(2)Multi-site evaluation Hb201+

O RIGINAL A RTICLE

Multiple-Site Analytic Evaluation of a New Portable Analyzer, HemoCue Hb201+,for Point-of-Care Testing

Sten-Erik Ba¨ck,PhD,*Carl G.M.Magnusson,PhD,?Lena K.Norlund,MD,PhD,?Henning H.von Schenck,MD,PhD,§Monica E.Menschik,BS,?and P.E.Stellan Lindberg,MS?

Abstract:The analytic performance of the HemoCue Hb201+sys-tem was validated to major automatic cell counters in the marketplace and to the previous HemoCue B-Hemoglobin system.In addition,the performance of all instruments was compared against the ICSH ref-erence method.Between119and138samples were analyzed at4 different hospitals.In all,497patient samples were tested.Impreci-sion calculated from duplicate samples for all systems ranged from 0.5to1.1%.The correlation for all systems against the reference method was better than0.99overall,with biases ranging from–0.28 to0.21g/dL.Correlations between the new Hb201+and ADVIA120 (Bayer Diagnostics),GEN-S(Beckman Coulter),Sysmex XE2100, CellDyn4000(Abbott),and the HemoCue B-Hemoglobin system showed all r>0.99.The HemoCue Hb201+had a mean bias of0.10 g/dL from the reference method and between–0.06to0.43g/dL against the other instruments.Imprecision calculated from duplicate samples on the HemoCue Hb201+system was0.75%.The authors conclude that all hemoglobin methods tested including the new HemoCue Hb201+system showed excellent correlation and very small bias to the international reference method.The Hb201+system yields results that agreed well with all tested systems,with an accu-racy and precision similar to the cell counters.

Key Words:automatic cell counters,HemoCue Hb201+,ICSH ref-erence method,hemoglobin methods

(Point of Care2004;3:60–65)

D etermination of hemoglobin is one of the most commonly

performed analyses in point-of-care(POC)testing situa-tions and the first choice in diagnosing anemia.Accuracy and precision are essential features of hemoglobin determinations because many decisions are based on fixed cutoff levels(eg, diagnosis of anemia,acceptance for blood donation,indica-tions of bleeding,and doping status).

The International Committee for Standardization in He-matology(ICSH)method1,2has been established as the inter-national reference method for hemoglobin determination. Nevertheless,the use of this method in routine analysis has disadvantages.The reagent is toxic,there are needs for precise pipetting,and the method is susceptible to turbidity.3 In hospital laboratories,large automated cell counters are most often used to determine blood hemoglobin levels. However,the need to provide accurate,reliable small instru-mentation to the POC testing environment is becoming in-creasingly important.The dominating POC system in the mar-ket is the HemoCue B-Hemoglobin system.3It is based on an optical measuring cuvette of small volume(10μL)and a short light path(approximately0.14mm)with a dry reagent depos-ited in the cavity of the cuvette.The cuvette is used as a sam-pling device and the blood sample is drawn into the cuvette cavity by capillary action.A new portable hemoglobin instru-ment,the HemoCue Hb201+system,was recently introduced. The cuvette and the reagents are similar to those in the He-moCue B-Hemoglobin system.The new instrument is of smaller size(dimensions,85×160×43mm;weight,350g batteries included)and is battery powered.

The reaction in the HemoCue cuvette is a modified azide methemoglobin reaction first described by Vanzetti et al.4 First,the erythrocyte membranes are disintegrated by sodium deoxycholate,followed by the conversion of the hemoglobin iron from the ferrous to the ferric state by nitrite to form met-hemoglobin,which then combines with azide to form azide methemoglobin.The HemoCue Hb201+system and HemoCue B-Hemoglobin system are both factory calibrated with human blood against the ICSH method(discussed later) according to Kwant et al.5There is no need for any further calibration by the user.The hemoglobin calibration process for the HemoCue systems is also verified by comparison of results from human blood samples distributed to several reference laboratories over the world.

From the*Department of Clinical Chemistry,Central Hospital,Kristianstad;

the?Department of Clinical Chemistry,Hospital of Engelholm;the?De-partment of Clinical Chemistry,University Hospital,Lund;the§Depart-ment of Clinical Chemistry,County Hospital,Halmstad;and?HemoCue AB,Department of Research and Development,Engelholm,Sweden. Reagents and laboratory tests supported by HemoCue AB.No other grants were received.

Reprints:P.E.Stellan Lindberg,HemoCue AB,Department of Research and Development,Box1204,SE-26223Engelholm,Sweden(e-mail:stellan.

lindberg@hemocue.se).

