An ultra-high-density protein microarray for high throughput single-tier serological detection of Lyme disease

Sci Rep. 2020 Oct 22;10(1):18085. doi: 10.1038/s41598-020-75036-2.

Abstract

Current serological immunoassays have inherent limitations for certain infectious diseases such as Lyme disease, a bacterial infection caused by Borrelia burgdorferi in North America. Here we report a novel method of manufacturing high-density multiplexed protein microarrays with the capacity to detect low levels of antibodies accurately from small blood volumes in a fully automated system. A panel of multiple serological markers for Lyme disease are measured using a protein microarray system, Lyme Immunochip, in a single step but interpreted adhering to the standard two-tiered testing algorithm (enzyme immunoassay followed by Western blot). Furthermore, an enhanced IgM assay was supplemented to improve the test's detection sensitivity for early Lyme disease. With a training cohort (n = 40) and a blinded validation cohort (n = 90) acquired from CDC, the Lyme Immunochip identified a higher proportion of Lyme disease patients than the two-tiered testing (82.4% vs 70.6% in the training set, 66.7% vs 60.0% in the validation set, respectively). Additionally, the Immunochip improved sensitivity to 100% while having a lower specificity of 95.2% using a set of investigational antigens which are being further evaluated with a large cohort of blinded samples from the CDC and Columbia University. This universal microarray platform provides an unprecedented opportunity to resolve a broad range of issues with diagnostic tests, including multiplexing, workflow simplicity, and reduced turnaround time and cost.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Algorithms
  • Bacterial Proteins / immunology*
  • Biomarkers / blood*
  • Borrelia burgdorferi / immunology*
  • Borrelia burgdorferi / isolation & purification*
  • Case-Control Studies
  • Cohort Studies
  • High-Throughput Screening Assays / methods*
  • Humans
  • Lyme Disease / blood
  • Lyme Disease / diagnosis*
  • Lyme Disease / immunology
  • Lyme Disease / microbiology
  • Protein Array Analysis / methods*
  • Serologic Tests

Substances

  • Bacterial Proteins
  • Biomarkers