Validation, performance, and reliability of two automated tests for vitamin B12 and folate assay.

Autor:	Bianciardi S; DIESSE Diagnostica Senese S.p.A. Società Benefit, Monteriggioni, Siena, Italy., Tesi G; DIESSE Diagnostica Senese S.p.A. Società Benefit, Monteriggioni, Siena, Italy., Cerutti H; DIESSE Diagnostica Senese S.p.A. Società Benefit, Monteriggioni, Siena, Italy., Cartocci A; Department of Medical Biotechnology, University of Siena, Siena, Italy., Guerranti R; Laboratorio Patologia Clinica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy., Silvestrini C; Laboratorio Patologia Clinica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy., Gori S; Laboratorio Patologia Clinica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy., Bandini T; DIESSE Diagnostica Senese S.p.A. Società Benefit, Monteriggioni, Siena, Italy., Brogi A; DIESSE Diagnostica Senese S.p.A. Società Benefit, Monteriggioni, Siena, Italy., Leoncini R; Laboratorio Patologia Clinica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
Jazyk:	angličtina
Zdroj:	Journal of public health research [J Public Health Res] 2023 Dec 13; Vol. 12 (4), pp. 22799036231217803. Date of Electronic Publication: 2023 Dec 13 (Print Publication: 2023).
DOI:	10.1177/22799036231217803
Abstrakt:	Background: Deficiency of Vitamin B12 and folate may determine hematological, neurological, and metabolic alterations; therefore, an accurate quantification of their serum levels is required, especially in the presence of symptoms that might suggest a deficiency. CHORUS VIT B12 and CHORUS FOLATE are two automated immunoassays, developed to quantify vitamin B12 and folate, respectively, in human serum. Design and Methods: This single-center, non-pharmacological, diagnostic study described the validation and characterization of CHORUS VIT B12 and CHORUS FOLATE, with a specific focus on performance, precision, and reliability. For each assay, 500 serum samples were analyzed. A comparison between CHORUS assays and commercially available kit was also performed. Results: For CHORUS VIT B12 the lower limit of quantification (LLoQ) was 165.0 pg/mL and the upper LoQ (ULoQ) was 1846.8 pg/mL. The assay was linear within the calibration range (150-2000 pg/mL) and the accuracy was described with the International Standard Vitamin B12, Serum Folate, HOLO TC (NIBSC code: 03/178), with a mean recovery on two lots of 111%. For CHORUS FOLATE (calibration range of 2.0-20.0 ng/mL), LLoQ was 2.0 ng/mL and ULoQ 19.6 ng/mL. The linearity was demonstrated from 2.4 to 20.0 ng/mL; the accuracy was described with the International Standard mentioned above, achieving a mean recovery on three lots of 92%. The lowest and highest values of both CHORUS and COBAS kits were similar and the median values did not significantly vary. Conclusion: CHORUS VIT B12 and CHORUS FOLATE performed well, accurately, and reliably in quantifying vitamin B12 and folate in human serum. Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Cerutti H, Tesi G, Bianciardi S, Bandini T, Brogi A declare to be “DIESSE Diagnostica Senese S.p.A. Società Benefit” employees. No other conflict of interest has been reported. (© The Author(s) 2023.)
Databáze:	MEDLINE
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