Hematology Analyzers, 2023

wdt_ID	Company Name	Contact	Email Address	City, State	Phone Number	Website	Name of instrument	First year installed in U.S./Outside U.S./No. of units sold Sept. 2022–Aug. 2023	No. units installed in U.S./Outside U.S./List price†	Menu of chartable tests (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)	Tests submitted for 510(k) clearance/Tests in development	Tests for research use only	Tests unique to analyzer	Differential method(s) used	• WBC count/RBC count	• Hemoglobin/Platelet	• MCV (fL) or Hct (%)	• Reticulocytes	• WBC count/RBC count	• Hemoglobin/Platelet	• MCV or Hct (%)	• Reticulocytes	Accuracy of automated differential compared with manual differential (per CLSI H20-A2)	• WBC	• RBC	• MCV or Hct	• Platelet	• Hemoglobin	Interfering substances: differential	Throughput: max. CBCs per hour/Max. CBCs and	Minimum specimen volume open/Closed/Sample dead	Microsample capability	Instrument prepares microscope slides automatically/No. of automatic slide makers installed	• Slide maker stainer sold separately or combined unit	Instrument archives patient data/Archiving is patient specific	Maximum amount of archived data accessible when system online	No. specimens for which numeric results saved in memory at once	No. specimens for which histo/cytogram results saved in memory at once	Instrument performs delta checks	Parameters for which flags may appear	Flagging is operator selectable	Tags and holds results for follow-up, confirmatory testing, or rerun	Parameters for flags for holding samples defined by user or vendor	Scattergram display: cell-specific color	Histogram display: color with thresholds	User interface can display choice of specimen or result information	LIS interface formats supported	Information transferred via LIS interface	LOINC codes transmitted with all results/Sent in message to LIS/Listing of machine codes and corresponding LOINC for each test	Interface available or planned to automated specimen-handling system	Barcode symbologies read on specimen tube	Accommodates barcode placement per CLSI standard Auto02-A2	No. of cleaning or maintenance reagents required/No. of routine liquid reagents required	Time required for daily, weekly, monthly maintenance	Onboard diagnostics for troubleshooting/Limited to software problems	Manufacturer can perform diagnostics via modem	Distinguishing features (supplied by company)
1	Abbott Diagnostics	Christy Thiessen	christy.thiessen@abbott.com	Abbott Park, IL	800-323-9100	https://www.corelaboratory.abbott.com	Alinity h-series*	2023/2017/—	—/>770/—	WBC, RBC, Hb, Hct, MCV, MCH, MCHC, Plt, neut %&#, mono %&#, lymph %&#, eos %&#, baso %&#, IG %&#, RDW, NRBC, NR/W, RETIC %&#, R %, IRF, MCHr, MPV, rP %	—	RDW-SD, microcytic RBC%, macrocytic RBC%, hypochromic RBC%, hyperchromic RBC%, HDW, CHCM, cHGB, MCVr, more	—	advanced MAPSS (multi-angle polarized scatter separation) technology using seven light scatter detectors and one fluorescent detector	0.04–447.00 × 10³ cells/µL/0.01–8.08 × 106 cells/µL	0.15–24.1 g/dL/0.46–5,325 × 10³ cells/µL	51.4–131.0 fL (MCV), 9.42–86.0% (Hct)	0.05–644 × 10³ cells/µL	≤3.5 CV% @ >4.0 × 10³ cells/µL/≤1.5 CV% @ >4.00 × 106 cells/µL	≤1.3 CV% @ >12.0 g/dL/≤4.5 CV% @ >50.00 × 103 cells/µL	≤1.0 CV% (MCV), ≤2.0 CV% for Hct >45%	≤7.0 CV% @ >200.00 × 10³ cells/µL	—	cryoglobulin, cryofibrinogen, fragile WBCs, nonviable WBCs, neutrophil aggregates, hemoglobin C crystals, NRBCs, PLT clumps/aggregates	RBC autoagglutinins, cold agglutinins, giant PLTs, RBC fragments	RBC autoagglutinins, cold agglutinins, giant PLTs, PLT clumps/aggregates, hyperglycemia	RBC autoagglutinins, cold agglutinins, cryoglobulin, cryofibrinogen, giant PLTs, PLT clumps/aggregates, PLT satellitism, RBC fragments, more	hemoglobin C crystals	cryoglobulin, cryofibrinogen, fragile WBCs, nonviable WBCs, neutrophil aggregates, hemoglobin C crystals, NRBCs, PLT clumps/aggregates	—/119	≤100 µL/≤100 µL/dependent on tube	no	yes/>150	sold as combined unit	yes/yes	—	most recent 100,000 results	most recent 100,000 results	yes	morphological flags including PLT clump, left shift, blast, variant LYM, RBC fragments, ASYM RBC, more	operator and vendor selectable	yes	user and vendor	yes	yes	yes	ASTM 1394-91, ASTM 1381, HL7	numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders	no/no/no	Abbott ACCELERATOR a3600, Abbott GLP systems Track	Codabar, Code 39, Code 128, Interleaved 2 of 5	yes	1 (Alinity hq module)/3 CBC/diff, 1 retic	daily: 0 (automatic) for Alinity hq, hs modules; weekly: 0 (automatic) for Alinity hq, hs modules	yes/no	no	high productivity, scalable systems that use only 3 reagents to provide CBC results with 6-part WBC differential and nRBC; duplicate reagents onboard, automated daily and weekly maintenance; seamless connectivity to Abbott ACCELERATOR a3600 lab automation system and AlinIQ middleware
