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Investigation of Determining Methods in Reportable Range

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  • (Clinical Laboratory, Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, China)

Received date: 2014-11-21

  Revised date: 2015-05-13

  Online published: 2015-09-16

Abstract

Abstract: Objective To investigate determining methods of the reportable range by using ALT, LDH, BUN and CRE as sample. Methods The reportable range was assured through detection of LoQ, upper limit of linear range, and maximum dilution times. Based on the ( low concentration of speciman-1.645SDlow concentration of speciman) –LoB ≥ 0 to calculate all low concentration of specimen. During the detection of upper limit of linear range, the high concentrations samples were diluted into 11 concentrations in different ratios (from 0∶10 to 10∶10), then the regression analysis was carried out using 5 concentration, then according the regression equation, high values were calculated and compared with the actual measured results. The highest value with the bias lower than 5% was the upper limit of linear range. And then, in detecting high value sample, the linear range relying on the maximum dilution detection was determined. Maximum dilution times can be detected by the samples with high concentration in the linear range. The reportable range was from LoQ to upper limit of linear range multiplied by maximum dilution times. Results The reportable ranges of ALT, LDH, BUN and CRE were 4.55-2466.3 U/L, 4.74-2438.7 U/L, 0.93-72.6 mmol/L and 3.75-9926.9 μmol/L respectively. Conclusion The method in this study is convenient and easy to implement.

Cite this article

CHEN Yan, CAO Jing-li, ZHANG Wei, LI Yu, CHEN Lan-zhi, HUANG Ze-yu, SUN Yu, QIAN Fang, LI Ran-ran, KANG Xi-xiong, WANG Ya-jie . Investigation of Determining Methods in Reportable Range[J]. Labeled Immunoassays and Clinical Medicine, 2015 , 22(7) : 694 . DOI: 10.11748/bjmy.issn.1006-1703.2015.07.032

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