Method Comparison of Erythrocyte Sedimentation Rate Automated Systems, the VES-MATIC 5 (DIESSE) and Test 1 (ALIFAX), with the Reference Method in Routine Practice.

Background: The erythrocyte sedimentation rate (ESR) is a routine and aspecific test that is still widely used. The reference-manual method for ESR determination is the Westergren method. The VES-MATIC 5 is a novel, fully automated, and closed system based on a modified Westergren method. This study conceived the aim of comparing two ESR analytical analysers, Test 1 and the VES-MATIC 5, with the reference method in routine practice. Methods: This study included 264 randomly analysed samples. A comparison between the two methods and Westergren was performed, and they were evaluated for inter-run and intra-run precision. In addition, we investigated possible interferences and different sensitivities to conventional analytes. Results: The comparison of methods by Passing-Bablok analysis provided a good agreement for both systems, with a better correlation for VES-MATIC 5 (p = 0.96) than Test 1 (p = 0.93), and sensitivity studies did not show any significant influence. Conclusions: The VES-MATIC 5 analyser demonstrated excellent comparability with the reference method, and it had better performance than Test 1. It can be employed in routine practice, bringing advantages such as a reduction in the probability of human error compared to the manual method, as well as an increase in operator safety and environmental protection.

Performance evaluation of alternate ESR measurement method using BC-780 automated hematology analyzer: a comparison study with the Westergren reference method.

OBJECTIVES: Implementation of alternate erythrocyte sedimentation rate (ESR) measurement method is increasing worldwide due to its various advantages. In this study, we aim to evaluate the analytical performance of the BC-780 automated hematology analyzer in measurement of ESR value. METHODS: Analyzer performance including precision study, carryover, sample stability and potential interferences are examined. Samples with ESR values spanning the whole analytical ESR range are included for method comparison study. Samples with different hematocrit (Hct) and mean corpuscular volume (MCV) values are also analyzed and compared with the results obtained from the Westergren reference method. RESULTS: Precisions and carryover results are consistent with the manufacturers' claim. ESR values do not change significantly in the samples stored at 2-8 °C for 24 h (h) or at room temperature (RT) for 8 h, but significantly decreased (p<0.001) when stored at RT for 24 h. Significant increase in ESR value is documented in samples that are hemolyzed (hemoglobin concentration ranged from 1.28-6.01 g/L) (p=0.010) or lipemic (triglyceride above 4.75 mmol/L) (p=0.001). Method comparison study yields a proportional difference with a regression equation=3.08+ 0.98x. Bland-Altman analysis shows a mean absolute bias of 3.12 mm. The obtained absolute mean biases are below 5 mm in all analytical categories except for the group where MCV>100 fL. CONCLUSIONS: Most tested parameters met the manufacturer's specifications and were comparable to the reference method. Despite the presence of positive bias, it falls within acceptable criteria. Extensive validation against potential interferences such as hemolysis/lipemia is still necessary in future.

Differential diagnosis of increased Erythrocyte Sedimentation rate.

The paper is aimed at differential diagnosis of increased sedimentation rate (ESR) from the point of internal medicine. After the interpretation of the term we describe the technique of the examination and possible errors in pre-analytical as well as analytical phase. The paper includes ranges for conventional FW assessment (analysis of ESR based on Fahraeus-Westergren) and the characteristics of newer methods. We list the overview of the most common causes that affect faster or slower ESR. The stress is put on the assessment of the causes of increased ESR and its persistence from the perspective of clinical practice, we also describe diseases with slower ESR. Attention is drawn to the comparison of the results of the most common acute phase reactants, especially to discordant results of ESR, CRP and procalcitonin in the serum, and to the contribution of the analysis of ESR and CRP in selected diseases. The final part is aimed at the correct diagnostic approach when assessing increased ESR of unknown etiology, underlining the significance of the patient´s history, physical examination and the position of basic as well as complementary laboratory methods and examinations including imaging techniques.

Analytical and Clinical Evaluation of Two Methods for Measuring Erythrocyte Sedimentation Rate in Eastern Indigo Snakes (Drymarchon couperi).

