Evaluation of AutoLumo A2000 Chemiluminescent Immunoassay for Detection of Respiratory Syncytial Virus and Adenovirus IgM Antibodies

Clin Lab. 2021 May 1;67(5). doi: 10.7754/Clin.Lab.2020.200918.

Abstract

Background: Respiratory syncytial virus and adenovirus are seasonal diseases that cause an enormous burden on health systems. Previously, our lab uses DHI D3-Ultra DFA for detecting antigen of respiratory syncytial virus (RSV) and adenovirus (ADV). This article will evaluate the performance of AutoLumo RSV-IgM and ADV-IgM assays compared to D3-Ultra DFA method.

Methods: We used quality control specimens to evaluate precision, cross-reactivity specimen to evaluate the specificity, exogenous interferent: Hb (1,000 mg/dL); total bilirubin (50 mg/dL), ANA titer (1:10,000), RF (500 IU/mL) to evaluate interference, and paired, nasopharyngeal swab and sera specimens to evaluate clinical sensitivity and specificity.

Results: AutoLumo RSV-IgM and ADV-IgM assay show good precision and no cross-reactivity with other pathogen-specific IgM antibodies; no hook effect; exogenous interferent substance: Hb < 1,000 mg/dL; total bilirubin < 50 mg/dL, ANA titer < 1:10,000, and RF < 500 IU/mL showed no interference to RSV-IgM and ADV-IgM antibodies. The paired comparison test showed that RSV-IgM and ADV-IgM appear partly on the fifth day of the disease and peaked on days six to fourteen.

Conclusions: AutoLumo RSV-IgM and ADV-IgM have good performance, but their sensitivities await further improvements.

MeSH terms

  • Adenoviridae
  • Humans
  • Immunoassay
  • Immunoglobulin M
  • Infant
  • Respiratory Syncytial Virus Infections* / diagnosis
  • Respiratory Syncytial Virus, Human*
  • Respiratory Tract Infections*
  • Sensitivity and Specificity

Substances

  • Immunoglobulin M