Copyright?2004by Lippincott Williams&Wilkins

This study was performed mainly to evaluate the perfor-mance of the HemoCue Hb 201+hemoglobin analyzer against the international reference method for hemoglobin testing ac-cording to the ICSH,1,2and to compare with results obtained from common clinical laboratory instruments.

MATERIALS AND METHODS

The study was performed in collaboration with 4clinical chemistry laboratories in Sweden:Central Hospital of Kris-tianstad (A),Hospital of Engelholm (B),University Hospital of Lund (C),and County Hospital of Halmstad (D).The study was performed in August to October 2002.Between 119to 138patient samples selected to cover the relevant measuring range were chosen from specimens submitted for routine analysis in each hospital.The samples were drawn in K 2-EDTA (Becton Dickinson)and were first analyzed by the routine method in duplicate,followed by duplicate measurements using the HemoCue B-Hemoglobin system and the new HemoCue Hb 201+system (HemoCue AB,Engelholm,Sweden).In all,497patient samples were analyzed and then transported to HemoCue AB in Engelholm,Sweden,for ICSH measure-ments.All studies were performed according to the NCCLS EP9-A guideline.6

The following routine instruments were used:GEN-S (Beckman Coulter,Pasadena,CA),ADVIA 120(Bayer Diag-nostics,Tarrytown,NY),Sysmex XE 2100(Sysmex Corpora-tion,Kobe,Japan),and CellDyn 4000(Abbott Laboratories,Abbott Park,IL;Table 1).All instruments were run,calibrated,and controlled according to recommendations from the manu-facturers.Recalibration of the instruments was not performed during the length of the study.All hospital laboratories are ac-credited according to EN45001.

The ICSH method was initially performed according to recommendations 1,2and then again with a slight modification of the procedure using a second blanking wavelength at 700nm instead of filtration.All measurements were performed on a Cary 300spectrophotometer (Varian Inc.,Palo Alto,CA).The method was calibrated using a commercial cyanmethemo-globin standard from Euro-Trol (CNMetHb batch 19-1-B518a).In addition,at site B (Table 1),to prove our modifi-cation of the reference method all samples with an absorbance greater than 0.002at 750nm were filtered and reanalyzed.The

results of the filtrated samples were compared with the ICSH method using only one wavelength (540nm),and with our modified method,which uses a second blanking wavelength at 700nm.

RESULTS

The susceptibility of the ICSH reference method to tur-bidity in the absence of filtration or other means for remov-ing the interference effect is evident from Figure 1A.The cor-relation using a single wavelength on the ICSH method dem-onstrated ICSH (Abs 540nm )=0.992ICSH Filtered +0.74,r =0.986,and s yx =0.33.A much better correlation was obtained between nonfiltered samples processed with the double-wavelength method and filtered samples assayed with the original procedure:ICSH (Abs 570-700nm )=1.013ICSH Filtered +0.01,with r =0.998and s yx =0.12(Fig.1B).

The results of the new HemoCue Hb 201+system,as well as those from all hematologic systems evaluated,com-pared with the modified ICSH method are illustrated in Figure 2.The 2-wavelength method showed a scatter (s yx )for all sys-tems in the range of 0.13to 0.21g/dL.Only minor biases from

TABLE 1.Overview of the Participating Laboratories Site Location

Instrument No.of Patients

A Central Hospital of Kristianstad Beckman Coulter GEN-S 138

B Hospital of Engelholm

Bayer ADVIA 120119C University Hospital of Lund Sysmex XE 2100120D

County Hospital of Halmstad

Abbott CellDyn 4000

120

FIGURE 1.ICSH methods with and without correction of back-ground for samples with turbidity The straight line in A and B represents the regression equation y =x.(A)The regres-sion equation for the comparison for ICSH(Abs 540nm )against ICSH Filtered is Y =0.99x +0.739;r =0.986;s yx =0.33.(B)The regression equation for the comparison for ICSH (Abs 540–700nm )against ICSH Filtered is Y =1.01x +0.010;r =0.998;s yx =0.12.

Point of Care ?Volume 3,Number 2,June 2004HemoCue Hb 201+

FIGURE https://www.wendangku.net/doc/c615915641.html,parison of hemoglobin measurements by different instruments and ICSH(Abs 540–700nm ).(A)Beckman Coulter GEN-S.(B)Bayer ADVIA 120.(C)Sysmex XE 2100.(D)Abbott CellDyn 4000.(E)HemoCue B-Hemoglobin.(F)HemoCue Hb 201+.All views plotted against ICSH(Abs 540–700nm ).

