BIONEXIA® Legionella

Rapid detection of Legionella pneumophila serogroup 1 infection

BIONEXIA® Legionella is a rapid urine antigen test. Non-invasive, it is also easy to perform for an accurate first-line answer:

  • Only 1 step
  • Result available after 15 minutes for early initiation of appropriate antibiotic therapy
  • Innovative control line: immediate conjugate quality check with no additional cost
  • 2 validated protocols for both non-concentrated and concentrated urines
Add to your selection

Do you need more information

Legionnaires’ disease is a severe and potentially fatal form of pneumonia. Although often associated with extrapulmonary signs and symptoms such as diarrhea, myalgia and impaired renal function, the clinical syndrome of the disease is generally non-specific1. Empirical antibiotic treatment of pneumonia is often primarily directed against Streptococcus pneumonia and does not always cover Legionella pneumonia, which should be treated with fluoroquinolones, macrolides or rifampicin2. Diagnostic testing for Legionella species for all patients admitted to the hospital for community-acquired pneumonia is therefore highly recommended3.

Our BIONEXIA® Legionella test detects the presence of Legionella pneumophila and its serogroup 1, the most commonly identified pathogens in Legionnaires’ disease4, directly from urine samples. It is ideal as a first-line test to enable early initiation of targeted therapy for improved patient outcomes3.
 

Only one step for a quick and accurate
Legionella detection

The BIONEXIA® Legionella test offers ease of use for universal practice:

bioNexia Legionella test kit - Accurate and Quick results
Simply add 3 drops of urine in the sample well using the pipette provided in the kit Read the result between
15 and 20 minutes later

 

  • Adapted to emergency situations
  • Compatibility with standard urine transport tubes.
  • Excellent performances (see technical details)
  • Validated protocols for non-concentrated and concentrated urines to fit with your quality process
     

Immediate quality check with no additional cost

The BIONEXIA® Legionella test includes an innovative control line (patent pending). The C+ line is coated with an inactivated Legionella pneumophila antigen serogroup 1 . In addition to migration checks, the C+ line confirms that the conjugate is “bioactive”.

  • Your benefit: 100% of tests are controlled with no additional cost!
     

A complete solution for Legionella testing

With a 50-year expertise in microbiology and in vitro diagnostics, bioMérieux offers a global Legionella testing offer, from first-line diagnosis to culture and PCR, following the HCSP 2013 algorithm5.

Suspicion of Legionella: diagnostic algorithm

 

Method

Product name

Reference

Detection after 15 minutes of Legionella pneumophila serogroup 1 in urine samples

BIONEXIA® Legionella

414 263

Culture media | Identification of all Legionella species

GVPC agar

43 031

Qualitative real time PCR detection of all Legionella pneumophila serogroups within 3.5 hours

ARGENE® Legio
pneumo/Cc r-gene®

71-046

 

 

References:

1. Yu VL, Ramirez J, Roig J, Sabria M. Clin Infect Dis. 2004;39(11):1734-7.

2. Stout JE, Sens K, Mietzner S, et al.  Comparative activity of quinolones, macrolides and ketolides against Legionella species using in vitro broth dilution and intracellular susceptibility testing.  Int J Antimicrob Agents. 2005;25:302-7.

3. British Thoracic Society: guidelines for the management of community acquired pneumonia in adults: update 2009.

4. ECDC surveillance report. Legionnaires’ disease in Europe. 2012.

5. Risque lié aux légionelles : guide d’investigation et d’aide à la gestion, Haut conseil de la santé publique. Collection Amis et Rapports 2013 page 1-80.

 

BIONEXIA® Legionella

Reference

414 263

Test format

Content of the kit

  • 25 individually sealed pouches each containing a test cassette with Intelligent Control Line, a disposable pipette and a desiccant
  • 1 quick user guide printed on the box
  • 1 package insert

Sample type

 Concentrated or non-concentrated urine

Sample volume

3 drops

Positive % agreement

Performance on non-concentrated urine* : 96.34%

Performance on concentrated urine* : 97.56%

Negative % agreement

Performance on non-concentrated urine* : 100%

Performance on concentrated urine* : 100%

Time to result

15 minutes
The test result is stable for 5 minutes.

Storage temperature

2 – 30°C

Shelf life

24 months

* Comparison with another Legionella rapid test performed on 282 samples. See package insert for further details.

 

Kits are for use by healthcare professionals in laboratories.

Consult your local bioMérieux representative for product availability in your country.

RELATED PUBLICATIONS

Congestrì F, et al. Comparative evaluation of the novel bioNexia® Legionella test with the BinaxNOW® Legionella card assay and SOFIA® Legionella FIA assay for the detection of Legionella pneumophila (serogroup 1) antigen in urine samples. J Clin Microbiol. 2016 Apr; 54(4):1164-6. doi: 10.1128/JCM.03340-15. Epub 2016 Feb 10.

Briand H, et al. Evaluation of the bioNexia® Legionella test: comparative study with five other urinary antigen detection tests

Poster presented at the ESGLI congress, London, September 2015.

Congestrì F, et al. Evaluation of the bioNexia® Legionella test in comparison with the BinaxNOW® Legionella urinary antigen card and Sofia® Legionella FIA: a preliminary study

Poster presented at the ESGLI congress, London, September 2015.

Beraud L, et al. Evaluation of the bioNexia® Legionella in comparison with the BinaxNOW® (Alere) Legionella Urinary Antigen Card: Preliminary Study

Poster presented at the ESGLI congress, Barcelona, September 2014.

 

GUIDELINES

Woodhead et al. Guidelines for the management of adult lower respiratory tract infections - Full version; Clin Microbiol Infect 2011; 17(Suppl. 6): E1–E59.

Yu VL, Ramirez J, Roig J, Sabria M. Legionnaires disease and the updated IDSA guidelines for community-acquired pneumonia. Clin Infect Dis. 2004;39(11):1734-7

British Thoracic Society guidelines for the management of community acquired pneumonia in adults: update 2009.

 

USEFUL LINKS

European Legionnaires’ Disease Surveillance Network (ELDSNet)

 

Please consult your local bioMérieux representative for product availability in your country

Pioneering diagnostics