A Poređenje optičke metode sa mehaničkom metodom u rutinskim testovima koagulacije

Poređenje optičke metode

  • Gozde Ulfer ASİSST PROF
DOI: https://doi.org/10.5937/jomb0-56100
Ključne reči: Testovi koagulacije, Optički metod, Mehanički metod, Bland-Altman parcele, Passing-Bablok regression

Sažetak


Pozadina: Ova studija je imala za cilj da uporedi vrednosti protrombinskog vremena (PT), međunarodnog normalizovanog odnosa (INR) i aktiviranog parcijalnog tromboplastinskog vremena (aPTT) dobijene fotooptičkom metodom i da proceni ove vrednosti prema referentnoj metodi koja je bila mehanička metoda .

Metode: Uzorci plazme od 340 pacijenata, dostavljeni u biohemijsku laboratoriju naše bolnice za PT, INR i aPTT analize, analizirani su mehaničkom koagulometrijskom metodom merenja u automatizovanom analizatoru koagulacije Stago Compact Mak3, koji je služio kao referentni uređaj. Isti uzorci su takođe analizirani korišćenjem automatizovanog analizatora Sunbio UP5500 sa simultanom optičkom metodom. Zamućeni uzorci su analizirani u oba uređaja bez isključenja iz studije. Analiza koeficijenta korelacije je sprovedena korišćenjem SPSS-a za procenu intervarijabilnih korelacija, a Passing-Bablok regresiona analiza je urađena u R softveru verzije 3.6.0 za poređenje vrednosti PT, INR i aPTT između dva uređaja. Bland-Altmanove parcele su korišćene za analizu sporazuma.

Rezultati: Nađen je dobar nivo statistički značajnog slaganja između vrednosti PT i INR merenih pomoću uređaja Stago Compact Mak3 i Sunbio UP 5500 (intraklasni koeficijent [ICC]: 0,627, p=0,001; p<0,01 i ICC: 0,653, p =0,001; p<0,01, respektivno). Pored toga, postojao je odličan nivo statistički značajnog slaganja za vrednosti aPTT (ICC: 0,902, p=0,001, p<0,01). Bland-Altmanova analiza je otkrila srednje granice od 95% vrednosti slaganja kao 2,46 (donja granica: -2,44, gornja granica: 7,37) za PT, 0,07 (donja granica: -0,32, gornja granica: 0,46) za INR i 2,45 ( donja granica: -1,67, gornja granica: 6,58) za aPTT. Rezultati Passing-Bablokove regresije su pokazali sistematsku razliku za merenje PT, ali ne i proporcionalnu razliku. Nisu pronađene sistematske ili proporcionalne razlike za izmerene vrednosti INR i aPTT između uređaja Stago Compact Mak3 i Sunbio UP 5500. Vrednosti koeficijenta varijacije unutar testa i među testovima (CV) iz kontrola nivoa 1 i nivoa 2 optičke metode bile su ispod 5%.

Zaključci: Rezultati optičke metode su konzistentni i pouzdani u poređenju sa mehaničkom metodom. Rezultati PT i INR su pokazali statistički dobro slaganje, dok su aPTT rezultati pokazali odlično slaganje.

 

 

 

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Objavljeno
2025/02/25
Broj časopisa
Vol. 44 Br. 3 (2025): Journal of Medical Biochemistry
Rubrika
Original paper

Sva prava zadržana (c) 2025 Gozde Ulfer

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