ALIFAX Test1血沉仪性能分析及临床应用价值验证

目的以2017年国际血液标准化委员会(ICSH)发布的关于红细胞沉降率改良和替代法测定指南为依据,评价魏氏替代法ALIFAX Test1血沉仪性能。方法收集2018年6月至12月南京医科大学第一附属医院体检健康者血液标本2 543例及40例门诊就诊患者血液样本,建立参考区间,并分别进行正确度、分析测量范围、携带污染率和精密度的验证,以及风湿免疫科临床适用性评估。用人新鲜血进行室内质控。结果 ALIFAX Test1血沉仪与魏氏法相关性良好(r=0.930 2,P0.01),分析测量范围对应魏氏法为2～90 mm/h,携带污染率为-7%,符合厂家要求。重复性、期间精密度、室内质控CV均15%,符合本实验室要求。参考区间与年龄、性别有关,男性以60岁为界,女性则以50岁为界。对于风湿免疫科患者,Test1与魏氏血沉法结果相关性良好(r=0.948,P0.01)。结论按照ICSH指南,ALIFAX Test1血沉仪的性能验证结果良好,基本可以满足本实验室的需求。     

Monitor-20全自动红细胞沉降率检测仪应用评价

目的：评价Monitor‐20全自动红细胞沉降率检测仪（简称Monitor‐20全自动血沉仪）与传统魏氏法测定红细胞沉降率（ESR）结果的可比性。方法分别用Monitor‐20全自动血沉仪和传统魏氏法同时测定50例临床标本的ESR ,并对数据进行比较分析。结果 Monitor‐20全自动血沉仪与魏氏法所测ESR比较差异无统计学意义（t＝0．4673,P＞0．05）,两者有较好的相关性（r＝0．9890,P＜0．01）。结论 Monitor‐20全自动血沉仪检测ESR与传统魏氏法比较具有良好的相关性,是一种检测ESR的快速、准确、可靠的方法,值得临床推广应用。     

2017 ICSH红细胞沉降率改良和替代法测定指南解读及应用

目的以2017年国际血液标准化委员会(ICSH)发布的关于红细胞沉降率改良和替代法测定指南为依据,评价魏氏替代法ALIFAX Test1血沉仪性能。方法收集2018年6月至12月南京医科大学第一附属医院体检健康者血液标本2 543例及40例门诊就诊患者血液样本,建立参考区间,并分别进行正确度、分析测量范围、携带污染率和精密度的验证,以及风湿免疫科临床适用性评估。用人新鲜血进行室内质控。结果 ALIFAX Test1血沉仪与魏氏法相关性良好(r=0.930 2,P0.01),分析测量范围对应魏氏法为2～90 mm/h,携带污染率为-7%,符合厂家要求。重复性、期间精密度、室内质控CV均15%,符合本实验室要求。参考区间与年龄、性别有关,男性以60岁为界,女性则以50岁为界。对于风湿免疫科患者,Test1与魏氏血沉法结果相关性良好(r=0.948,P0.01)。结论按照ICSH指南,ALIFAX Test1血沉仪的性能验证结果良好,基本可以满足本实验室的需求。     

VISION-B自动血沉仪和魏氏法测定红细胞沉降率结果的比较分析

目的验证VISION-B自动血沉仪检测红细胞沉降率(erythrocyte sediment rate,ESR)的重复性、准确性,以及比较其检测结果与魏氏法结果的相关性,以评价VISION-B自动血沉仪是否适合临床应用。方法以魏氏法测定的ESR结果为标准,选取检测结果从低到高的5份标本,在VISION-B自动血沉仪上分别重复检测4次,分析其重复性。收集门诊与住院患者218份标本,每份标本分别采用魏氏法和VISION-B自动血沉仪检测其ESR,并对检测结果进行统计学分析,分析VISION-B自动血沉仪检测结果的准确性及该方法与魏氏法结果的相关性。结果 VISION-B自动血沉仪检测ESR结果重复性较好(CV<10%);自动血沉仪检测结果与魏氏法结果相关性较好(r=0.971);两种方法的检测结果中魏氏法均值高于自动血沉仪法。结论 VISION-B自动血沉仪法操作简便安全、检测时间短、无需其他耗材、无需转移标本,有较好的临床应用前景。然而由于VISION-B自动血沉仪检测结果较魏氏法低,在使用该仪器检测ESR时需建立新的参考范围,并在检验报告单上注明检验方法和参考范围。     

