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The first method, the Ves‐Matic Cube 200, uses analog sensors and provides a 20‐min ESR result normalized due to the Westergren international standard 6. Automated measurement of the erythrocyte sedimentation rate: method validation and comparison. Between‐run precision was performed with normal and abnormal controls which were analyzed three times a day for five consecutive days. Patients’ samples with low (<20 mm/hr), medium (20–80 mm/hr), and high (>80 mm/hr) levels of ESR were analyzed by 20 replicate measurements in the iSED and Ves‐Matic Cube 200. We found a negative correlation between ESR results of the Ves‐Matic Cube 200 and iSED with hematocrit levels (r = −0.615, r = −0.441, respectively; P < 0.0001, P < 0.0001, respectively). The Bland‐Altman difference plot was used to assess the absolute differences, and a Deming regression analysis was used to determine the degree of correlation between the iSED and StaRRsed analyzers. Adult and pediatric samples with adequate volume (>4 mL) from inpatients and outpatients which covered ESR values in the analytical range of 2‐120 mm/h were randomly selected in May 2018.15 Samples were collected in K2EDTA tubes or BD Microtainer MAP microtubes (Vacutainer, Becton Dickinson, UK). Please call customer service for assistance: 1-800-766-7000. In the microflow cell, RBC aggregation is directly measured by an optical detector in 20 seconds. Learn about our remote access options, Clinical Biochemistry Laboratory, Ankara Numune Education and Research Hospital, Ankara, Turkey, Clinical Biochemistry Department, Yıldırım Beyazıt University Medical Faculty, Ankara, Turkey. The iSED sedimentation method (n = 136) yielded a slope of (0.61–0.84), with an intercept of (−2.32 to 1.89), which resulted in a mean bias of 13; and the Ves‐Matic Cube 200 method (n = 136) yielded a slope of (0.85–1.00), with an intercept of (0.00–3.07), which resulted in a mean bias of 1.4 in Passing–Bablok regression analysis compared to the reference method. The conventional manual Westergren method was applied by diluting four volumes of blood with one volume of sodium citrate, according to the ICSH protocol 5. Precision, stability, and interference studies of the methods were performed. Seditrol commercial controls (Alcor Scientific, Rhode Island, USA) used for the evaluation were supplied by the manufacturer. But we did not face this problem because we used dry EDTA 6. A limitation of this study is that samples with interfering substances such as fibrinogen and paraprotein, which increase rouleaux formation, were not collected during the study period. According to Bland–Altman analysis, this resulted in a mean bias of 13 (95% limit of agreement between 61.6 and −35.7). Although traditional Westergren method is accepted as the gold standard method for the measurement of ESR, but being time‐consuming, laborious, and having contamination risks 2 it is not preferred for routine use. The system works directly from dry EDTA tube. Learn more. Similarly, hemolysis does cause a falsely low ESR measurement in Ves‐Matic Cube 200 (P = 0.005). Lipemia and hemolysis were performed for interference studies. Statistical significance was assumed to be P < 0.05. Analysis was performed on K2EDTA samples at three ESR measurement ranges (<20, 20‐80 and >80 mm/h) in 120 pediatric and adult inpatients and outpatients over a 2‐week period. Measurement of ESR was performed in iSED (Alcor Scientific) at fresh, 4, 6, 8, 24 hr after blood samples were drawn and after storage for 24 hr either at 4°C or room temperature (RT). This was not clinically significant and within the manufacturer's limit. Biederman et al19 reported a mean bias of 6 ± 36 mm/h at ESR levels > 30 mm/h when compared to the Streck ESR Autoplus (Streck, Omaha, NE). Sezer et al. This prospective study included blood samples from 136 patients (87 females and 49 males) selected randomly from both inpatients and outpatients who were admitted to Ankara Numune Education and Research Hospital in June 2013. As a result, the iSED analyzer cannot be used interchangeably with the Westergren method because of its poor correlation and high bias. The iSED device gives the results in 20 sec and the results are expressed as millimeter per hour. 12.3.0.0) and “The Statistical Package for Social Sciences for Windows” (SPSS v18) software. Ten randomly selected samples were measured by the iSED and Ves‐Matic Cube 200 analyzers. According to CLSI H2‐A4 guideline, acceptable performance limits are defined for different ESR concentrations 7 and CVs% (where CV is coefficient of variation) calculated from acceptable performance limits are between 10.88 and 38.88 for different ESR values. Learn about our remote access options, Clinical Biochemistry Laboratory, Ankara Numune Education and Research Hospital, Ankara, Turkey, Clinical Biochemistry Department, Yıldırım Beyazıt University Medical Faculty, Ankara, Turkey. The results are given in millimeter per hour. Sezer et al. The calculations were performed by using “MedCalc” statistical software (ver. ESR results of the iSED, when the specimens are stored at room temperature, did not change significantly after 24‐hr collection but ESR results of refrigerated samples increased significantly. Analytical validation of the iSED automated analyzer for erythrocyte sedimentation rate. Treated samples with lipid solution and hemolysate solution were labeled as “Spiked” and untreated samples were identified as “Neat.”