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Pregled bibliografske jedinice broj: 1045305

Analytical Validation of the iSED Automated Analyzer for Erythrocyte Sedimentation Rate


Lapić, Ivana; Miloš, Marija; Piva, Elisa; Tosato, Francesca; Zadro, Renata; Rogić, Dunja; Plebani, Mario
Analytical Validation of the iSED Automated Analyzer for Erythrocyte Sedimentation Rate // International journal of laboratory hematology, Epub Ahead of print (2019), 1-7 doi:10.1111/ijlh.13120 (međunarodna recenzija, članak, stručni)


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Naslov
Analytical Validation of the iSED Automated Analyzer for Erythrocyte Sedimentation Rate

Autori
Lapić, Ivana ; Miloš, Marija ; Piva, Elisa ; Tosato, Francesca ; Zadro, Renata ; Rogić, Dunja ; Plebani, Mario

Izvornik
International journal of laboratory hematology (1751-5521) Epub Ahead of print (2019); 1-7

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, stručni

Ključne riječi
automation, erythrocyte sedimentation rate, iSED, validation, Westergren metho

Sažetak
Introduction: iSED is an alternate automated analyzer for erythrocyte sedimentation rate (ESR) based on photometric rheology technology that estimates ESR by measuring rouleaux formation. The aim was to evaluate the analytical performance of the iSED analyzer and compare the results with the Westergren method and another alternate ESR analyzer, TEST1. Methods: Validation was performed at two study sites according to the recommendations by the International Council for Standardization in Haematology and included determination of intrarun precision and inter‐run precision, bias, carryover, and method comparison, which was further assessed for samples with normal and low hematocrit, as well as per low, middle, and upper third of the analytical range. Results: Intrarun coefficients of variation (CVs) with commercial controls were 4.0% and 1.8%, while inter‐run CVs 7.5% and 0.7%, for the normal and pathological range, respectively. Intrarun CVs obtained with patient samples were 19.9%, 9.9%, 10.3%, and 9.4%, the highest being for the lowest ESR value. Correlation coefficients for the comparison between iSED and Westergren were 0.862 (Site‐1) and 0.916 (Site‐2). While proportional difference with a positive bias was revealed at Site‐1, comparison at Site‐2 showed both constant and proportional difference and a negligible negative bias. Higher correlation was obtained for samples with low than normal hematocrit. Comparison between iSED and TEST1 yielded a correlation coefficient of 0.986, constant and proportional difference, and positive bias. Carryover was 3.2%. Conclusion: This study proved the analytical validity of the iSED analyzer, despite minor discrepancies to the Westergren method that can be attributed to methodological differences.

Izvorni jezik
Engleski



POVEZANOST RADA


Profili:

Avatar Url Renata Zadro (autor)

Avatar Url Ivana Lapić (autor)

Avatar Url Dunja Rogić (autor)

Avatar Url Marija Miloš (autor)

Citiraj ovu publikaciju

Lapić, Ivana; Miloš, Marija; Piva, Elisa; Tosato, Francesca; Zadro, Renata; Rogić, Dunja; Plebani, Mario
Analytical Validation of the iSED Automated Analyzer for Erythrocyte Sedimentation Rate // International journal of laboratory hematology, Epub Ahead of print (2019), 1-7 doi:10.1111/ijlh.13120 (međunarodna recenzija, članak, stručni)
Lapić, I., Miloš, M., Piva, E., Tosato, F., Zadro, R., Rogić, D. & Plebani, M. (2019) Analytical Validation of the iSED Automated Analyzer for Erythrocyte Sedimentation Rate. International journal of laboratory hematology, Epub Ahead of print, 1-7 doi:10.1111/ijlh.13120.
@article{article, year = {2019}, pages = {1-7}, DOI = {10.1111/ijlh.13120}, keywords = {automation, erythrocyte sedimentation rate, iSED, validation, Westergren metho}, journal = {International journal of laboratory hematology}, doi = {10.1111/ijlh.13120}, volume = {Epub Ahead of print}, issn = {1751-5521}, title = {Analytical Validation of the iSED Automated Analyzer for Erythrocyte Sedimentation Rate}, keyword = {automation, erythrocyte sedimentation rate, iSED, validation, Westergren metho} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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