A Comparison Between the HORIBA Yumizen H500 Point-Of-Care Hematology Analyzer with a 5-Part White Cell Differential and the HORIBA Pentra 120

ORIGINAL ARTICLE

A Comparison Between the HORIBA Yumizen H500 Point-of-Care Hematology Analyzer With a 5-Part White Cell Differential and the HORIBA Pentra 120

Timothy Woolley, MSc, CSci, FIBMS, Bethan Jade Davies, MSc, Emma Rutter, MSc, Charlotte Probert, Leanne Fitzgerald, MSc, and William Relf

administration of chemotherapeutic drugs. One drawback of POCT Abstract: The release of new and innovative platforms has helped the hematology analyzers however has long been the lack of a 5-part point-of-care testing market to grow and cement its wider uptake in various WBC differential. clinical settings. Driven by the introduction of novel patient pathways often The FBC along with the WBC count is one of the most fre- centered on clinics remote from a laboratory, the need for laboratory grade quently requested laboratory tests. The WBC typically includes parameters and results from point-of-care analyzers is now critical. 5 white cell subgroups and is used to diagnose and monitor a In this paper, we compare the 5-part white blood cell (WBC) differential variety of pathologic conditions such as bacterial and viral infec- from HORIBA Medicals mainline hematology analyzer, the Pentra 120, tions, inflammation, leukemia, immunodeficiency disorders, and and those provided from the recently released Yumizen H500 point-of- postchemotherapy states.2–4 care analyzer. Patients with chemotherapy-induced neutropenia are at risk The Yumizen H500 is based on HORIBA's Micros platform and is aimed at for severe bacterial infections. This risk is often dependent on the point-of-care/primary care market. The Yumizen H500 is capable of the depth and duration of the neutropenia and the type of underly- measuring a full blood count (27 parameters) including a 5-part WBC dif- ing disease, in which case, the use of antibacterial prophylaxis to μ ferential using only 20 L of whole blood in approximately 2 minutes. The prevent serious infections requires the clinician to balance the ex- analyzer also has both open and closed venous tube options, making it suit- pected benefit against the risks such as adverse drug-related able for pediatric and capillary samples as well as easier and safer to use in events and emergence of antibiotic resistance.5 the point-of-care setting. The widespread use of intensive therapies means that the We found that all full blood count parameters were intra-assay reproducible 2 proportion of patients with moderate to severe leucopenia can be and compared well with previous precision studies; likewise, the patient R significant, as such the use of the FBC to monitor patients has values for neutrophils, lymphocytes, monocytes, and eosinophils also com- increased.5–7 This has come at the same time as major changes pared well at 0.994 for WBC, 0.952 for neutrophils, 0.942 for lymphocytes, in national pathology models including the increase in hub labora- 0.84 for monocytes, and 0.81 for eosinophils. In conclusion, the Yumizen tories; because of this, access to a 24/7 laboratory may be limited H500 provides reproducible, precise, and accurate results compared with and not fully meet the needs of some clinical settings. our institute's mainline laboratory analyzers. The 5-part differentials that are performed in hub laboratories provide, as a minimum, results for neutrophils, lymphocytes, Key Words: point-of-care, hematology, HORIBA, Yumizen H500, white blood cell count, 5-part differential, neutrophils, lymphocytes, eosinophils (Point of Care 2017;16: 89–92) TABLE 1. Within-day and Between-day Precision for the H500 Using the Low IQC (n = 10) he release of new and innovative platforms has helped the T point-of-care testing (POCT) market to grow and cement its Low Mean SD CV use in the wider clinical arena. Driven in part by the introduction RBC 2.2 0.025 1.2 of novel patient pathways often centered on clinics remote from a laboratory, the need for laboratory grade parameters and results HGB 65.1 0.516 0.8 from point-of-care analyzers is now critical. HCT 0.2 0.003 1.5 Traditionally, POCT devices have been discipline specific; MCV 84.8 0.361 0.4 however, crossover units are now being released, one such platform MCH 29.6 0.315 1.1 is the Micros CRP (HORIBA Medical, Northampton, UK). This MCHC 348.9 4.433 1.3 analyzer provides a full blood count (FBC) including a 3-part dif- PLT 76.6 3.847 5.0 ferential white blood cell (WBC) count with a C-reactive protein MPV 9.0 0.163 1.8 1 assay; recently published data identified that this platform gave WBC 2.4 0.067 2.8 laboratory quality results for FBC and C-reactive protein. The NEU 1.2 0.042 3.5 use of such an analyzer in the point-of-care setting could be used LYM 0.6 0.047 7.5 to manage appropriate antibiotic prescription or to monitor the MON 0.2 0.016 6.5 EOS 0.2 0.024 15.1 From the SYNLAB UK, Gavenny Court, Abergavenny, Monmouthshire, South Wales, UK. BAS 0.2 0.016 10.6 Reprints: Timothy Woolley, MSc, CSci, FIBMS, SYNLAB UK, Gavenny Court, Abergavenny, Monmouthshire, South Wales, UK. BAS indicates basophil; EOS, eosinophil; HGB, haemoglobin; LYM, E‐mail: [email protected]. lymphocyte; MCH, mean cell haemoglobin; MCHC, mean cell haemoglobin The authors declare no conflict of interest. concentration; MCV,mean cell volume; MON, monocyte; MPV,mean platelet Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. volume; NEU, neutrophil; PLT, platelets. ISSN: 1533-029X

