
| Name of instrument | Sysmex XE-2100D |
| First year installed in U.S./Outside U.S./No. of units sold in 2011 | 2004/2004/>15 |
| No. units installed in U.S./Outside U.S./List price | >200/>205/$235,640 |
| Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, % neut, mono, lymph, eos, baso): | standard menu (left) plus: RDW-SD, RDW-CV |
| • Laboratory | — |
| • Flags | PLT clumps, PLT abnormal distribution, WBC abnormal scattergram, blast, left shift, atypical lymphocytes, abnormal lymphocytes/blast, RBC abnormal distribution, RBC lyse resistance, RBC agglutinins, turbidity |
| FDA-cleared tests not clinically released | — |
| Tests not available but submitted for 510(k) clearance | — |
| Tests in development | — |
| Tests for research use only | P-LCR, PCT, PDW |
| Tests unique to analyzer | optional: IG % |
| Differential method(s) used | fluorescent flow cytometry |
| Linearity: | |
| • WBC count/RBC count | 0–440/0–8 |
| • Hemoglobin/platelet | 0–25/0–5,000 |
| • MCV (fL) or Hct (%) | 0–75 (Hct) |
| Precision: | |
| • WBC count/RBC count | ≤3%/≤1.5% |
| • Hemoglobin/platelet | ≤1.0%/≤4.0% |
| • MCV or Hct | ≤1.5% (Hct) |
| Accuracy of automated differential compared with manual differential (per CLSI H-20A2) | neut% r=0.95, y=0.92x+5.46; lymph% r=0.95, y=0.88x+2.46; mono% r=0.79, y=0.77x+1.88; eos% r=0.92, y=0.97x+0.29; baso% r=0.82, y=1.01x+0.01; NRBC% r=0.96, y=1.12x+0.11; IG% r=0.83, y=0.9332x+0.0922 |
| Interfering substances: | |
| • WBC | cold agglutinins, PLT aggregation, cryoglobulin, lyse-resistant RBCs, NRBCs |
| • RBC | cold agglutinins, severe microcytosis, fragmented RBCs, leukocytosis |
| • MCV or Hct | Hct: cold agglutinins, ABN red cell fragility, spherocytosis, leukocytosis |
| • Platelet | pseudothrombocytopenia, PLT aggregation, increased microcytosis, megaloblasts |
| • Hemoglobin | lipemia, ABN proteins, leukocytosis (>100,000/µL) |
| Interfering substances: Differential | lyse-resistant RBCs |
| Maximum CBCs per hour/Maximum CBCs and differentials per hour | 150/150 |
| Minimum specimen volume open/Closed/Sample dead volume closed | 130 µL/200 µL/1 mL |
| Microsample capability | yes |
| Prepares microscope slides automatically or flags problems for slide prep | yes (with Alpha or HST upgrade) |
| Number of automatic slidemakers available/List price | >1,000/— |
| Archives patient data/Previous patient results included with recent results | yes/yes |
| Maximum archived data accessible when system online | 10,000 samples |
| No. specimens for which numeric results saved in memory at once | 10,000 samples |
| No. specimens for which histo/cytogram results saved in memory at once | 10,000 samples |
| Performs delta checks | yes |
| Tags and holds results for followup, confirmatory testing, or rerun | yes |
| Parameters for flags for holding samples defined by user or vendor | user or vendor |
| Scattergram display: cell-specific color | yes |
| Histogram display: color with thresholds | yes |
| User interface can display choice of specimen/result information | yes |
| LIS interface formats supported | RS-232C/TCP IP |
| Information transferred on LIS interface | numeric and flag results, histograms and scatterplots, patient demographics, orders |
| LOINC codes transmitted with all results | no |
| Sent in message to LIS | no |
| Listing of machine codes and corresponding LOINC for each test | yes |
| Interface available or planned to automated specimen-handling system | on automation platform |
| Bar-code symbologies read on specimen tube | Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5, ITF, NW7, EAN 8 and 13, ISBT |
| Accommodates bar-code placement per CLSI standard Auto2A | yes |
| Time required for maintenance by lab personnel | daily: <3 minutes |
| Onboard diagnostics for troubleshooting/Limited to software problems | yes/no |
| Manufacturer can perform diagnostics via modem | yes, also via Internet |
| Distinguishing features (supplied by company) | 150 CBCs per hour; platelet linearity to 5 million, hematocrit extended to 75%; standardized technology, reagents, controls, and operations; ISBT compliant; FDA-cleared application for blood component products in specified anticoagulants |