Clinical Performance Of Exigo H400 4-part Hematology Analyzer Compared .
Clinical performance of Exigo H400 4-parthematology analyzer compared with areference 5-part instrumentExigo H400 automated hematology analyzer is routinely used in laboratory diagnostics for determinationof patients’ blood status. This work demonstrates the performance of Exigo H400 4-part hematologyanalyzer in comparison with a more technically advanced 5-part reference analyzer in complete bloodcount (CBC) analyses of patient samples taken from the normal routine screening. The results show thatthe analyzers are in good agreement, indicating the suitability for use of Exigo H400 in veterinary clinics.Before, blood cell counts were performed manually bymicroscopy. Although manual examination of blood smearsis still used as a control method for verification of results fromabnormal samples, the automated hematology analyzershave largely replaced the manual method for determination ofhematology parameters in routine use.The Exigo H400 system is an automated hematology analyzerfor in vitro diagnostic use under laboratory conditions (Fig. 1).The analyzer is intended for determination of hemoglobin(HGB) concentration, for counting of red blood cells (RBC)and platelets (PLT), as well as for counting and differentiationof white blood cells (WBC) into four subpopulations, namelylymphocytes (LYM), monocytes (MONO), neutrophils (NEU),and eosinophils (EOS). The measurement principles ofthe Exigo H400 are based on impedance for cell countsand spectrophotometry for HGB. Although such a 4-parthematology analyzer provides enough information for thesmaller local hospital laboratory, trends show an increasedinterest in 5-part laser instruments, typically used in largerreference labs, also for use in smaller clinics.Fig. 1. Exigo H400 automated 4-part hematology analyzer.IntroductionA CBC is highly useful in general screenings as a tool to aid indiagnosis and monitoring of disease conditions. Automatedinstruments for this type of analyses were developed as earlyas in the 1950s, with the first European cell counter developedby Erik Ohlin, the founder of the human Swelab Instruments(now part of Boule Diagnostics). Boule launched their firstveterinary system 2004.boule.comWhile a 5-part analyzer offers improved WBC assessment,differentiating them into neutrophils (NEU), lymphocytes (LYM),monocytes (MONO), eosinophils (EOS), and basophils (BASO),a 3-part or 4-part instrument can offer great cost benefits togeneral screenings of patients’ blood status (1). Moreover, onthe veterinary hematology side, BASO are known to show nocorrelation with reference manual microscope method on anyhematology analyzer available today. Also, as for the possiblelinks of diagnosis to BASO, neoplasia and heartworms tendto increase not only BASO but also EOS at the same time (2).The objective of this study was to evaluate the performanceof Exigo H400 4-part hematology analyzer against a 5-partreference instrument.Application note, ANE35382-1
Materials and methodsResultsExigo H400 4-part hematology analyzer and associated reagents,calibrator, and control material were used as test system. Asreference system, the Sysmex XT-2000iV 5-part hematologyanalyzer and associated reagents, calibrator, and controlmaterial (Sysmex Corp.) were used. Control blood was analyzedin duplicates daily before and after sample runs. Fresh normaland abnormal dog, cat, and horse whole blood samples (n 125 dog samples, n 63 cat samples and n 60 horsesamples), collected for routine analyses, were analyzed induplicate on the test analyzer and on the reference analyzer.Samples included in the study were primarily selected tosupport the main test parameters