Legionella Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Legionella Antigen Rapid Test?

The EZER™ Legionella Antigen Rapid Test is a lateral flow immunochromatographic assay designed to detect Legionella pneumophila serogroup 1 LPS antigens in human urine. The test identifies antigens using latex microsphere-labeled monoclonal antibodies, generating visual colored lines on a test cassette.

Kit contents:

• 40 test devices

• 40 transfer pipettes

• 1 package insert

Each device includes internal procedural controls. Test kits are intended for in vitro diagnostic use only and must be stored at 2–30°C. The test works with both fresh and preserved urine, with no centrifugation required.

Role of Legionella in Disease

Legionella pneumophila is a Gram-negative bacterium found in natural and man-made water systems, such as cooling towers and hospital hot water systems. Inhalation of contaminated aerosols can lead to Legionnaires’ disease, a severe form of pneumonia with symptoms including:

• High fever

• Cough

• Muscle aches

• Headaches

• Chest pain

• Shortness of breath

• GI disturbances

The majority (90%) of infections are caused by Legionella pneumophila, with serogroup 1 responsible for over 80% of cases. This makes serogroup 1 the critical diagnostic target.

Legionellosis is not contagious, but it poses a significant risk to immunocompromised individuals, transplant patients, smokers, and the elderly. Rapid identification of Legionella-positive patients is essential to prevent severe complications and limit hospital-acquired infections.

Due to the overlap in symptoms with other pneumonias, a Legionella-targeted diagnostic test is essential for differentiation and accurate treatment.

About the EZER™ Legionella Antigen Rapid Test

Produced by Genesis Biotech, the EZER™ Legionella Antigen Rapid Test delivers high performance through a validated design. Clinical evaluation (n=123) showed:

• Positive agreement: 93.5% (43/46)

• Negative agreement: 100.0% (77/77)

• Overall accuracy: 97.6%

The test detects L. pneumophila serogroup 1 antigens down to 5.0 × 10⁴ CFU/mL, with no observed cross-reactivity with:

• Other Legionella serogroups (2–15)

• Bacteria like E. coli, Staph. aureus, Candida albicans, P. aeruginosa, S. pneumoniae, etc.

The test is unaffected by common interfering substances including:

• Glucose (up to 4000 mg/dL)

• Urea (up to 3000 mg/dL)

• Hematuria (up to 0.5%)

This makes it suitable even for complex or polymicrobial clinical samples.

Principle and Workflow

The test operates via lateral flow immunochromatography:

1. Sample collection: Mid-stream urine is collected (no centrifugation).

2. Application: 80 μL of sample is added using the included pipette.

3. Reaction: Latex-labeled antibodies form immune complexes with Legionella antigens.

4. Detection: Complexes migrate and bind to immobilized antibodies at the test line (T).

5. Control line: Confirms procedural integrity at position (C).

6. Result: Visually inspect after 15 minutes (no later than 30 minutes).

A visible test line indicates a Legionella-positive result. Absence of the control line renders the test invalid.

Clinical Application

The EZER™ Legionella Antigen Rapid Test is ideal for:

• Clinical microbiology labs needing rapid rule-in/rule-out of Legionella infection

• ICUs and emergency departments requiring fast decisions for pneumonia cases

• Hospital infection control teams screening nosocomial pneumonia

• Public health surveillance during outbreaks in care homes or hotels

This Legionella-targeted rapid assay fits seamlessly into high-throughput or urgent diagnostic workflows and supports improved outcomes through early detection and intervention.

With its strong performance, minimal training requirement, and high diagnostic confidence, the EZER™ test is a reliable solution for clinicians and laboratory professionals alike.