Test1自动血沉仪检测评价

目的对Test1快速血沉仪测定血沉进行方法学评价。方法随机抽取门诊患者100例,分别应用Test1自动血沉仪及魏氏法(Westergren)同时检测血沉(ESR),比较这两种方法的相关性和两种方法的血沉结果差异有无显著性,以及在Test1上检测ESR的重复性。结果Test1测定结果与魏氏法比较,血沉低值(ESR≤20mm/h)和中值(ESR>20～40mm/h)结果差异无显著性(P>0.05),但在血沉高值(ESR>40mm/h)时,两种方法结果差异有显著性(P<0.05)。两种方法相关性良好(r=0.95;y=0.947x-1.91),重复性较好(CV=3.6%～8.4%)。结论Test1自动血沉仪检测低值和中值血沉快速、准确、可靠;对于血沉高值与魏氏法相比有一定差异,应与魏氏法进行对比。     

应用Microtest 1 自动血沉仪检测红细胞沉降率及其参考范围的建立

目的评价Microtest1自动血沉仪检测红细胞沉降率(ESR)的可靠性。方法随机抽取门诊就诊患者50人,分别应用Microtest1自动血沉仪及魏氏法同时检测ESR,对数据进行统计分析及比较;健康体检者男女各50人,应用Microtest1自动血沉仪检测ESR,统计健康人参考范围。结果Microtest1自动血沉仪与魏氏法检测ESR的回归方程为Y=0959X 0433,r=0965,重复性好;检测ESR的参考范围为男性为(45±36)mm/h,女性为(86±51)mm/h,两组间有显著差异。结论Microtest1自动血沉仪检测ESR与魏氏法相比较具有良好的相关性,是一种检测ESR的快速、准确、可靠的新方法。     

Test1自动血沉仪检测评价

目的对Test1快速血沉仪测定血沉进行方法学评价.方法随机抽取门诊患者100例,分别应用Test1自动血沉仪及魏氏法(Westergren)同时检测血沉(ESR),比较这两种方法的相关性和两种方法的血沉结果差异有无显著性,以及在Test1上检测ESR的重复性.结果Test1测定结果与魏氏法比较,血沉低值(ESR≤20mm/h)和中值(ESR＞20～40mm/h)结果差异无显著性(P＞0.05),但在血沉高值(ESR＞40mm/h)时,两种方法结果差异有显著性(P＜0.05).两种方法相关性良好(r=0.95;y=0.947x-1.91),重复性较好(CV=3.6%～8.4%).结论Test1自动血沉仪检测低值和中值血沉快速、准确、可靠;对于血沉高值与魏氏法相比热有一定差异,应与魏氏法进行对比.     

TEST1自动血沉仪的应用评估以及上海地区健康人群红细胞沉降率参考区间的建立

目的评价TEST1自动血沉仪(简称TEST1血沉仪)的主要性能指标,探讨其临床应用价值,同时建立上海地区健康人群红细胞沉降率(ESR)的参考区间。方法评价TEST1血沉仪的重复性和稳定性,比较TEST1血沉仪和用乙二胺四乙酸二钾(EDTA-K2)抗凝的Westergren法(标准方法)检测ESR的结果差异。34份EDTA-K2抗凝血标本采用TEST1血沉仪法和标准方法进行检测,同时评价TEST1血沉仪法的批内重复性和稳定性,并建立上海地区20~81岁成年人ESR的参考区间。结果 TEST1血沉仪法的准确性、重复性和稳定性比标准方法好。健康女性的ESR值比健康男性更高,并且随着年龄的增长而增加。结论 TEST1血沉仪具有安全、简便、快速以及标本处理的一致性等特点。TEST1血沉仪法参考区间的建立对检测大样本量的临床实验室较适宜。     

DRAGONMED 2010型自动血沉仪性能评价

目的探讨DRAGONMED 2010血沉仪检测红细胞沉降率(ESR)的重复性、准确性及其影响因素。方法抽取90例门诊患者,分别采用DRAGONMED2010血沉仪和国际血液学标准化委员会(ICSH)推荐的魏氏法测定,统计分析仪器法的准确性;抽取其中高、中、低值共5份标本进行重复性测定;另取5例标本分别配成5种红细胞比容水平,以仪器法测其ESR,分析ESR与红细胞比容的相关性。结果准确性:DRAGONMED2010血沉仪测定结果与魏氏法比较差异无统计学意义(P0.05),两种方法的相关性良好,相关系数(r)=0.994;Y=0.953X+0.244。重复性:5例变异系数均小于5%。仪器法ESR值与红细胞比容呈负相关,r绝对值为0.938～0.999。结论 DRAGONMED2010血沉仪是一种检测ESR快速可靠的新方法 ,有较高的准确性。     

