Evaluation of a novel array-based toxoplasma, rubella, cytomegalovirus, and herpes simplex virus IgG enzyme linked immunosorbent assay and its comparison with virion/serion enzyme linked immunosorbent assays

Ann Lab Med. 2014 Jan;34(1):38-42. doi: 10.3343/alm.2014.34.1.38. Epub 2013 Dec 6.

Abstract

Background: The dramatic increase in use of the IgG test for toxoplasma, rubella, cytomegalovirus (CMV), and herpes simplex virus (HSV) [TORCH] has led to the requirement for a high-efficiency method that can be used in the clinical laboratory. This study aimed to compare the results of BGI-Array ELISA TORCH IgG (BGI-GBI, China) screening method to those of Virion/Serion TORCH IgG ELISA (Virion/Serion, Germany).

Methods: Serum specimens (n=400) submitted for routine IgG testing by Virion/Serion ELISA were also tested using the BGI-Array ELISA method. The agreements of these two kinds of method were analyzed by κ-coefficients calculation.

Results: Following repeat testing, the BGI-Array ELISA TORCH IgG assays demonstrated agreements of 99.5% (398/400 specimens), 98% (392/400 specimens), 99% (396/400 specimens), and 99.5% (398/400 specimens), respectively. The BGI-Array ELISA IgG assays provided results comparable to Virion/Serion ELISA results, with κ-coefficients showing near-perfect agreement for the HSV (κ=0.87), rubella (κ=0.92) and CMV (κ=0.93) and substantial agreement for the toxoplasma (κ=0.80) IgG assays. The use of the BGI-Array ELISA TORCH IgG assays could reduce the turnaround time (1.5 hr vs. 5 hr by Virion/Serion ELISA for 100 specimens) and were easy to use.

Conclusions: BGI-Array ELISA TORCH IgG shows a good agreement with Virion/Serion ELISA methods and is suitable for clinical application.

Keywords: Agreement; ELISA; Protein array; TORCH test.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / blood
  • Cytomegalovirus / immunology
  • Cytomegalovirus / metabolism*
  • Enzyme-Linked Immunosorbent Assay*
  • Humans
  • Immunoglobulin G / analysis*
  • Immunoglobulin G / blood
  • Protozoan Infections / diagnosis
  • Reagent Kits, Diagnostic
  • Rubella virus / immunology
  • Rubella virus / metabolism*
  • Sensitivity and Specificity
  • Simplexvirus / immunology
  • Simplexvirus / metabolism*
  • Toxoplasma / immunology
  • Toxoplasma / metabolism*
  • Virion / immunology*
  • Virion / metabolism
  • Virus Diseases / diagnosis

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Reagent Kits, Diagnostic