Design and validation of an immuno-PCR assay for IFN-α2b quantification in human plasma

Aim: Nowadays, IFN-α is considered a promising therapeutic target for systemic lupus erythematosus. An immuno-PCR (iPCR) was developed to quantify low amounts of IFN-α in human plasma followed by a deep analysis of the methodologic robustness throughout quality by design approach. Results: An accurate, sensitive, selective and versatile iPCR was validated. The critical iPCR procedural steps were identified, applying a Plackett-Burman design. Also, this assay demonstrated an outstanding LOD of 0.3 pg/ml. A significant aspect relies on its high versatility to detect and quantify other cytokines in human plasma as the appropriate biotinylated antibody is employed. Conclusion: This reliable iPCR assay can be clinically used as an alternative method for quantitating and detecting low IFN-α2b concentrations in human plasma samples.

Medienart:

E-Artikel

Erscheinungsjahr:

2019

Erschienen:

2019

Enthalten in:

Zur Gesamtaufnahme - volume:11

Enthalten in:

Bioanalysis - 11(2019), 23 vom: 20. Dez., Seite 2175-2188

Sprache:

Englisch

Beteiligte Personen:

Attallah, Carolina [VerfasserIn]
Rodríguez, María C [VerfasserIn]
Lozano, Victoria [VerfasserIn]
Etcheverrigaray, Marina [VerfasserIn]
Oggero, Marcos [VerfasserIn]

Links:

Volltext

Themen:

Accuracy
ELISA
IFN-α
Immuno-PCR
Interferon alpha-2
Interferon-alpha
Interferon-alpha2b
Journal Article
Linear range
Precision
Quality by design
Robustness
Selectivity
Sensitivity
Validation Study

Anmerkungen:

Date Completed 27.04.2020

Date Revised 04.12.2021

published: Print-Electronic

Citation Status MEDLINE

doi:

10.4155/bio-2019-0225

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM303278412