ABSTRACT
Objective To investigate the necessity of dilution in samples with high concentrations of D-Dimer and optimum dilution multiple.Methods Quality control products and calibration were detected by using Sysmex CS5100 for precision evaluation,including within-batch and between-run precision.Calibration were detected for validation of linear range and clinical reportable.Samples with D-Dimer5 mg/L and FDP>20 μg/mL were also serially diluted and detected to calculated recovery rate.Results Within-batch and between-run coefficients of variation were both less than 3%.Within the scope of 0.207-5.170 mg/L,the linear distribution was fine.The clinical reportable range was 0.207-165.440 mg/L.For samples with D-Dimer5 mg/L and FDP>20 μg/mL,there was obvious antigen excess phenomenon,and gradient dilution was required.Conclusion For samples with D-Dimer>5 mg/L and FDP>20 μg/mL,dilution should be performed to ensure the accuracy of detected results.
ABSTRACT
Objective To establish detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method and evaluate by clinical application.Methods Referring to the Clinical and Laboratory Standards Institute (CLSI) relevant documents,the programme of blank limit (LoB),detection limit (LoD),quantitative detection limit (LoQ),analytical range of measurement (AMR),clinical reportable range (CRR) for detection of anti-HBs by chemiluminescence method,were designed and measured.The established clinical reportable range and maximum dilution were used to predict the recovery stage of acute hepatitis B patients and to evaluate the effectiveness of different vaccines.Results LoB,LoD,LoQ,AMR and CRR for detection of anti-HBs by chemiluminescence method were 0.87,1.89,3.0,0～970.50 and 3.0 ～48 525 mIU/ml respectively,and the maximum dilution was 1 ∶ 50.The patient with acute hepatitis B showed elevated anti-HBs at fourth weeks after treatment (CRR).The anti-HBs mean was the highest in the B vaccine of the three vaccines.Conclusion The establishment of detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method was better meet the requirements of clinical laboratories,provide reliable results for clinical laboratories.