ABSTRACT
BACKGROUND: The erythrocyte sedimentation rate (ESR) is a nonspecific inflammatory indicator and is widely used in clinical diagnosis. Westergren is the gold standard method recommended by the International Committee for Standardization of Hematology (ICSH), but it is time-consuming and inconvenient and has biosafety risks. A new alternate method for ESR (Easy-W ESR) measurement was designed and integrated into the Mindray BC-720 series automated hematology analyzer to meet the clinical needs of hematology laboratories for efficiency, safety, and automation. In this study, the performance of the new ESR method was evaluated based on the ICSH recommendations on modified and alternate ESR methods. METHODS: Methodological comparisons using the BC-720 analyzer, TEST 1, and the Westergren method were performed to assess repeatability, carryover, sample stability, reference range validation, factors influencing the ESR, and clinical applicability in rheumatology and orthopedics. RESULTS: The correlation between the BC-720 analyzer and the Westergren method was good (Y = 2.082 + 0.9869X, r = 0.9657, P > 0.0001, n = 342), carryover was <1%, the repeatability standard deviation was ≤1 mm/h, and the coefficient of variation (CV) was ≤5%. The reference range meets the manufacturer's claim. For rheumatology patients, the BC-720 analyzer showed a good correlation with the Westergren method (Y = 1.021X-1.941, r = 0.9467, n = 149). For orthopedic patients, the BC-720 analyzer also showed a good correlation with the Westergren method (Y = 1.037X + 0.981, r = 0.978, n = 97). CONCLUSION: This study verified the clinical and analytical performance of the new ESR method, indicating that the results are very similar to those obtained using the Westergren method.
Subject(s)
Hematology , Humans , Blood Sedimentation , Hematology/methods , Reference Standards , Research Design , AutomationABSTRACT
Background: The accuracy of low-value platelet (PLT) testing is a key reference for clinical decision-making regarding PLT transfusion or surgery. This study aimed to evaluate the capability to detect low-value PLT of the 8 times optical platelet counting (PLT-8X) mode of the BC-6800Plus auto hematology analyzer. Methods: Totally 40 fresh anticoagulated venous whole blood samples with PLT ≤50×109/L were collected from the clinical laboratory at the First Affiliated Hospital of Soochow University to evaluate the precision of low-value PLT in PLT-8X mode. Moreover, 67 samples with PLT <100×109/L were collected, and a methodological comparison was conducted between the results of PLT-8X and those obtained by the reference method [red blood cell (RBC)/PLT ratio method] recommended by the International Committee for Standardization of Hematology (ICSH). In addition, fresh whole blood and PLT-free plasma were used to prepare samples at a series of concentrations within the low-value ranges to evaluate the linearity of PLT and finally investigate the limit of blank (LoB) and limit of detection (LoD) for low-value PLT in PLT-8X mode. Results: The precision low-value PLT in PLT-8X mode was significantly superior to that in PLT-I (P<0.0001); and the correlation coefficient of PLT-8X mode compared with the reference method of flow cytometer was 0.992. The expected bias at the low-value medical decision levels (5×109/L, 10×109/L and 20×109/L) of PLT fell within the range of ±1.0×109/L, and that at 50×109/L fell within the range of ±1.5×109/L. In addition, the correlation coefficient of PLT-8X in the low-value ranges (0 to 30×109/L and 0 to 100×109/L) of PLT was greater than 0.99, and its nonlinear coefficients were not significantly different from 0 (P>0.05). Finally, the LoB and LoD of PLT-8X mode were 0.33×109/L and 0.89×109/L, respectively. Conclusions: The PLT-8X mode of the BC-6800Plus auto hematology analyzer has extremely low detection sensitivity for low-value PLTs in anticoagulated venous whole blood samples. With good linearity, its precision and accuracy can sufficiently meet the needs for hematology laboratory use, and it can effectively help clinicians to accurately diagnose and treat patients with thrombopenia-related diseases.