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03-15 / 9308849/008/GB/A / Document and/or pictures not legally binding. Modifications by bioMérieux can be made without prior notice / BIOMÉRIEUX, the blue logo, ARGENE, BIONEXIA, DIVERSILAB, FIRST LINE BIOLOGY, R-GENE and VITEK are used, pending and/or registered
trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies / Any other name or trademark is the property of its respective owner / bioMérieux S.A. 673 620 399 RCS Lyon / Photos : C. Ganet / Printed in France / thera RCS Lyon B 398 160 242
Our complete solution for Legionella testing
Culture media GVPC
and VITEK® MS
First Line Biology® tests
for Laboratories
bioNexia® Legionella
Detection within 15 min
of Legionella pneumophila
serogroup 1 in urine samples
Identification of
all Legionella species
GVPC agar - 20 plates (90 mm)
Ref. 43031
bioNexia® Legionella - 25 tests
Ref. 414263
URINE SAMPLE
Legionella pneumophila Urinary antigen (Lp1)
+
HIGH SUSPICION
LOWER RESPIRATORY SAMPLE
LOWER RESPIRATORY SAMPLE
CULTURE
(systematic)
+
PCR
-
+
Strain sent to
reference lab
TYPING
STOP
■
CULTURE
-
+
STOP
Sample sent to
reference lab
ARGENE®
Strain sent to
reference lab
TYPING
DiversiLab®
Legio pneumo/
Cc r-gene®
DL Propionibacterium kit
Automated Legionella strain
typing in 4 hours for
epidemiological surveillance
Qualitative real time PCR
detection of all Legionella
pneumophila serogroups
within 3.5 hours
DL Propionibacterium kit
24 tests - Ref. 410987
Legio pneumo/Cc r-gene®
60 tests - Ref. 71-046
REFERENCES
1. Beauté J, Zucs P, de Jong B. Euro Surveill. 2013;18(10):pii=20417.
2. ECDC surveillance report. Legionnaires’ disease in Europe. 2012.
3. Fields BS, Benson RF, Besser RE. Clin Microbiol Rev. 2002;15(3):506-26.
4. Lück PC.. Legionella: Molecular Microbiology. Editors: Heuner K, Swanson M. Caister Academic Press. UK. 2008.
5. Yu VL, Ramirez J, Roig J, Sabria M. Clin Infect Dis. 2004;39(11):1734-7.
6. British Thoracic Society guidelines for the management of community acquired pneumonia in adults: update 2009.
7. Mandell LA, Wunderink RG, Anzueto A, et al. Clin. Infect. Dis. 2007;44(suppl 2):527-572.
8. Stout JE, Sens K, Mietzner S, et al. Int J Antimicrob Agents. 2005;25:302-7.
bioMérieux S.A.
69280 Marcy l’Etoile
France
Tel. : +33 (0)4 78 87 20 00
Fax : +33 (0)4 78 87 20 90
www.biomerieux-diagnostics.com
www.firstlinebiology.com
marked products
Contact your local bioMérieux representative for availability
bioNexia Legionella
®
All of bioMérieux’s microbiology expertise
in a rapid urine antigen test
bioNexia Legionella
®
Did you know?
Rapid detection of Legionella pneumophila
serogroup 1 directly from urine samples
Why perform a Legionella
Rapid Urine Antigen Test?
Legionnaires’ disease (LD) is a common cause of severe
pneumonia requiring hospitalization.
l The clinical syndrome of Legionella pneumonia is
generally non-specific.5
71%
of cases are
community-acquired,
20% are travel-associated,
8% are linked to
healthcare facilities.1
lD
iagnostic testing for Legionella species for
Among confirmed cases of
pneumonia due to Legionella 2:
Excellent performance to ensure an accurate first-line answer
all patients admitted to the hospital for CAP* is
therefore highly recommended.6
98% are caused by
Performance on
non-concentrated urine
lE
arly initiation of targeted antibiotics is crucial for
L. pneumophila,
successful treatment and to reduce mortality rates
.7,8
85% by L. pneumophila
disease is essential to:
- decrease prescription of broad-spectrum antibiotics,
- shorten length of stay,
- improve patient outcomes through rapid, and
targeted therapy.6
1% - 22%
of legionellosis cases
observed among
pneumonia cases. 3,4
(79/82)
Negative % Agreement
100%
97.56%
100%
(279/282)
(280/282)
(200/200)
98.94%
▲
(80/82)
96.34%
Global % Agreement
▲
Performance on
concentrated urine
Positive % Agreement
lA
ccurate laboratory diagnosis of Legionella
serogroup 1.
