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Multicentric evaluation of analytical performances digital morphology with respect to the reference methods by manual optical microscopy
  1. Giorgio Da Rin1,
  2. Anna Benegiamo2,
  3. Anna Maria Di Fabio3,
  4. Francesco Dima4,
  5. Sara Francione5,
  6. Alessandra Fanelli6,
  7. Luca Germagnoli7,
  8. Maria Lorubbio6,
  9. Alessandro Marzoni8,
  10. Rachele Pajola9,
  11. Silvia Pipitone2,
  12. Roberta Rolla10,
  13. Michela Seghezzi11,
  14. Maria del Carmen Baigorria Vaca11,
  15. Andrea Bartolini12,
  16. Sabrina Buoro11
  1. 1IRCCS Hospital Policlinico San Martino, Genova, Italy
  2. 2University Hospital of Parma, Parma, Italy
  3. 3Hospital Civile San Salvatore, L'Aquila, Italy
  4. 4University of Verona, Verona, Italy
  5. 5ASL Novara, Borgomanero, Italy
  6. 6Hospital Careggi, Firenze, Italy
  7. 7Synlab Suisse, Bioggio, Switzerland
  8. 8Synlab Italy, Castenedolo, Italy
  9. 9Ospedali Riuniti Padova Sud Schiavonia, Monselice, Italy
  10. 10Department of Health Sciences, University of Eastern Piedmont 'Amedeo Avogadro', Novara, Italy
  11. 11ASST Papa Giovanni XXIII, Bergamo, Italy
  12. 12AUSL Bologna, Bologna, Italy
  1. Correspondence to Dr Sabrina Buoro, Papa Giovanni XXIII Hospital, Clinical Chemistry Laboratory, Bergamo 24157, Italy; sbuoro{at}asst-pg23.it

Abstract

Aims Optical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of the laboratory haematological workflow. The morphological cell analysis is time-consuming and expensive and it requires skilled operator. To address these challenges, automated image-processing systems, as digital morphology (DM), were developed in the last few years. The aim of this multicentre study, performed according to international guidelines, is to verify the analytical performance of DM compared with manual OM, the reference method.

Methods Four hundred and ninety PB samples were evaluated. For each sample, two May Grunwald-stained and Giemsa-stained smears were performed and the morphological evaluation of cells was analysed with both DM and OM. In addition, the assessment times of both methods were recorded.

Results Comparison of DM versus OM methods was assessed with Passing-Bablok and Deming fit regression analysis: slopes ranged between 0.17 for atypical, reactive lymphocytes and plasma cells (LY(AT)) and 1.24 for basophils, and the intercepts ranged between −0.09 for blasts and 0.40 for LY(AT). The Bland-Altman bias ranged between −6.5% for eosinophils and 21.8% for meta-myemielocytes. The diagnostic agreement between the two methods was 0.98. The mean of assessment times were 150 s and 250 s for DM and OM, respectively.

Conclusion DM shows excellent performance. Approximately only 1.6% of PB smears need the OM revision, giving advantages in terms of efficiency, standardisation and assessment time of morphological analysis of the cells. The findings of this study may provide useful information regarding the use of DM to improve the haematological workflow.

  • automation
  • cell count
  • haematology
  • morphological and microscopic findings
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Footnotes

  • Handling editor Mary Frances McMullin.

  • Contributors All authors confirmed that they have contributed to the intellectual content of this paper and have met the following three requirements: (1) significant contributions to the conception and design, acquisition of data or analysis and interpretation of data; (2) drafting or revising the article for intellectual content and (3) final approval of the published article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Following the assessment of the Ethics Committee of ASST Papa Giovanni XXIII, this type of study does not require the approval of the bioethics committee. The sample data were subjected to anonymisation procedure.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article.

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