Erythrocyte sedimentation rate (ESR) is a hematological test that can detect inflammatory activity within the body. Although not specific for any particular disease, ESR is often used as a screening "sickness indicator" due to its reliability and low cost. The Westergren method is a manual ESR technique commonly used but requires special graduated pipettes and over 1mL of whole blood, precluding its use in smaller patients where limited sample volumes can be obtained. A modified micro-ESR technique has been described using hematocrit capillary tubes but is used less commonly. ESR has been reported to be a useful inflammatory indicator in gopher tortoises (Gopherus polyphemus) and box turtles (Terrapene spp.) but not in Florida cottonmouth snakes (Agkistrodon conanti). Having an inexpensive screening test for inflammation can help guide medical decisions within conservation efforts of imperiled species. This study evaluated the correlation between these two ESR methodologies in threatened eastern indigo snakes (Drymarchon couperi, EIS) and found a very strong correlation (rs = 0.897), without constant or proportional biases and a reference interval of 0 (90% CI -1-1)-9 mm/h (90% CI 8-11) was defined. Additionally, a significant difference was found between healthy EIS and EIS in mid-ecdysis (p = 0.006) and EIS with gastric cryptosporidiosis (p = 0.006), indicating ESR as a useful inflammatory indicator in EIS.

Analytical validation of the modified Westergren method on the automated erythrocyte sedimentation rate analyzer CUBE 30 touch.

OBJECTIVES: Analytical validation of automated erythrocyte sedimentation rate (ESR) analyzers is necessary prior to their implementation into routine practice. Our aim was to perform the analytical validation of the modified Westergren method applied on the CUBE 30 touch analyzer (Diesse, Siena, Italy). METHODS: Validation included determination of within-run and between-run precision following the Clinical and Laboratory Standards Institute EP15-A3 protocol, comparison with the reference Westergren method, sample stability assessment at both room temperature and 4 °C, after 4, 8 and 24-h storage, and checking the extent of hemolysis and lipemia interference. RESULTS: Coefficients of variation (CVs) for within-run precision were 5.2% for the normal and 2.6% for the abnormal range, while between-run CVs were 9.4 and 2.2%, respectively. Comparison with the Westergren method (n=191) yielded Spearman's correlation coefficient of 0.93, no constant nor proportional difference [y=0.4 (95% CI: -1.7-1.0) + 1.06 (95% CI: 1.00-1.14)x] and a non-significant mean absolute bias of -2.6 mm (95% CI: -5.3-0.2). Lower comparability was evidenced with increasing ESR values, with both constant and proportional differences for ESR values between 40 and 80 mm, and above 80 mm. Sample stability was not compromised up to 8-h storage both at room temperature (p=0.054) and 4 °C (p=0.421). Hemolysis did not affect ESR measurement up to 1.0 g/L of free hemoglobin (p=0.089), while lipemia index above 5.0 g/L affects the ESR result (p=0.004). CONCLUSIONS: This study proved that CUBE 30 touch provides reliable ESR measurement and satisfactory comparability with the reference Westergren methods, with minor variation related to methodological differences.

Performance comparison of Westergren modified SRS 100/II and alternate iSED® method for erythrocyte sedimentation rate.

INTRODUCTION: The erythrocyte sedimentation rate (ESR) includes three phases, each prone to different interferences. Due to many disadvantages of the reference Westergren method, modified and alternate methods have been introduced. The aim of this study was to compare the modified Westergren method on SRS 100/II analyzer in citrate blood with the alternate method on iSED® analyzer in EDTA sample. Additionally, possible interfering factors and ESR stability during 6 h at room temperature were evaluated. METHODS: A total of 188 samples were included in the method comparison. Additionally, the effects of inflammation, haematocrit and MCV values on ESR were evaluated. To determine ESR stability in different samples, ESR was evaluated at three time points; within 15 min of blood sampling and after 3 and 6 h in different sample types and analyzers (N = 65). RESULTS: Results indicated the constant difference between tested methods with obtained mean bias of 5 mm (95% CI: 3-7). There was higher absolute mean bias in groups with ESR > 40 mm and elevated inflammation markers (p < 0.001). Regarding different MCV and haematocrit groups there was no statistically significant difference in obtained absolute mean biases for MCV (p = 0.087) while there was higher bias in low haematocrit group compared to normal haematocrit (p = 0.004). In addition, there was a significant difference between ESR values at different time points for iSED® (p < 0.001) and no difference for SRS 100/II analyzer (p = 0.406). CONCLUSION: There are differences in ESR values between tested methods. EDTA sample on iSED® should be analysed as soon as possible to avoid falsely increased ESR.

