A total of 425 clinical specimens and 93 simulated specimens were tested with TBP in this study
For clinical samples, the TBP panel demonstrated a 100% positive percent agreement for the identification of Anaplasma phagocytophilum, Borrelia miyamotoi, Borrelia mayonii, and Rickettsia rickettsii and negative percent 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 U.S. 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, said Blake Buchan, Ph.D., D(ABMM), Associate Director, Clinical Pathology, Medical College of Wisconsin1. 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.
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 the most common qPCR instrumentation in laboratories around the world with no instrument modifications or additional hardware, avoiding expensive capital and service costs usually associated with multiplex testing.