STREPTOCOCCUS
TEST
Description
Rapid test for the detection of Group A Streptococcus in throat infections.
Directions for use
Sample collection
Use only the reagents and sterile swabs supplied in the kit.
Collect the sample with the sterile throat swab supplied in the kit. Wipe the swab over the posterior pharynx, tonsils and other inflamed areas.
Avoid touching the tongue, cheeks and teeth with the swab.
The test should preferably be performed immediately after sample collection. Samples can be stored in a clean, dry plastic tube at room temperature for up to 8 hours or at 2-8°C for up to 72 hours. Swabs containing modified Stuart or Amies transport medium can also be used with this product.
If a culture is desired, gently roll the swab tip onto a Group A selective (GAS) blood agar plate before using the swab with the Strep A rapid test card (throat swab).
Test procedure
Bring the card, reagents, throat swab and/or controls to room temperature (15-30°C) before testing.
Remove the card from the sealed pouch and use it immediately.
Holding the Reagent 1 bottle upright, add 4 drops (approx. 240 mcl) to a sample extraction tube. Reagent 1 is red. Holding the Reagent 2 bottle upright, add 4 drops (approx. 160 mcl) to the tube. Reagent 2 is colourless. Mix the solution by gently swirling the tube. Adding Reagent 2 to Reagent 1 changes the colour of the solution from red to yellow.
Immediately place the throat swab into the yellow solution in the tube. Swirl the swab in the tube 15 times. Leave the swab in the tube for 1 minute. Then press the swab against the inside of the tube and squeeze the bottom of the tube while removing the swab. Discard the swab.
Fit the dropper tip onto the top of the tube. Place the card on a clean, flat surface. Add 3 drops of solution (100 mcl) to the sample well (S) and start the timer.
Wait for the red band(s) to appear.
Read the result after 5 minutes. Do not interpret the result after 10 minutes.
Interpretation of results
Positive: two distinct red bands appear, one in the control zone (C) and the other in the test zone (T). A positive result indicates that Streptococcus A has been detected in the sample.
Negative: one red band appears in the control zone (C). No red or pink band is visible in the test zone (T). A negative result indicates that Streptococcus A antigen is not present in the sample or is present below the detection threshold of the test. The patient's sample should be cultured to confirm the absence of Streptococcus A infection. If clinical symptoms are not consistent with the results, collect another sample for culture.
Invalid: no band appears. The most likely reasons for the control band not appearing are insufficient sample volume or incorrect procedure. Review the procedure and repeat the test with a new card. If the problem persists, stop using the kit and contact your local distributor.
Warnings
If swallowed: if you feel unwell, call a poison centre or doctor.
In case of contact with the eyes: rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If irritation persists, consult a doctor.
Do not freeze. Do not use after the expiry date.
For professional in vitro diagnostic use only.
Do not eat, drink or smoke in the area where samples and kits are handled.
Handle all samples as potentially infectious. Observe appropriate precautions against microbiological hazards at all stages of testing and follow standard procedures for the correct disposal of samples.
Wear protective clothing when testing samples: lab coat, disposable gloves and eye protection.
Humidity and temperature may adversely affect results.
Do not use the test if the pouch is damaged.
Reagent 2 contains an acidic solution. If the solution comes into contact with the skin or eyes, rinse with plenty of water.
The positive and negative controls contain Proclin300 as a preservative.
Do not interchange the caps of the reagent bottles.
Do not interchange the caps of the external control solution bottles.
The Strep A rapid test card (throat swab) is for in vitro diagnostic use only. The test should be used for the detection of Streptococcus A antigen on throat swabs only. It cannot determine either the quantitative value or the rate of increase of Streptococcus A antigen.
This test only indicates the presence of Streptococcus A antigen in the sample due to Group A Streptococcus bacteria, whether viable or non-viable.
A negative result must be confirmed by culture. A negative result may be due to a concentration of Streptococcus A antigen in the throat swab that is inadequate or below the detectable level of the test.
The sterile swabs supplied with this test must be used for sample collection. No other swabs have been validated for this test.
An excessive amount of blood or mucus on the swab may interfere with the test results and cause a false positive result. Avoid contact of the swab with the tongue, cheeks and teeth and with any areas of the mouth with open wounds when collecting samples.
As with all diagnostic tests, results must be interpreted in the light of the patient's overall clinical picture.
Storage
Store at room temperature or in the fridge (2-30°C).
Shelf life in unopened packaging: 16 months.
Pack size
Kit contents:
- Strep A reagent 1 (sodium nitrite 2 M)*;
- Strep A reagent 2 (citric acid 0.027 M);
- card;
- sterile swabs;
- instructions;
- dropper dispenser;
- sample extraction tubes;
- tube/reagent holder;
- Strep A positive control (non-viable Strep A, Proclin 300 0.01%);
- Strep A negative control (non-viable Strep C, Proclin 300 0.01%).
*Keep out of the reach of children. Wear gloves and eye and face protection.
Code 70773
