Accuracy study of a novel alternate method measuring erythrocyte sedimentation rate for prototype hematology analyzer Celltac α+

Abstract

Introduction The erythrocyte sedimentation rate (ESR) is a nonspecific inflammation indicator. In laboratory testing, automated ESR analyzers may use the reference Westergren method (Reference WG), modified Westergren (Modified WG), or Alternate ESR method (Alternate ESR) based on photometric rheology. A prototype hematology analyzer Celltac α+ (Nihon Kohden Corporation) with built‐in Novel ESR analysis technology (Novel ESR) was developed to improve the accuracy of Alternate ESR. Alternate ESR uses only the aggregation phase information of Reference WG. The Novel ESR adds sedimentation and packing phase information obtained by hematology analyzer measurands. High correlation with WG was ensured by predicting the ESR value using Hematocrit (Hct) and MCV values as correcting parameters. Methods Novel ESR was compared with Modified WG (MONITOR‐40, Joko Corporation) and Reference WG, according to internationally recognized guidelines: Precision, carryover, limit of quantification, comparability, linearity, accuracy, and fibrinogen sensitivity. Samples from healthy volunteers and clinical patients were used. The correction performance of Novel ESR and Modified WG was compared with Reference WG by regression analysis in three range categories for ESR and measurands affecting ESR correction (Hct, MCV, and MCH). Results Novel ESR showed sufficient basic performance and comparability with Modified WG. In the accuracy study comparing with Reference WG, the regression equation was y = 1.026x + 0.5(r = .945,P < .001;n = 271). When evaluating the correction performance, the slopes were within 0.8‐1.2, except for the high part of Hct. All intercepts were within 10 mm. Conclusion This study validated the correction performance to the initial estimated ESR value by aggregation phase information using information reflecting sedimentation and packing phase obtained from automated hematology analyzer. The Celltac α+ Novel ESR provided results equivalent to Reference WG.

A rapid and accurate method for estimating the erythrocyte sedimentation rate using a hematocrit-corrected optical aggregation index

“…In addition, the device can simultaneously measure the syllectogram and CBC in a few minutes, making it suitable for our ESR estimation methods that require the Ht. The clinical performance of a rapid ESR measuring system using a similar method had been evaluated prior to this report [ 40 ]. In the present study, we clarified the details of the method for calculating the sedimentation rate using the HAI with the optimal measurement time and modified Stokes’ law.…”

Clinical application of a new method for determination of the erythrocyte sedimentation rate using the BC‐720 automated hematology analyzer

“…The 342 samples (covering HTV and LTV) from different departments were selected for comparability evaluation of ESR. The results suggested that the ESR test results of the BC‐720 hematology analyzer had a good correlation with that of the Westergren method, and were superior to most of the similar products reported so far 30,32–34 . Passing–Bablok regression analysis showed that BC‐720 hematology analyzer ( Y = 2.082 + 0.9869 X , r = 0.9657, n = 342) had a better correlation with Westergren method that TEST 1 ( Y = 1.436 + 1.366 X , r = 0.8665, n = 334).…”

“…ESR is the result of the interaction of multiple substances, and the common ESR influencing factors are mainly most substances such as HCT, Fbg, GLB, and ALB 30,34 ; the analytical results of the above four types of abnormal samples showed that the BC‐720 ESR results all correlated well with the Westergren method, indicating that it has certain antiinterference ability.…”

“…This experiment mainly verified the basic and clinical performance of the BC‐720 hematology analyzer. By collecting blood samples with different ranges of different parameters for continuous detection and analysis, the LTV and HTV ESR values all showed good repeatability, the results of samples in each range were good, and the SD and CV were lower than the manufacturer's claims, similar performance to similar product, 29,30 which is important for monitoring and follow‐up of clinical diseases. The d value and d % of the low‐temperature samples were in line with the requirements of the manufacturer, but the low‐temperature samples had lower values at 12 h than at 24 h, possibly due to the automatic dissolution of Fbg within 12 to 24 h, that is, related to Fbg dissolution 31 .…”

“…The results suggested that the ESR test results of the BC-720 hematology analyzer had a good correlation with that of the Westergren method, and were superior to most of the similar products reported so far. 30,[32][33][34] Passing-Bablok regression analysis showed that BC-720 hematology analyzer (Y = 2.082 + 0.9869X, r = 0.9657, n = 342) had a better correlation with Westergren method that TEST 1 (Y = 1.436 + 1.366X, r = 0.8665, n = 334). Due to the large volume of blood required for the TEST 1 test, the number of samples for TEST 1 test is smaller than that of the BC-720 blood cell analyzer.…”