RCB, HGB, PLT, andWBC. The analyzers were co-calibrated prior to the statisticalanalyses using the first 5 normal (non-flagged) dog samples.Correlation results, with specification limits for the correlationcoefficient (r) between test and reference systems, aregiven in Table 2. As shown, all parameters passed thecorrelation requirements, except for the mean cell volume(MCV), for which the correlation coefficient was just belowthe acceptance criterion. The specifications were applicablefor dogs only. The results of the performance of the Exigoanalyzer using cat and horse samples were presented forinformational purposes.The strength of the relationship between the cell count inthe test and the reference systems was measured usingPearson correlation coefficient (r). Passing-Bablok regressionanalysis and Bland-Altman difference plots for estimation ofagreement and possible systematic bias between the testand the reference systems were performed on matchedsamples. For comparison with the Exigo H400 4-part system,results from the Sysmex 5-part differential were combined intogranulocytes (GRAN)/NEU, MONO, LYM and EOS as givenin Table 1. The evaluation was performed in collaborationwith Evidensia Specialist Veterinary Hospital in Strömsholm(hereafter, Strömsholm), Sweden.DogsCorrelation plots for the dog samples are shown in Fig. 2.According to the specifications, the Exigo H400 analyzerpassed the correlation requirements when compared tothe Sysmex analyzer, except for MCV, where the correlationcoefficient was slightly below the acceptance limit. The diluentscontain substances that make the cells spherical beforeanalysis, and clinical conditions with high bilirubin can inducedifferences in membrane plasticity and swelling. Thus, MCVmight be recorded differently in the two systems.There were no observations of deviating samples in the plotsfor PLT, RBC, HGB, and WBC.Table 2. Agreement between the Sysmex XT-2000iV and the Exigo H400veterinary hematology analyzer CBC for dogsParameterNo outliers were deleted as they did not affect the results.Most of the flags obtained from the analyzers were related toWBC indices. The Sysmex XT-2000iV analyzer did not reportMPV-values for the cat profile. For that reason, agreementbetween the Sysmex and the Exigo analyzers for MPV couldnot be evaluated.Table 1. Correlation of parameters between 4-part and 5-part differentialUnitrsr specificationRBC1012/L0.997* 0.98HGBg/L0.995* 0.98 WBC109/L0.994* 0.979 0.70Exigo H400Sysmex XT-2000iVLYM10 /L0.736*GRAN/NEUNeutrophils basophilsMONO910 EOS10 /L0.585*EOSEosinophils* 0.959 0.90Correlation is significant at the 0.01 level (2-tailed). rs Spearman rho.The systems showed results comparable with manualmicroscopy (Table 3).2
(A)(B)(C)Passing-Bablok fit(y 0.2865 x 0.9682 x)10240Passing-Bablok fit(y 1.924 x 0.9048 x)6Exigo H400: MCV (fL)Exigo H400: HGB (g/L)Exigo H400: RBC (1012/L)8081901404022468Sysmex: RBC (1012/L)504010(D)90140190Sysmex: HGB (g/L)240(E)30400200153045Sysmex: HCT (%)060604020200400Sysmex: PLT (109/L)6000204060Sysmex: WBC (109/L)80(H)15.0Passing-Bablok fit(y -0.04054 x 0.8108 x)Passing-Bablok fit(y 0.23284 x 1.083 x)60Exigo H400: GRAN/NEU (109/L)12.5Exigo H400: LYM (109/L)2400015140190Sysmex: MCV (fL)Passing-Bablok fit(y -0.1447 x 1.058 x)Exigo H400: WBC (109/L)459080Passing-Bablok fit(y -8 x 1 x)600Exigo H400: PLT (109/L)Exigo H400: HCT (%)6040(F)Passing-Bablok fit(y 2.253 x 0.8938 x)7060904(G)90Passing-Bablok fit(y 3 x 1 x)10.07.55.040202.50002.55.07.510.0Sysmex: LYM (109/L)12.515.00204060Sysmex: NEU BASO (109/L)Fig. 2. Agreement between the Sysmex XT-2000iV (reference) and the Exigo H400 (test) hematology analyzer for dog CBC shown in Passing-Bablokregression graphs RBC (A), HGB (B), MCV (C), HCT (D), PLT (E),WBC (F), LYM (G), and GRAN (H). The thin line is the line of identity (x y) and the thickline is the line of best fit.Table 3. Agreement between the manual WBC differential count (reference method) and the automated count in the Sysmex XT-2000iV and the ExigoH400 veterinary hematology analyzers for dogsNNEU/GRANSpearman *0.701*-0.01-0.06* Correlation is significant at the 0.01 level (2-tailed).3
