INTENDED USE
The
StrongStep® Strep A Rapid Test Device is a rapid immunoassay for
the qualitative
detection of Group A Streptococcal (Group A Strep) antigen from
throat swab
specimens as an aid to the diagnosis of Group A Strep pharyngitis
or for culture
confirmation.
INTRODUCTION
Beta-haemolytic
Group B Streptococcus is a major cause of upper
respiratory infections
in humans. The most commonly occurring Group A
Streptococcal disease
is pharyngitis. The symptoms of this, if left untreated, can
become more severe
and further complications such as acute rheumatic fever, toxic
shocklike syndrome
and glomerulonephritis can develop. Rapid identification can
facilitate clinical
management to prevent disease progression. Conventional
methods used to identify Group A Streptococcus involve the
isolation and
subsequent identification of the organisms, which can take 24-48
hours to complete.
The StrongStep® Strep A Rapid Test Device detects Group A Streptococci directly from throat swabs so that more rapid results are achieved. The test detects bacterial antigen from swabs, therefore it is possible to detect Group A Streptococcus, which may fail to grow in culture.
PRINCIPLE
The
Strep A Rapid Test Device has been designed to detect Group A
Streptococcal antigen
through visual interpretation of color development in the
internal strip. The membrane
was immobilized with Rabbit anti Strep A antibody on the test
region. During
the test, the specimen is allowed to react with another rabbit
anti-Strep A antibody
colored particals conjugates, which were precoated on the sample
pad of the
test. The mixture then moves on the membrane by a capillary
action, and interact
with reagents on the membrane. If there were enough Strep A
antigens in specimens,
a colored band will form at the test region of the membrane.
Presence of
this colored band indicates a positive result, while its absence
indicates a negative
result. Appearance of a colored band at the control region serves
as a procedural
control. This indicates that proper volume of specimen has
been added
and membrane wicking has occurred.
STORAGE AND STABILITY
■ The
kit should be stored at 2-30°C until the expiry date printed on
the sealed
pouch.
■ The
test must remain in the sealed pouch until use.
■ Do
not freeze.
■
Cares should be taken to protect components in this kit
from contamination.
Do not use if there is evidence of microbial contamination
or
precipitation. Biological contamination of dispensing
equipments, containers
or reagents can lead to false results.