2	Abbott Diagnostics	Christy Thiessen	christy.thiessen@abbott.com	Abbott Park, IL	800-323-9100		CELL-DYN Emerald*	2009/2008/—	>1,700/>2,800/$30,000	WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, lymph %&#, gran %&#, mid %&#, RDW, MPV	—	—	—	electrical impedance counting	0.4–96.1 K/µL/0.22–7.61 M/µL	3.3–24.6 g/dL/9–1,375 K/µL	48.8–115 fL (MCV), 5.3–75.6% (Hct)	48.8–115 fL (MCV), 5.3–75.6% (Hct)	3.5% (95% confidence limit)/2.0% (95% confid. limit)	2.1% (95% confidence limit)/6.1% (95% confid. limit)	0.8% MCV (95% confid. limit), 1.7% Hct (95% confid. limit)		—	cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, nucleated red cells, platelet clumping, unlysed red cells, clotting, smudge cells, uremia plus immunosuppressants	cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells	cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), hyperglycemia (>600 mg/dL), autoagglutination, clotting, in vitro hemolysis, more	cryoglobulin, cryofibrinogen, in vivo and in vitro hemolysis, microcytic red cells, red cell inclusions, white cell fragments, clotting, giant platelets, heparin, platelet, more	carboxyhemoglobin (>10%), cryoglobulin, cryofibrinogen, in vivo hemolysis, heparin, high white cell count (>50,000 K/μL), hyperbilirubinemia, lipemia, monoclonal proteins, clotting	platelet aggregates, NRBCs, giant platelets, cryoglobulin, incomplete lysis of RBCs, small lymphocytes, fibrin clots, shift in WBC cell distrib. due to EDTA anticoagulant equilibration	57/57	9.8 µL/—/—	no	no/—	—	yes/no	300,000 on USB and 1,500 results on internal memory	300,000 on USB and 1,500 results on internal memory	300,000 on USB and 1,500 results on internal memory	no	dispersional data alerts, suspect measurand flags, and count invalidation flags	yes	no	user	no	no	yes	proprietary	numeric and flag results, instrument to LIS	no/no/no	no	Codabar, Code 39, Code 128, Interleaved 2 of 5, Chinese post, Code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, MSI/Plessey, more	no	1/2	daily: none; weekly: ~15 min.; biannually: ~10 min.	no/no	no	small: sample size, reagent volumes used, and physical size; reliable: averages one service call per year; easy to use: system has touchscreen software with intuitive icons and minimal layers
3	Abbott Diagnostics	Christy Thiessen	christy.thiessen@abbott.com	Abbott Park, IL	800-323-9100		CELL-DYN Emerald 22*	2016/2016/—	—/—/$64,000	standard menu plus: RDW, MPV, mono %&#, lymph %&#, eos %&#, baso %&#	—	—	—	UNI-FLOW Optical Technology	0.4–90 K/µL/1.2–8.3 M/µL	5.5–22 g/dL/11–1,485 K/µL	53.2–118.4 fL (MCV), 12.1–66.1% (Hct)	—	3.2% CV/2.0% CV	1.2% CV/7.1% CV	0.8% CV (MCV)		—	cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, nucleated red cells, platelet clumping, unlysed red cells, clotting, smudge cells, uremia plus immunosuppressants	cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells	cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), hyperglycemia (>600 mg/dL), autoagglutination, clotting, in vitro hemolysis, more	cryoglobulin, cryofibrinogen, in vivo and in vitro hemolysis, microcytic red cells, red cell inclusions, white cell fragments, clotting, giant platelets, heparin, platelet, more	carboxyhemoglobin (>10%), cryoglobulin, cryofibrinogen, in vivo hemolysis, heparin, high white cell count (>50,000 K/μL), hyperbilirubinemia, lipemia, monoclonal proteins, clotting	platelet aggregates, erythroblasts, small lymphocytes, immature cells, resistant RBCs, giant or hypersegmented neutrophils, bands	45/45	17 µL/—/—	no	no/—	—	yes/no	300,000 on USB and 1,000 records with histograms on internal memory	300,000 on USB and 1,000 records with histograms on internal memory	300,000 on USB and 1,000 records with histograms on internal memory	no	dispersional data alerts, suspect parameter flags, and count invalidation flags	yes	no	user	yes	yes	yes	proprietary	numeric and flag results, instrument to LIS	no/no/no	no	Codabar, Code 39, Code 128, Interleaved 2 of 5, Chinese post, Code 39 full ASCII, Code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, more	no	2-Jan	daily: none; weekly: 15 minutes; quarterly: ~10 minutes	no/no	no	small physical footprint, only 3 reagents used (2 of 3 reagents stored onboard), and built-in monitor; automated start-up, shut down, and cleaning; 5-part differential using UNI-FLOW optical flow cytometry technology with a patented lyse allowing for clear separation of the 5 WBC populations