Evaluation of the ESR fast detector and Improve® ESR analyzer as modified Westergren methods for erythrocyte sedimentation rate.

The erythrocyte sedimentation rate (ESR) has been commonly ordered in hematology laboratories and used to screen for monitoring responses to therapy and identifying inflammatory conditions. To overcome the limitations of traditional ESR measurements, various methods have been developed and compared to the established reference method. This study evaluates the analytical performance of ESR fast detector and Improve® ESR analyzer compared to the reference method. Method validation and comparison were performed in 189 volunteer blood samples according to the International Council for Standardization in Hematology recommendations. The analytical efficacy of ESR fast detector and Improve® ESR analyzer was also assessed and compared with the reference method and C-reactive protein (CRP) levels. The results demonstrated that the precision of ESR fast detector and Improve® ESR analyzer was considered as the acceptance criterion for the ESR measurement. The method comparison analysis between the two modified Westergren methods and reference method demonstrated a strong correlation with the Spearman's rank correlation coefficient of 0.94, with a mean difference of -2.1 and -7.7 mm/h in the ESR fast detector and Improve® ESR analyzer, respectively. Analysis of the area under the receiver operating curve illustrated a high analytical performance compared to the reference method and CRP level. The measurement of ESR level using the ESR fast detector and Improve® ESR analyzer is a reliable method and has a high analytical performance, which can be used instead of the reference method for screening inflammatory conditions.

Performance evaluation of the BC-720 auto hematology analyzer and establishment of the reference intervals of erythrocyte sedimentation rate in healthy adults.

Background: Erythrocyte sedimentation rate (ESR) is a new reporting parameter of the BC-720 auto hematology analyzer; however, no biological reference interval for healthy adults has been established for this parameter. Methods: Outpatients or hospitalized patients with ESR test orders were selected. The ESR was measured by the standard method of ESR (Westergren) recommended by the International Council for Standardization in Hematology (ICSH), the BC-720 hematology analyzer, and the LBY-XC40B auto ESR analyzer. The data were statistically analyzed and compared among different methods. The repeatability and carryover rate (CR) of the BC-720 were assessed in randomly selected samples for each range segment. Blood Samples from three hospitals in China were collected, and the reference interval of the BC-720 ESR was determined. Results: The ESR results measured by the BC-720 correlated well with the Westergren method (r=0.957, y = 0.359 + 1.016x), and there was no significant difference between these two methods (P>0.05). The correlation between LBY-XC40B auto ESR analyzer and Westergren was y = 1 + 1.25x and r=0.856. The BC-720 ESR has good repeatability [standard deviation (SD) ≤1 mm/h, coefficient of variation (CV) ≤5%], and the CR was less than 1%. The 95th percentile of the biological reference interval for BC-720 ESR is 15 mm/h for men and 24 mm/h for women. Conclusions: The Mindray BC-720 ESR showed high accuracy and good repeatability, which provided a faster, safer, and more reliable method to measure ESR. The reference intervals for BC-720 ESR could guide better clinical decisions for the laboratories utilizing this new method.

Erythrocyte sedimentation rate measurements using MIX-RATE® X20 and VISION A automated analyzers: Method validation and comparison study.

