南京地区表观健康成人氨基末端脑利钠肽前体(化学发光法)检测参考区间的建立
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Establishment of reference range for the dection of N-terminal pro brain-type natriuretic peptide in apparently healthyadults of Nanjing area using the chemiluminescence method
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    摘要:

    摘要:目的建立符合南京地区表观健康成人的氨基末端脑利钠肽前体(N-erminal pro lrain-type natriuretic peptide,NT-proBNP)化学发光法检测的参考区间。方法―筛选表观健康人群获得有效样本525例,进一步分为4组:18~49岁男性组和女性组,50~75岁男性组和女性组。收集入组人群血清标本,采用UmiCel Dxl 800免疫分析系统及配套试剂(Beckman平台)进行NT-proBNP的检测,判断检测结果的离群值,并计算95%参考区间以及90%置信区间。另从入组人群中随机筛选294例标本,在Roche cobas e801全自动电化学发光分析仪及配套试剂(Roche平台)上检测NT-proBNP表达水平,比较2个系统检测结果的差异性以及相关性。结果Beckman平台检测样本结果呈右偏态。对18~49岁女性组样本分析时,识别出1个检测结果为298.4 ng/L的潜在离群值,经仔细审查,未发现该样本在检测过程中存在明显的失误,确认为有效数据。计算上述数据的95%参考区间以及90%置信区间,最终获得的参考区间为;18~49岁男性≤58.72(49.40,102.00) ng/L,18~49岁女性≤113.72(88.40,141.40) ng/L,50~75岁男性≤97.66(84.00,215.50) ng/L,50~75岁女性≤146.35(126.60,320.80)ng/L,75岁以下人群≤116.69(103.50,126.70) ng/L。Beckman平台与Roche平台检测数据差异有统计学意义(P<0.05) ,两组数据呈正相关(r=0.964,P<0.05) ,检测结果可靠性较高。结论初步建立了符合南京地区表观健康成人的NT-proBNP参考区间,适于在临床诊疗中的应用推广。

    Abstract:

    Abstract : Ohjective To establish the rference range for the chemiluminescence detection of N-erminal pro brain-type natriureticpeptide ( NT-proBNP) in apparently healthy aduls of Nanjing area.Methods A total of 525 effective apparently healthy adults wereobtained through screening. They were further divided into 4 groups ; male and female groups aged 18-49, and male and female groupsaged 50-75.Their serum samples were collected , and the UniCel Dxl 800 immunoassay system ( Beckman) and matching reagents wereused to delect serum NT-poBNP levels.The outliers in the detection results were identifiedl, and the 95% reference interval and 90%confidlence interval were calculated. Additionally, 294 samples were randomly selected from the enrolled population and the levels of senum NT-proBNP were detected on the Roche cobas e801 automated electrochemiluminescence analyzer ( Roche ). The differences andcorrelations of the detection results between the two systems were compared.Results The test results on the Beckman system showed a right skewed distribution. When analyzing the samples of females aged 18-49 yeas , a poltential outlier with a detection result of 298.4 ng/L was identified.After careful examination, no significant errors were found in the deection process of the sample.The result wasconlimed to be valid. Then , the 95% reference interval with a 90%e confidence interval was calculated.The final reference intervals ob-tained were ≤58.72 (49.40,102.00) ng/l for males aged 18-49 years,≤113.72( 88.40,141.40) ng/L for females aged 18-49 years,≤97.66 (84.00,215.50) ng/L for males aged 50-75 years,≤146.35 (126.60,320.80) ngr L ior remates ageu fu-1J yecais,and ≤116.69 ( 103.50,126.70) ng/Ll for individuals under 75 years , respectively. There were sinitcant diferences in tmhe atetcciondata between the Beckman system and Roche system (P<0.0.5) , and the data between the two systems were positively correlated ( r= 0.964, P<0.05) , indicating a high reliability of the detection result. ConclusionThe reference interval of NT-proBNP accordantwith the apparently healthy adults in Nanjing area is preliminarily established , which is suitable for application and promotion in clinical diagnosis and treatment.

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王恒,王书奎.南京地区表观健康成人氨基末端脑利钠肽前体(化学发光法)检测参考区间的建立[J].临床检验杂志,2025,43(05):374-377

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  • 收稿日期:2025-02-05
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