BIOSYNEX® TETANOS

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

Rapid test for the detection of anti-tetanus toxoid antibodies

in whole blood, serum and plasma

Efficient- 0.1 UI/mL detection limit according to WHO- Results in 10 minutes

Convenient- Storage 18 months at 2-30°C- Compatible with BIOSYNEX® Reader- Positive control available

High performances ** Clinical study performed on capillary blood, venous blood and serum from the same patients and compared to ELISA method

S

C

T

TETANUS

Positive

Kit content• 20 test cassettes• 20 disposable plastic pipettes• 1 dilution buffer vial• Instructions for use• Barcode card for test batch identification and traceability when using the BIOSYNEX® Reader

CT

CT

BIOSYNEX SA22 Boulevard Sébastien Brant

67400 ILLKIRCH-GRAFFENSTADEN - FranceTel. : +33 3 88 77 57 52 - Fax : +33 3 88 78 76 78

E-mail : export@biosynex.comwww.biosynex.com FL

Y_1030

016_

EN_V

0120

1806

R02

THE SOLUTIONThe tetanus toxin of Clostridium tetani bacteria binds to the cell membranes of the peripheral nerves and inhibits the delivery of neurotransmitters. Immunization is the best way to prevent Clostridium tetani infections in children and adults. It is sometimes desirable to know the level of anti-tetanus toxoid antibodies in a subject, in order to evaluate his/her immunitary status and determine the need for complementary vaccination. TETANOTOP® test is a rapid immunochromatographic test for the detection of anti-tetanus toxoid antibodies in human serum, plasma or whole blood, to evaluate anti-tetanus immunity.

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

Test procedure (for capillary blood) **

BIOSYNEX® Reader

References

Performances * Capillary blood Venous blood Serum

Negativeif = 0.1

Positive if = 0.1

Specificity 90% 100%

Sensitivity 83% 79%

Negative if = 0.1

Positive if = 0.1

Specificity 100% 100%

Sensitivity 93% 88%

Negative if = 0.1

Positive if = 0.1

Specificity 100% 100%

Sensitivity 91% 87%* Internal study performed on capillary blood, venous blood and serum from the same patients and compared to ELISA method (see instructions for use for more information) by AllDiag.

• Ref. 1030016 - TETANOTOP® - 20 tests

• Ref. 6030001 - Control Tetanus Positive 0.5 mL (10 controls)

• Ref. 5060001 - BIOSYNEX® Reader - 1 reader

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

1 2 3Results

BIOSYNEX

opTricon Gesellschaft für optische Technologien (GERMANY)

** Simplified procedure. Refer to the instructions for use for complete procedure.

Prick the fingertip using a sterile lancet.

45°

Collect the drop of blood using the pipette provided using pressing the

head of the pipette.

Transfer the blood sample into the ‘S’ well of the cassette.

Read the results at 10 minutes, either visually or using the

Biosynex® Reader.

CT

Negative

Negative result : absence of protection in an unvaccinated subject or a subject whose vaccination is not up to date.

Positive result : level of anti-tetanus antibodies in the sample > 0.1 UI/mL.

10