The test is designed to detect Streptococcus A infection. It is used for in vitro diagnostic purposes and is performed under the supervision of a health professional.
Accuracy 97,1 %
Sensitivity 95,1 %
Specificity 97,8 %
Results in 5 minutes.
The sample is a throat swab.
The problem
The main symptoms of Strep A infection are sore throat, difficulty swallowing, fever, swollen tonsils, red spots and rashes, headache, nausea and vomiting (rare)
- Test cartridges
- Extraction tubes
- Sterile tampons
- Drip tips
- Package leaflet
- 1 extraction reagent (2M NaNO2)
- 2 Extraction reagent (0,027M citric acid)
- Positive control (non-viable streptococcus A; 0.01% Proclin300)
- Negative control (non-viable streptococcus C; 0.01% Proclin300)
- Remove the test cassette from the sealed foil bag and use it within one hour. The best
results are obtained when the test is carried out as soon as the foil bag is opened. - Hold 1 vial of extraction reagent upright and add 4 drops (approximately 240 μl) to
extraction tube. Extraction reagent 1 is red. Keep 2 extraction
hold the reagent vial upright and add 4 drops (approximately 160 μl) to the tube. 2 Extraction reagent
is colourless. Mix the solution by gently swirling the extraction tube. 2 Extraction reagent
the colour of the solution changes from red to yellow on addition of extraction reagent 1. See illustration 1. - Immediately place the swab in the extraction tube, swirl the swab vigorously 15 times, leave it
in the extraction tube for 1 minute. See illustration 2. Press the swab against the side of the tube and
Press the bottom of the tube when you pull out the smear to keep most of the liquid in the tube. Discard
smear. See illustration 3. - Place the dropper tip on top of the extraction tube. Place the test cartridge on a clean and
a smooth surface. Add three drops of solution (approximately 100 μl) to the sample well and start the timer.
Check the result after 5 minutes. After 10 minutes, do not check the results again.
APPLICABLE:* two coloured lines appear. One coloured line should appear in the control line area (C) and the other in the test line area (T). A positive result means that streptococcus A has been detected in the sample.
* NOTE: The intensity of the colour in the test line area (T) will vary depending on the concentration of Streptococcus A in the sample. Therefore, any shade in the test line area (T) should be considered a positive result.
DENIED: A single coloured line appears in the control area (C). No line is visible in the test line area (T). A negative result means that streptococcal antigen A is absent from the sample or below the detectable level of the test. A sample from the patient is required to confirm the absence of Streptococcus A infection. If clinical symptoms are not consistent with the results, take another sample for culture.
DISABILITY: the control line does not appear. The most likely reasons for the non-appearance of the reference line are insufficient sample quantity or an incorrect procedure. Revise the procedure and repeat the test with a new test.
Ingredients
- Test cartridges
- Extraction tubes
- Sterile tampons
- Drip tips
- Package leaflet
- 1 extraction reagent (2M NaNO2)
- 2 Extraction reagent (0,027M citric acid)
- Positive control (non-viable streptococcus A; 0.01% Proclin300)
- Negative control (non-viable streptococcus C; 0.01% Proclin300)
Instructions
- Remove the test cassette from the sealed foil bag and use it within one hour. The best
results are obtained when the test is carried out as soon as the foil bag is opened. - Hold 1 vial of extraction reagent upright and add 4 drops (approximately 240 μl) to
extraction tube. Extraction reagent 1 is red. Keep 2 extraction
hold the reagent vial upright and add 4 drops (approximately 160 μl) to the tube. 2 Extraction reagent
is colourless. Mix the solution by gently swirling the extraction tube. 2 Extraction reagent
the colour of the solution changes from red to yellow on addition of extraction reagent 1. See illustration 1. - Immediately place the swab in the extraction tube, swirl the swab vigorously 15 times, leave it
in the extraction tube for 1 minute. See illustration 2. Press the swab against the side of the tube and
Press the bottom of the tube when you pull out the smear to keep most of the liquid in the tube. Discard
smear. See illustration 3. - Place the dropper tip on top of the extraction tube. Place the test cartridge on a clean and
a smooth surface. Add three drops of solution (approximately 100 μl) to the sample well and start the timer.
Check the result after 5 minutes. After 10 minutes, do not check the results again.
Results
APPLICABLE:* two coloured lines appear. One coloured line should appear in the control line area (C) and the other in the test line area (T). A positive result means that streptococcus A has been detected in the sample.
* NOTE: The intensity of the colour in the test line area (T) will vary depending on the concentration of Streptococcus A in the sample. Therefore, any shade in the test line area (T) should be considered a positive result.
DENIED: A single coloured line appears in the control area (C). No line is visible in the test line area (T). A negative result means that streptococcal antigen A is absent from the sample or below the detectable level of the test. A sample from the patient is required to confirm the absence of Streptococcus A infection. If clinical symptoms are not consistent with the results, take another sample for culture.
DISABILITY: the control line does not appear. The most likely reasons for the non-appearance of the reference line are insufficient sample quantity or an incorrect procedure. Revise the procedure and repeat the test with a new test.
Informative video
Instruction leaflet
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