Description
The Strep A rapid test is a rapid immunochromatographic test for the qualitative detection of Strep A antigens in pharyngeal swab samples to aid in the diagnosis of Group A Streptococcus infections.
Early diagnosis and treatment of Group A streptococcal pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis. Therefore, it would be useful to have a test at hand at home to be able to make a diagnosis at the onset of the first symptoms.
When the sample is added to the appropriate well, capillary action causes the sample to migrate through the membrane. When the levels of Group A streptococcal antigen in the samples are equal to or greater than the cut-off, a visible colored line appears in the test zone, indicating a positive result. The absence of such a colored line in the Test (T) zone suggests a negative result.
If the test has been performed correctly, a colored line will appear in the control (C) zone as a procedural control.

Instructions for use
Sample collection and preparation
1. Collect the sample with the sterile pharyngeal swab provided in the kit.
2. Hold the tongue down with a tongue depressor. Swab the back of the pharynx, tonsils, and other inflamed areas. Avoid touching the tongue, cheeks, and teeth with the swab.
3. The test should ideally be performed immediately after sample collection.

Procedure
Bring the device and extraction reagents to room temperature (10 °C-30 °C) before performing the test.
1. Add 4 drops of extraction reagent A and 4 drops of reagent B into the respective extraction tube and mix completely.
2. Place the sample extraction swab into the tube.
Shake the swab ten times. Leave the swab in the tube for one minute. Then remove the swab while pressing the swab head against the inside of the tube as you remove it to eliminate as much liquid as possible from the swab. Discard the swab.
3. Cap the tube and mix the contents by gently shaking.
The sample must be tested immediately.
4. Remove the test from the sealed aluminum pouch by tearing at the notch and place the test on a clean, dry, flat surface. Add 3 drops of mixed liquid sample from the tube to the sample well (depicting an arrow) of the test cassette by inverting and squeezing the tube.
5. Wait 10 minutes and read the results. Do not read the results after 15 minutes.

Reading the results
Positive
If two colored lines are visible in both the test (T) zone and the control (C) area, the result is positive. It indicates that you may be in a Strep A infection phase and you should consult your doctor.
Negative
If only one colored line appears in the control (C) zone and no colored line appears in the test (T) band, the result is negative. It indicates that the concentration of Group A streptococcal antigen is equal to or below the detection limit of the test.
Invalid
No visible line or only one visible line in the test zone but not in the control zone. This is an indication of procedural error and/or that deterioration of the test reagent has occurred. Repeat the test with a new kit. If the test is still invalid, please contact the distributor or the store where you purchased the product, providing the lot number.

Precautions
1. This kit is for in vitro self-diagnostic use only. Do not swallow.
2. Do not swap caps between reagents.
3. Do not use the test beyond the expiration date.
4. Keep out of reach of children.
5. Do not use the test if the pouch is perforated or not well sealed.
6. Discard after use. The test is single-use.
7. Avoid contact of reagents A and B with eyes, sensitive mucous membranes, membranes, cuts, abrasions, etc. If these reagents come into contact with skin or eyes, rinse thoroughly with water.
8. Do not eat, drink or smoke in the area where samples are located and where the test will be performed.
9. Protective gloves should be worn when handling the sample. Wash hands thoroughly after the procedure.
10. The used device, swab, and extraction tube should be treated as infectious waste and therefore discarded in biohazard containers.

Limitations
1. The results of this test should not be used to determine pharyngitis infections, as pharyngitis can be caused by organisms other than Group A streptococcus. This test provides no information on pharyngitis other than that caused by Group A streptococcal infection.
2. A negative result may occur due to an insufficient amount of sample collected, or insufficient addition of reagents A and B. If symptoms persist or worsen, always consult your doctor.
3. Excess blood or mucus in the collected sample could interfere with test performance and could lead to a false positive result. Do not touch the tongue, cheeks, teeth, or any bleeding areas of the mouth with the swab during the sample collection phase.
4. As with any diagnostic procedure, a diagnosis should be confirmed exclusively by a doctor after evaluating all clinical and laboratory results.
5. Since the test kit contains a toxic composition and the highest morbidity rate from upper respiratory tract infections has been found in children, the test should be performed by parents or another adult family member on all minors under 16 years of age.

Storage
Store between 4 °C and 30 °C in the sealed packaging until the expiration date. Keep away from sunlight, humidity and heat. Do not freeze. Preferably open the pouch just before performing the test.

Format
Pack containing:
2 individually sealed pouches, each containing:
- test device;
- desiccant sachet.
The desiccant is for storage purposes only, it is not used during the test procedure.
2 extraction tubes.
2 sterile pharyngeal swabs. The swab is used to collect the sample.
Extraction reagents A and B (attention: reagent B is toxic if ingested).
Package insert with instructions for use.

Code 971664533