Point of Care • Volume 16, Number 2, June 2017 89

TABLE 2. Within-day and Between-day Precision for the H500 TABLE 4. Manufacturers Precision Specifications for the Using the Normal IQC (n = 10) Yumizen H500

Normal Mean SD CV Parameters Precision (CV), % Linearity RBC 4.4 0.057 1.30 WBC <3.0 0–300 Â 109/L HGB 130.3 0.400 0.31 RBC <2.0 0–8 Â 1012/L HCT 0.4 0.005 1.24 HGB <1.5 0–240 g/L MCV 85.0 0.289 0.34 HCT <2.0 0–67 L/L MCH 29.6 0.339 1.15 PLT <5.0 0–2500 Â 109/L MCHC 347.9 4.080 1.17 PLT (PLT concentrate) <5.0 0–4000 Â 109/L PLT 250.0 6.561 2.63 HGB indicates haemoglobin; PLT, platelets. MPV 9.0 0.120 1.34 WBC 7.2 0.083 1.15 NEU 3.8 0.067 1.77 LYM 2.4 0.078 3.23 of POCTanalyzers capable of producing an FBC with a 5-part dif- MON 0.6 0.038 6.41 ferential is limited; however, newer analyzers do include the EOS 0.2 0.036 15.41 HemoScreen (PixCell Medical, Israel) and the Yumizen H500 (HORIBA Medical, Northampton, UK).1,8–10 BAS 0.2 0.017 11.43 Previous papers have compared the red cell and platelet BAS indicates basophil; EOS, eosinophil; HGB, haemoglobin; LYM, parameters of the Micros platform1 and that will not be covered lymphocyte; MCH, mean cell haemoglobin; MCHC, mean cell haemoglobin here; in this paper, we aim to compare 5-part differentials obtained concentration; MCV,mean cell volume; MON, monocyte; MPV,mean platelet from the department's mainline hematology analyzer, the Pentra volume; NEU, neutrophil; PLT, platelets. 120 (HORIBA Medical, Northampton, UK), with those provided from the recently released Yumizen H500 (HORIBA Medical, Northampton, UK). monocytes, eosinophils, and basophils. However, smaller POCT The Yumizen H500 is based on Horiba's Micros platform and analyzers until recently have only provided a 3-part differential, is aimed at the point-of care/primary care market. The Yumizen where the neutrophils, eosinophils, and basophils are grouped to- H500 is capable of measuring an FBC (27 parameters) including gether to produce a total granulocyte count. However, the absolute a 5-part WBC differential using only 20 μL of whole blood in neutrophil count is an important criterion to clinicians when mak- approximately 2 minutes. The analyzer also has both open ing decisions about the treatment of oncology patients. and closed venous tube options, making it suitable for pediatric The hematology POCT market has a number of novel ana- and capillary samples as well as easier and safer to use in the lyzers capable of producing 3-part differentials, including the point-of-care setting. Hemocue WBC (HemoCue AB, Angelholm, Sweden), the pocH- 100i (Sysmex Corporation, Kobe, Japan), and the ABX Micros MATERIALS AND METHODS series (HORIBA Medical, Northampton, UK). The availability HORIBA Medical provides 3 levels of internal quality control (IQC) material in an FBC control pack; all 3 levels (low, normal, and high; lot number: PX401; expiry, 5/11/16) were used to TABLE 3. Within-day and Between-day Precision for the H500 establish the H500's within-day (5 runs on 1 day) and between-day Using the High IQC (n = 10)

High Mean SD CV RBC 5.0 0.043 0.87 HGB 151.9 0.469 0.31 HCT 0.4 0.003 0.70 MCV 88.1 0.202 0.23 MCH 30.3 0.176 0.58 MCHC 343.4 2.380 0.69 PLT 523.2 8.219 1.57 MPV 9.3 0.092 0.98 WBC 17.1 0.248 1.45 NEU 11.8 0.209 1.77 LYM 2.6 0.069 2.65 MON 1.5 0.058 3.84 EOS 0.7 0.055 7.43 BAS 0.5 0.042 8.88 BAS indicates basophil; EOS, eosinophil; HGB, haemoglobin; LYM, lymphocyte; MCH, mean cell haemoglobin; MCHC, mean cell haemoglobin FIGURE 1. concentration; MCV,mean cell volume; MON, monocyte; MPV,mean platelet Patient sample comparison of the WBC from the volume; NEU, neutrophil; PLT, platelets. Pentra 120 and H500. This figure can be viewed online in color at www.poctjournal.com.

