Title Analitička procjena automatizirane metode određivanja sedimentacije eritrocita na analizatoru Alcor iSED® Author Ida Taradi Mentor Mirjana Mariana Kardum Paro (mentor)Committee member Jozsef Petrik (predsjednik povjerenstva)Committee member Mirjana Mariana Kardum Paro (član povjerenstva)Committee member Marija Grdić Rajković (član povjerenstva)Granter University of Zagreb Defense date and country 2023-09-28, Croatia Scientific / art field, BIOMEDICINE AND HEALTHCARE Abstract Cilj istraživanja
Sedimentacija eritrocita je laboratorijska pretraga koja se najčešće koristi u postavljanju dijagnoze i praćenju upalnih, autoimunih i malignih bolesti. To je pretraga kod koje dolazi do taloženja eritrocita zbog različite gustoće eritrocita i plazme, a najčešće ukazuje na povećanu koncentraciju proteina akutne faze odnosno upalu (1).
Cilj istraživanja je u rutinski rad uvesti automatiziranu metodu za određivanje brzine sedimentacije na analizatoru iSED (Alcor Scientific, Smithfield, SAD) nakon provedbe verifikacije metode u Kliničkom zavodu za medicinsku biokemiju i laboratorijsku medicinu Kliničke bolnice Merkur akreditiranom prema nacionalnoj i međunarodnoj normi HRN EN ISO 15189, sukladno preporukama Međunarodnog odbora za standardizaciju u hematologiji (engl. International Council for Standardization in Haematology; ICSH). Postupak obuhvaća ispitivanje preciznosti, stabilnosti, prijenosa prethodnog uzorka povišene sedimentacije na uzorak snižene koji se analizira neposredno nakon (engl. carryover), usporedbu metode s referentnom metodom određivanja sedimentacije po Westergrenu, verifikaciju referentnih intervala, sudjelovanje u vanjskoj kontroli kvalitete neovisnog organizatora, korelaciju s upalnim parametrima i praćenje vremena izdavanja nalaza (engl. turnaround time, TAT) u odnosu na referentnu metodu (2).
Materijali i metode
U provedenom istraživanju analizirano je ukupno 704 humana uzorka ispitanika različitih dobnih skupina. Brzina sedimentacije eritrocita je određena iz uzoraka venske krvi
referentnom metodom po Westergrenu i automatiziranom metodom na analizatoru iSED.
Analizator iSED je potpuno automatizirani analizator za određivanje brzine sedimentacije eritrocita metodom fotometrijske reologije (3), dok je referentna metoda po Westergrenu koja se temelji na očitavanju visine stupca plazme iznad istaloženih eritrocita (4).
Ispitivanje preciznosti analizatora iSED je učinjeno sukladno smjernicama Instituta za kliničke i laboratorijske standarde (engl. Clinical and Laboratory Standards Institute; CLSI) EP15-A2 i EP09-A3 (5-6). Usporedba brzine sedimentacije eritrocita između automatizirane i referentne metode je provedena na 704 humana uzoraka. Ispitivanje stabilnosti uzoraka je učinjeno u 10 uzoraka ispitanika, a ispitivanje potencijalnog prijenosa je napravljeno sukladno CLSI smjernicama H26-A2 (7). Verifikacija referentnih intervala provedena je sukladno CLSI smjernicama 28-A3c analizom 20 referentnih osoba ispitivane populacije (8). Sudjelovali smo u dva programa vanjske kontrole kvalitete koja su organizirana od strane dva neovisna organizatora vanjske kontrole kvalitete: Europskog društva za vanjsku procjenu kvalitete (engl. European Society for External Quality Assessment; ESfEQA) i Američkog udruženja patologa (engl. College of American Pathologists; CAP). Spearmanovim koeficijentom korelacije je ispitana korelacija podataka između sedimentacije eritrocita dobivene analizatorom iSED s brojem leukocita i koncentracijom fibrinogena i CRP-a. Praćeno je vrijeme izdavanja nalaza koristeći obje metode tijekom mjesec dana.
Rezultati
Koeficijent varijacije za ukupnu laboratorijsku preciznost automatiziranog analizatora
sedimentacije eritrocita Alcor iSED iznosio je 14% za područje normalnih razina primjenjivanog kontrolnog materijala, dok je za patološku razinu iznosio 3,1%. Usporedbom metoda između automatizirane i referentne metode za određivanje sedimentacije eritrocita na 704 uzoraka ispitanika koristeći Passing-Bablok regresijsku analizu je dobivena konstantna razlika između navedenih metoda. Analiza uzorka visoke sedimentacije eritrocita uzrokuje potencijalnu kontaminaciju od 4,1% na sljedeći uzorak. Referentni intervali dobiveni automatiziranom metodom su potvrđeni u odnosu na Westergrenovu referentnu metodu. Sudjelovanjem u vanjskoj kontroli kvalitete neovisnih organizatora je dokazano da su svi rezultati organizatora zadovoljeni u svim ciklusima. Brzina sedimentacije eritrocita i koncentracija fibrinogena imaju najviši Spearmanov koeficijent korelacije, slijedi korelacija s koncentracijom CRP-a, dok nije nađena statistički značajna korelacija s brojem leukocita. Uvođenje automatizirane metode za određivanje brzine sedimentacije eritrocita u rutinski rad skraćuje vrijeme od primitka uzorka do izdavanja nalaza 2,6 puta.