. The high ESR results can be observed in various infectious diseases, infarctions, malignancies, and autoimmune diseases 3. Ninety‐nine volumes blood and one volume lipid solution were mixed. They suggested the use of four‐sample DMV ESR analyzer instead of the Westergren method for ESR measurements in hospitals or clinical laboratories 10. iSED sedimentation showed a poor correlation and a high bias (>10%) with the Westergren method, and Ves‐Matic Cube 200 method showed a higher correlation and a lower bias than the iSED device when compared with Westergren reference method. Perovic et al. Sezer et al. Learn more. The within‐run imprecisions were 14.2%, 8.92%, and 8.48% for the iSED and 19.9%, 10.1%, and 9.90% for the Ves‐Matic Cube 200 in low, medium, and high levels, respectively. We aimed to compare the instruments using new methods, iSED (Alcor Scientific) and Ves‐Matic Cube 200 (Diesse Diagnostica Senese, Italy) with the Westergren method. Comparison of two methods for ESR measurement: Ves‐Matic Cube 200 and Westergren method. The tubes are directly put into the analyzers, which reduces the risk of contamination, and also is more practical for routine intense work. 1 and 2). Results which indicated analysis failure were excluded from the final analysis. The second method, the iSED, uses photometric rheoscope method. According to the manufacturer's operator manual, K2EDTA samples were inserted manually into the sample entry port. showed good agreement with the Ves‐Matic system and ICSH values with a tendency to false high results. The conventional manual Westergren method was applied by diluting four volumes of blood with one volume of sodium citrate, according to the ICSH protocol 5. In our study, systematic bias was calculated as 13 and limits of agreement were found in the range of −35.7 and +61.6. The iSED and Ves‐Matic Cube 200 sedimentation method showed poorer correlation with the Westergren method in increscent ESR levels. There was a significant positive correlation between C‐reactive protein (CRP) levels and ESR results measured by the Ves‐Matic Cube 200 (r = 0.654, P < 0.001). RBC count and hematocrit levels were negatively correlated with ESR results measured by the iSED (r = −0.299, P = 0.001; r = −0.441, P < 0.001, respectively). Curvers et al. Please check your email for instructions on resetting your password. Temperature correction is applied. Ves-Matic CUBE 200: is modified Westergren method for erythrocyte sedimentation rate a valid alternative to the gold standard?. Each sample was analyzed by the Westergren method, iSED, and Ves‐Matic Cube 200; and the results were compared with the results of the Westergren method. The iSED device gives the results in 20 sec and the results are expressed as millimeter per hour. This raises concern that alternate and Westergren methods are not interchangeable. The results are corrected using the temperature correction equation at 18°C and transformed to 60‐min measurement according to the manufacturer's recommendations. The iSED is a small bench‐top device (36cmx27cmx34 cm) which has been developed for small to medium‐sized laboratories. ESR results measured by using the iSED and Ves‐Matic Cube 200 analyzers were compared with the reference Westergren method. The results of Bland–Altman, Passing–Bablok, and Spearman's rank correlation analysis are shown in Tables 7-9, respectively. Two of these methods are the Ves‐Matic Cube 200 (Diesse Diagnostica Senese, Italy) and iSED (Alcor Scientific, USA). Mahlangu et al and Vennapusa et al showed a correlation of 0.96 and 0.83 with a mean bias of 6.6 mm/h (CI 5.0‐8.1) and 7.13 mm/h, respectively, across all ranges on the Streck ESR Autoplus.10, 20 In contrast, other novel methods have been reported to underestimate the ESR, in particular at lower ESR levels.11, 13 Curvers et al13 showed a correlation of 0.83 with a mean bias of −5.7 mm/h (CI −50.8 to 39.4) on the Ves‐Matic Cube 200 (Diesse Diagnostica Senese, Siena, Italy), as compared to the Westergren method. Manufacturer: Alcor™ 11212001 Catalog No. The iSED (Alcor Scientific Inc, Rhode Island, USA) is a newly developed automated alternate ESR analyzer. The majority of the data points were within the 95% limits of agreement with few outliers (n = 6). Daily internal quality control was performed with normal and abnormal StaRRsed ESR controls (Mechatronics, Richmond, USA). We considered additional potential factors that might be responsible for the observed systematic bias between the iSED and StaRRsed. and you may need to create a new Wiley Online Library account. International Journal of Laboratory Hematology. These findings are supported by our results. RBC count and hematocrit levels were negatively correlated with ESR results measured by the Ves‐Matic Cube 200 (r = −0.597, P < 0.001; r = −0.615, P < 0.001, respectively). They suggested the use of four‐sample DMV ESR analyzer instead of the Westergren method for ESR measurements in hospitals or clinical laboratories 10. On subgroup analysis, a poor correlation between the iSED and StaRRsed methods at ESR levels at the lower and upper third of the analytical range (2‐130 mm/h) with a large mean bias of 1.79 mm/h (CI −1.76 to 5.35) and 8.66 mm/h (−0.42 to 17.73), respectively, were found. Analytical validation of the iSED automated analyzer for erythrocyte sedimentation rate. RBC count (r = −0.597, r = −0,299, respectively; P < 0.0001, P = 0.0001, respectively) and CRP levels (r = 0.654, r = 0.643, respectively, P < 0.0001, P < 0.0001, respectively) were positively correlated with ESR results of the Ves‐Matic Cube 200 and iSED. Learn about our remote access options, E-mail address: elise.schapkaitz@nhls.ac.za, Department of Molecular Medicine and Hematology, Faculty of Health Sciences, University of Witwatersrand Medical School, Johannesburg, South Africa. The traditional Westergren method has several well‐described limitations for routine laboratory practice.8 In order to address these, novel alternate and modified methods have been developed for ESR measurement. Systematic bias for the Ves‐Matic Cube 200 was found to be higher in increscent ESR levels (mean bias of low levels = −6.2, mean bias of medium levels = 0.6, mean bias of high levels = 16.7). A previous report by Van der Maas et al11 however, showed a correlation of 0.67 with a mean bias of −4.4 mm/h (CI −7.8.4 to 1.0) as compared to the StaRRsed at 60 minutes. The authors do not have any conflict of interest. In addition, the StaRRsed flagged an additional 13 samples as unreliable owing to the presence of bubbles on sampling.

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