全自动血沉仪采用乙二胺四乙酸抗凝血检测的临床应用分析

目的采用乙二胺四乙酸(EDTA)抗凝全血的血沉仪同传统魏氏法及采用枸橼酸钠抗凝血的血沉仪红细胞沉降率(ESR)测定结果进行比较,以选择适合临床应用的自动化血沉仪。方法选择40例研究对象,分别采用传统的魏氏法、枸橼酸钠抗凝血的XC-A30自动血沉分析仪(以下简称XC血沉仪法)、EDTA抗凝血的VISION-C全自动动态血沉仪(以下简称VISION血沉仪法)测定ESR,将3种方法测定的ESR结果进行统计分析,并对VISION血沉仪法进行重复性试验。结果 3种方法测得ESR结果比较,差异有统计学意义(F=86.497,P=0.000)。XC血沉仪法与魏氏法ESR检测结果比较,差异有统计学意义(t=-4.08,P=0.004);VISION血沉仪法与魏氏法ESR检测结果呈正相关(r=0.975,P=0.000),二者检测结果比较,差异无统计学意义(t=0.65,P=0.638)。VISION血沉仪法两个水平质控品的重复性试验显示,批内及日间变异系数(CV)均低于10%。结论 VISION血沉仪法与魏氏法测得ESR结果相关性好,且操作简便、结果可靠,适合临床推广应用。     

Erythrocyte sedimentation rate measurement by VES Matic Cube 80 in relation to inflammation plasma proteins

Westergren method is considered as the reference procedure to measure Erythrocyte Sedimentation Rate (ESR) by the International Council for Standardization in Haematology. However, a closed automated method, VES Matic Cube 80 (DIESSE S.p.A., Siena, Italy), has been introduced as a new ESR measurement instrument. In this article, we report two different studies: first, we compared the two methods (Westergren and VES Matic Cube 80) and second, we correlated the inflammatory state of 248 patients with their ESR values. Total protein, albumin, C-reactive protein, and other inflammatory proteins were detected in each sample. The results obtained using VES Matic Cube 80 demonstrated a good correlation with those obtained using the Westergren method (Ordinary linear regression: y=0.955x-0.205, r(2) =0.816, P<0.05; Passing-Bablock regression equation: y=0.9153x-0.5763; Bland-Altman analysis: bias 1.2; limits of agreement -17.4-19.9) and with the inflammatory protein levels (CRP: r=0.554 and r=0.498 and Fibrinogen: r=0.699 and r=0.663 for Ves Matic Cube 80 and Westergren, respectively), supporting the hypothesis that VES Matic Cube 80 offers a fast and safe ESR determination, ensuring precision and a very good correlation with the reference method.     

Comparison of TEST 1 with SRS 100 and ICSH reference method for the measurement of the length of sedimentation reaction in blood.

BACKGROUND: We evaluated the measurement of length of sedimentation reaction in blood (LSRB) by TEST 1 and compared the results with those for the Westergren and Sed Rate Screener 100 (SRS 100) methods. METHODS: LSRB was measured in 113 paired blood samples. RESULTS: TEST 1 correlated significantly with the Westergren (r=0.94) and SRS 100 (r=0.90) methods with low bias (-0.29 and -1.92 mm/h, respectively) and limits of agreement (-14.5 to 13.9, and -23.4 to 19.6 mm/h, respectively). Hematocrit (Htc) correlated negatively with LSRB in TEST 1 (r=-0.54) and SRS 100 (r=-0.53) only in samples with high Htc (>/=35%). The bias and limits of agreement between TEST 1 and Westergren in samples with low (-1.46 and -22.3 to 19.3 mm/h) and high (0.43 and -7.29 to 8.14 mm/h) Htc were comparable to those between SRS 100 and Westergren (1.83 and -27.2 to 30.9 mm/h for low, 0.71 and -7.27 to 8.70 mm/h for high Htc samples). Total protein and fibrinogen correlated similarly with LSRB in both TEST 1 (r=0.23 and 0.48, respectively) and SRS 100 (r=0.30 and 0.51, respectively). CONCLUSIONS: The findings suggested that TEST 1 is a reliable, precise and accurate system for measurement of LSRB in clinical laboratories with high workload.     

