ABSTRACT
Definiting the workflow and key link of the risk management in medical laboratory by FMEA.Identifying risk factors of the workflow and key link of blood coagulation test by the criteria for laboratory accreditation , such as ISO15189 recognition criteria and CAP laboratory accreditation inspection . Through the evaluation of the blood coagulation test , effective corrective actions and examining performance data periodically , the quality of the blood coagulation test can be improved continuously.
ABSTRACT
Objective To investigate the diagnostic value and monitoring application of anti-phospholipase A2 receptor antibodies ( PLA2R ) in patients with idiopathic membranous nephropathy ( IMN) .Methods A retrospective study was used .48 patients were diagnosed as idiopathic membranous nephropathy by puncturing kidney from January of 2013 to June of 2014 in the Hospital of Liaoning Traditional Chinese Medical University and Shengjing Hospital of China Medical University were included. 43 patients were diagnosed as non-idiopathic membranous nephropathy ( NIMN ).35 healthy volunteers were selected as control groups.Serum PLA2R were detected by indirect immunofluorescence.The intensity of antibodies fluorescence and the level of urine protein in 24 hours(24 h PRO) ,serum UREA ,serum CYSC, serum UA,GFR were compared in each groups.Measurement data was shown as mean ±standard deviation;Count data was shown as frequency or composition, t test andχ2 test were used as statistical method.Results (1) Among 48 cases with IMN,37 cases showed positive PLA2R (positive rate 77.08%).All of cases were negative in NIMN group.The sensitivity and the specificity of serum PLA2R were 77.08%and 100%.(2) Compared with control groups, the levels of UREA, CYSC and UA were found statistically significant differences in patients with IMN ( P 0.05 ) . ( 3 ) Positive correlation were found between 24 h PRO(r=0.877,P=0.00),serum UA (r=0.766,P=0.00 ) with the level of PLA2R antibodies fluorescence intensity.( 4 ) There were no correlation between serum PLA2R antibody with IMN pathology aging (r=0.087,0.194,0.182;P=0.598,0.399,0.667).PLA2R positive rate(Ⅰstage:37.50%,Ⅱstage:84.85%, Ⅲstage 85.71%) may increases with the increasing of illness severity.Conclusion Serum PLA2R antibody would be a new laboratory diagnosis standard in patients with IMN.(Chin J Lab Med, 2015, 38:595-599 ) Objective To investigate the diagnostic value and monitoring application of anti-phospholipase A2 receptor antibodies ( PLA2R ) in patients with idiopathic membranous nephropathy ( IMN) .Methods A retrospective study was used .48 patients were diagnosed as idiopathic membranous nephropathy by puncturing kidney from January of 2013 to June of 2014 in the Hospital of Liaoning Traditional Chinese Medical University and Shengjing Hospital of China Medical University were included. 43 patients were diagnosed as non-idiopathic membranous nephropathy ( NIMN ).35 healthy volunteers were selected as control groups.Serum PLA2R were detected by indirect immunofluorescence.The intensity of antibodies fluorescence and the level of urine protein in 24 hours(24 h PRO) ,serum UREA ,serum CYSC, serum UA,GFR were compared in each groups.Measurement data was shown as mean ±standard deviation;Count data was shown as frequency or composition, t test andχ2 test were used as statistical method.Results (1) Among 48 cases with IMN,37 cases showed positive PLA2R (positive rate 77.08%).All of cases were negative in NIMN group.The sensitivity and the specificity of serum PLA2R were 77.08%and 100%.(2) Compared with control groups, the levels of UREA, CYSC and UA were found statistically significant differences in patients with IMN ( P 0.05 ) . ( 3 ) Positive correlation were found between 24 h PRO(r=0.877,P=0.00),serum UA (r=0.766,P=0.00 ) with the level of PLA2R antibodies fluorescence intensity.( 4 ) There were no correlation between serum PLA2R antibody with IMN pathology aging (r=0.087,0.194,0.182;P=0.598,0.399,0.667).PLA2R positive rate(Ⅰstage:37.50%,Ⅱstage:84.85%, Ⅲstage 85.71%) may increases with the increasing of illness severity.Conclusion Serum PLA2R antibody would be a new laboratory diagnosis standard in patients with IMN.