Farklı yöntem ve cihazlarda ölçülen prokalsitonin test performansının karşılaştırılması

Year 2023, Volume: 14 Issue: 4, 723 - 728, 30.12.2023

Hatıce Nur Halıpcı Topsakal , Bagnu Dundar

https://doi.org/10.18663/tjcl.1333344

Abstract

Amaç: Bu çalışmada prokalsitonin test performansının ayrı kit ve cihazlarda karşılaştırması incelenmiştir. Prokalsitonin (PCT), Kalsitoninin 116 amino asitten oluşan prohormonudur. Serumda PCT seviyelerindeki yükselmeler ciddi sepsis ve viral enfeksiyonlar ile ilişkilidir. Serumdaki PCT seviyesi genellikle bakteriyel enfeksiyonu olan hastalarda görülür, bu nedenle bakteriyel ve viral bulaşıcı hastalıkları ayırt etmek için güvenli bir biyobelirteç olarak kullanılmaktadır. PCT' nin kantitatif ölçümünün sepsisin prognozunu değerlendirmeye ve antibiyotik başlatma ve sonlandırmaya rehberlik etmeye yardımcı olabileceği bilinmektedir. Serum PCT' nin kantitatif ölçümü için yöntemler esas olarak floresan, kemilüminesan ve elektrokemilüminesan immünoanaliz gibi yöntemleri içermektedir.
Gereç ve Yöntemler: Hastaneden alınan 40 hasta örneği Prokalsitonin ölçümü için toplandı ve etik kurul onayı alındı.
Prokalsitonin ölçümleri biyokimya laboratuvarında ARCHITECT ci4000 system (CMIA, Abbott Diagnostic) ile Autolumo A2000 Plus (CLIA, Autobio Diagnostic) sistem cihazlarda ardışık olarak yapıldı. Yöntem karşılaştırma çalışmaları Clinical Laboratory Standards Institue tarafından yayımlanan National Committee for Clinical Laboratory Standards (NCCLS)’in EP15-A2 protokolüne göre gerçekleştirildi.
Bulgular: Çalışmamızda hasta örneklerinin prokalsitonin konsantrasyonları 0,01-53,1 ng/ml arasındaydı. Hasta sonuçlarının her iki cihaz için ortalama ve standart sapma değerleri X=7,71±1,22 ve Y=8,4±1,32 idi. Her iki yöntem ile ölçülen hasta sonuçları karşılaştırıldığında istatistiksel olarak anlamlı bir fark elde edilmedi ( p>0,05).
Sonuç: Prokalsitonin için her iki cihazda da ölçüm sonuçlarının korelasyonunu inceledik ve sonuçların birbiriyle korale olduğunu tespit ettik.

Keywords

prokalsitonin, kemilüminesan immunassay, CLIA, analitik performans

Supporting Institution

Bulunmamaktadır

Project Number

-

Thanks

Bu çalışmaya destek olan Istanbul Üniversitesi Medicine Hastanesi Tıbbi Laboratuvar çalışanlarına teşekkür ederiz.

Comparison of procalcitonin test performance measured in different methods and devices.

Abstract

Aim: In this study, the comparison of procalcitonin test performance in different kits and devices was examined. Procalcitonin (PCT) is the prohormone of Calcitonin, consisting of 116 amino acids. Elevations in PCT levels in serum are associated with severe sepsis and viral infections. PCT level in serum is often observed in patients with bacterial infection, so it is used as a safe biomarker to distinguish bacterial and viral infectious diseases. It is known that quantitative measurement of PCT can help assess the prognosis of sepsis and guide antibiotic initiation and discontinuation. Methods for quantitative measurement of serum PCT mainly include methods such as fluorescent, chemiluminescent and electrochemiluminescent immunoassay.
Material and Methods: 40 patient samples collected from the patients were collected for procalcitonin measurement and ethics committee approval was obtained.
Procalcitonin measurements were made consecutively in the biochemistry laboratory on ARCHITECT ci4000 system (CMIA, Abbott Diagnostic) and Autolumo A2000 Plus (CLIA, Autobio Diagnostic) system devices. Method comparison studies were carried out according to the EP15-A2 protocol of the National Committee for Clinical Laboratory Standards (NCCLS) published by the Clinical Laboratory Standards Institute.
Findings: In our study, procalcitonin concentrations of patient samples were between 0.01-53.1 ng/ml. The mean and standard deviation values of patient results for both devices were X=7.71±1.22 and Y=8.4±1.32. When patient results measured by both methods were compared, no statistically significant difference was obtained (p>0.05).
Results: We examined the correlation of measurement results for procalcitonin in both devices and found that the results were correlated with each other.

Keywords

procalcitonin, chemiluminescent immunoassay, CLIA, analytical performance

Project Number

-

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