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    Optimization of laboratory workflow in clinical hematology

    laboratory with reduced manual slide review: comparison

    between Sysmex XE-2100 and ABX Pentra DX120M. HUR*, J.-H. CHO*, H. KIM*, M.-H. HONG*, H.-W. MOON*, Y.-M. YUN*, J. Q. KIM

    INTRODUCTION

    The complete blood count (CBC) with leukocyte dif-

    ferential counts (LDC) is one of the most frequently

    requested tests in clinical laboratories. Technical evo-

    lutions in automated hematology analyzers have

    improved the analytic performance greatly and have

    broadened the range of information provided (Buttarello

    *Department of Laboratory

    Medicine, Konkuk University

    School of Medicine, Seoul, KoreaKonkuk University, Seoul, Korea

    Correspondence:

    Mina Hur, Department of

    Laboratory Medicine, Konkuk

    University School of Medicine,

    Konkuk University Hospital, 4-12,

    Hwayang-dong, Kwangjin-gu,

    Seoul 143-729, Korea.

    Tel.: +82 2 2030 5581;

    Fax: +82 2636 6764;

    E-mail: [email protected]

    This work was supported by

    Konkuk University in 2010.

    doi:10.1111/j.1751-553X.2011.01306.x

    Received 24 September 2010;

    accepted for publication 21

    December 2010

    Keywords

    Slide, review, Sysmex XE-2100,

    ABX Pentra DX120, hematology

    SUMMARY

    Introduction: The validation of automated hematology analyzer results

    by manual slide review (MSR) is currently an inevitable work process

    in clinical hematology laboratories. The laboratory workload wouldbe optimized if the requirement for MSR could be reduced without

    compromising patient care. We investigated whether slide-making

    rates would be different between two hematology analyzers, which

    were paired with their own automated slide makers/stainers: Sysmex

    XE-2100 with SP-1000i (Sysmex, Kobe, Japan) and ABX Pentra

    DX120 with SPS evolution (ABX-Horiba, Montpellier, France).

    Methods: A total of 943 samples were run in parallel on the Sysmex

    XE-2100 and ABX Pentra DX120. Reflex slides were automatically

    made in each analyzer according to its own criteria, which reflected

    the criteria of MSR in our laboratory. The slide-making rates were

    compared, and the results were further confirmed using the criteriaof MSR.

    Results: The slide-making rates in Sysmex XE-2100, ABX Pentra

    DX120, and manual review were 22.5% (212/943), 15.91% (150/

    943), and 11.5% (108/943), respectively. In 774 (82.1%) samples,

    the three methods showed concordant results, and all made slides in

    82 samples. Using the manual method as a standard, the sensitivity

    and specificity were 86.1% and 85.8% in Sysmex XE-2100 and

    89.8% and 93.7% in ABX Pentra DX120.

    Conclusion: Our data show that the slide-making rates are variable in

    different hematology analyzers. It also implies that although MSRcannot be fully substituted by modern hematology analyzers, it can

    be effectively reduced to optimize laboratory workload.

    ORIGINAL ARTICLE INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY

    434 2011 Blackwell Publishing Ltd, Int. Jnl. Lab. Hem. 2011, 33, 434440

    International Journal of Laboratory HematologyThe Official journal of the International Society for Laboratory Hematology

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    RESULTS

    The comparison data of slide preparation by Sysmex

    XE-2100, ABX Pentra DX120, and manual review

    are presented in Table 2. The slide-making rates in

    Sysmex XE-2100, ABX Pentra DX120, and MSR were

    22.5% (212/943), 15.91% (150/943), and 11.5%

    (108/943), respectively. All the three methods showed

    concordant results in 774 (82.1%) samples: all posi-

    tive in 82 samples and all negative in 692 samples.

    Discrepant results were observed in 169 samples. No

    case showed a positive result by manual review but

    Figure 2. Workflow of slide review with Sysmex XE-2100 and SP-1000i.

    Figure 1. The decision-making criteria for manual slide review.

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    negative results by both Sysmex XE-2100 and ABX

    Pentra DX120. However, there were discrepant results

    between the Sysmex XE-2100 and ABX Pentra DX120

    in 26 samples with positive MSR results: 15 were Sys-

    mex negative and Pentra positive and the other 11were Sysmex positive and Pentra negative. Using

    MSR as a reference method, the sensitivity and speci-

    ficity were 86.1% (95% confidence interval (CI),

    78.192.0%) and 85.8% (95% CI, 83.288.0%) in

    Sysmex XE-2100 and 89.8% (95% CI, 82.594.8%)

    and 93.7% (95% CI, 91.895.2%) in ABX Pentra

    DX120, respectively (Table 3). Significant differences

    in the specificity and specificity of the analyzers were

    observed, with a difference of 3.7% (95% CI, 0.69

    6.71; P = 0.0165) for sensitivity and 8.0% (95% CI,

    5.210.8; P < 0.0001) for specificity (chi-square test).

