Analytical Performance Evaluation of Goldstream Fungus (1-3)-β-D Glucan

Min Kyung So, Jungwon Huh, Miae Lee, Soo Kyung Kim

Research output: Contribution to journalArticlepeer-review

Abstract

Background: (1-3)-β-D-glucan (BDG) is a fast and simple assay to diagnose invasive fungal infection. In this study, we evaluated the performance of the Goldstream BDG assay (Beijing Gold Mountainriver Tech Development) performed on the automated analyzer, IGL-200 (Genobio Pharmaceutical). Methods: The precision and linearity of the Goldstream BDG assay were evaluated according to Clinical and Laboratory Standards Institute procedures. BDG results performed on the IGL-200 were compared to a manual photometer, MB-80A (Genobio Pharmaceutical). The manufacturer-provided reference interval was verified. Results: Within-laboratory imprecision (% Coefficient of Variation) was 9.4%. The best polynomial fit was third-order within the manufacturer’s claimed linear range (32.0 - 830.0 pg/mL). The BDG assay performed on IGL-200 and MB-80A showed a total agreement of 97.6%. All healthy subjects were within range of the manufacture provided reference interval. Conclusions: The analytical performance of the Goldstream BDG assay was clinically acceptable.

Original languageEnglish
Pages (from-to)2428-2432
Number of pages5
JournalClinical Laboratory
Volume68
Issue number5
DOIs
StatePublished - 2022

Keywords

  • (1-3)-β-D-glucan
  • evaluation
  • performance

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