title: 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.
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.
authors.affiliation: Department of Laboratory Medicine, Suzhou Municipal Hospital, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou, China.
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Wu
authors.affiliation: Department of Laboratory Medicine, Suzhou Municipal Hospital, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou, China.
authors.forename: Yuanjian
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Laboratory Medicine, Suzhou Municipal Hospital, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou, China.
authors.forename: Liuhong
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Laboratory Medicine, Suzhou Municipal Hospital, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou, China.
authors.forename: Weidong
authors.initials: W
authors.lastname: Xu
authors.affiliation: Department of Laboratory Medicine, Suzhou Municipal Hospital, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou, China.
authors.forename: Qiao
authors.initials: Q
authors.lastname: Zhong
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D003587:Cytomegalovirus / Q000276:immunology / Q000378:metabolism*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis* / Q000097:blood; D011528:Protozoan Infections / Q000175:diagnosis; D011933:Reagent Kits, Diagnostic; D012412:Rubella virus / Q000276:immunology / Q000378:metabolism*; D012680:Sensitivity and Specificity; D018139:Simplexvirus / Q000276:immunology / Q000378:metabolism*; D014122:Toxoplasma / Q000276:immunology / Q000378:metabolism*; D014771:Virion / Q000276:immunology* / Q000378:metabolism; D014777:Virus Diseases / Q000175:diagnosis
chemical_list: D000914:Antibodies, Viral; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic
keywords: Agreement; ELISA; Protein array; TORCH test