Zaključak
Ispitivana automatizirana metoda određivanja brzine sedimentacije eritrocita zadovoljava postavljene analitičke kriterije kvalitete te je prihvatljiva za rutinsku kliničku primjenu. Glavne prednosti uvođenja automatizirane metode određivanja sedimentacije eritrocita su: standardizacija, korištenje barkodiranih epruveta, veća točnost i reproducibilnost, brže vrijeme izdavanja rezultata pretrage, manja količina potrebnog uzorka za analizu, veća efikasnost u radu laboratorijskog osoblja i niži troškovi.
Abstract (english) Objectives
Erythrocyte sedimentation rate is a laboratory test that is mostly used in the diagnosis and monitoring of inflammatory, autoimmune and malignant diseases. It is a test in which erythrocytes are precipitated due to the different density of erythrocytes and plasma, and most often indicates an increased concentration of acute phase proteins, respectively inflammation (1).
The aim of the study is to introduce an automated method for determining the sedimentation rate on the analyzer iSED (Alcor Scientific, Smithfield, USA) in routine work by performing verification in the Department of Medical Biochemistry and Laboratory Medicine of the Clinical Hospital Merkur accredited according to the national and international standard HRN EN ISO 15189, in accordance with the recommendations of the International Council for Standardization in Haematology (ICSH). The procedure includes examination of precision, stability, carryover of the previous sample of elevated sedimentation to the sample of low sedimentation that is analyzed immediately after, comparison of the method with the reference method of determining sedimentation according to Westergren, verification of reference intervals, participation in external quality control programs organised by an independent organizers, correlation with inflammatory parameters and monitoring the turnaround time (TAT) in relation to the reference method (2).
Patients and Methods
The iSED analyzer is a fully automated analyzer for determining the erythrocyte
sedimentation rate using the photometric rheology (3), while the reference method is the Westergren method, which is based on reading the height of the plasma column above the precipitated erythrocytes (4).
The precision test of the iSED analyzer was performed in accordance with the guidelines of the Clinical and Laboratory Standards Institute (CLSI) EP15-A2 and EP09-A3 (5-6). A comparison of the erythrocyte sedimentation rate between the automated and reference method was performed on 704 human samples. Sample stability testing was performed on 10 samples and potential carryover testing was made according to CLSI guidelines H26-A2 (7). The verification of reference intervals was performed according to CLSI guidelines 28-A3c by analyzing 20 reference persons of the studied population (8). We participated in two external quality control programs organized by the two independent organizers: European Society for External Quality Assessment (ESfEQA) and the College of American Pathologists (CAP). Spearman's correlation coefficient was used to test the correlation of data between erythrocyte sedimentation rate obtained by the iSED analyzer with the number of leukocytes and the concentration of fibrinogen and CRP. The turnaround time was monitored using both methods for one month.
Results
The coefficient of variation for the within-laboratory precision of the automated analyzer Alcor iSED which measures the erythrocyte sedimentation rate was 14% for the normal range of the used control material, while it was 3,1% for the pathological range. Comparison of the automated and reference method for determining the erythrocyte sedimentation rate on 704 human samples using Passing-Bablok regression analysis revealed
a constant difference between the methods. Analyzing a sample with high erythrocyte sedimentation rate causes a potential contamination of 4,1% to the next sample. The reference intervals obtained by the automated method were verified with the Westergren reference method. Participation in the external quality control program of independent organizers proved that all the results of the organizers were satisfied in all cycles. Erythrocyte sedimentation rate and concentration of fibrinogen have the highest Spearman correlation coefficient, followed by correlation with concentration of CRP, while no statistically significant correlation was found with the number of leukocytes. The introduction of an automated method for determining the sedimentation erythrocyte rate in routine work shortens the turnaround time by 2,6 times.
Conclusion
The tested automated method for determining the erythrocyte sedimentation rate meets the set analytical quality criteria and is acceptable for routine clinical use. The main advantages of introducing an automated method for determining erythrocyte sedimentation rate analysis are: standardization, use of barcoded test tubes, higher accuracy and reproducibility, shorter turnaround time, smaller amount of sample required for analysis, increased efficiency in the work of laboratory staff and lower costs.
Keywords
sedimentacija eritrocita
analizator iSED
Alcor iSED
automatizirani analizator
Keywords (english)
erythrocyte sedimentation
iSED analyzer
Alcor iSED
automated analyzer
Language croatian URN:NBN urn:nbn:hr:163:228069 Study programme Title: Medical biochemistry and laboratory medicine Type of resource Text File origin Born digital Access conditions Open access Terms of use Created on 2024-06-06 12:28:55
