Dilution validation of high level D-dimer samples in Sysmex CS5100 instrument
10.3969/j.issn.1673-4130.2017.12.017
- VernacularTitle:Sysmex CS5100检测高浓度D-二聚体的稀释验证分析
- Author:
Nan YAN
;
Ling QU
;
Shanluan ZHENG
;
Xiaoke HAO
- Keywords:
Sysmex CS5100;
D-dimer;
within-batch;
between-run precision;
linear range;
clinical reportable range;
high concentration;
dilution
- From:
International Journal of Laboratory Medicine
2017;38(12):1630-1633
- CountryChina
- Language:Chinese
-
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-Dimer<5 mg/L and fibrinogen degradation products(FDP)<20 μg/mL were serially diluted and detected to calculate recovery rate.Samples with D-Dimer>5 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-Dimer<5 mg/L and FDP<20 μg/mL,no antigen excess phenomenon was found,and gradient dilution was not necessary.For samples with D-Dimer>5 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.
