Naslov
Verifikacija metode za određivanje kalprotektina u ekstraktu stolice na automatskom analizatoru Beckman Coulter AU2700Plus
(Verification of the method for calprotectin determination in a stool extract on the Beckman Coulter AU2700Plus automatic analyzer)

Autori
Tomičević, Marina ; Žarak, Marko ; Šimac, Brankica ; Škorvaga, Sanja

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Izvornik
Biochemia Medica 2018 ; 28(Suppl 1):S1–S223 / - , 2018, 134-135

Skup
9. kongres hrvatskog društva za medicinsku biokemiju i laboratorijsku medicinu (HDMBLM)

Mjesto i datum
Zagreb, Hrvatska, 09.05.2018. - 12.05.2018

Vrsta sudjelovanja
Poster

Vrsta recenzije
Domaća recenzija

Ključne riječi
verifikacija, usporedba, kalprotektin
(verification, comparison, calprotectin)

Sažetak
Introduction:Faecal calprotectin is a non- invasive biomarker of the inflammatory bowel disease diagnostics. The aim of this study was to verify the method (immunoturbidimetry) for calprotectin determination in a stool extract on the Olympus AU2700Plus automatic analyzer (Beckman Coulter Inc., Tokyo, Japan). Materials and methods: Verification was performed according to CSLI EP 15-A2 protocol. Commercial control samples at low (L1) and high (L2) levels (fCAL turbo, Bühlmann Laboratories AG, Switzerland) were used. The precision (CVp) and trueness (BIAS) were interpreted according to manufacturer’s criteria (20%). 33 examiner’s samples were used to compare immunoturbidimetry with ELISA method (fCAL ELISA, Bühlmann Laboratories AG, Schönenbuch, Switzerland) on the BEP 2000 Advance analyzer (Siemens Healtcare, Marburg, Germany). The results were analyzed by Passing-Bablok regression and Bland-Altman plot. Linearity was tested by serial dilutions (100%, 75%, 50%, 25%, 0%)in duplicate. Results:The obtained CVs were 6.3% (L1 ; target value 73.5 μg/g), 2.0% (L2 ; target value 245.5 μg/g) with mean CV of 4.2%. Trueness values were - 4.1% (L1), - 1.9% (L2) with mean BIAS of 3.0%. Passing-Bablok analysis yields the regression line Y = - 8.3083 + 0.9888X (95% CIfor the y-intercept - 26.6455 to - 1.4489 and for slope 0.9213 to 1.0523). Bland-Altman plot showed the average BIAS of 14.7%, which meets manufacturer’s criteria. The linearity test is within allowed deviation for each of the expected values in the dilution series. Conclusion:Determination of fecal calprotectin by the immunoturbidimetric method on the Olympus AU2700Plus analyzer meets the criteria for precision and trueness. The results of the comparison between the two methods indicate a constant error with no clinical significance, since immunochemical and immunological methods cannot be compared. Finally, the immunoturbidimetry is considered as acceptable method for routine application. The simple performance of the proposed method allows the clinician to obtain real-time information without testing delay caused by laboratory rationalization.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti

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