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.

     

Determination of the length of sedimentation reaction in blood using the TEST 1 system: comparison with the Sedimatic 100 method, turbidimetric fibrinogen levels, and the influence of M-proteins.

BACKGROUND: Determination of the length of sedimentation reaction in blood (LSRB) is frequently used in daily practice to assess disease intensity. Recently, a micro-sedimentation method was introduced (TEST 1) that uses EDTA anti-coagulated blood samples. The aim of this study was to characterize this method by comparing it to a conventional Westergren method (Sedimatic 100). Furthermore, correlation between fibrinogen and the LSRB and the influence of M-proteins on the LSRB was investigated. METHODS: Unselected paired samples were used for comparison between the TEST 1 and Sedimatic 100 methods (n=733); fibrinogen was measured in EDTA samples (n=765) using a turbidimetric method. Furthermore, LSRB was measured in 29 EDTA samples in paired serum tubes from patients in whom an M-protein was detected. RESULTS: TEST 1 showed excellent correlation with the Sedimatic 100 method (y=1.00x; n=733; r=0.92, 95% CI 0.90-0.93; p<0.0001), and had no significant bias (0.15 mm/h, 95% CI -0.48 to 0.75 mm/h). Furthermore, TEST 1 LSRB showed satisfactory correlation with the fibrinogen content (y=3.13+0.06x; n=765; r=0.78, 95% CI 0.75-0.80; p<0.0001). In samples containing M-proteins, satisfactory correlation between the M-protein content and TEST 1 LSRB was found (y=0.69+0.22x; n=29; r=0.71, 95% CI 0.45-0.85; p<0.0001), while excellent correlation was found when only M-proteins of the IgM type were taken into account (y=-0.95+0.23x; n=9; r=0.93, 95% CI 0.71-0.99; p<0.0002). CONCLUSIONS: The results confirm previous reports that TEST 1 is a reliable method to measure the LSRB, and shows for the first time the quantitative relationship between TEST 1 LSRB and M-proteins, particularly those of the IgM type.     

红细胞沉降率参考方法、魏氏法和仪器法的应用比较

目的探讨红细胞压积（PCV）对红细胞沉降率（ESR）测定的影响及美国临床实验室标准化研究所（CLSI）H2-A4文件参考方法、魏氏法、LDY-CX40型仪器法3种检测ESR方法的可比性。方法按照CLSI参考方法调整1名健康人PCV后检测ESR;随机选择60例门诊和病房患者,分别采用CLSI参考方法、魏氏法与LDY-CX40型仪器法同时测定ESR。结果 PCV对ESR的影响为一倒抛物曲线：Y=611.81X2-698.12X＋200.31,决定系数（r2）=0.994 5;不同检测方法间配对t检验显示P〈0.01;参考方法、魏氏法、仪器法3者进行两两线性回归分析,r2均〉0.976（P〈0.01）;魏氏法和仪器法的结果均在CLSI制定的比较参考方法和工作方法的可接受范围内。结论 PCV对ESR的影响十分明显,应该将PCV调整在恒定的一个水平,才能获得一个更准确和更有价值的ESR结果;3种不同的检测方法之间差异有统计学意义,应该使用不同的参考区间。     

Length of sedimentation reaction in blood: a comparison of the test 1 ESR system with the ICSH reference method and the sedisystem 15.

The aim of this study was to compare the performance of the automatic TEST 1 ESR system, SIRE Analytical Systems (TEST 1), with that of the the Sedisystem 15, Becton Dickinson (SEDI), and the International Council for Standardization in Haematology reference method (Westergren) for measuring the length of sedimentation reaction in blood (LSRB). This reaction was measured in 418 paired blood samples drawn in K2-EDTA vacuum tubes and specific tubes from patients scheduled for routine LSRB measurement. The TEST 1 system uses micro-sedimentation and quantitative capillary photometry technology, whereas the SEDI uses a CCD camera. For Westergren, a 200 mm column with 3.0 mm internal diameter was used. Compared to Westergren, TEST 1 gives accurate values of LSRB in most of the samples (mean of differences: 0.99 +/- 10.4 mm; 95% CI, -0.807 to 2.78 mm; n =131). Similar results were obtained in the comparison with SEDI (mean of differences: -0.626 +/- 8 mm; 95% CI, -1.756 to 0.5 mm; n = 195). Compared to those of fresh blood samples, LSRB values were significantly lower in 24 h stored samples, either at 4 degrees C (21.5 +/- 2.3 vs. 19.4 +/- 2.2 mm; p (Spearman's coefficient of correlation): 0.981; n = 44) or at room temperature (19.1 +/- 2.5 vs. 16.2 +/- 2.1 mm; p: 0.903; n = 46). In conclusion, TEST 1 is a rapid, reliable system for automatic measurement of LSRB in standard K2-EDTA blood samples. It has a very low imprecision and maintains a good performance in 24 h stored samples. In addition, due to its operational characteristics (60 samples/20 min) it is a suitable tool for clinical laboratories with a high work load as well as for emergency laboratories.     

