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La Rivista Italiana della Medicina di Laboratorio 2019 Dicembre;15(4):284-93

DOI: 10.23736/S1825-859X.19.00036-7


language: Italian

Evaluation of a new chemiluminescent immunoassay for the measurement of biochemical/serological markers of atrophic gastritis

Domenico DE MARCHI 1, Maria P. PANOZZO 1, Antonio ANTICO 1 , Renato TOZZOLI 2

1 Laboratorio di Patologia Clinica, Ospedale Santorso, Santorso, Vicenza, Italia; 2 Laboratorio di Patologia Clinica, Ospedale S. Maria degli Angeli, Pordenone, Italia

BACKGROUND: Gastric mucosa function can be investigated by measuring the serum concentrations of pepsinogen I (PGI) and II (PGII) and of gastrin 17 (G17). We evaluated the analytical performance of a new automated immunochemiluminescent method (CLIA) for the measurement of the four markers, and we compared the results obtained with those of the immunoenzymatic method (ELISA). We also correlated the results of anti-Helicobacter pylori IgG antibodies (HP-IgG) of the two methods.
METHODS: For the CLIA method, linearity and precision tests have been carried out for each parameter. To compare the two methods, the markers were measured on sera of 97 patients (35 males, 62 females, mean age 52 years) and the results analyzed by Passing-Bablok and Bland-Altman regression.
RESULTS: The total variation coefficients obtained from the repeatability tests carried out on three concentration levels were 8.00% (PGI), 6.59% (PGII), 5.76% (G17) and 5.92% (HP-IgG). Linearity tests identified the acceptable concentration range 0-230 ng/mL (PGI), 0-30 ng/mL (PGII), 0-60 pmol/L (G17) and 0-150 EIU/mL (HP-IgG). The correlation coefficient showed a good association for all the parameters considered (P<0.0001). The Passing-Bablok regression analysis showed the absence of a statistically significant error between the two methods for PGI and G17, but not for PGII and HP-IgG. However, considering the Cohen K index for the comparison of the clinical outcome between CLIA-ELISA and CLIA-histological report, the concordance was 100%.
CONCLUSIONS: The use of CLIA method for PGI, PGII and G17 could offer clinical information comparable to that provided by the ELISA method. For HP-IgG, in few discordant cases, it is necessary to confirm the results by means of an antigen detection method.

KEY WORDS: Pepsinogen I; Pepsinogen II; Gastrin 17; Helicobacter pylori; Atrophic gastritis; Chemiluminescence

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