Self-prepared quality control product for urinary retinal-binding protein and its performance evaluation / 国际检验医学杂志

ABSTRACT

Objective To investigate the preparation of the internal quality controls for urinary retinal binding protein(RBP)de-tected by the latex enhanced immunoturbidimetry assay and its performance evaluation.Methods The urine specimens from the pa-tients with nephropathy and healthy people with physical examination were collected,centrifuged by 3 500 r/min for removing sedi-ment,urinary RBP levels were adjusted to the low value for healthy population and the high value for the patients with nephropa-thy;then conducted the anticorrosion,packed and stored at -20 ℃.By using the urinary RBP commodity kits,the latex enhanced immunoturbidimetry was adopted to detect urinary RBP,the intra-batch and inter-batch precisions were detected respectively.Then the high and low values of self-prepared controls were detected once per day for consecutive 5 months.The data were processed by using the SPSS13.0 software.Then the performance of self-prepared urinary RBP quality control was evaluated.Results The intra-batch imprecision of 2 levels of urinary RBP controls was less than 5% and the inter-batch imprecision was less than 6%;the stable period by storage at -20 ℃ was at least 5 months,the imprecision had no statistical difference within 5 months(P >0.05).Conclu-sion The high and low levels of self-prepared urinary RBP quality controls can meet the operating requirements of internal quality controls.