▲
(200/200)
99.29%
Comparison with another Legionella rapid test performed on 282 samples
✔ Validated protocols for non-concentrated and concentrated urines to fit with your quality process.
100% of bioNexia Legionella tests are quality checked
How to diagnose
a Legionella infection?
with no additional cost
URINE SAMPLE
Legionella pneumophila Urinary antigen (Lp1)
Suspicion of Legionella: diagnostic
algorithm (adapted from HSCP**, 2013)
✔ Innovative control line (patent pending): the C+ line is coated with an inactivated
+
Legionella pneumophila antigen.
-
✔ In addition to migration checks, bioNexia® Legionella confirms conjugate
is “bioactive” for all cassette tests.
HIGH SUSPICION
LOWER RESPIRATORY SAMPLE
LOWER RESPIRATORY SAMPLE
CULTURE
(systematic)
+
PCR
-
+
Strain sent to
reference lab
* Community-Acquired Pneumonia
** HCSP : Haut Conseil de Santé Publique
■ Symptoms, outbreaks, at risk patients
TYPING
STOP
■
STOP
Sample sent to
reference lab
✔ A 15 minute answer for emergency situations.
CULTURE
-
Ease-of-use for universal practice
+
✔ 1 simple step with addition of 3 drops of urine.
✔ bioNexia® Legionella is compatible with standard urine transport tubes.
Strain sent to
reference lab
More information in the Instructions for Use
TYPING
03-15 / 9308849/008/GB/A / Document and/or pictures not legally binding. Modifications by bioMérieux can be made without prior notice / BIOMÉRIEUX, the blue logo, ARGENE, BIONEXIA, DIVERSILAB, FIRST LINE BIOLOGY, R-GENE and VITEK are used, pending and/or registered
trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies / Any other name or trademark is the property of its respective owner / bioMérieux S.A. 673 620 399 RCS Lyon / Photos : C. Ganet / Printed in France / thera RCS Lyon B 398 160 242
Our complete solution for Legionella testing
Culture media GVPC
and VITEK® MS
First Line Biology® tests
for Laboratories
bioNexia® Legionella
Detection within 15 min
of Legionella pneumophila
serogroup 1 in urine samples
Identification of
all Legionella species
GVPC agar - 20 plates (90 mm)
Ref. 43031
bioNexia® Legionella - 25 tests
Ref. 414263
URINE SAMPLE
Legionella pneumophila Urinary antigen (Lp1)
+
HIGH SUSPICION
LOWER RESPIRATORY SAMPLE
LOWER RESPIRATORY SAMPLE
CULTURE
(systematic)
+
PCR
-
+
Strain sent to
reference lab
TYPING
STOP
■
CULTURE
-
+
STOP
Sample sent to
reference lab
ARGENE®
Strain sent to
reference lab
TYPING
DiversiLab®
Legio pneumo/
Cc r-gene®
DL Propionibacterium kit
Automated Legionella strain
typing in 4 hours for
epidemiological surveillance
Qualitative real time PCR
detection of all Legionella
pneumophila serogroups
within 3.5 hours
DL Propionibacterium kit
24 tests - Ref. 410987
Legio pneumo/Cc r-gene®
60 tests - Ref. 71-046
REFERENCES
1. Beauté J, Zucs P, de Jong B. Euro Surveill. 2013;18(10):pii=20417.
2. ECDC surveillance report. Legionnaires’ disease in Europe. 2012.
3. Fields BS, Benson RF, Besser RE. Clin Microbiol Rev. 2002;15(3):506-26.
4. Lück PC.. Legionella: Molecular Microbiology. Editors: Heuner K, Swanson M. Caister Academic Press. UK. 2008.
5. Yu VL, Ramirez J, Roig J, Sabria M. Clin Infect Dis. 2004;39(11):1734-7.
6. British Thoracic Society guidelines for the management of community acquired pneumonia in adults: update 2009.
7. Mandell LA, Wunderink RG, Anzueto A, et al. Clin. Infect. Dis. 2007;44(suppl 2):527-572.
8. Stout JE, Sens K, Mietzner S, et al. Int J Antimicrob Agents. 2005;25:302-7.
bioMérieux S.A.
69280 Marcy l’Etoile
France
Tel. : +33 (0)4 78 87 20 00
Fax : +33 (0)4 78 87 20 90
www.biomerieux-diagnostics.com
www.firstlinebiology.com
marked products
Contact your local bioMérieux representative for availability
bioNexia Legionella
®
All of bioMérieux’s microbiology expertise
in a rapid urine antigen test