Strep A Rapid Test, Group A Streptococcal infection, Infectious Disease Test Kit
A rapid test for the qualitative detection of Strep A antigens in throat swab specimens. For professional in vitro diagnostic use only.
The Strep A Rapid Test Dipstick is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigens that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.
Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.
The Strep A Rapid Test Dipstick is a rapid test to qualitatively detect the presence of Strep A antigens in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigens in a throat swab specimen.
The Strep A Rapid Test Dipstick a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region.
The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The test contains Strep A antibody coated particles and Strep A antibodies coated on the membrane.
1. For professional in vitro diagnostic use only. Do not use after the expiration date.
2. Do not eat, drink or smoke in the area where the specimens and kits are handled.
3. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
5. The used test should be discarded according to local regulations.
6. Humidity and temperature can adversely affect results.
7. Do not use test if pouch is damaged.
8. Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes of water.
9. The positive and negative controls contain sodiumazide (Proclin300) as a preservative.
10. Do not interchange reagent bottle caps.
11. Do not interchange external control solution bottle caps
DIRECTIONS FOR USE
Allow the test, reagents, throat swab specimen, and/or controls to reach room temperature (15-30℃) prior to testing.
1. Remove the test dipstick from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240μL) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in color. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160μL) to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the color of the solution from red to yellow.
See illustration 1.
3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, Leave the swab in the extraction test tube for 1 minute. See illustration 2
4. Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab. See illustration 3.
5. With arrows pointing down, place the dipstick into the tube of solution and then start the timer. If the procedure is followed correctly, the liquid should be at or just below the maximum line (MAX) on the test dipstick. See the illustration 4.
6. Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not interpret the result after 10 minutes. See illustration 5.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Strep A was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Strep A present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One 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 below the detectable level of the test. The patient’s specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms are not consistent with results, obtain another specimen for culture.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Internal Quality Control
Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
External Quality Control
It is recommended that a positive and negative external control be run every 25 tests, and as deemed necessary by internal laboratory procedures. External positive and negative controls are supplied in the kit. Alternatively, other Group A and non-Group A Streptococcus reference strains may be used as external controls. Some commercial controls may contain interfering preservatives; therefore, other commercial controls are not recommended.
Procedure for External Quality Control Testing
1. Add 4 full drops of Extraction Reagent 1 and 4 full drops of Extraction Reagent 2 into an extraction tube. Tap the bottom of the tube gently to mix the liquid.
2. Add 1 full drop of positive or negative control solution into the tube, holding the bottle upright.
3. Place a clean swab into this extraction tube and agitate the swab in the solution by rotating it at least 15 times. Leave the swab in the extraction tube for 1 minute. Then express the liquid from the swab head by rolling the swab against the inside of the extraction tube and squeezing the extraction tube as the swab is withdrawn. Discard the swab.
4. Continue with Step 5 of Directions For Use. If the controls do not yield the expected results, do not use the test results. Repeat the test or contact your distributor
|Strep A Rapid Test Dipstick (Control Line in Red)
|Strep A Rapid Test Cassette (Control Line in Red)
|Strep A Rapid Test Dipstick (Control Line in Blue)
|Strep A Rapid Test Cassette (Control Line in Blue)