| Abstract | Uvod:
Verifikacija metode ključan je segment implementacije nove metode u rutinski rad laboratorija.
Testosteron, kao primarno muški spolni hormon, odgovoran je za brojne funkcije u muškaraca,
ali može biti okidač raznih stanja i u žena. Za mjerenje testosterona rutinski se koriste
imunokemijske metode, dok je referentna metoda LCMS/MS.
Cilj istraživanja:
Cilj istraživanja bio je ispitati verifikacijske značajke CLIA metode na analizatoru Unicel DxI
600 (preciznost, točnost, linearnost, referentni intervali) te usporediti CLIA metodu sa
LCMS/MS metodom.
Ispitanici i metode:
Za provjeru preciznosti i točnosti korišteni su kontrolni uzorci mjereni u triplikatu u dvije
razine. Za provjeru linearnosti korišteni su kalibratori mjereni kroz pet mjerenja u duplikatu.
Provjera referentnih intervala napravljena je na uzorcima 20 naizgled zdravih žena. Za provjeru
usporedivosti metode korištena su 123 ostatna uzorka seruma pacijenata. Uzorci su mjereni
LCMS/MS, zatim CLIA metodom.
Rezultati:
Ponovljivost niske koncentracijske razine iznosi 6,3 %, visoke 4,2 %. Međupreciznost niske
koncentracijske razine iznosi 6,1 %, visoke 3,6 %. Izmjereni bias iznosi 2,4 za visoko i -15,2
za nisko koncentracijsko područje. Srednja vrijednost koncentracija testosterona LCMS/MS
metodom je 0,97 (95 % CI 0,85 – 1,20), CLIA metodom 1,71 (95 % CI 1,43 – 1,99). BlandAltman prikazuje srednju vrijednost razlike u mjerenjima (0,1502) te SD razlike u mjerenjima
(-3,8777 – 4,1780). Passing-Bablok regresijska analiza rezultira jednadžbom pravca
y = 0,139474 (95 % CI -1,906 – 0,4019) + 1,210526 (95 % CI 0,9900 – 1,4537)x.
Zaključak:
Istraživanjem je potvrđeno da je imunokemijska metoda tvrtke Beckman Coulter za analizator
7. SAŽETAK
20
Unicel DxI 600 prikladna za određivanje koncentracije testosterona. |
| Abstract (english) | Introduction:
Verification of the method is a key segment of the implementation of the new method in the
routine work of the laboratory. Testosterone, as a primarily male sex hormone, is responsible
for numerous functions in men, but it can trigger various conditions in women as well.
Immunochemical methods are routinely used to measure testosterone, while the reference
method is LCMS/MS.
Objectives:
The aim of the research was to examine the verification features of the CLIA method on the
Unicel DxI 600 analyzer (precision, accuracy, linearity, reference intervals) and to compare the
CLIA method with the LCMS/MS method.
Participants and methods:
To check the precision and accuracy of the method, control samples measured in triplicate at
two levels were used, while to check the linearity, calibrators were used, measured through five
measurements in duplicate. The verification of the reference intervals was made on the samples
of 20 apparently healthy women. To check the comparability of the method, 123 patient serum
samples were used. The samples were first measured by the LCMS/MS method and then by the
CLIA method on a Unicel DxI 600 analyzer.
Results:
Reproducibility of low concentration level is 6,3 %, reproducibility of high concentration level
is 4,2 %. Intermediate precision of low concentration level is 6,1 %, of high concentration level
is 3,6 %. The measured bias is 2,4 for the high and -15,2 for the low concentration area. The
mean value of testosterone concentrations by the LCMS/MS method was 0.97 (95% CI 0,85 –
1,20), and by the CLIA method 1,71 (95 % CI 1,43 – 1,99). Bland-Altman shows the mean
value of the difference in measurements (0,1502) and the SD of the difference in measurements
8. SUMMARY
22
(-3,8777 – 4,1780). Passing-Bablok regression analysis results in the line equation y = 0,139474
(95 % CI -1,906 – 0,4019)) + 1,210526 (95 % CI 0,9900 – 1,4537)x. The correlation coefficient
is P < 0,0001
Conclusion:
This research confirmed that the Beckman Coulter immunochemical method for the Unicel DxI
600 analyzer is suitable for determining testosterone concentration. |
