Pubblicazioni

Autori:

Lippi, Giuseppe; Pighi, Laura; Paviati, Elisa; Demonte, Davide; De Nitto, Simone; Gelati, Matteo; Montagnana, Martina; Gandini, Giorgio; Henry, Brandon M; Salvagno, Gian Luca

Titolo:

Analytical evaluation of the novel Mindray high sensitivity cardiac troponin I immunoassay on CL-1200i

Anno:

2024

Tipologia prodotto:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Lingua:

Inglese

Formato:

A Stampa

Referee:

Sì

Nome rivista:

Clinical Chemistry and Laboratory Medicine

ISSN Rivista:

1434-6621

N° Volume:

62

Numero o Fascicolo:

7

Editore:

Walter De Gruyter

Intervallo pagine:

1433-1437

Parole chiave:

immunoassay, method evaluation, myocardial infarction, troponin

Breve descrizione dei contenuti:

Objectives: The current study was designed to evaluate the analytical performance of the new Mindray highly sensitive cardiac troponin I (hs-cTnI) chemiluminescent immunoassay on Mindray CL-1200i, as a thorough validation of novel hs-cTnI methods is required before introduction into clinical practice. Methods: The evaluation of the analytical performance of this hs-cTnI immunoassay encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, 99th percentile upper reference limit (URL) and concordance with another previously validated hs-cTnI chemiluminescent immunoassay. Results: The LOB and LOD were 0.32 and 0.35 ng/L, whilst the functional sensitivity (expressed as cTnI value with <10 % imprecision), was 0.35 ng/L. The linearity was excellent throughout a wide range of clinically measurable values (r=1.00 between 0.8 and 9,726.9 ng/mL). The intra-assay, inter-assay and total imprecision were 1.1-1.3 %, 5.5-8.1 % and 5.6-8.2 %, respectively. The 99th percentile URL calculated using residual plasma from 246 ostensibly healthy blood donors was 9.2 ng/L (4.3 ng/L in women vs. 12.3 ng/L in men). The Spearman's correlation between Mindray hs-cTnI and Access hs-TnI was 0.97, with mean bias of 7.2 % (95 % CI, 2.6-11.9 %). Conclusions: Although we failed to confirm the very optimistic analytical characteristics previously reported for this method, our evaluation of the novel Mindray hs-cTnI immunoassay on CL-1200i demonstrated that the overall performance is comparable to that of other commercially available hs-cTnI techniques, making it a viable alternative to other methods.

Pagina Web:

https://www.degruyter.com/document/doi/10.1515/cclm-2023-1448/html

Id prodotto:

136922

Handle IRIS:

11562/1116667

ultima modifica:

25 luglio 2024

Citazione bibliografica:

Lippi, Giuseppe; Pighi, Laura; Paviati, Elisa; Demonte, Davide; De Nitto, Simone; Gelati, Matteo; Montagnana, Martina; Gandini, Giorgio; Henry, Brandon M; Salvagno, Gian Luca, Analytical evaluation of the novel Mindray high sensitivity cardiac troponin I immunoassay on CL-1200i «Clinical Chemistry and Laboratory Medicine » , vol. 62 , n. 7 , 2024 , pp. 1433-1437

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