VN

Asan Easy Test Adeno

Code: 206

 

INTRODUCTION

Adenovirus has six subgenera and 51 serotypes and is an major cause of upper
respiratory tract infections and gastroenteritis in infants and young children, also
observed in adults.

EXPLANATION OF THE TEST

Asan Easy Test® Adeno is a membrane-based immunogold assay for the qualitative
detection of various adenovirus serotypes present in nasopharyngeal swab,
aspirate and fecal samples.
The membrane is pre-coated with mouse monoclonal antibodies, on the test band
region, against viral antigens. During testing, the sample is allowed to react with
the colored conjugate(mouse monoclonal antibodies). The mixture then moves
upward on the membrane by capillary action. As the sample flows through the
test membrane, the colored particles migrate. In the case of a positive result the
specific antibodies present on the membrane will capture the colored conjugate.
The mixture continues to move across the membrane to the immobilized antibody
placed in the control band region.

MATERIALS PROVIDED

Asan Easy Test® Adeno contains the following items to perform the assay.
1. Test strip in aluminum pouch with a desiccant.
2. Extraction Solution (10
/vial).
3. Sample collection swabs.
4. Sample extraction tubes.
5. Disposable droppers.
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

Specimens should be obtained and handled by standard methods for the collection
of nasopharyngeal swab and aspirate.

A. Nasopharyngeal swab:
1. Sterile swab is inserted into one or both nostrils to nasopharyngeal area and gently
rotated against nasopharyngeal inside wall to collect specimen as much as possible.
2. Specimens must be tested as soon as they are collected. If necessary, they may be
stored at 2~8
for up to 24 hours.
B. Nasopharyngeal aspirate:
1. Nasopharyngeal Aspirate should be collected by a specialist using a mucus trap
and a catheter.
2. Specimens must be tested as soon as they are collected. If necessary, they may be
stored at 2~8
for up to 48hours or at -20
oC for longer periods.
C. Fecal samples:
Approximately 30of stool should be collected using disposable sample
collection swab.

TEST PROCEDUERE

1. All materials should be equilibrated to room temperature (4~30) before performing
the test.
2. Prepare sample collection swabs and sample extraction tubes as you need.
3. a. Nasopharyngeal Swabs:
Add 300
of extraction solution (up to 2nd marked in disposable dropper) into
extraction tube. Swirl the swab at least 10times in the tube and then discard the
swabs squeezing against the wall of the extraction tube .
b. Nasopharyngeal Aspirates:
Mix 150
of aspirates with 150of extraction solution in the extraction tube.
4. Remove the test strip from the its protective pouch.
5. 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)
6. Let them react for 15minutes and read the result.

INTERPRETATION OF RESULTS

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® Adeno should be stored between 4 to 30(39.2~86).
2. Expiration date of this kit is 24 months after its manufacture date.

LIMITATIONS OF THE PROCEDURE
1. Asan Easy Test® Adeno is highly sensitive and specific for adenovirus antigen. The
monoclonal antibody in this test reacts with the group specific hexon antigen. It
will detect all known serotypes, but cannot be used to di erentiate types.
2. A negative result does not exclude the possibility of adenovirus infection in the
patient. False negative results may occur due to low concentration levels of the
improper sampling or handling of the specimen.
3. Test results depend on the level of antigen in clinical specimens.
4. All positive results should be interpreted with caution, since adenovirus is
capable latency and recrudescence.
5. This test provides a presumptive diagnosis for Adenovirus infections. A confirmed
infection diagnosis should only be made by a physician after all clinical and
laboratory findings have been evaluated

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