Length of erythrocyte sedimentation rate (ESR) adjusted for the hematocrit: reference values for the TEST 1 method

It is known that the erythrocyte sedimentation rate is related to the erythrocyte concentration in blood. Recently, some authors have proposed a method for estimating the relation between the Westergren erythrocyte sedimentation rate and the erythrocyte sedimentation rate adjusted on an hematocrit of 0.35 L/L. In this study we firstly evaluated in 236 samples the relation between the erythrocyte sedimentation rate measured by the TEST 1 analyzer in samples corrected to 0.35 L/L of hematocrit and the erythrocyte sedimentation rate measured in undiluted samples, and the hematocrit and the hemoglobin concentration, obtaining a multiple correlation coefficient of 0.956; (p < 0.001). Comparison between the corrected for HCT erythrocyte sedimentation rate, measured vs estimated, showed a bias of 0.0 (0.95 CI: -0.98 to 0.98 mm/h) with an agreement limit +/- 14.5 mm/h. Then, the reference intervals for the estimated erythrocyte sedimentation rate at 0.35 L/L of hematocrit were calculated by means of an indirect method (Kairisto), using the one-year stored data (47810 results) in our laboratory database. Our data showed that the erythrocyte sedimentation rate corrected to 0.35 L/L of hematocrit could be estimated by a simple formula using the TEST 1 results; the reference ranges were higher than the reference ranges for uncorrected samples. New reference intervals were needed for an improved evaluation of the patients, and a table of reference intervals for age and sex is presented.     

红细胞的压积及介质差异对其沉降率的影响

目的探讨红细胞的压积及介质差异对其沉降率的影响.方法计算红细胞压积与血沉的相关系数;检验压积相差0.06,同性别的血沉的差异;检验男女等压积的血沉差异;观察红细胞在不同介质中的沉降率变化.结果红细胞压积与血沉呈明显负相关,相关系数绝对值为0.928～0.999(P<0.05 or P<0.01);压积相差0.06时,男、女血沉均有非常显著性差异(t值3.096～9.904,P<0.01);男女等压积组沉降率无显著性差异(t=1.338,P>0.05);不同介质对红细胞沉降率有明显影响.结论判断红细胞沉降率是否异常,红细胞压积要有可比性;红细胞在生理盐水中的沉降率很低.     

ESR-30自动血沉仪与魏氏法红细胞沉降率测定结果对比分析

目的：评价ESR-30全自动血沉仪检测结果的可靠性。方法：我院136例门诊、体检和住院患者,分别应用ESR-30全自动血沉仪和魏氏法同时测定红细胞沉降率（ESR）,并将结果进行比对分析。结果：两法ESR测定结果相关性良好（r＝0.992）,当仪器法测定结果在0～80mm/h 时各组差异无统计学意义（P＞0.05）,但ESR＞80mm/h 时差异有统计学意义（P＜0.05）。结论：ESR-30自动血沉仪操作简便、检测速度快、结果准确,值得临床推广使用。但对于ESR＞80 mm/h时建议用魏氏法复查。     

Micro-Test1血沉仪在免疫性疾病中的应用

目的初步评价Micro-Test1血沉仪并观察在免疫性疾病中红细胞沉降率(ESR)与C-反应蛋白(CRP)的关系。方法测定Micro-Test1血沉仪的精密度,比较血沉仪与魏氏法测定ESR的相关性及正常对照组和疾病组的ESR和CRP指标。结果Micro-Test1血沉仪具有较好的精密度,中值样本和高值样本的变异系数(CV)<5.0%;与魏氏法测定ESR结果比较,两者之间有较好的相关性(r=0.943)。结论Micro-Test1血沉仪操作简便、快速、准确,适用于临床的需要。