What is in the Leptospira Detection Kit?

The TRUPCR® Leptospira Detection Kit is an in vitro nucleic acid amplification test designed to detect DNA from pathogenic Leptospira spp. in clinical samples. This includes blood, urine, and kidney tissue—key matrices in the diagnosis of leptospirosis.

Each kit contains all required reagents, including:

• Primer-probe mixes targeting Leptospira-specific DNA

• Fluorescent reporter probe (HEX)

• Primer-probe mix for endogenous internal control (TEX RED)

• PCR master mix with hot-start Taq polymerase

• Positive and negative controls

The single-tube dual-reaction format streamlines lab processes while maintaining high sensitivity. The kit is CE-IVD certified and validated across a broad spectrum of instruments, making it adaptable and reliable for clinical and research use.

Role of Leptospira Targets in Disease

Leptospira is a genus of spiral-shaped, flagellated bacteria that includes both pathogenic and non-pathogenic species. Pathogenic Leptospira, such as L. interrogans, L. borgpetersenii, and L. kirschneri, are responsible for leptospirosis, a re-emerging zoonotic disease that affects humans and a variety of animals.

Humans typically contract Leptospira-positive infections via contact with contaminated water or urine from carrier animals. Once in the body, leptospires can spread rapidly, causing symptoms ranging from mild flu-like illness to severe organ damage (hepatorenal failure, meningitis, pulmonary hemorrhage).

The disease progresses in phases, and early detection during the bacteremic phase—when the pathogen is present in the blood—is critical. Molecular detection by PCR offers a much faster and more sensitive alternative to traditional serology, which may not detect infection until after antibody development.

About the TRUPCR® Leptospira Detection Kit

The TRUPCR® Leptospira Detection Kit leverages advanced real-time PCR technology for the rapid and reliable identification of Leptospira spp. DNA in a range of clinical specimens. Its one-step, closed-tube format ensures low contamination risk and ease of use, making it well suited for high-throughput testing in diagnostic laboratories.

Kit highlights include:

• Hot-start Taq polymerase for high specificity

• Endogenous internal control to monitor extraction and amplification quality

• Validated on clinical samples from patients suspected of leptospirosis

• Flexible pack sizes and instrument compatibility (ABI, Roche, Bio-Rad, Qiagen, etc.)

The inclusion of internal controls in every reaction not only prevents false negatives but also allows labs to verify sample quality and PCR performance in each run.

Principle and Workflow

The detection principle is based on real-time fluorescence PCR, where a probe hybridizes to a specific DNA sequence within the Leptospira genome. Here’s how the workflow is structured:

1. Sample Extraction: DNA is isolated from blood, urine, or tissue.

2. Reaction Setup: All reagents are prepared in a single tube per sample.

3. PCR Amplification:

   • HEX channel detects Leptospira DNA

   • TEX RED channel monitors the internal control (IC)

4. Detection & Interpretation: Fluorescence is measured during each PCR cycle. Ct values indicate the presence or absence of Leptospira DNA.

This design enhances result clarity, minimizes manual errors, and accelerates time-to-result.

Clinical Application

The TRUPCR® Leptospira Detection Kit is an invaluable tool in:

• Clinical microbiology labs for early and definitive diagnosis

• Outbreak surveillance, especially in endemic and flood-prone areas

• Zoonotic infection monitoring in veterinary or one-health programs

• Hospital laboratories assessing febrile illness of unknown origin

Its high analytical performance enables the detection of Leptospira-targeted infections during the crucial early stage—before seroconversion—offering an advantage over traditional diagnostic methods.

By helping clinicians quickly confirm or rule out leptospirosis, this kit supports timely therapeutic intervention and reduces diagnostic uncertainty.