VIASURE Borrelia, Anaplasma & Coxiella Real Time PCR Detection Kit is a real-time PCR test designed for the qualitative detection of genomic DNA specific for Borrelia burgdorferi sensu lato (s.l.)/Borrelia miyamotoi/Borrelia hermsii, Anaplasma phagocitophylum and/or Coxiella burnetii in clinical samples from patients with signs and symptoms compatible with Tick Borne diseases such as biopsy skin, cerebrospinal fluid (CSF) and synovial fluid and clinical samples for epidemiological surveillance and control such as blood, serum, tissue samples and microbiological culture from ticks.

This test is intended for use as an aid in the diagnosis of Tick Borne diseases in combination with clinical and epidemiological risk factors. This test is not designed to diagnose Lyme disease, it detects but not differentiate Borrelia burgdorferi sensu lato (s.l.), Borrelia miyamotoi and Borrelia hermsii.

DNA is extracted from clinical specimens, multiplied using Real Time amplification and detected using fluorescent reporter dye probes specific Borrelia burgdorferi sensu lato s.l., Borrelia miyamotoi and Borrelia hermsii, Anaplasma phagocitophylum and Coxiella burnetii.

Ticks are obligate blood feeding arthropods. They carry bacteria, helminths, protozoa, and viruses that are pathogenic to their vertebrate hosts, including humans, domestic and wild animals. Ticks transfer pathogens from their gut to the host bloodstream by their saliva (Garcia et al., 2022) causing the Tick Borne diseases (TBDs). The incidence and geographic distribution of Tick-borne diseases (TBDs) have been steadily increasing over the past few decades, leading to substantial morbidity and occasionally mortality in affected individuals (Rowan et al., 2023). Tick Borne diseases affecting humans include Lyme disease, relapsing fever, anaplasmosis, Q fever, Tick Borne encephalitis and spotted fever among others.

“Ehrlichiosis” is a generic name for infections caused by obligate intracellular bacteria in the family Anaplasmataceae, chiefly in the genera Anaplasma. (Dumler et al., 2007) transmitted by ticks that cause flu-like symptoms such as fever, muscle aches, and headache. It may take up to 14 days after a tick bite to begin showing signs and symptoms of anaplasmosis. Untreated anaplasmosis can result in serious or life-threatening complications.

Lyme borreliosis (Lyme disease) is caused by spirochaetes of the Borrelia burgdorferi sensu lato species complex, which are transmitted by ticks. Most common clinical manifestation is erythema migrans, which eventually resolves, even without antibiotic treatment. However, the infecting pathogen can spread to other tissues and organs, causing more severe manifestations that can involve a patient’s skin, nervous system, joints, or heart. The incidence of this disease is increasing in many countries.

Coxiella burnetii is an obligate intracellular, pleomorphic gram-negative rod-shaped bacteria that causes Q fever. Q fever can present as a febrile illness, pneumonia, or hepatitis. If it is not appropriately treated, it can lead to complications such as osteomyelitis, endocarditis, and vascular infections. It is, therefore, important to promptly identify and treat this condition. (Neupane et al. 2023)

Since most Tick-Borne diseases show similar symptoms, diagnosis can be problematic. Real-time PCR assays have been shown to be a sensitive and specific diagnostic tool for the detection of the causative agent.