Description
Wondfo
Strep A
One Step Strep A Swab Test
Description
An immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens, to aid in the early diagnosis of Group A Streptococcal infection.
When you add sample to the sample well, capillary action causes the sample to migrate across the membrane.
When Group A Strep antigen levels in specimens are at or above the cut-off, a visible colored line appears in the test region indicating a positive result. The absence of such a colored line in the test region suggests a negative result.
If the test was performed correctly a colored line will appear in the control region as a procedural control.
How to use
Sample collection and preparation
Collect the sample with the sterile throat swab provided in the kit. Hold down your tongue with a tongue depressor. Swab the back of your throat, tonsils, and other inflamed areas. Avoid touching your tongue, cheeks, and teeth with the swab.
The test should ideally be performed immediately after sample collection.
Running the test
Bring the device and extraction reagents to room temperature (10-30 °C) before performing the test.
Add 4 drops of Extraction Reagent A and 4 drops of Reagent B to the respective extraction tube and mix thoroughly. Place the sample extraction swab into the tube. Swirl the swab in the solution ten times. Leave the swab in the tube for one minute. Then remove the swab while squeezing the swab head against the walls of the tube to extract as much liquid from the swab as possible. Discard the swab. Close the tube and mix the contents by gently swirling the tube.
Remove the test from the sealed foil pouch and place the test on a clean, flat, dry surface. Add 3 drops of mixed sample to the sample well of the test cassette.
Wait 10 minutes and read the results. Do not read the results after 15 minutes.
Interpretation of results
POSITIVE: Two colored lines appear, one in the test region (T) and one in the control region (C). You may have a Group A Streptococcus infection; please consult your doctor.
NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T). The concentration of Group A Streptococcus antigen is at or below the detection limit of the test.
INVALID: No colored line appears or only one colored line appears in the test region (T) and no colored line appears in the control region (C). Failure to display the control line (C) indicates that an error occurred during the testing procedure or deterioration of the test reagent. Repeat the test with a new kit. If the test still gives an invalid result, contact your local distributor.
Warnings
For in vitro self-diagnostic use only.
Do not ingest.
Do not interchange caps between reagents.
Do not use the test beyond the expiration date.
Keep out of reach of children.
Do not use the test if the package is punctured or not properly sealed.
The test is single use: discard after use.
Avoid contact of reagents A and B with eyes, sensitive mucous membranes, membranes, cuts, abrasions, etc. If reagents come into contact with skin or eyes, rinse thoroughly with water.
Do not eat, drink or smoke in the area where specimens are handled and the test is performed.
Wear protective gloves when handling the sample. Wash your hands thoroughly after the procedure.
The device used, the swab and the extraction tube must be treated as contagious waste and therefore thrown into the containers for biohazard waste.
Conservation
Store at 4-30°C. Keep away from sunlight, moisture and heat. Do not freeze.
Format
The kit contains:
- 2 sealed sachets (each containing a test device and a desiccant sachet);
- 2 extraction tubes;
- 2 sterile throat swabs;
- extraction reagents A and B;
- package leaflet.
Cod. W39-CH
An immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens, to aid in the early diagnosis of Group A Streptococcal infection.
When you add sample to the sample well, capillary action causes the sample to migrate across the membrane.
When Group A Strep antigen levels in specimens are at or above the cut-off, a visible colored line appears in the test region indicating a positive result. The absence of such a colored line in the test region suggests a negative result.
If the test was performed correctly a colored line will appear in the control region as a procedural control.
How to use
Sample collection and preparation
Collect the sample with the sterile throat swab provided in the kit. Hold down your tongue with a tongue depressor. Swab the back of your throat, tonsils, and other inflamed areas. Avoid touching your tongue, cheeks, and teeth with the swab.
The test should ideally be performed immediately after sample collection.
Running the test
Bring the device and extraction reagents to room temperature (10-30 °C) before performing the test.
Add 4 drops of Extraction Reagent A and 4 drops of Reagent B to the respective extraction tube and mix thoroughly. Place the sample extraction swab into the tube. Swirl the swab in the solution ten times. Leave the swab in the tube for one minute. Then remove the swab while squeezing the swab head against the walls of the tube to extract as much liquid from the swab as possible. Discard the swab. Close the tube and mix the contents by gently swirling the tube.
Remove the test from the sealed foil pouch and place the test on a clean, flat, dry surface. Add 3 drops of mixed sample to the sample well of the test cassette.
Wait 10 minutes and read the results. Do not read the results after 15 minutes.
Interpretation of results
POSITIVE: Two colored lines appear, one in the test region (T) and one in the control region (C). You may have a Group A Streptococcus infection; please consult your doctor.
NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T). The concentration of Group A Streptococcus antigen is at or below the detection limit of the test.
INVALID: No colored line appears or only one colored line appears in the test region (T) and no colored line appears in the control region (C). Failure to display the control line (C) indicates that an error occurred during the testing procedure or deterioration of the test reagent. Repeat the test with a new kit. If the test still gives an invalid result, contact your local distributor.
Warnings
For in vitro self-diagnostic use only.
Do not ingest.
Do not interchange caps between reagents.
Do not use the test beyond the expiration date.
Keep out of reach of children.
Do not use the test if the package is punctured or not properly sealed.
The test is single use: discard after use.
Avoid contact of reagents A and B with eyes, sensitive mucous membranes, membranes, cuts, abrasions, etc. If reagents come into contact with skin or eyes, rinse thoroughly with water.
Do not eat, drink or smoke in the area where specimens are handled and the test is performed.
Wear protective gloves when handling the sample. Wash your hands thoroughly after the procedure.
The device used, the swab and the extraction tube must be treated as contagious waste and therefore thrown into the containers for biohazard waste.
Conservation
Store at 4-30°C. Keep away from sunlight, moisture and heat. Do not freeze.
Format
The kit contains:
- 2 sealed sachets (each containing a test device and a desiccant sachet);
- 2 extraction tubes;
- 2 sterile throat swabs;
- extraction reagents A and B;
- package leaflet.
Cod. W39-CH