    The causes of false-positive and false-negative

    results were analyzed (Table 4). In the 119 samples

    with false-positive results by Sysmex XE-2100, slide

    flag was the most frequent cause followed by delta

    check and department; slide flag and/or delta check

    comprised three-quarters (75.7%) of the total false-

    positive causes. In ABX Pentra DX120, the two causes

    of false-positive results were slide flag (64.2%) and

    monocytosis with large immature cells (35.8%).

    Regarding false-negative results, the causes were

    department (n = 11) and absence of result (n = 4) in

    Sysmex XE-2100, and absence of flag (n = 11) in ABX

    Pentra DX120. The quantitative values or flags in 11

    samples with false-negative results by ABX PentraDX120 are presented in Table 5. The Sysmex XE-2100

    also showed flags and/or quantitative abnormalities

    that triggered MSR in these 11 samples. However,

    these did not correspond to our criteria for the

    manual confirmation, except for one sample with 3%

    basophils (sample 8).

    DISCUSSION

    The manual examination of blood smears is time-con-

    suming and expensive and may not be always neces-

    sary. To increase the clinical sensitivity, most

    laboratories tend to develop less strict criteria so as

    not to miss potentially important abnormalities. This

    would be more conspicuous especially when a hospi-

    tal has a large pool of hemato-oncological patients.

    According to the College of American Pathologists

    Q-Probes Study with 263 participating institutions,

    the rates of MSR varied considerably among partici-

    pants (26.7% in the median, 9.9% in the 10th per-

    centile, and 50.0% in the 90th percentile institutions)

    and were elevated with increased numbers of hospital

    beds (Novis et al., 2006). That study showed that therates of MSR were directly related to the efficiency in

    generating CBC results. Most of the MSR were trig-

    gered by hematology analyzer flags, and these thresh-

    old limits also varied widely among participants.

    Recently, the use of automated slide makers and

    stainers has increased in large-sized clinical laborato-

    ries. They are used in combination with their multipa-

    rameter hematology analyzers, and their performances

    are reported to be comparable to well-prepared man-

    ual processes (Simson, Gascon-Lema & Brown, 2009).

    Compared with manual procedures, the introduction

    of automated slide makers and stainers has signifi-

    cantly reduced the workload of slide preparation as

    well as the turn-around-time of the final CBC report.

    On the other hand, not all the automatically prepared

    slides are reviewed manually. If slide-making rules of

    the instrument do not perfectly match the slide-review

    criteria of the laboratory, there may be a discrepancy

    between the prepared slides and reviewed slides. Con-

    sidering the general policy of laboratories not to miss

    Table 1. The rules for slide making in Sysmex XE-2100

    Quantitative abnormalities

    Leukocytopenia/leukocytosis: WBC < 2.0 109/l or

    WBC > 20 109/l

    Neutropenia/neutrophilia: neutrophils < 30% or

    neutrophils > 85.5%

    Lymphocytopenia/lymphocytosis: 70%

    Monocytosis: monocytes > 15.5%

    Eosinophilia: eosinophils > 20%

    Basophilia: basophils > 2%

    Nucleated RBCs > 2/100 WBCs

    Thrombocytopenia/thrombocytosis: PLT < 100 109/l or

    PLT > 600 109/l

    Flags

    PLT clumps or abnormal distribution

    Fragments

    Blasts

    Immature granulocytesLeft shift

    Atypical lymphocytes

    Abnormal lymphocytes/lymphoblasts

    WBC, white blood cell count; RBC, red blood cell count;

    PLT, platelet count.

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    any possible pathologic samples, the presence of these

    unnecessarily prepared slides might be regarded as

    inevitable. However, construction of the rules to

    reflect the laboratories own criteria may be variable in

    each hematology analyzer, and consequently, the gap

    between the prepared and reviewed slides may be dif-

    ferent. To the best of our knowledge, no study has

    focused on this practical issue in routine hematology

    laboratory so far.

    This study investigated whether the slide-making

    rates would be different between two hematology

    analyzers when paired with their own automated slide

    Figure 3. Workflow of the rules for slide making in Pentra DX120. PDX, ABX Pentra DX120; SPS, SPS evolution;

    PML, Pentra multilink data management system.

    Table 2. Slide preparation by Sysmex XE-2100, ABX

    Pentra DX120, and manual review

    Sysmex

    XE-2100

    ABX Pentra

    DX120

    Manual

    review

    Number

    (%)

    Positive Positive Positive 82 (8.7)

    Positive Negative Positive 11 (1.2)

    Negative Positive Positive 15 (1.6)

    Negative Negative Positive 0 (0)

    Negative Negative Negative 692 (73.4)

    Positive Negative Negative 90 (9.5)

    Negative Positive Negative 24 (2.5)

    Positive Positive Negative 29 (3.1)

    Positive means the slide preparation, and negative vice

    versa.

