Analytical and Clinical Validation of an Automated Microfluidic Interleukin-6 Immunoassay.
Ann Clin Lab Sci
; 54(3): 388-393, 2024 May.
Article
em En
| MEDLINE
| ID: mdl-39048159
ABSTRACT
OBJECTIVE:
We validated an automated microfluidic interleukin-6 (IL-6) immunoassay on the Ella platform for clinical use.METHODS:
The assay was validated for precision, lower limit of quantification, analytical measurement range, accuracy, specificity, interference of biotin, tocilizumab, GP130, IL-6Rα, hemolysis, icterus, and lipemia, and establishing the reference value. The clinical performance was evaluated in 96 COVID-19 patients.RESULTS:
The within-run and between-run coefficient of variations (CV) ranged 1.8%-4.8%. This assay has an analytical measurement range (AMR) 0.7-2652 pg/ml. There was a moderate correlation between Ella IL-6 assay (y) and a Luminex Quantitative Multiplex Bead Assay in a reference lab (x) y=8.561x-475.38, R=0.5047, SEE=1592.8 pg/mL, N=48). Measurement of IL-6 in plasma samples from 45 healthy adults showed the upper limit of reference of 5.0 pg/mL. 95.83% (95% CI 89.67%-98.85%) of COVID-19 patients had IL-6 >5.0 pg/mL. This assay is resistant to the interference from hemoglobin up to 1,144 mg/dL, triglyceride 1,699 mg/dL, bilirubin 35 mg/dL, biotin 1000 ng/mL, tocilizumab 240 µg/mL, IL-11 50,000 pg/mL, GP130 50,000 pg/mL, and IL-6Rα 1,000 pg/mL.CONCLUSIONS:
The IL-6 assay on the Ella platform is robust with minimum manual operation. The analytical and clinical performance characteristics meet the clinical needs.Palavras-chave
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Interleucina-6
/
COVID-19
Limite:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Ann Clin Lab Sci
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos