Descrizione Clinica
IT'S CALLED A STRAP
Description
Specific immunological test for detection of group A streptococcus bacteria in throat infections. It helps to quickly know if throat pain is caused by a streptococcus A or other germs (usually virus) that do not require antibiotic treatment.
Mode of use
Relief and preparation of samples
Place the contents of the box on a clean, dry and flat surface.
Wash your hands thoroughly. Use soap and warm water.
Place the extraction tube in a work station hole.
Collect a sample from the throat using the swab and lower tongue provided. Open the box containing the lower tongue and place it close. Open the box containing the pad and extract it by seizing the plastic handle. Avoid touching with your hands the absorbent cotton tip of the tampon.
Put in front of a mirror, tilt your head backwards and open your mouth as much as possible. Using the lower tongue with one hand, press the tongue and with the other hand rub the head of the tampon on the back of the throat, around the tonsils and on any reddish dolent areas (ugola, soft palate) to collect the sample.
You can ask another person for help in collecting the sample.
Test procedure
After picking up the sample, insert the tampon absorbent tip into the extraction tube on the work station.
First open the dropper bottle with blue cap (unscrew only the blue cap and leave the white cap well closed) containing the extraction solution 1, dispense 6 drops in the tube and close the bottle. Keep the pad for the plastic handle and rotate it carefully against the wall of the tube (about 10 times) to mix the solution. Leave the swab inside the incubation test for a minimum of 2 minutes to a maximum of 5 minutes.
At the end of incubation time, remove the test tube from the work station (with the swab and liquid extracts still inside the test tube) and, using the thumb and index press the walls of the test tube to squeeze the cotton tip of the tampon so as to collect as much liquid as possible (procede in this way by removing the swab from the test tube).
Dispose the buffer into a special waste container and place the pipe with the extracted solution in a work station hole.
Open the aluminum protective envelope, hold the test strip for the blue end and insert it into the tube containing the extracted solution. Leave the test strip inside the test tube from 5 minutes (minimum) to 10 minutes (maximum) so that the reaction takes place. Read the result immediately after the reaction time has passed.
Interpretation of results
POSITIVE: Two (2) red/violet lines appear on the test strip. The color intensity of the lines could be different. This result is positive and means that streptococcus A was found in the sample. Consult a doctor.
NEGATIVE: Only a red line (control line) appears near the blue end of the test strip. This result is negative and means that streptococcus A was not found in the sample or was not sufficiently concentrated to be detected.
NOT VALIDO: there is no visible red line near the blue end of the test strip (control line). The test is not valid and must be repeated using a new test strip and a new sample.
Warnings
This test is intended for in vitro diagnostic use.
Only for external use. Don't swallow.
Read the instructions carefully before running the test. The test is interpretable only if the instructions are scrupulously respected. Strictly follow the indicated reaction time, buffer sample collection methodology and extraction phases.
Do not use after the printed expiration date on the label and the protective envelope or if the envelope is damaged.
Do not reuse the test.
Keep out of reach of children.
After use, all used components can be thrown into a garbage can.
Not suitable for children under 2 years of age.
If liquids come into contact with eyes, skin or other mucous membranes, rinse immediately and abundantly with water and contact a doctor.
Do not ingest liquid extract and other parts of the box. In case of ingestion, consult a doctor immediately and bring the remaining parts of the box along with instructions for use and packaging.
Conservation
Store between 4 °C and 30 °C. Don't freeze.
Format
The kit contains:
- 1 test strip;
- 1 sterile swab;
- 1 sterile lower tongue in wood;
- 1 dropper bottle of extraction solution 1 (blue cap): 1 ml;
- 1 dropper bottle of extraction solution 1 (green cap): 1 ml;
- 1 vacuum extraction tube;
- 1 workplace;
- leaflet.
Cod. 6037/EN2
Specific immunological test for detection of group A streptococcus bacteria in throat infections. It helps to quickly know if throat pain is caused by a streptococcus A or other germs (usually virus) that do not require antibiotic treatment.
Mode of use
Relief and preparation of samples
Place the contents of the box on a clean, dry and flat surface.
Wash your hands thoroughly. Use soap and warm water.
Place the extraction tube in a work station hole.
Collect a sample from the throat using the swab and lower tongue provided. Open the box containing the lower tongue and place it close. Open the box containing the pad and extract it by seizing the plastic handle. Avoid touching with your hands the absorbent cotton tip of the tampon.
Put in front of a mirror, tilt your head backwards and open your mouth as much as possible. Using the lower tongue with one hand, press the tongue and with the other hand rub the head of the tampon on the back of the throat, around the tonsils and on any reddish dolent areas (ugola, soft palate) to collect the sample.
You can ask another person for help in collecting the sample.
Test procedure
After picking up the sample, insert the tampon absorbent tip into the extraction tube on the work station.
First open the dropper bottle with blue cap (unscrew only the blue cap and leave the white cap well closed) containing the extraction solution 1, dispense 6 drops in the tube and close the bottle. Keep the pad for the plastic handle and rotate it carefully against the wall of the tube (about 10 times) to mix the solution. Leave the swab inside the incubation test for a minimum of 2 minutes to a maximum of 5 minutes.
At the end of incubation time, remove the test tube from the work station (with the swab and liquid extracts still inside the test tube) and, using the thumb and index press the walls of the test tube to squeeze the cotton tip of the tampon so as to collect as much liquid as possible (procede in this way by removing the swab from the test tube).
Dispose the buffer into a special waste container and place the pipe with the extracted solution in a work station hole.
Open the aluminum protective envelope, hold the test strip for the blue end and insert it into the tube containing the extracted solution. Leave the test strip inside the test tube from 5 minutes (minimum) to 10 minutes (maximum) so that the reaction takes place. Read the result immediately after the reaction time has passed.
Interpretation of results
POSITIVE: Two (2) red/violet lines appear on the test strip. The color intensity of the lines could be different. This result is positive and means that streptococcus A was found in the sample. Consult a doctor.
NEGATIVE: Only a red line (control line) appears near the blue end of the test strip. This result is negative and means that streptococcus A was not found in the sample or was not sufficiently concentrated to be detected.
NOT VALIDO: there is no visible red line near the blue end of the test strip (control line). The test is not valid and must be repeated using a new test strip and a new sample.
Warnings
This test is intended for in vitro diagnostic use.
Only for external use. Don't swallow.
Read the instructions carefully before running the test. The test is interpretable only if the instructions are scrupulously respected. Strictly follow the indicated reaction time, buffer sample collection methodology and extraction phases.
Do not use after the printed expiration date on the label and the protective envelope or if the envelope is damaged.
Do not reuse the test.
Keep out of reach of children.
After use, all used components can be thrown into a garbage can.
Not suitable for children under 2 years of age.
If liquids come into contact with eyes, skin or other mucous membranes, rinse immediately and abundantly with water and contact a doctor.
Do not ingest liquid extract and other parts of the box. In case of ingestion, consult a doctor immediately and bring the remaining parts of the box along with instructions for use and packaging.
Conservation
Store between 4 °C and 30 °C. Don't freeze.
Format
The kit contains:
- 1 test strip;
- 1 sterile swab;
- 1 sterile lower tongue in wood;
- 1 dropper bottle of extraction solution 1 (blue cap): 1 ml;
- 1 dropper bottle of extraction solution 1 (green cap): 1 ml;
- 1 vacuum extraction tube;
- 1 workplace;
- leaflet.
Cod. 6037/EN2
