OneStep Strep A #176550 Test
Atlas Link
InstaTest Strep A
OneStep Group A Streptococcus Test
Catalog # 176550-50 (50 tests)
refrigerator, allow all specimens and reagents to warm to room
temperature (18-25°C) before testing. All drops must be freefalling with the reagent bottles held vertically. In order to
avoid contamination of reagents, do not allow the tips of the
bottles to come in contact with the extraction cups. The
Positive Control and Negative Control are provided in order to
monitor the integrity of the reagents and assure that the test
procedure has been performed correctly.
EXTRACTION
INTRODUCTION TO InstaTest Strep A
Group A Streptococcus is a principal cause of upper
respiratory infections such as tonsillitis, pharyngitis, and
scarlet fever. Since pharyngitis can lead to rheumatic fever or
acute glomerulonephritis, it is important to differentiate
streptococcal pharyngitis from viral diseases during early
infections. The Strep A Rapid Test is a simple and rapid test
which can detect Group A Streptococcal antigen directly from
throat swabs or culture plate which allow physicians to
diagnose and administer therapy immediately.
1. Place the specimen swab into the extraction tube. Add 3
drops of Reagent A followed with 3 drops of Reagent B
into extraction tube. Mix contents well with the swab and
let stand for 1 minute, but no longer than 10 minutes.
2. Add 3 drops of Reagent C to extraction tube. Use swab to
mix. Remove liquid from the swab by pinching the rim of
the extraction tube between thumb and finger and gently
removing the swab from the tube.
3. The extraction mixture can be tested immediately or at any
time within the following 24 hours.
REAGENTS AND MATERIALS PROVIDED
ASSAY TEST PROCEDURE
1.
1. Bring up all reagents and specimens to room temperature.
2. Label the device with specimen identification.
3. Add 3 drops from the
extraction tube to the
sample well marked “S”.
4. Read the result within 5
minutes, do not interpret
result after 10 minutes.
2.
3.
4.
5.
6.
Testing Device, 50 pcs. Individually sealed in foil
pouches. Each pouch contains a sample dropper.
Reagent A, 1x8ml, 1M Sodium Nitrate.
Reagent B, 1x8ml, 1M Acetic Acid.
Reagent C, 1x8ml, 1.5 M Tris Buffer.
Positive Control, 1x1ml, Extracted Antigens of Strep A
with Sodium Azide. (optional)
Negative Control, 1x1ml, Extracted Antigens of Strep B
with Sodium Azide. (optional)
EQUIPMENT REQUIRED BUT NOT PROVIDED
Clock or timer.
The test results should not be interpreted after more than ten minutes.
To avoid confusion, read the result at ten minutes and discard the
Testing Device.
STORAGE CONDITIONS
The Strep A Rapid Test including all reagents can be stored at
room temperature or refrigerated (2-28°C).
SPECIMEN COLLECTION AND STORAGE
A specimen should be collected by standard throat swab
collection methods. It is preferable to use Dacron-tipped
sterile swabs with plastic shafts. Swabs should be processed
as soon as possible after collection. If swabs are not processed
immediately, they should be placed into a sterile, dry, tightly
capped tube or bottle. Swabs which have been transported in
liquid media, such as modified Stuart’s Transport Medium,
may be used in the test provided. The liquid medium is 1 ml
or less. Do not use calcium alginate or wooden shafted swabs.
Do not use semi-solid transport media or media containing
charcoal.
Specimen swabs may be stored refrigerated (2-8°C) for up to
5 days.
NOTE A difference in intensity may occur between the lines
in the test region (T) and control region (C) but this does not
affect the interpretation of the results.
INTERPRETATION OF RESULTS
POSITIVE Two pink colored bands appear, one in the control
region (C) and one in the test region (T), indicating a positive
result and that the sample contains Streptococcal Group A
antigen.
NEGATIVE Only one pink colored band appear on the
control region (C), the result is negative for Streptococcal
Group A antigen.
INVALID If no bands appear, or a test band appears without a
control band, the test should be repeated using a new device.
PERFORMING THE TEST
If specimen, control, or reagents have been stored in the
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, info@atlaslink-inc.com
OneStep Strep A #176550 Test
C
T
C
T
C
T
S
S
S
POSITIVE
NEGATIVE
INVALID
LIMITATION
1. The Strep A Rapid Test is designed for use with throat
swabs or colonies taken from culture plates.
2. The test does not differentiate between carriers and
infected individuals. Pharyngitis may be caused by other
organisms beside Group A Streptococci.
3. 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 specimens.
4. Additional follow-up testing using the culture method is
required if the test result is negative and clinical
symptoms persist.
5. A test result read after 10 minutes may not be consistent
with the original reading obtained within a 5 minute test
period.
Rev. 4/99
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, info@atlaslink-inc.com