(A)60Passing-Bablok fit(y -0.1083 x 0.9833 x)60Automated count: Exigo GRAN/NEU (109/L)Automated count: Sysmex NEU (109/L)705040302010010203040Manual count50604030201070015102030Manual count40506030Manual count4050603Manual count45660Passing-Bablok fit(y 0.2592 x 1.064 x)Passing-Bablok fit(y 0.1884 x 0.87 x)Automated count: Exigo LYM (109/L)Automated count: Sysmex LYM (109/L)5000(B)Passing-Bablok fit(y -0.3954 x 0.9852 x)129630504030201000369121501020Manual count(C)6Automated count: Exigo MONO (109/L)Automated count: Sysmex MONO (109/L)6Passing-Bablok fit(y -0.0814 x 1.033 x)42Passing-Bablok fit(y 0.1866 x 0.5224 x)5432100024Manual count6012Passing-Bablok fit(y 0.05 x 0.8 x)3Automated count: Exigo EOS (109/L)Automated count: Sysmex EOS (109/L)(D)210Passing-Bablok fit(y 0 x 0.5815 x)3210012Manual count3012Manual count3Fig. 3. Agreement between the manual WBC differential count and the automated count in the Sysmex XT-2000iV (left) and the Exigo H400 (right)veterinary hematology analyzers for dogs. Passing-Bablok regression graphs for NEU/GRAN (A), LYM (B), MONO (C), and EOS (D). The thin line is the lineof identity (x y) and the thick line is the line of best fit.4
CatsTable 4. Agreement between the Sysmex XT-2000iV and the Exigo H400veterinary hematology analyzer CBC for catsCorrelation plots for the cat samples are shown in Fig. 4.The Exigo H400 showed good to excellent correlation whencompared to the Sysmex analyzer (Table 4, Fig. 4), exceptfor the MONO and LYM, where slightly lower correlation wasobserved. MONO are present at a substantially lower levelin comparison to LYM and GRAN, which can also lower thecorrelation coefficient.ParameterAs for the MCV, where the correlation coefficient was slightlybelow the acceptance limit, with the same explanation asabove for the dogs.RBC10 /L0.986* 0.98g/L0.990* 0.98 0.95MCVfL0.926*HCT%0.966*PLT109/L0.642* 0.95WBC910 /L0.883* 0.97LYM109/L0.521* 0.70MONO910 /L0.522*GRAN910 /L0.969*EOS109/L0.750*97 0.90Correlation is significant at the 0.01 level (2-tailed). rs Spearman rho.(C)Passing-Bablok fit(y 2.189 x 0.997 x)55Exigo H400: MCV (fL)11r specificationHGBPassing-Bablok fit(y 3 x 1 x)190Exigo H400: HGB (g/L)Exigo H400: RBC (1012/L)(B)Passing-Bablok fit(y 0.8071 x 0.8496 x)13rs12*(A)Unit1409045355403357911Sysmex: RBC (1012/L)254013(D)90140Sysmex: HGB (g/L)19025(E)Passing-Bablok fit(y 5.072 x 0.7733 x)Passing-Bablok fit(y -37.65 x 0.7846 x)3080040020010203040Sysmex: HCT (%)200050(H)8400800Sysmex: PLT (109/L)1200020Sysmex: WBC (109/L)4030Passing-Bablok fit(y -0.1167 x 1.013 x)Exigo H400: GRAN/NEU (109/L)Passing-Bablok fit(y -0.3797 x 0.4721 x)Exigo H400: LYM (109/L)301010(G)55Passing-Bablok fit(y -0.1834 x 1.006 x)40Exigo H400: WBC (109 /L)12004045Sysmex: MCV (fL)(F)Exigo H400: PLT (109/L)Exigo H400: HCT (%)50356422010000246Sysmex: LYM (109/L)801020Sysmex: NEU BASO (109/L)30Fig. 4. Agreement between the Sysmex XT-2000iV (reference) and the Exigo H400 (test) hematology analyzer for cat CBC. Passing-Bablok regressiongraphs for RBC (A), HGB (B), MCV (C), HCT (D), PLT (E), WBC (F), LYM (G), and GRAN (H). The thin line is the line of identity (x y) and the thick line isthe line of best fit.5