BACKGROUND: The Westergren method for erythrocyte sedimentation rate (ESR) measurement has a few drawbacks such as being a time-consuming process, poses a risk of biohazard exposure and requires high sample volume. Recent alternative methods and analyzers were developed to overcome those limitations. In this study, we validated two automated ESR analyzers, MIX-RATE® X20 and VISION A, and assessed their analytical performance against the Westergren method. METHODS: The analyzers were validated for inter-run and intra-run precision. Hemolysis interference and sensitivity to fibrinogen were also analysed. Analytical performance was performed using 177 patient samples spanning low (<40 mm/h), medium (40-80 mm/h), and high (>80 mm/h) ESR ranges. Method agreement and bias against the Westergren method were calculated. RESULTS: The highest intra-run imprecision was seen in the low ESR range for both analyzers. They showed very high agreement with the Westergren method assessed by Spearmen rank correlation coefficient analysis, r = 1.000, p < .0001 for both analyzers. Bland-Altman analysis yielded overall insignificant mean biases for all comparisons. However, systematic positive and negative bias were observed at medium and high ESR levels analysed by MIX-RATE® X20 while negative bias was evidenced in the high ESR level measured by VISION A. CONCLUSIONS: Overall, results from both automated ESR analyzers showed comparable analytical performance with the Westergren method especially for low ESR levels. However, both positive and negative systematic bias were documented in the high levels. Thus, for clinical use, it must be assessed whether these biases could affect the cut-off for significant clinical values.

Effect of storage temperature and time on erythrocyte sedimentation rate.

OBJECTIVE: This paper explores the effect of blood sample storage temperature and time on the erythrocyte sedimentation rate (ESR) by using the Weiss method. METHODS: Whole blood samples were collected from 80 patients and diluted 1:9 with sodium citrate solution. Each sample was split into two tubes. Using the Weiss method, ESR was tested within 1 h of collection, and one sample was placed at 4 °C and the other at room temperature (23 ± 2 °C). ESR was then measured at 2, 4, 6, 8, 12, and 24 h. The data were statistically analyzed with consideration for temperature and time. RESULTS: ESR decreased gradually over 6 h at room temperature, but the results were not statistically significant. Similarly, there was no significant difference in the decline of ESR within 8 h at 4 °C. However, ESR results decreased significantly after the samples were stored at room temperature for more than 6 h or at 4 °C for more than 8 h. ESR reduction was lower in the samples stored at 4 °C than in those stored at room temperature over the same time period. CONCLUSION: Blood sample storage temperature and duration can affect the measurement of ESR using the Weiss method. ESR testing should be completed within 4 h of sample collection in clinical work.

The VES-Matic 5 system: performance of a novel instrument for measuring erythrocyte sedimentation rate.

OBJECTIVES: The VES-Matic 5 is an automated analyzer that assesses erythrocyte sedimentation rate based on a modified Westergren sedimentation technique. Instrument performance was established by addressing the recommendations of the International Council for Standardization in Haematology. METHODS: Comparison against the reference Westergren method was performed for all samples, and further for the low, middle, and upper third of the analytical range. Intra-run precision, inter-run precision, and interference studies were further assessed. This study included the evaluation of reference ranges. RESULTS: The comparison of methods by Passing-Bablok analysis has shown a good agreement without systematic or proportional differences. The regression equation was y=-0.646 + 0.979x. The mean bias of -0.542 was obtained by Bland-Altman analysis and the upper limit of 8.03 with the lower limit of -9.11 can be considered clinically acceptable. Intra-run and inter-run precision were good for each parameter and interference studies did not show any significant bias with exception of anemia samples, which showed a proportional difference when comparing high erythrocyte sedimentation rate values. Using the local adult reference population, we verified the reference ranges in comparison to those available in the literature, and according to the Clinical Laboratory Standards Institute (CLSI) EP28-A3C document. We determined the upper limit partitioned by gender and the following age groups: from 18 to 50, from 50 to 70, and over 70. CONCLUSIONS: The VES-Matic 5 analyzer presented good comparability with the reference method. As there are commercial quality control and suitable external quality assessment (EQA) material and programs, the VES-Matic 5 can be employed appropriately for routine purposes.

Verification of automatic analysers Roller 20PN and iSED for measuring erythrocyte sedimentation rate.

