Strep a streptoc cassette test - rapid test for the detection of strep a 20 cassettes

Product Description

The Gima Strep A Streptoc Cassette Test is a rapid immunochromatographic test for the qualitative detection of group A streptococcus antigen in throat and tonsil specimens. It is intended for professional in vitro diagnostic use only.

Indications

Rapid test for the qualitative detection of group A streptococcus antigen in throat and tonsil specimens. For in vitro diagnostic use only in point-of-care or professional laboratory testing.

The rapid test for the detection of group A streptococcus is a rapid immunochromatographic test for the qualitative detection of group A streptococcus antigen in throat and tonsil specimens. A rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcal antigen in throat and tonsil specimens. The Rapid Strip Test for the Detection of Group A Streptococcal antigen is intended for in vitro diagnostic use only in point-of-care or professional laboratory settings and is intended to be used as an aid in the diagnosis of Group A Streptococcal infections.

The test provides preliminary results; negative results do not preclude Group A Streptococcal infection and should not be used as the sole basis for treatment or management decisions.

It is not intended for use in in vitro diagnostic laboratory settings. Suitable for self-testing.

The Rapid Group A Streptococcus Test Strip is a lateral flow immunochromatographic test for the detection of Group A Streptococcus carbohydrate antigen in a throat swab. In this test, the Group A Streptococcus carbohydrate antigen-specific antibody is coated on the test line region. During testing, the throat swab reacts with the Group A Streptococcus antibody 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 region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. For procedural control purposes, a colored line will always appear in the control region, indicating that the correct amount of specimen has been added and the membrane has been saturated.

Directions for Use and Dosage

Sample Collection and Preparation

• Collect the throat-tonsillar specimen using a sterile swab provided in the kit. Transport swabs containing Stuart or modified Amies medium can also be used with this product. Collect the swab from the posterior pharynx, tonsils, and other inflamed areas. Avoid touching the tongue, cheeks, and teeth with the swab.The test should be performed immediately after collecting the samples. If the swab is not processed immediately, it is strongly recommended that it be stored in a clean, dry plastic tube for up to 8 hours at room temperature or 72 hours at 2-8°C.
• If a culture is desired, gently rotate the swab tip on the Group A Strep Selective Blood Agar cassette (Gas) before using the swab in the Rapid Strip Test for the Detection of Group A Strep.

Directions for Use

• Allow the test, reagents, throat and tonsil swab, and/or controls to reach room temperature (15-30°C) before testing.
• Remove the test cassette from the sealed foil pouch and use it within one hour. Best results are obtained if the test is cultured. Performed immediately after opening the foil pouch.
• Insert the extraction tube into the workstation, hold the Extraction Reagent 1 bottle upright, and add 4 full drops (approximately 240 mcl) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red. Hold the Extraction Reagent 2 bottle upright and add 4 full drops (approximately 160 mcl) to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. Dispensing Extraction Reagent 2 into Extraction Reagent 1 changes the color of the solution from red to yellow.
• Immediately add the swab to the extraction tube and shake vigorously 15 times; leave the swab in the extraction tube for 1 minute.
• Press the swab against the side of the tube and, while pressing the bottom of the tube, extract the swab, so that as much liquid as possible remains in the tube. Discard the swab.
• Insert the dropper tip 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.
• Read the result after 5 minutes. Do not interpret the result after 10 minutes.

Note: It is recommended not to use Extraction Reagent 1 and Extraction Reagent 2 more than 6 months after opening the vial.

Interpretation of Results

Positive:* Two colored lines appear. One blue line should be in the control line region (C) and the other colored line should appear in the test line region (T). A positive result indicates that Group A Streptococcus has been detected in the specimen.

*Note: The intensity of the color in the test line region (T) will vary depending on the specimen. depending on the concentration of Group A Streptococcus in the specimen.

Negative: A colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Strep A antigen is not present in the specimen or is present at levels lower than those detectable by the test. In this case, the patient's specimen should be cultured to confirm the absence of Group A Streptococcus infection. If clinical symptoms do not match the results, culture a new specimen.

Invalid: The control line does not appear. Insufficient specimen quantity or incorrect technical procedure are the most likely reasons for the lack of control line appearance. Review the procedure and repeat the test using a new test. If the problem persists, discontinue use of the kit immediately and contact your local distributor.

Warnings

Please read all information in this package insert before performing the test.

• For in vitro diagnostic use only in point-of-care or professional laboratory settings. Do not use after the expiration date.
• Do not eat, drink, or smoke in the area where specimens and kits are handled.
• Treat all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for proper specimen disposal.
• When analyzing specimens, wear protective clothing, such as lab coats, disposable gloves, and eye protection.
• The used test must be disposed of according to local regulations.
• Humidity and temperature may adversely affect results.
• Do not use if the package is damaged.
• Extraction Reagent 1 contains Nano2. If the solution comes into contact with eyes or skin, rinse thoroughly with water.
• Do not interchange reagent bottle caps.
• Do not interchange external control solution bottle caps.
• Wash hands thoroughly before and after handling.
• Any serious incident related 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

• 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 strep antigen in throat and tonsil specimens. This qualitative test cannot determine either the quantitative value or the rate of increase in group A strep antigen concentration.
• This test will only indicate the presence of group A strep antigen in the specimen from both viable and nonviable group A strep bacteria.
• A negative result should be confirmed by culture. A negative result may be obtained if the concentration of Group A Streptococcal antigen in the throat-tonsillar specimen is insufficient or below the detectable value of the test.
• Excess blood or mucus on the swab can interfere with the performance of the test and may result in false-positive results. Avoid touching the tongue, cheeks, teeth, and any bleeding areas of the mouth with the swab during specimen collection.
• As with all diagnostic tests, results should be interpreted by the 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 in the sealed 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 removing it from the foil pouch.

Format

Materials Provided:

• Test Cassettes - 20;
• Extraction Reagent 2-1;
• Extraction Tubes - 20;
• Workstation - 1;
• Instruction Sheet - 1;
• Negative Control - 1;
• Dropper Tips - 20;
• Extraction Reagent 1-1;
• Positive Control - 1;
• Sterile Swabs - 20.