X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

Performance Metrics

Clinical Evidence

The foundational evidence is the multicentre method comparison by Katz and colleagues (International Journal of Laboratory Hematology, 2021), conducted at Tel Aviv Sourasky Medical Center, the University of Pennsylvania and Brigham and Women's Hospital. The study analysed 645 peripheral blood smears — 335 normal and 310 abnormal, drawn from patients with a range of clinical conditions — against manual microscopy as the reference method. Reported white-blood-cell performance was 96.3 percent classification efficiency with 87.9 percent sensitivity and 97.6 percent specificity, and red-cell morphology agreement of 99.8 percent, with high correlation across tested parameters. The study should be read as manufacturer-affiliated: the first author discloses a consultancy to Scopio Labs. The independent check arrived with De Iuliis and Chiatamone Ranieri (International Journal of Laboratory Hematology, February 2026), a single-centre evaluation of the X100HT at G. Mazzini Hospital in Teramo, Italy, on 400 smears from the routine workload — 40 from healthy individuals and 360 selected under criteria aligned with international consensus-group review guidance. Correlation with manual microscopy was strong for neutrophils and lymphocytes (r = 0.93) and moderate for eosinophils (r = 0.80). The more consequential finding concerns standalone detection of pathological cells: ROC analysis put the system's unaided accuracy for blasts at an AUC of 0.72, immature myeloid cells at 0.79 and nucleated red blood cells at 0.71 — moderate figures that improved with expert review. The honest reading across both studies is of a reliable digitisation and pre-classification layer for the routine differential whose flagging of abnormal cells is a screen, not a verdict; the qualified reviewer remains the diagnostic step.

Inside the Auris+ Listing

Regulatory Approvals

Safety Record

No recall, FDA safety communication or adverse-event cluster attributable to the X100, X100HT or the Full Field PBS application was located in indexed public sources as of August 2026. The FDA's MAUDE and enforcement databases could not be queried directly from this environment, so that absence is "none found in public reporting" rather than an exhaustive register audit. The cleared design bounds the risk surface: the application locates, displays and pre-classifies cells but issues no autonomous result — a qualified laboratory professional verifies the differential, the red-cell grading and the platelet estimate before any report leaves the laboratory. Procurement reviewers should note that the independent 2026 evaluation found standalone abnormal-cell detection only moderate (AUC 0.71–0.79 across blasts, immature myeloid cells and nucleated red cells), which underlines that laboratories cannot treat the pre-classification as a substitute for expert smear review.

Intended Use & Indications

The Full Field Peripheral Blood Smear application runs on two Scopio imaging platforms: the X100, where slides are loaded individually, and the high-throughput X100HT, whose slide loader feeds cassettes of slides into the scanner automatically. Both digitise the smear at high resolution across the full scan region rather than imaging a limited set of pre-selected cells, and both present the resulting full-field scan alongside AI decision support: a pre-classified white-blood-cell differential, red-blood-cell morphology grading and a platelet pre-estimate. The application is an assistive tool for haematology laboratories — it does not issue autonomous results. A qualified laboratory professional verifies each pre-classification, completes the morphological assessment and signs the report, either at the instrument or from a remote workstation on the laboratory's network.