INTRODUCTION: Automated erythrocyte sedimentation rate (ESR) analysers are based on different methodology than Westergren method. It is questionable whether ESR values obtained from those analysers are comparable with determined values with Westergren method. The aim was verification of the precision, method comparison and accuracy of automated ESR analysers: Roller 20PN (Alifax S.p.A., Polverara, Italy) and iSED (Alcor Scientific, Smithfield, USA). MATERIALS AND METHODS: Blood samples (N = 752 for Roller 20PN and N = 213 for iSED) were sampled into K2EDTA (Kima, Italy) tubes for automated and 3.8% Na-citrate tubes (Kima, Italy) for Westergren method. The data was divided into three groups according to the ESR values obtained with the Westergren method: Group Low (L) (ESR ≤ 20 mm), Group Medium (M) (ESR 21-60 mm), and Group High (H) (ESR ≥ 61 mm). Method agreement was assessed by Bland-Altman analysis and Passing-Bablok regression. RESULTS: Analyser iSED has shown better comparability with Westergren method (bias 0.0 (95%Cl -1.4 to 1.5) range than Roller 20 PN (bias = - 6.4 (95%Cl - 7.1 to -5.7) in the whole measuring. For Roller 20 PN, Passing-Bablok regression has shown constant and proportional difference for Groups L and M, and for iSED only for Group H. Roller 20 PN had lower sensitivity (0.51 (95%Cl: 0.45-0.57) than iSED (0.72 (95%Cl: 0.59-0.80) while they had comparable specificity (> 0.90) and accuracy (≥ 0.80) in comparison with the Westergren method. CONCLUSION: Both analysers are not comparable with the Westergren method and should not be used interchangeably.

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

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.

Comparison of the StaRRsed Interliner device with Westergren method in erythrocyte sedimentation rate measurement.

INTRODUCTION: With recent advances in technology, many manual tests are being replaced by automated devices due to a wide range of advantages. One of these tests is the erythrocyte sedimentation rate (ESR) test that is used to determine inflammatory activity. This study aimed to evaluate the agreement between the Starrsed Interliner sedimentation device and the gold standard method, that is the Westergren method, used in ESR measurement. METHODS: One hundred fifty-one patients who presented to Gaziantep University Faculty of Medicine, Sahinbey Training and Research Hospital were included in this study. ESR values were measured simultaneously within 2 hours using the ESR analyzer Starrsed Interliner device and the gold standard method of measuring ESR, that is the Westergren method, from blood samples collected from the same patients in EDTA and citrate tubes. RESULTS: Agreement between the results from the Starrsed Interliner device and the Westergren method was evaluated using the Intraclass Correlation method. Consequently, a poor correlation was observed at values <20 mm/h, a moderate correlation was observed at values 20 to 80 mm/h and >80 mm/h, and an excellent correlation was observed when all results were considered. Method comparison was conducted according to the Passing-Bablok regression analysis (y = -1.50 + 0.75x) (P < .0001). The mean difference between the two methods was 10.1 according to the Bland-Altman analysis. CONCLUSIONS: Despite the advantages of the Starrsed Interliner device, such as lower laboratory workloads, lower costs and turnaround time, the difference between the two methods, as found in this study, may lead to different clinical interpretations for results in some patient.

Evaluation of the Diesse Cube 30 touch erythrocyte sedimentation method in comparison with Alifax test 1 and the manual Westergren gold standard method.