Ba ¨ck et al Point of Care ?Volume 3,Number 2,June 2004

FIGURE https://www.wendangku.net/doc/c615915641.html,parison of hemoglobin measurements by Hb 201+and different instruments.(A)Hb 201+plotted against the Beckman Coulter GEN-S.(B)Against Bayer ADVIA 120.(C)Against Sysmex XE 2100.(D)Against Abbott Cell-Dyn 4000.(E)A summary plot against all cell counters.(F)Against HemoCue B-Hemoglobin.Point of Care ?Volume 3,Number 2,June 2004HemoCue Hb 201+

the reference method were observed.The ADVIA showed slightly lower results,with an average bias of–0.18g/dL.The GEN-S showed results on average–0.28g/dL and the negative bias was more apparent at higher hemoglobin concentrations. The CellDyn gave results nearly equal to the reference method. Results from the HemoCue B-Hemoglobin system were about 0.21g/dL higher than the ICSH https://www.wendangku.net/doc/c615915641.html,parisons between the Hb201+and the2-wavelength reference method showed y= 1.009x–0.01;r=0.998;bias=0.10g/dL;n=497.

Results between the HemoCue Hb201+and the other systems tested are summarized in Figure3.The201+system gave excellent correlation to all methods,with r=0.998to 0.999and s yx=0.14to0.19.There was a slight positive bias to the ADVIA of0.30g/dL and to the GEN-S of0.43g/dL.The bias was greater with the GEN-S at higher hemoglobin con-centrations.The same result was found in the comparison of the GEN-S against the ICSH method.The graph in Figure3E shows the results of the Hb201+compared with a summary of all cell counters.The correlation was excellent:y=1.014x+ 0.05—and the bias was,on average,0.23g/https://www.wendangku.net/doc/c615915641.html,pared with the HemoCue B-Hemoglobin system,the Hb201+system gave,on average,a0.11g/dL lower result.

Duplicate samples were analyzed on all systems accord-ing to the NCCLS protocol.6The means,standard deviations and coefficients of variation(CV)are shown in Table2.For the cell counters the CVs varied from0.51to0.72%over the range4to20g/dL.Hb201+presented similar CVs(0.57–0.92%)at all sites,which are slightly better than the HemoCue B-Hemoglobin system.

DISCUSSION

In this study comparing hemoglobin methods,it was clear that the choice of blood specimens could be a source of error.The effect of sample turbidity from lipids,proteins,and cell stroma often produces falsely elevated results on hemo-globin determinations.The number of patients affected by these errors was higher than expected.Rather than using the original ICSH reference method for hemoglobin requiring fil-tration of the samples before measurement,we demonstrated that a more simple way to correct for background turbidity is to include a second wavelength at700nm when performing the ICSH measurement.For both HemoCue systems a second wavelength,880nm,is incorporated to compensate for back-ground turbidity.They are therefore less susceptible to high lipid contents and high levels of leukocytes.

The CLIA88analytic quality requirement7for hemoglo-bin states that95%of the samples should be within±7%com-pared with results of the reference method.All methods evalu-ated in this study fulfilled this requirement compared with the 2-wavelength reference method.

The accuracy and precision of hemoglobin determina-tions are extremely important because many decisions are based on fixed cutoff levels(eg,diagnosis of anemia,accep-tance for blood donation,indications of bleeding,and doping status).All instruments evaluated in this study gave results that met these criteria of needed performance including the new HemoCue Hb201+system.The data from this study show that the Hb201+has a low CV,similar to the automated laboratory cell counters,and proven accuracy to the ICSH reference method.The new,smaller design makes it attractive in POC testing,which,together with the battery power,makes it a flex-ible system to use in ambulances and screening programs.

CONCLUSION

All examined cell counters and hemoglobin systems demonstrated excellent correlation and very small bias to the ICSH reference method.Both accuracy and precision of all systems were extremely good.The new HemoCue Hb201+ system provides results that correlate well to the ICSH refer-ence method and to all automated cell counters tested.Based on this study,the performance of the HemoCue201+system is equal to that obtained by many common clinical laboratory

https://www.wendangku.net/doc/c615915641.html,parative Methods and Hb201+

Comparative Methods(X)n Comparative

Method(X),

mean,g/dL

Hb201+(Y),

mean,g/dL

Comparative

Method(X)Hb201+(Y)

SD,*g/dL CV,%SD,*g/dL CV,%

Beckman Coulter GEN-S13812.4512.880.0640.510.0740.57 Bayer ADVIA12011912.6212.920.0850.670.1020.79 Sysmex XE210012013.0013.220.0920.710.0910.69 Abbott CellDyn400012012.7612.700.0920.720.1170.92 All laboratory instruments49712.7012.930.0830.650.0970.75 ICSH A540–A70049712.8212.930.0660.510.0970.75 HemoCue B-Hemoglobin49713.0412.930.138 1.060.0970.75 *Standard deviation(SD)for2replicates is calculated according to the following formula:√?d2/2n,where d is the difference between each sample and n is the total number of samples.