4	Abbott Diagnostics	Christy Thiessen	christy.thiessen@abbott.com	Abbott Park, IL	800-323-9100		CELL-DYN Emerald 22 Autoloader*	2019/—/—	—/—/$75,000	standard menu plus: RDW, MPV, mono %&#, lymph %&#, eos %&#, baso %&#	—	—	—	UNI-FLOW Optical Technology	0.4–90 K/µL/1.2–8.3 M/µL	5.5–22 g/dL/11–1,485 K/µL	53.2–118.4 fL (MCV), 12.1–66.1% (Hct)	—	3.2% CV/2.0% CV	1.2% CV/7.1% CV	0.8% CV (MCV)	—	neut% r=1.00, slope=0.97, y=1.88; lymph% r=0.99, slope=1.00, y=0.30; mono% r=0.92, slope=0.96, y=0.42; eos% r=0.97, slope=0.93, y=0.22; baso% r=0.63, slope=0.26, y=0.04	cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, nucleated red cells, platelet clumping, unlysed red cells, clotting, smudge cells, uremia plus immunosuppressants	cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells	cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), hyperglycemia (>600 mg/dL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells	cryoglobulin, cryofibrinogen, in vivo and in vitro hemolysis, microcytic red cells, red cell inclusions, white cell fragments, clotting, giant platelets, heparin, platelet clumping, platelet satellitosis	carboxyhemoglobin (>10%), cryoglobulin, cryofibrinogen, in vivo hemolysis, heparin, high white cell count (>50,000 K/μL), hyperbilirubinemia, lipemia, monoclonal proteins, clotting	platelet aggregates, erythroblasts, small lymphocytes, immature cells, resistant RBCs, giant or hypersegmented neutrophils, bands	40/40	21 μL/21 μL/500 μL	no	no/—	—	yes/yes	300,000 on USB and 1,000 records with histograms on internal memory	300,000 on USB and 1,000 records with histograms on internal memory	300,000 on USB and 1,000 records with histograms on internal memory	no	dispersional data alerts, suspect parameter flags, and count invalidation flags	no	yes	vendor	yes	yes	yes	proprietary	numeric and flag results, instrument to LIS	no/no/no	no	Codabar, Code 39, Code 128, Interleaved 2 of 5, Chinese post, Code 39 Full ASCII, Code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, MSI/Plessey, UK/Plessey, Telepen, TriOptic, S-Code, UPC A, UPC E	no	1/2	daily: none; weekly: 15 minutes; quarterly: ~10 minutes	no/no	no	small: number of reagents used, footprint, sample size; safe, open tube sampling device; closed tube, continuous autoloading with automated rerun
5	Abbott Diagnostics	Christy Thiessen	christy.thiessen@abbott.com	Abbott Park, IL	800-323-9100		CELL-DYN Ruby*	2006/2006/—	>550/>2,700/$185,000	standard menu plus: MPV, RDW, retic %&#, mono %&#, lymph %&#, eos %&#, baso %&#	—	—	atypical depolarization flag	MAPSS (multi-angle polarized scatter separation)	0.02–246 × 10³/µL/0.00–7.50 × 10⁶/µL	0.00–25.0 g/dL/0.00–3,000 × 10³/µL	58–139 (MCV), 8.3–79.8% (Hct)	—	2.4%/1.8%	1.4%/3.8%	0.8% (MCV)		neut% r=0.983, slope=0.97, y=-1.98; lymph% r=0.921, slope=0.95, y=0.94; mono% r=0.711, slope=1.10, y=1.93; eos% r=0.952, slope=1.04, y=0.01; baso% r=0.146, slope=0.18, y=1.22	fragile WBC, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin paraproteins	elevated WBC, increased numbers of giant PLTs, autoagglutination, in vitro hemolysis	MCV: elevated WBC, hyperglycemia, in vitro hemolysis, increased number of giant PLTs	WBC fragments, in vitro hemolysis, microcytic RBCs, cryofibrinogen, cryoglobulin, PLT clumping, increased number of giant PLTs	elevated WBC, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lytic-resistant RBCs	fragile WBC, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin, paraproteins	84/84	150 µL/230 µL/1.2 mL	no	no/—	—	yes/yes	10,000 results	10,000 results	10,000 results	no	NRBC, FWBC, NWBC, RRBC, band, IG, blast, variant lymph, RBC morph., DFLT, MCHC, LRI, URI, LURI, ATYPDEP, high-low interp. message, WBC	yes	yes	user	yes	yes	yes	proprietary	numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders	no/no/no	no	Codabar, Code 39, Code 128, Interleaved 2 of 5, ISBT	no	1/2	daily: ~30 seconds; weekly: ~5 min.; monthly: ~10 min.	yes/no	yes	touch-sensitive screen, all optical technology; onboard maintenance videos; lyse-resistant RBC mode; rules-based result annotations
	Company Name						Name of instrument

