상관（P＜0．01）。결론량충시제합구유등효성。
Objective To compare the coincidence rate and the equivalence of quantitative detection between the procalcitonin(PCT ) quantitative detection kit(immunochromatography) researched and developed by the Maans‐han Guosheng Biotechnology Co .,Ltd .and the approved marketed similar products to judge whether the developed product meeting the clinical use requirements .Methods 122 cases of various clinical samples collected from March to April 2014 were selected and detected by the two kinds of method .The detection results by using the two kinds of re‐agent kit were compared .The statistical software adopted the Bland‐Altman analysis ,regression analysis ,intraclass correlation analysis and Pearson product correlation analysis .The consistency of the two kinds of detection method was analyzed .Results When the cut off value was 0 .5 ng/mL ,the analysis consistency of the two kinds of method was 99 .18% ;when the cut off value was 2 ng/mL ,which was 95 .08% .The consistency limit values were 0 .205 7 and 0 .088 4 ,which were less than the profession value ± 0 .5 .The Pearson correlation coefficient was 0 .979 5 ,the Spearman correlation coefficient was 0 .972 1 ,showing the detection results by the two kinds of reagent kit had a sig‐nificant correlation(P< 0 .01) .Conclusion The two kinds of reagent kit possess the equivalence .