Strep A Test for the Detection of Streptococcus 20 Pieces Gima

Description
Rapid test for the qualitative detection of the Group A streptococcus antigen in pharyngeal-tonsillar samples. For in vitro diagnostic use only in decentralized or professional laboratory analysis.
The rapid test for the detection of Group A streptococcus is a rapid chromatographic immunoassay for the qualitative detection of the Group A streptococcus antigen in pharyngeal-tonsillar samples. The rapid test strip for the detection of Group A streptococcus is intended solely for in vitro diagnostic use in decentralized or professional laboratory analysis and should be used as an aid in the diagnosis of Group A streptococcus infections.
The test provides preliminary results; negative results do not rule out Group A streptococcus infection and cannot be used as the sole basis for treatment or management decisions.
Not suitable for self-testing.
The rapid test strip for the detection of Group A streptococcus is a lateral flow immunochromatographic test for the detection of the carbohydrate antigen of Group A streptococcus in a pharyngeal-tonsillar sample. In this analysis, the specific antibody for the carbohydrate antigen of Group A streptococcus is coated on the test line area. During the test, the pharyngeal-tonsillar sample reacts with the Group A streptococcus antibody that is coated on particles. The mixture migrates to the membrane to react with the Group A streptococcus antibody on the membrane and create a colored line in the test line area. The presence of this colored line in the test line area indicates a positive result, while its absence indicates a negative result. For procedural control purposes, a colored line will always appear in the control area, indicating that a correct amount of sample has been added and that the membrane has been soaked.

Instructions for Use
Sample Collection and Preparation
1. Collect the pharyngeal-tonsillar sample with a sterile swab provided in the kit. This product can also use transport swabs containing Stuart or modified Amies medium. Collect the swab from the posterior pharynx, tonsils, and other inflamed areas. Avoid touching the tongue, cheeks, and teeth with the swab.
2. The test should be performed immediately after collecting the samples. If the swab is not processed immediately, it is strongly recommended to store it in a clean, dry plastic tube for a maximum of 8 hours at room temperature or 72 hours at 2-8 °C.
3. If a culture is desired, gently rotate the tip of the swab on the selective blood agar plate for group A streptococcus (GAS) before using the swab in the rapid test strip for the detection of group A streptococcus.
Instructions for use
Allow the test, reagents, throat-tonsil swab, and/or controls to reach room temperature (15-30 °C) before testing.
1. Remove the test cassette from the sealed aluminum pouch and use it within one hour. The best results are obtained if the test is performed immediately after opening the pouch film.
2. Insert the extraction tube into the workstation, hold the bottle of Extraction Reagent 1 vertically and add 4 full drops (approximately 240 mcL) of extraction reagent 1 to an extraction tube. Extraction reagent 1 is red. Hold the bottle of extraction reagent 2 vertically and add 4 full drops (approximately 160 mcL) to the tube. Extraction reagent 2 is colorless. Mix the solution by gently shaking the extraction tube. Dispensing extraction reagent 2 into extraction reagent 1 changes the color of the solution from red to yellow.
3. Immediately add the swab to the extraction tube and shake vigorously for 15 times; leave the swab in the extraction tube for 1 minute.
4. Press the swab against the side of the tube and, pressing the bottom of the tube, withdraw the swab, so that as much liquid as possible remains in the tube. Discard the swab.
5. Insert the tip of the dropper into the top of the extraction tube. Place the test cassette on a clean, flat surface. Add 3 drops of solution (approximately 100 mcL) to the sample well(s) and start the timer.
6. Read the result at 5 minutes. Do not interpret the result after 10 minutes.
Note: It is recommended not to use extraction reagent 1 and extraction reagent 2 beyond 6 months from the opening of the vial.

Interpretation of results
POSITIVE:* two colored lines appear. A blue line must be located in the control line area (C) and the other colored line must appear in the test line area (T). A positive result indicates that group A streptococcus has been detected in the sample.
*NOTE: the intensity of the color in the test line area (T) will vary depending on the concentration of group A streptococcus present in the sample.
NEGATIVE: a colored line appears in the control line area (C). No line appears in the test line area (T). A negative result indicates that group A streptococcus antigen is not present in the sample, or is present at levels below those detectable by the test. In this case, the patient's sample should be cultured to confirm the absence of group A streptococcus infection. If clinical symptoms do not match the results, perform a culture on a new sample.
NULL: the control line does not appear. Insufficient sample quantity or incorrect technical procedure are the most plausible reasons for the absence of the control line. Review the procedure and repeat the analysis using a new test. If the problem persists, immediately discontinue use of the kit and contact your local distributor.

Warnings
Before performing the test, please read all the information contained in this leaflet.
For in vitro diagnostic use only in decentralized or professional laboratory analysis. Do not use after the expiration date.
Do not eat, drink, or smoke in the area where samples and kits are handled.
Treat all samples as if they contain infectious agents. Follow established precautions against microbiological hazards throughout the procedure and adhere to standard procedures for the proper disposal of samples.
During sample analysis, wear protective clothing, such as lab coats, disposable gloves, and eye protection.
The test used must be disposed of according to local regulations.
Humidity and temperature can negatively affect the results.
Do not use if the packaging is damaged.
The extraction reagent 1 contains NaNO2. If the solution comes into contact with eyes or skin, rinse thoroughly with water.
Do not exchange the caps of the reagent bottles.
Do not swap the caps of the external control solution bottles.
Wash hands thoroughly before and after handling.
Any serious incident that occurs in relation to the device must be reported to the manufacturer and the competent authority.
The kit components are approved for use in the rapid strip test for the detection of group A streptococcus. Do not use other commercial kit components.

Restrictions
1. The rapid strip test for the detection of group A streptococcus is for in vitro diagnostic use only. The test should be used only to detect group A streptococcal antigen in pharyngeal-tonsillar samples. This qualitative test cannot determine either the quantitative value or the rate of increase of group A streptococcal antigen concentration.
2. This test will only indicate the presence of group A streptococcal antigen in the sample from both viable and non-viable group A streptococci.
3. A negative result should be confirmed by culture examination. A negative result may occur if the concentration of group A streptococcal antigen present in the pharyngeal-tonsillar sample is insufficient or below the detectable value of the test.
4. Excess blood or mucus on the swab may interfere with test performance and may yield false positive results. Avoid touching the tongue, cheeks, teeth, and any bleeding area of the mouth with the swab during sample collection.
5. As with all diagnostic tests, results should be interpreted by a physician, taking into account other available clinical data.

Storage
The kit can be stored at room temperature or in the refrigerator (2-30 °C). The test is stable until the expiration date printed on the pouch label. The test must remain sealed in the pouch until use. Do not freeze. Do not use after the expiration date.
Note: It is recommended to use the test cassette within one hour of removal from the aluminum pouch.

Format
Supplied materials:
- test cassette - 20;
- extraction reagent 2-1;
- extraction tubes - 20;
- workstation - 1;
- instruction leaflet - 1;
- negative control - 1;
- tips for droppers - 20;
- extraction reagent 1-1;
- positive control - 1;
- sterile swabs - 20.

Code: 24520