Naslov
Verification of the method for determining human chorionic gonadotropin on Cobas e411 analyzer

Autori
Filipi, Petra ; Doželenčić, Monika ; Zec, Ivana ; Miler, Marijana ; Nikolac, Nora ; Šimundić, Ana- Maria

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

Izvornik
Biochemia Medica / Šimundić, Ana-Maria - Zagreb : Hrvatsko društvo za medicinsku biokemiju i laboratorijsku medicinu (HDMBLM), 2015, S101-S102

Skup
8. kongres Hrvatskog društva za medicinsku biokemiju i laboratorijsku medicinu s međunarodnim sudjelovanjem

Mjesto i datum
Rijeka, Hrvatska, 22.09.2015. - 26.09.2015

Vrsta sudjelovanja
Poster

Vrsta recenzije
Domaća recenzija

Ključne riječi
analytical verification; precision; hemolysis

Sažetak
Introduction: The aim of this study was to check the reproducibility, hemolysis interference and carryover for human chorionic gonadotropin (hCG) test on Cobas e411 analyzer (Roche, Mannheim, Germany). Materials and Methods: The reproducibility was examined using control samples (Preci Control Universal 1 and 2) for five days in triplicate. Manufacturers acceptability criteria were used: CV (PCU1)=2.1% ; CV (PCU2)=4.0%. The impact of hemolysis was tested at three hCG concentration levels according to CLSI protocol EP7-A2. Plasma hemolysate was prepared by osmotic shock. Hemolytic samples were prepared by adding hemolysate in increasing concentrations to reach free hemoglobin concentrations of 0 (no hemolysate), 2.5 ; 5.0 ; 7.5 and 10.0 g/L. To assess the impact of hemolysis, RCPA (Royal College of Pathologist of Australasia) acceptability criteria were used: ±1 IU/L for hCG <10.0 IU/L ; ±10% for hCG >10.0 IU/L. Effect of carryover was examined by analyzing the low concentration sample in triplicate, immediately after the sample with high concentration in duplicate, according to the IUPAC (International Union of Pure and Applied Chemistry) protocol. All samples were analyzed on Cobas e411 with original reagent. Statistical analysis was performed using Microsoft Excel. Results: For lower concentration level, reproducibility was out of the acceptable criteria (2.8% for PCU1 and 1.5% for PCU2). In examination of hemolysis interference, the maximum biases in the concentration levels of 181 and 3076 mU/mL were 6.1% and -7.5%. In samples with low hCG concentration (7.9 mU/mL), bias was greater than 1 IU/L in the sample with Hb>5 g/L. We did not observe false positive results in the carryover experiment. Conclusion: The method for hCG determination has satisfactory reproducibility. Impact of hemolysis was clinically significant only in the samples with low analyte concentrations in hemoglobin levels above 5 g/L. There is no influence of carryover from samples with the high concentration.

Izvorni jezik
Engleski

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