Strep A Rapid Test, Group A Streptococcal infection, Infectious
Disease Test Kit
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette |
| Specimen | Throat Swab |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 20T/25T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
IST-501
A rapid test for the qualitative detection of Strep A antigens in
throat swab specimens. For professional in vitro diagnostic use
only.
INTENDED USE
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.
SUMMARY
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.
PRINCIPLE
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.
REAGENT
The test contains Strep A antibody coated particles and Strep A
antibodies coated on the membrane.
PRECAUTIONS
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.
QUALITY CONTROL
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
Order Information
| Cat. No. | Product | Specimen | Pack |
| IST-501 | Strep A Rapid Test Dipstick (Control Line in Red) | Throat Swab | 25 T |
| IST-502 | Strep A Rapid Test Cassette (Control Line in Red) | Throat Swab | 20T |
| ISTB-501 | Strep A Rapid Test Dipstick (Control Line in Blue) | T.hroat Swab | 25 T |
| ISTB-502 | Strep A Rapid Test Cassette (Control Line in Blue) | Throat Swab | 20T |