HorsesTable 5. Agreement between the Sysmex XT-2000iV and the Exigo H400veterinary hematology analyzer CBC for horsesCorrelation plots for the horse samples are shown in Fig. 5.The Exigo H400 showed good to excellent correlation whencompared to the Sysmex analyzer, except for the MONO(Table 5, Fig. 5).Parameter(B)13Passing-Bablok fit(y 0.6145 x 0.8698 x)r specificationRBC10 /L0.996* 0.98HGBg/L0.997* 0.98 0.95MCVfL0.962**HCT%0.989*PLT109/L0.822* 0.95WBC910 /L0.983* 0.97LYM109/L0.891* 0.70MONO910 /L0.504*GRAN910 /L0.986*EOS109/L0.679* 0.90Correlation is significant at the 0.01 level (2-tailed). rs Spearman rho.(C)Passing-Bablok fit(y 1 x 1 x)180rs12*(A)UnitPassing-Bablok fit(y 3.252 x 0.8958 x)5097Exigo H400: MCV (fL)Exigo H400: HGB (g/L)Exigo H400: RBC (1012/L)111401005454035306033579Sysmex: RBC (1012/L)11(D)256013(E)251803545Sysmex: MCV (fL)(F)800Passing-Bablok fit(y 1.832 x 0.8715 x)45100140Sysmex: HGB (g/L)Passing-Bablok fit(y -5774 x 0.957 x)Passing-Bablok fit(y 0.02069 x 1.034 x)3525400200152535Sysmex: HCT (%)45(G)200400600Sysmex: PLT (109/L)800051015Sysmex: WBC (109/L)2020Passing-Bablok fit(y -0.5779 x 1.011 x)Passing-Bablok fit(y -0.134 x 0.8642 x)Exigo H400: GRAN/NEU (109/L)81000(H)155015Exigo H400: LYM (109/L)600Exigo H400: WBC (109 /L)Exigo H400: PLT (109/L)Exigo H400: HCT (%)20642161284000246Sysmex: LYM (109/L)8051015Sysmex: NEU BASO (109/L)20Fig. 5. Agreement between the Sysmex XT-2000iV (reference) and the Exigo H400 (test) hematology analyzer for horse CBC. Passing-Bablok regressiongraphs for RBC (A), HGB (B), MCV (C), HCT (D), PLT (E), WBC (F), LYM (G), and GRAN (H). The thin line is the line of identity (x y) and the thick line isthe line of best fit.6
ConclusionDisclaimerThis study points to some of the differences between a moretechnically advanced 5-part analyzer, intended for use in alarger reference laboratory, and a 4-part analyzer, intendedfor use in general health screenings at local veterinary clinics.Although some samples included in this study were frompatients with pathological states that are not applicable tothe placement of a 4-part hematology analyzer, these samplesprovide the analytical parameter range necessary for theevaluation.The results from this study demonstrate that theperformance of Exigo H400 hematology analyzer is in goodagreement with that of the reference analyzer and the manualreference method, indicating the suitability of Exigo H400 foruse in routine hematology analysis at veterinary clinics.The results and conclusions presented in this study arevalid for this specific study only. Other study conditions andassumptions could have significant impact on the outcome.References1. White Paper: Hematology analyzers: 3-part or 5-part, that isthe question. Boule Diagnostics, WP31183, Edition 1 (2019).2. White Paper: Introduction of veterinary hematologyparameters: factors affecting parameters, clinical relevanceand inter-species variations. Boule Diagnostics, WP34071,Edition 2 (2019).7
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This work demonstrates the performance of Exigo H400 4-part hematology analyzer in comparison with a more technically advanced 5-part reference analyzer in complete blood count (CBC) analyses of patient samples taken from the normal routine screening. . the Sysmex XT-2000iV 5-part hematology analyzer and associated reagents, calibrator .
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Contract HHSM-500-2015-00246C ; Enhanced Direct Enrollment (EDE) API Companion Guide Version 5.6 August 17, 2020 : CMS FFE Companion Guide ii . Document Control . Author Versio n Rev. date Summary of Changes Section Page Abigail Flock, Alexandra Astarita, Sean Song 1.0 . 1/23/2018 . Initial Version . All . All . Scott Bickle, Alexandra Astarita, Sean Song 2.0 . 3/15/2018 . Incorporated Client .
