Asan Easy Test Strep A

EXPLANATION OF THE TEST

The Asan Easy Test® Strep A is a chromatographic immunoassay kit for rapid and
qualitative detection of group A Streptococcal antigen from throat swabs. The
test detects bacterial antigen and may therefore detects from swab organisms
which may fail to grow on culture.
The extracted antigen is transferred to sample pad, it moves through the
conjugate pad and mobilizes gold anti-Strep A polyclonal antibody conjugate
that is coated on the conjugate pad. The mixture moves along the membrane by
capillary action and reacts with anti-Strep A polyclonal antibody that is coated
on the test region. If Strep A antigen is present, the result is the formation of a
colored band in the test region. If Strep A antigen is lower than detection level
in the sample, the area will remain colorless. The sample continues to move to
the control area where Goat anti-rabbit IgG antibody will capture gold antibody
conjugate to form a pink to purple color, indicating the test is working and the
result is valid

MATERIALS PROVIDED

Asan Easy Test® Strep A contains the following items to perform the assay.
1. Test strip in aluminum pouch with a desiccant.
2. Extraction Solution A (15㎖/vial).
3. Extraction Solution B (15㎖/vial).
4. Sample collection swabs.
5. Sample extraction tubes.
6. Instruction manual for use.

PRECAUTIONS

1. For in-vitro diagnostic use only.
2. The test kit should remain in the sealed pouch until ready for use.
3. The test kit is sensitive to humidity and to heat.
4. Do not smoke, eat or drink in areas where specimens or kit component are
handled.
5. All specimens and reagents should be considered potentially hazardous and
handled in the same manner as an infection agent.
6. Wear protective gloves while handling samples and wash hands thoroughly
after the assay is complete.
7. Avoid any contact with the eyes, broken skin or mucous membranes.
8. The test strip and all materials should be discarded in a proper biohazard
container after testing.

SPECIMEN COLLECTION AND STORAGE

1. Specimen collection
Specimens should be obtained and handled by standard throat swab collection
methods. It is preferable to use dacron-tipped sterile swabs with plastic shafts
such as those provided. Do not use calcium alginate or wooden shafted swabs.
2. Specimen storage
Specimens must be tested as soon as they are collected. If necessary, they may
be stored at 2~8℃ for up to 24hours.
NOTE: To use Asan Easy Test® Strep A as a culture confirmation test, remove an
isolated beta-haemolytic colony from the culture plate with a clean swab. Then,
proceed as described in below

TEST PROCEDURE

1. All materials should be equilibrated to room temperature (2~30℃ ) before
performing the test.
2. Add 3 drops (150㎕ ) of Extraction Solution A and Extraction Solution B each to a
sample extraction tube.
3. Place the specimen swab into the tube and swirl the swab at least 10times.
4. Keep the swab in the tube for 2~10 minutes, but no longer than 10 minutes.
5. Discard the swab squeezing against the wall of tube.
6. Immerse the test strip in the tube in the direction indicated by the arrow.
(NOTE: Care should be taken not to contact solution or specimen with test line
on the strip)
7. Let them react for 15minutes and read the result.

EXPECTED RESULTS

It is believed that approximately 19% of all upper respiratory tract infections are
caused by group A streptococci. Streptococcal pharyngitis is most prevalent in
winter and early spring and the highest incidence of disease occurs in crowded
populations such as school children. Males and females are equally affected by group
A streptococcal infection.

INTERPRETATION OF THE TEST

A. Negative result:
The presence of only one red color band (“C” band) within the result window
indicates a negative result.
B. Positive result:
The presence of two red color bands (“T” band and “C” band) within the result
window regardless of which band appears first indicates a positive result.
C. Invalid result:
If no band is visible within the window after performing the test, the result is
considered invalid. Some causes of invalid results are: not following the directions
correctly or the test may have deteriorated beyond the expiration date. It is
recommended that the specimen be re-tested using a new test kit.

STORAGE & EXPIRATION

1. Asan Easy Test® Strep A Kit should be stored at 2 to 30℃ (35.6~86 ℉ ).

2. Expiration date of this kit is 24 months after its manufacture date.

LIMITATIONS OF RESULTS

Asan Easy Test® Strep A is for use only with throat swabs or colonies taken from
culture plates. The performance of the test with swabs taken from other sources
or with other samples such as saliva or urine has not been established.
The test does not differentiate between carriers and infected individuals.
Pharyngitis may be caused by other organisms beside group A streptococci.
Negative results may be obtained when the amount of extracted antigen is
below the sensitivity of the test. False negatives may result from improperly
taken samples.
Additional follow-up testing using the culture method is required if the Asan
Easy Test® Strep A result is negative and clinical symptoms persist.
Do not use Test Units which have become wet or which have been left out of the
foil pouch more than 24 hours.