Achieving molecular diagnostics for Lyme disease

Abstract

Early Lyme disease is often difficult to diagnose. Left untreated, symptoms can last for many years leading to chronic health problems. Serological tests for the presence of antibodies that react to Borrelia burgdorferi antigens are generally used to support a clinical diagnosis. Due to the biologically delayed antibody response, serology is negative in many patients in the initial 3 weeks after infection and a single test cannot be used to demonstrate active disease, although certain specialized tests provide strong correlation. Because of these limitations there exists a need for better diagnostics for Lyme disease that can detect Borrelia genomic material at the onset of symptoms.

Keywords::

• borreliosis
• Borrelia burgdorferi
• Lyme disease
• Lyme disease diagnosis
• PCR-based assay
• tick-borne disease

Financial & competing interests disclosure

MW Eshoo, DJ Ecker, CD Crowder and H Carolan are employees of Ibis Biosciences, an Abbott company; Abbott manufactures the technology described in the review. SE Schutzer is supported by grants from the NIH and Ibis Biosciences, Inc., an Abbott Company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties

The authors acknowledge the assistance of Jacqueline Wyatt, of J&L Scientific Editing, in writing this manuscript.

Key issues

• • Traditional culture-based diagnostics for Lyme disease are:

  • – difficult and unreliable

  • – not fast enough for clinical utility

• • Current serological diagnostics are:

  • – not sensitive for early Lyme disease

  • – cannot distinguish active infection from prior exposure

  • – yield ambiguous results that are subject to operator/laboratory interpretation

  • – no one test can detect all Lyme causing Borrelia species

• • Conventional or nested PCR on blood samples as practiced in the past has had low sensitivity and specificity problems.

Notes