Ba¨ck et al Point of Care?Volume3,Number2,June2004

methods currently in use.The new,smaller HemoCue device is,therefore,a suitable alternative for use in POC testing.

ACKNOWLEDGMENT

The authors thank all laboratory staff involved for tech-nical assistance.

REFERENCES

1.Reference and Selected Procedures for the Quantitative Determination of

Hemoglobin in Blood.2nd ed.,vol.14,no.6.Approved standard.NCCLS document no.H15-A2.Wayne,PA:1987:May1994.2.Recommendation for reference method for haemoglobinometry in human

blood(ICSH standard1995)and specifications for international haemo-globincyanide standard.J Clin Pathol.1996;49:271–274.

3.Von Schenck H,Falkensson M,Lundberg B.Evaluation of HemoCue,a

new device for determining hemoglobin.Clin Chem.1986;32:526–529.

4.Vanzetti G,Nardeschi A.An azide–methemoglobin method for hemoglo-

bin determination in blood.J Lab Clin Med.1966;January:116–126. 5.Kwant G,Oeseburg B,Zwart A,et al.Calibration of a practical haemo-

globinometer.Clin Lab Haematol.1987;9:387–393.

6.Method Comparison and Bias Estimated Using Patient Samples:Ap-

proved Guideline.Vol.15,no.17.NCCLS document no.EP9-A.Decem-ber1995.

7.CLIA88Proficiency Testing Criteria Acceptable Analytical Perfor-

mance.Code of Federal Register57(40);7002–7186;February1992.

Point of Care?Volume3,Number2,June2004HemoCue Hb201+

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英文essay outline怎么写(附上范例)

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英语正式论文thesis outline范例

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论文写作outline

论文题目（英语） How To Treat Middle school Students' Errors in the Classroom ———————————————————————————————————————（以下部分用中文阐述） 一、意义简述（100字内） 古人说：“金无足赤，人无完人。”在学习过程中，每个学生多多少少都会不可避免地犯一些错误，通过学生的错误教师可以观察出他们在学习方面面临的问题和需要改进的地方。本文试图提出几条处理错误的方法，以改进教学实践。然而老师对待学生们的学习问题时所采取的措施不尽相同。基于上述情况，本文通过调查初中英语课堂上教师与学生的错误观及纠错方式。旨在提升教师的纠错方式，并促进中国教师与学生英语学习的共同进步。 二、文献综述（150字内） 本文将对以下问题作相应研究探讨： 1.研究中学生英语错误的必要性 2学生英语错误在当今的研究 3.范围界定：正确认识英语学习中”errors”和”mistakes”的区别 4.如何应对中学生英语学习中的错误 教学中只有正确对待学生的错误，才能更有效促进学生的学习和教师工作的开展，进而激发学生自主学习的欲望。 三、研究方法 1）理论基础（100字内） 错误分析法 1、罗列学生在学习过程中已发生或可能发生的错误。 2、分析发生错误的原因。

3、评价错误的后果。 2）研究问题或假设（150字内） 1. 学生们在课堂学习过程中可能出现那些错误？ 2. 教师应如何应对学生的不同错误？ 3）研究对象与研究方法、工具（如果是调查或课堂观察研究方法，注明研究工具，如自己设计还是采纳已有问卷表）（100字内） 以课堂观察的形式对中学生中英语学习者进行研究，课后对学生进行调查并及时记录 4）研究步骤（200字内） 1, 查阅相关书籍文献，收集可供参考的理论，依据，材料； 2. 联系所收集的理论，联系课堂观察中教师对学生学习错误的不同应对策略及效果，撰写教师应对学生错误的正确策略总结； 3. 指定整体论文框架，咨询导师吸收修改意见； 4. 撰写并修改论文； 5.导师终审并提交论文终稿； 6.论文开题答辩。 五、预期结论与研究局限性（150字） 预期结论：对学生英语错误的合在英语教学中具有重要地位。本文能够客观真实地指出，教师使用科学的、针对性的策略来解决学生英语学习错误能更有效地促进学生的英语学习。 研究局限性：调查范围有限，怕不够全面的反映问题。

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