The erythrocyte sedimentation rate (ESR) is a traditional nonspecific laboratory test used for the assessment of inflammation. Even if its usefulness is nowadays being largely debated, it is still considered a valuable laboratory test in selected clinical conditions, such as rheumatoid diseases, orthopedic infections and Hodgkin's lymphoma, and it can be used for the infectious, inflammatory, malignancies, and autoimmune diseases follow-up. The introduction of new methodologies on semi-automated and automated analyzers started about four decades ago and opened a new era of ESR analysis characterized by shorter assay time, use of (EDTA) undiluted blood, that increases sample stability and allows using a single sample for also other hematologic tests, and greater safety for laboratory personnel. In this context, the aim of this study was to evaluate the performances of new device Diesse Cube 30 touch, comparing it with Alifax Test 1 and with the gold standard Westergren method. The new Diesse Cube 30 touch for determination of the ESR shows a good correlation with the manual Westergren gold standard method in a shorter time, and in a standardized way, since all the phases of the test are automatized. The Diesse Cube 30 touch respect the manual gold standard method, displayed a small bias to confirm that the new automated test system tended to have a small bias for ESR values (mean positive bias +0.2 mm/h). The findings of the present study show that the Diesse Cube 30 touch Westergren-based method can be a valid alternative in laboratory analysis for the determination of ESR.

A comparison of erythrocyte sedimentation rates of bloods anticoagulated with trisodium citrate and EDTA among TB presumptive patients at the University of Gondar comprehensive specialized hospital, northwest Ethiopia.

OBJECTIVE: The purpose of this study was comparing the erythrocyte sedimentation rate (ESR) results of trisodium citrate (TSC) and ethylene diamine tetra-acetic acid (EDTA) anticoagulants. A comparative cross-sectional study was conducted at the University of Gondar specialized referral hospital, northwest Ethiopia. A total of 70 TB presumptive participants were recruited. From each of the 70 participants of the study, 3 and 1.6 ml of blood was collected in EDTA tubes and 0.4 ml of trisodium Citrate anticoagulant containing test tubes, respectively. RESULTS: The mean ± SD values of ESR were 57.9 ± 41.45 mm/h in EDTA and 50.99 ± 43.5 mm/h in TSC anticoagulated blood. The mean difference of ESR values between EDTA and TSC blood (6.91 ± 13.66 mm/h) was statistically significant. The Mean ± SD of ESR values using EDTA and TSC in males were 59.57 ± 42.31 and 53.57 ± 44.61 mm/h while for females it was 54.71 ± 40.44 and 46.04 ± 41.82 mm/h, respectively. The study indicated that there was a significant difference between ESR values with EDTA and TSC anticoagulants.

Analytical validation of the iSED automated analyzer for erythrocyte sedimentation rate.

INTRODUCTION: iSED is an alternate automated analyzer for erythrocyte sedimentation rate (ESR) based on photometric rheology technology that estimates ESR by measuring rouleaux formation. The aim was to evaluate the analytical performance of the iSED analyzer and compare the results with the Westergren method and another alternate ESR analyzer, TEST1. METHODS: Validation was performed at two study sites according to the recommendations by the International Council for Standardization in Haematology and included determination of intrarun precision and inter-run precision, bias, carryover, and method comparison, which was further assessed for samples with normal and low hematocrit, as well as per low, middle, and upper third of the analytical range. RESULTS: Intrarun coefficients of variation (CVs) with commercial controls were 4.0% and 1.8%, while inter-run CVs 7.5% and 0.7%, for the normal and pathological range, respectively. Intrarun CVs obtained with patient samples were 19.9%, 9.9%, 10.3%, and 9.4%, the highest being for the lowest ESR value. Correlation coefficients for the comparison between iSED and Westergren were 0.862 (Site-1) and 0.916 (Site-2). While proportional difference with a positive bias was revealed at Site-1, comparison at Site-2 showed both constant and proportional difference and a negligible negative bias. Higher correlation was obtained for samples with low than normal hematocrit. Comparison between iSED and TEST1 yielded a correlation coefficient of 0.986, constant and proportional difference, and positive bias. Carryover was 3.2%. CONCLUSION: This study proved the analytical validity of the iSED analyzer, despite minor discrepancies to the Westergren method that can be attributed to methodological differences.

Automated measurement of the erythrocyte sedimentation rate: method validation and comparison.

