The Quansys multiplex immunoassay for serum ferritin, C-reactive protein, and α-1-acid glycoprotein showed good comparability with reference-type assays but not for soluble transferrin receptor and retinol-binding protein

PLoS One. 2019 Apr 29;14(4):e0215782. doi: 10.1371/journal.pone.0215782. eCollection 2019.

Abstract

The Quansys multiplex (Q-Plex) measures ferritin (Fer), soluble transferrin receptor (sTfR), C-reactive protein (CRP), α-1-acid glycoprotein (AGP), and retinol-binding protein (RBP). We compared Q-Plex results with reference-type assays and evaluated Q-Plex performance. Pearson correlation and Lin's concordance coefficients between the Q-Plex and reference assay were: Fer 0.98 and 0.91, sTfR 0.88 and 0.35, CRP 0.98 and 0.98, AGP 0.82 and 0.81, and RBP 0.68 and 0.31, respectively. The median relative difference between the Q-Plex and reference assay were: Fer -2.4%, sTfR 107%, CRP 0.03%, AGP -1.3%, and RBP 51%. The Q-Plex intra-assay CVs were <5%; the inter-assay CVs were higher: Fer 11%, sTfR 14%, CRP 9.3%, AGP 7.5%, and RBP 19%. EDTA plasma produced 74% higher Q-Plex sTfR concentrations compared to serum. Analyte stability was good for ≤5 freeze-thaw cycles. After adjusting Q-Plex data to the reference assays, sensitivity and specificity were >85% for Fer and CRP; specificity was >85% for sTfR, AGP, and RBP. Using performance criteria derived from biologic variation, Fer, CRP, and AGP met the minimum allowable imprecision (<10.7%, <31.7%, and <8.5%, respectively) and difference from the reference assay (<±7.7%, <±32.7%, and <±10.3%, respectively), while sTfR and RBP exceeded these thresholds (<8.5% and <7.8% for imprecision and <±7.7% and <±12% for difference, respectively). The Q-Plex measures multiple biomarkers simultaneously, is easy to perform, and uses small sample volumes. With some improvements in accuracy and precision (i.e., sTfR and RBP), this assay could be a useful tool for low-resource laboratories conducting micronutrient surveys for epidemiologic screening applications. These findings need to be verified using other populations, particularly those with inadequate micronutrient status.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • C-Reactive Protein / metabolism*
  • Female
  • Ferritins / blood*
  • Humans
  • Immunoassay / methods*
  • Internationality
  • Male
  • Orosomucoid / metabolism*
  • Receptors, Transferrin / blood*
  • Reference Standards
  • Retinol-Binding Proteins / metabolism*
  • Solubility
  • Temperature

Substances

  • Orosomucoid
  • Receptors, Transferrin
  • Retinol-Binding Proteins
  • C-Reactive Protein
  • Ferritins

Grants and funding

The authors received no specific funding for this work.