Molecular diagnostics company ChromaCode, Carlsbad, Calif, says a multisite study demonstrates the effectiveness of its high-definition polymerase chain reaction (HDPCR) Tick-Borne Pathogen (TBP) panel RUO.1

Conducted by the Medical College of Wisconsin and the Gundersen Medical Foundation, the study tested a combination of clinical whole-blood samples and simulated samples. The study used ChromaCode’s TBP panel to test a total of 425 clinical specimens and 93 simulated specimens. Major findings include:

  • For clinical samples, the TBP panel demonstrated 100% positive identification of Anaplasma phagocytophilum,Borrelia mayonii, Borrelia miyamotoi, and Rickettsia rickettsia, and negative agreement greater than 99.8% for all nine TBP targets.
  • For the simulated specimens, the TBP panel demonstrated a sensitivity and specificity of 100% and 99.9%, respectively.

“The United States is seeing an increase in the incidence of tick-borne infections, novel pathogens that can be transmitted by ticks, and ticks harboring multiple disease agents,” says Blake Buchan, PhD, D(ABMM), associate director for clinical pathology at the Medical College of Wisconsin.

Buchan

Blake Buchan, PhD, D(ABMM), Medical College of Wisconsin.

“During this study, molecular characterization of tick-borne pathogens with a syndromic panel proved to be a beneficial adjunct to existing lab testing, enabling detection of infection in an acute stage during which serologic testing is frequently negative, as well as identifying emerging tick-borne pathogens that are not frequently tested for,” says Buchan.

The TBP panel is ChromaCode’s first commercial assay using the company’s proprietary HDPCR multiplexing technology, and detects nine of the most common tick-borne pathogens in a single reaction. The assay is platform-agnostic and can be performed on most common real-time PCR instrumentation without instrument modifications or additional hardware, thereby avoiding expensive capital and service costs usually associated with multiplex testing.

For more information, visit ChromaCode.

Reference

  1. Buchan BW, Jobe DA, Mashock M, et al. Evaluation of a novel multiplex high-definition PCR assay for the detection of tick-borne pathogens in whole-blood specimens. J Clin Microbiol. 2019;57(11):e00513–e00519; doi: 10.1128/jcm.00513-19.