Background Development of automated analyzers for erythrocyte sedimentation rate (ESR) has imposed the need for extensive validation prior to their implementation in routine practice, to ensure comparability with the reference Westergren method. The aim of our study was to perform the analytical validation of two automated ESR analyzers, the Ves-Matic Cube 200 and the TEST1. Methods Validation was performed according to the recent International Council for Standardization in Hematology recommendations and included determination of intrarun and inter-run precision, assessment of sample carryover, hemolysis interference, sensitivity to fibrinogen, method comparison with the gold standard Westergren method and stability test. Results The highest intrarun imprecision was obtained for the low ESR range (33.5% for Ves-Matic Cube; 37.3% for TEST1) while inter-run coefficients of variation on three levels were much better for the TEST1 (0%, 2% and 1.2%) compared to the Ves-Matic Cube 200 on two levels (24.9% and 5.8%). Both Ves-Matic Cube 200 and TEST1 showed no statistically significant difference when compared with Westergren. Bland-Altman analysis yielded overall insignificant mean biases for all comparisons, but a wider dispersion of results and 95% limits of agreement for comparisons including the Ves-Matic Cube 200. Carryover was considered insignificant, while hemolysis had a negative effect on all assessed ESR methods. The highest sensitivity to fibrinogen was observed for the Ves-Matic Cube 200, followed by Westergren and the least sensitive was the TEST1. Conclusions The obtained results proved the analytical validity of the TEST1 and the Ves-Matic Cube 200, and high comparability with the gold standard Westergren method, showing obvious improvements in standardization of ESR methods.

Test-1 analyzer and conventional Westergren method for erythrocyte sedimentation rate: A comparative study between two laboratories.

BACKGROUND: Measurement of the length of sedimentation reaction in blood (LSRB), also called erythrocyte sedimentation rate (ESR), is a widely used hematology test. This study intends to compare ESR levels measured by Test-1 method and International Council for Standardization in Hematology's (ICSH) reference method, and analyzes the effect of hematocrit (Hct) on ESR results. MATERIAL AND METHODS: A total of 755 patients from 2 hospitals were included in the study, and samples with EDTA were studied by Test-1 method for ESR measurement and total blood count, whereas citrated samples were studied with reference Westergren method. Then, 2 methods were compared. Distribution of ESR results according to the ESR(≤20, >20 mm/h) and Hct(≥35%, <35%) levels and hospital type was analyzed. ESR levels with Hct levels<35% were corrected with Fabry's formula. RESULTS: The mean and SD values for the Test-1 method, reference Westergren method, and corrected ESR measurement were 21.30 ± 18.39, 28.59 ± 25.82, and 24.92 ± 20.58 mm/h, respectively. Within the whole group, the correlation coefficient (r) was .77 (.7-.80) with a significance level P < .001. Passing-Bablok regression analysis of the methods resulted in a regression equation y = 1.00 (95% Cl: 0.43-1.88) + 0.75 (95% Cl: 0.70-0.78)x while the significance of linearity was acceptable (P < .01). All subgroup linear regression analyses revealed that the correlation was acceptable, except ESR > 20 mm/h group, Hct < 35% group, and corrected ESR group (significance level were P > .10). CONCLUSION: The study showed that the role of the hospital and the capacity of testing are important in choosing the instrument for measuring ESR. Furthermore, the patient profile, especially malignancy possibility and Hct level, may be important for instrument selection.

Application evaluation of Monitor-20 automated erythrocyte sedimentation rate analyzer / 国际检验医学杂志

Objective To evaluate the comparability of erythrocyte sedimentation rate (ESR) between the Monitor‐20 automated ESR analyzer and manual Westergren method .Methods ESR of 50 clinic samples were detected by Monitor‐20 automated ESR an‐alyzer and Westergren method respectively ,and the results of ESR were compared analyzed .Results There there was no significant differences between ESR results detected by by Monitor‐20 automated ESR analyzer and Westergren method (t= 0 .4673 ,P> 0 . 05) .The satisfactory correlation was founded between the two method (r=0 .9890 ,P<0 .01) .Conclusion There may be a satisfac‐tory correlation between Monitor‐20 automated ESR analyzer and manual Westergren method in the determination of ESR .Monitor‐20 automated ESR analyzer could be a rapid ,precise ,accurate method in measuring ESR ,and could be worthy to extend the applica‐tion in clinic .