Application evaluation of HC-900 urine analyzer for rapidly screening urine microalbumin / 国际检验医学杂志

ABSTRACT

Objective To evaluate the clinical application value of the HC-900 fully automated urine dry chemistry analyzer and its matched test strip (HC-900 analysis system) for detecting urine microalbumin (U-mAlb) .Methods 660 urine samples were collected with the negative urine protein detected by the HC-900 analysis system as the standard ,among them ,159 samples with positive U-mAlb screened by the test strip and 106 samples with the partial negative were performed the quantitative analysis by the Immage 800 fully automatic specific protein analyzer for verifying the results screened by the HC-900 analysis system .The compari-son of the U-mAlb quantitative detection results between the screening positive group and the screening negative group adopted the two samples rank sum test .The comparison between the enumeration data was carried out by Kappa test for consistency .Results Among 660 samples ,159 samples with positive U-mAlb were quantitatively detected by the Immage 800 analyzer and 101 samples were confirmed positive U-mAlb with the real positive rate of 63 .5% .Among 106 samples of negative U-mAlb randomly extracted by the HC-900 analysis system ,9 samples were confirmed to be positive U-mAlb quantitatively detected by the Immage 800 analy-zer .By the consistency test ,the difference between the two methods had statistical significance (Kappa=0 .495 ,P<0 .01) .The U-mAlb level was 18 .02(8 .23-34 .89)mg/L in the screening positive group ,which was significantly higher than 4 .78(2 .51-8 .46) mg/L in the screening negative group ,the difference had statistical significance (Z= -8 .689 ,P<0 .01) .Relative to the detection by the Immage 800 quantitative analyzer ,the sensitivity and specificity of the U-mAlb for the rapid screening by the dry chemistry method was 91 .8% (101/110) and 62 .5% (97/155) respectively .Conclusion The HC-900 analysis system for screening U-mAlb has a certain clinical application value .