In hematology, making the most of automated solutions

October 2023—Hematology analyzers and the related workflow, expertise, efficiency, and IT matters were the topic of a roundtable when CAP TODAY publisher Bob McGonnagle met online Aug. 29 with two pathologists and representatives from Horiba, Siemens, Sysmex, CellaVision, Sight, and Abbott. Their conversation follows. Click here for CAP TODAY’s guide to hematology analyzers.

Dr. Chaves

Fernando Chaves, what are the advances in artificial intelligence in the field of hematology, particularly automated hematology, since we spoke during our roundtable at this time last year?
Fernando Chaves, MD, global head of hematology, Siemens Healthineers: Technology now enables full-field digital morphology, a full image of the entire slide scan. Now we can do with hematology what has been done for over a decade in surgical pathology. It brings benefits to customers because it not only preclassifies cells and facilitates the technologist’s work but also enables full remote consultation.

Having digital images under a full slide context creates an opportunity for clinical innovations. It’s already happening with applications for reviewing bone marrows and interpreting morphological abnormalities in the blood, and it could also be done in the future through automation and artificial intelligence solutions. Some of the sepsis parameters that are based on hematology are primarily morphologic parameters that are identified through a histogram. Now we have more sensitive technology that can identify abnormalities such as granularity of cells and heterogeneity of volume. All of that is because images are now digital and can be quantitatively analyzed through artificial intelligence image analysis algorithms.

Jonathan Galeotti, for years we’ve hypothesized that there’s more to be learned from studying the cells than we’ve been able to realize. Now we seem to be on the brink of breaking through in several important areas. Fernando mentioned sepsis but there’s also a plethora of hematologic malignancies that we may be able to understand better. How are you dealing with this at the clinical level in your institution at Chapel Hill?
Jonathan Galeotti, MD, clinical assistant professor, Department of Pathology and Laboratory Medicine, Division of Hematopathology, University of North Carolina School of Medicine: As the field moves forward, it takes a little time for it to work its way through academic labs and into clinical practice. We’re on the front end and have not yet incorporated it much into our hematology practice. There is certainly a need—we still have staffing issues. Anything you can do to streamline the process, to make review and autoverification easier, is on our minds all the time. Hope is there, but we haven’t realized it yet.