H500's WBC result with those obtained from the department's mainline laboratory platforms. The Yumizen H500 platform is based on the Micros family of analyzers but incorporates aspects seen in the larger Pentra units such as thermally controlled reaction chambers. We have previously reported precision and patient comparison data for the FBC with 3-part differential for this platform; however, we report for the first time WBC 5-part differential precision and patient comparison data for the H500.

DISCUSSION Precision values for the H500 on all analytes can be seen in Tables 1–3; these values were calculated from 5 runs over 1 day and 5 runs over 5 separate days. We found that the WBC, red blood cell (RBC), hemoglobin, hematocrit (HCT), and platelet parameters were intra-assay reproducible over the IQC range [n = 10; coefficient of variations (CVs), <5.0%], which compared FIGURE 2. Patient sample comparison of the neutrophil counts well with the manufacturer's specifications (see Table 4), the pre- from the Pentra 120 and the H500. This figure can be viewed cision seen with the Pentra 120, and data published elsewhere for online in color at www.poctjournal.com. the Micros platform.1 The WBC differential CVs were again intra-assay reproducible for neutrophils (<5%), lymphocytes (<5%), and monocytes (<6%). Eosinophil and basophil CVs were higher (<15%), which reflects the low levels seen in the IQC material and is to be expected. As can be seen in Figures 1–3, patient comparison data for WBC, neutrophil, and lymphocyte data show good correlation (r2 of 0.96, 0.95, and 0.94, respectively). Monocyte and eosinophil data were also acceptable, being r2 of 0.84 and 0.81, respectively. It must be noted however that only low levels were seen in these cell subtypes and were from a normal patient cohort (monocytes, 0.2–1.0; eosinophils, 0.1–0.3); this will likely have adversely af- fected the results. The eosinophil's performance is particularly important, given that this cell type is often monitored in patients receiving therapeutics where allergic reactions can be a notable adverse effect. From these findings, the H500 was revealed to produce com- parable laboratory quality results for all WBC parameters. The use of such an analyzer in the point-of-care setting could be used to both manage antibiotic prescription and monitor the administra- FIGURE 3. Patient sample comparison of the lymphocyte counts tion of chemotherapeutics as well as drugs that have neutropenic from the Pentra 120 and the H500. This figure can be viewed adverse effects such as clozapine. online in color at www.poctjournal.com. REFERENCES precision (1 run over 5 days). One hundred patient samples were 1. Woolley T. A comparison between the Horiba Microsemi point-of-care then analyzed using vacutainer EDTA (ethylenediaminetetraacetic C-reactive protein and full blood cell analyzer and the Horiba Pentra 120 and Roche Cobas 6000. Point Care: J Near-Patient Test Technol.2014;13 acid) tubes (Becton Dickenson, Oxford, UK). Ethylenediamine- (2):66–69. tetraacetic acid samples for FBC were initially processed on the Pentra 120 hematology analyzer (HORIBA Medical, Northampton, 2. Evans AT, Husain S, Durairaj L, et al. Azithromycin for acute bronchitis: a randomised, double-blind, controlled trial. Lancet. UK). All samples were analyzed within 2 hours of each other and – were between 12 and 24 hours old on receipt. The analyzers were 2002;359:1648 1654. maintained and controlled as per the manufacturer's instructions, 3. Quenot JP,Luyt CE, Roche N, et al. Role of biomarkers in the management and samples were treated as per the department's standard operat- of antibiotic therapy: an expert panel review II: clinical use of biomarkers ing procedures. Both platforms were controlled daily using the for initiation or discontinuation of antibiotic therapy. Ann Intensive Care. manufacturer's IQC material. 2013;3(1):21. 4. Casey JR, Pichichero ME. A comparison of 2 white blood cell count devices to aid judicious antibiotic prescribing. Clin Pediatr (Phila).2009; 48(3):291–294. RESULTS 5. Segal BH, Freifeld AG. Antibacterial prophylaxis in patients with All 3 levels of IQC (low, normal, and high) were used to estab- neutropenia. J Natl Compr Canc Netw. 2007;5(2):235–242. lish the H500's within-day and between-day precision. One hundred 6. Elliott MA, Litzow MR, Letendre LL, et al. Early peripheral blood patient samples were then analyzed to enable a comparison of the blast clearance during induction chemotherapy for acute myeloid

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