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Rapid test for serogroup 1 Legionella pneumophila antigens ...€¦ · • Ref. 5060001 -...

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S C T Legionella Rapid - Easy handling in only 1 step - Results in 15 minutes High performances - Specificity 99% - Sensitivity 99% Convenient - Compatible with Biosynex ® Reader - Positive control included - 18 months shelf life - Storage between 2-30°C BIOSYNEX ® Legionella BACTERIOLOGY Rapid test for serogroup 1 Legionella pneumophila antigens in urine
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Page 1: Rapid test for serogroup 1 Legionella pneumophila antigens ...€¦ · • Ref. 5060001 - BIOSYNEX® Reader 1 Reader opTricon Gesellschaft für optische Technologien (GERMANY) THE

S

C

T

Legionella

Rapid- Easy handling in only 1 step- Results in 15 minutes

High performances- Specificity 99% - Sensitivity 99%

Convenient- Compatible with Biosynex® Reader- Positive control included- 18 months shelf life- Storage between 2-30°C

BIOSYNEX® Legionella

B A C T E R I O L O G Y

Rapid test for serogroup 1 Legionella pneumophila antigens in urine

Page 2: Rapid test for serogroup 1 Legionella pneumophila antigens ...€¦ · • Ref. 5060001 - BIOSYNEX® Reader 1 Reader opTricon Gesellschaft für optische Technologien (GERMANY) THE

BIOSYNEX SA22 Boulevard Sébastien Brant

67400 ILLKIRCH-GRAFFENSTADEN - FranceTél. : 03 88 78 80 88 - Fax : 03 88 78 76 78

E-mail : [email protected]

Positive

CT

CT

• Ref. 5060001 - BIOSYNEX® Reader 1 Reader

opTricon Gesellschaft für optische Technologien (GERMANY)

THE SOLUTIONLegionnaires’ disease is a serious form of pneumonia, whose mortality reaches 10-15% in healthy people. The disease can cause flu symptoms followed by a dry cough, frequently progressing to pneumonia. The incubation period normally lasts from 2 to 10 days, with the disease is typically occurring after 3 to 6 days. Legionellosis can occur as an epidemic of two or more cases, following a single-source limited exposure in time and space, in the form of a series of independent cases serial in an area where the disease has become very endemic ; or as sporadic cases with no obvious geopgraphic or temporal grouping.BIOSYNEX® Legionella is a single-use immunochromatographic rapid test, for serogroup 1 Legionella pneumophila infection early diagnostics, by specific antigen detection in urine.

• Automated reading of the results• Results storage• Printer, barcode reader & adhesive paper• S.I.L connectivity

Kit content• 20 test cassettes• 20 plastic sampling pipettes• 1 positive control : inactivated L. pneumophila swab• Barcode card for test batch identification when using BIOSYNEX® Reader

Test procedure Results

BIOSYNEX® Reader

References

Performances*

BIOSYNEX® Legionella

Specificity >99%

Sensitivity >99%

• Ref. 1030001 - BIOSYNEX® Legionella 20 tests

Carefully read the instructions on the labeling and / or reagent notices.

1 2

Comparative to Binax NOW® Legionella Urinary Antigen, Alere (see instructions for use).

BIOSYNEX

Transfer 4 drops of urine or CSF sample to the cassette well with the

provided pipette.

Read the results at 15 mn. Visual reading or with

the BIOSYNEX® Reader.

BIOSYNEX® Reader compatible

CT

Negative

15

Page 3: Rapid test for serogroup 1 Legionella pneumophila antigens ...€¦ · • Ref. 5060001 - BIOSYNEX® Reader 1 Reader opTricon Gesellschaft für optische Technologien (GERMANY) THE

BIOSYNEX® S. pneumoniae

B A C T E R I O L O G Y

Rapid- Easy handling in only 2 steps- Results in 15 minutes

High performances- Specificity 96% - Sensitivity 93%

Convenient- Compatible with Biosynex® Reader- Positive control included- 18 months shelf life- Storage between 2-30°C

Rapid test for the detection of Streptococcus pneumoniae antigens

in urine and CSF

S

C

T

S.pneumoniae

Page 4: Rapid test for serogroup 1 Legionella pneumophila antigens ...€¦ · • Ref. 5060001 - BIOSYNEX® Reader 1 Reader opTricon Gesellschaft für optische Technologien (GERMANY) THE

Positive

CT

CT

CT

Negative

BIOSYNEX SA22 Boulevard Sébastien Brant

67400 ILLKIRCH-GRAFFENSTADEN - FranceTél. : 03 88 78 80 88 - Fax : 03 88 78 76 78

E-mail : [email protected]

FLY_

1030

001_

1030

002_

EN_V

0120

1802

R02

THE SOLUTIONStreptococcus pneumoniae is a Gram-positive, capsular bacterium commensal to upper airways. In some cases, such as immunodeficiency, S. pneumoniae can become highly pathogenic. The bacterium represents the first cause of me-ningitis, communautary acquired-pneumonia (CAP) and acute otitis media (AOM) in adults. BIOSYNEX® S. pneumoniae test is a single-use, rapid immunochromatographic test for the detection of S. pneumo-niae specific antigen detection in urine and CSF.

• Automated results reading• Results storage• Printer, barcode reader & adhesive paper• S.I.L connectivity

BIOSYNEX® Reader

References

Performances

BIOSYNEX® S. pneumoniae

Specificity 96%

Sensitivity 93%

PPV 92%

NPV 97%

• Ref. 1030002 - BIOSYNEX® S.pneumoniae 20 tests

• Ref. 5060001 - BIOSYNEX® Reader 1 reader

1 2 3

Comparatively to another marketed rapid test (see the instructions for use)

G. Descombes et al. (poster P-242 RICAI 2016).

Test procedure Results

Carefully read the instructions on the labeling and / or reagent notices.

BIOSYNEX® Readercompatible

Lille Hospital University evaluation 766

BIOSYNEX

opTricon Gesellschaft für optische Technologien (GERMANY)

Transfer 1 drop of urine or CSF in the cassette well with the provided

pipette.

Add 3 drops of buffer Read the results at 15 minutes. Visual reading or with the

BIOSYNEX® Reader.

15

patients versus BinaxNow® S. pneumoniae.

Conclusion : «BIOSYNEX® test equivalent to BinaxNow® test»

Kit content• 20 test cassettes• 20 plastic sampling pipettes• 1 Buffer dropper• 1 positive control : inactivated S. pneumoniae suspension• Barcode card for test batch identification when using BIOSYNEX® Reader


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