Self-test for the detection of the level of antibodies (class G Immunoglobulins – IgG) against tetanus in whole blood samples
Tetanus is an acute infectious disease of bacterial origin characterized by spasms of the voluntary muscles. Clostridium tetani is the bacterium responsible for this pathology.
The bacillus is often present in the form of a spore in the soil and can penetrate the human body through contaminated scratches and wounds (e.g., with rusty iron objects, handling of soil, hay, animal waste and during gardening activities). Once inside the body, the bacterium turns into its vegetative form which produces an extremely powerful neurotoxin that causes widespread spasms and contractions. Without an adequate treatment, the disease can be lethal in 30-50% of cases. Vaccination is the only way to prevent this disease, with an efficacy of over 95%. The duration of protection over time is approximately 10 years and it is further guaranteed by the administration of periodic boosters.
WHO IS THIS TEST FOR?
TETANUS TEST is useful for anyone who wants to check their antibody protection against the infection.
It is important not to use this device in emergency situations or if an ongoing infection is suspected, in such cases seek immediate medical attention.
TETANUS TEST is an immunochromatographic device that detects the presence of specific IgG anti-tetanus antibodies in whole blood. A positive result indicates that the antibody concentration is close to the cut-off of 0.1 IU/mL.
1 test cassette
1 vial with dropper containing the diluent
2 sterile lancets
1 pipette for blood sampling
1 cleanser gauze
instructions for use
Draw a blood sample by using the sterile lancet provided;
Collect the sample indicated with the black line by using the capillary pipette provided;
Deposit the collected specimen into the sample well (S) indicated on the test cassette;
Add 2 drops of the diluent and wait 5 minutes before reading the result.
no antitoxin antibodies have been detected in the sample or their concentration is below the cut-off. This may suggest a non-coverage against tetanus infection. Check for a further vaccination recall with your doctor.
antitoxin antibodies have been detected in the sample, indicating proper protection against tetanus. Low-positive results may, however, indicate the need for a booster.
1. Tetanus vaccines: WHO position paper – February 2017.
2. Bae C, Bourget D.: “Tetanus.” StatPearls Publishing; 2018 Jan.
3. WHO Immunological Basis for Immunization Series Module 3: Tetanus
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" secrion of the instructions for use.
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
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