    Table 3. Comparison of the results between Sysmex

    XE-2100, ABX Pentra DX120, and manual review

    Sysmex XE-2100 ABX Pentra DX120

    Positive Negative Positive Negative

    Manual review

    Positive

    (n = 108)

    93 15 97 11

    Negative

    (n = 835)

    119 716 53 782

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    makers/stainers: Sysmex XE-2100 with SP-1000i and

    ABX Pentra DX120 with SPS evolution. Our data

    showed that the sensitivity and specificity of slide

    preparation were different between these two systems

    and that the performance of ABX Pentra DX120

    with SPS evolution was superior to that of Sysmex

    XE-2100 with SP-1000i (Table 3). In particular, the

    number of false-positive samples was decreased in

    ABX Pentra DX120, and the main causes of difference

    were attributable to delta check and department,

    which could not be included in the rules for Sysmex

    XE-2100 (Table 4). Department was also the main

    cause of false-negative results in Sysmex XE-2100,

    and in the routine practice of our laboratory, this was

    one of the main causes of extra workload.

    Eleven samples showed false-negative results by

    ABX Pentra DX120 with no flags. In contrast, they

    mostly showed flags of blasts, atypical lymphocytes, or

    immature granulocytes and/or quantitative abnormali-

    ties by Sysmex XE-2100 (Table 5). According to our

    decision-making criteria for slide review, MSR was

    triggered by the results of Sysmex XE-2100, and the

    Table 4. Causes of false-positive and false-negative results by Sysmex XE-2100 and ABX Pentra DX120

    Sysmex XE-2100 ABX Pentra DX120

    False-positive Total (n = 119, 100%) Total (n = 53, 100%)Slide flag (n = 46, 38.7%) Slide flag (n = 34, 64.2%)

    Delta check (n = 34, 28.6%) Mono + Lic (n = 19, 35.8%)

    Department (n = 21, 17.6%)

    Slide flag and delta check (n = 10, 8.4%)

    Department and delta check (n = 8, 6.7%)

    False-negative Total (n = 15, 100%) Total (n = 11, 100%)

    Department (n = 11, 73.3%) No flag (n = 11, 100%)

    No result (n = 4, 26.7%)

    Mono + Lic, monocytosis and large immature cells.

    Table 5. Quantitative values or flags in samples with false-negative results by ABX Pentra DX120

    Dep

    Quantitative values (%) or flags

    ABX Pentra DX120 Sysmex XE-2100 Manual differential count (%)

    1 IM Lic: 1.0 Abn L/L-Blasts N: 67, Nb: 2, L: 25, M: 6

    2 IM E: 16.9 Eosinophilia, Blasts N: 65, L: 8, M: 8, E: 19

    3 IM No flags Abn L/L-Blasts N:73, L:16, M:6, E:3, B:2

    4 IM Lic: 1.0 Aty L N: 73, Nb: 2, L: 17, M: 4, E: 1, B: 2, Aty L: 1

    5 IM Lic: 2.2 Immature Granulocytes N: 78, Nb: 2, L: 12, M: 4, E: 2, B: 1, Mm: 1

    6 IM M:13.6, Lic: 0.4, Aty L: 1.5 Abn L/L-Blasts N: 43, Nb: 1, L: 39, M: 13, E: 3, B: 1

    7 IM nRBC, platelet aggregates,

    monocytosis, (M: 11.4,

    Lic: 0.6, Aty L: 1.4)

    Basophilia N: 65, Nb: 1, L: 22, M: 7, E: 4, B: 1

    8 IM Lic: 0.8, Aty L: 0.9 Blasts N: 46, Nb: 2, L: 43, M: 6, B: 3

    9 PED Neutropenia (M: 10.2,

    Lic: 0.8, Aty L: 2.2)

    Neutropenia,

    Abn L/L-Blasts

    N: 15, Nb: 4, L: 64, M: 11, E: 3, B: 2, Aty L: 1

    10 IM Lic: 2.0, Aty L: 1.7 Aty L N: 79, Nb: 4, L: 10, M: 5, B: 1, Aty L: 1

    11 IM M: 12.8, Lic: 0.9, Aty L: 1.4 Aty L N: 61, L: 25, M: 9, E: 2, Aty L: 3

    Dep, department; IM, internal medicine; PED, pediatrics; Lic, large immature cells; Aty L, atypical lymphocytes; Abn L,

    abnormal lymphocytes; nRBC, nucleated RBCs; L-Blasts, lymphoblasts; N, neutrophils; Nb, band-form neutrophils; L,

    lymphocytes; M, monocytes; E, eosinophils; B, basophils; Mm, metamyelocytes; My, myelocytes.

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