Methodological Research on Latex Enhanced Immune Turbidimetric Method for the Detection of Urine Free Hemoglobin / 现代检验医学杂志

ABSTRACT

Objective To establish the test way of latex enhanced immune turbidimetric method for the concentration detection of urine free hemoglobin on the automatic biochemical analyzer,and evaluated the detection performance.Methods Prepared the detection reagents of latex enhanced immune turbidimetry method for detection of urine free hemoglobin with materials such as hemoglobin HBA0 antibody (8.5 mg/ml),80 nm carboxylic olystyrene latex microspheres (estapor,nanometer microspheres) and so on.Then,seted the project parameters on TBA120 automatic biochemical analyzer and proceeded the calibrations.Evaluated the detection performance by accuracy,precision,linear range,sensitivity,specificity and other indicators.Lastly,established the biological reference interval for urine free hemoglobin of healthy people in the region and verified it.Results To seted the project parameters on TBA120 automatic biochemical analyzer and passed the calibration.The calibration fitting curve had a smooth trend and no obvious deviation with each measuring point.In the recovery tests,added standard liquid with different concentrations of 100 mg/L and 500 mg/L to the samples with low values,the recovery rate was 95.3％ and 102.7％ respectively.Same to the samples with high values,the recovery rate was 104.2％ and 103.5％ respectively.In the precision test,samples with low and high value had a precision CV of 6.52％ and 4.18％ respectively.The linear range was 0 ～ 1 100 mg/L,analysis sensitivity was 2.8 mg/L.In the interference test,found that,samples had no obvious disturbance to the test with lower concentrations of free bilirubin,combined with bilirubin,vitamin C,animal hemoglobin lower than 342 μmol/L,342 μmol/L,0.03 g/L,500 mg/L respectively,while had significant interference when the concentration of chyle was higher than 870 FTU.Their study had established the biological reference interval of healthy people,male was 0～ 13.3 mg/L and female 0 ～ 17.1 mg/L,there was no significant difference between them by a t test (P＞0.05).Conclusion The latex enhanced immune turbidimetric method for the detection of urine free hemoglobin has the performance of testing clinical urine specimen,which not only solved the lackage problem of specificity for occult blood in the urine dry chemistry test and realized batch automation quantitative detection.The experimental data of this study provides a theoretical basis for the application of the method in other types of clinical samples.