SoFarma
STREP A TEST
Description
Specific immunological test for detecting group A streptococcus bacteria in throat infections. It helps you find out quickly whether a sore throat is caused by streptococcus A or by other germs (usually viruses) that do not require antibiotic treatment.
Directions for use
Place the contents of the box on a clean, dry, flat surface (e.g. a table).
Wash your hands thoroughly. Use soap and warm water.
Place the extraction tube in a hole of the workstation.
Sample collection
Collect a sample from the throat using the swab and tongue depressor provided. Open the pack containing the tongue depressor and place it nearby. Open the pack containing the swab and remove it by holding the plastic handle.
Avoid touching the absorbent cotton tip of the swab with your hands.
Stand in front of a mirror, tilt your head back and open your mouth as wide as possible. Using the tongue depressor in one hand, press down the tongue and with the other hand brush the soft cotton tip over the back of the throat, around the tonsils and over any red, sore areas (uvula, soft palate) to collect the sample.
Of course, you can ask someone to help you collect the sample.
Performing the test procedure
After collecting the throat sample, insert the absorbent cotton tip of the swab into the extraction tube placed on the workstation.
First open the blue-capped dropper bottle (unscrew only the blue cap and leave the white cap tightly closed) containing extraction solution 1, dispense 6 drops into the tube and close the bottle. Then open the green-capped dropper bottle (unscrew only the green cap and leave the white cap tightly closed) containing extraction solution 2, dispense 6 drops into the tube and close the bottle.
Hold the swab by the plastic handle and rotate it thoroughly against the wall of the tube (about 10 times) to mix the solution. Leave the swab inside the tube to incubate for a minimum of 2 minutes and a maximum of 5 minutes. At the end of the incubation time, remove the tube (with the swab and liquid extracts still inside) and, using your thumb and index finger, squeeze the walls of the tube to wring out the cotton tip of the swab so as to collect as much liquid as possible (while removing the swab from the tube). Dispose of the swab in a suitable waste container and place the tube with the extracted solution in a hole of the workstation.
Open the protective aluminium pouch, hold the strip by the blue end and insert it into the tube containing the extracts. Leave it inside the tube for 5 minutes (minimum) to 10 minutes (maximum) for the reaction to take place.
Read the result immediately after the reaction time has elapsed.
Interpreting the results
POSITIVE: two (2) red/purple lines appear on the strip. The colour intensity of the lines may differ. This result is positive and means that streptococcus A has been found in the sample and that you should consult a doctor.
NEGATIVE: only one (1) red line (control line) appears near the blue end of the strip. This result is negative and means that streptococcus A was not found in the sample or was not present in a sufficient concentration to be detected.
INVALID: if there is no visible red line near the blue end of the strip (control line), the test is invalid and must be repeated using a new test and a new sample.
Warnings
This test is intended for in vitro diagnostic use.
For external use only. Do not swallow.
Read the instructions carefully before performing the test. The test can only be interpreted if the instructions are followed scrupulously. Strictly follow the indicated reaction time, swab sample collection and extraction steps.
Do not use after the expiry date printed on the label and protective pouch or if the pouch is damaged.
Do not reuse the STREP A TEST.
Keep out of the reach of children.
After use, all components can be disposed of in a household waste bin.
Not suitable for children under 2 years of age.
If the liquids come into contact with the eyes, skin or other mucous membranes, rinse immediately with plenty of water and contact a doctor.
Do not swallow the liquid extract or other parts of the kit. If swallowed, consult a doctor immediately and take the remaining parts of the kit with you together with the instructions for use and packaging.
Storage
Store between 4 °C and 30 °C. Do not freeze.
Size
- 1 sealed aluminium pouch containing: 1 test strip and 1 desiccant sachet.
- 1 sterile swab.
- 1 sterile wooden tongue depressor.
- 1 dropper bottle of extraction solution 1 (blue cap): 1 ml.
- 1 dropper bottle of extraction solution 2 (green cap): 1 ml.
- 1 empty extraction tube.
- 1 workstation.
- 1 instruction leaflet.
Code SF013
