Intended Use - Gima STREP A Manual De Uso

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E NGLISH
A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.
For professional in vitro diagnostic use only.

INTENDED USE

The Strep A Twist Rapid Test Device (Throat Swab) is a rapid chromatographic immunoassay
for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis
of Group A Streptococcal infection.
SUMMARY
Streptococcus pyogenes is a non-motile gram-positive cocci, which contains the Lancefield
Group A antigen that can cause serious infections such as pharyngitis, respiratory infection,
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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. 3,4
The Strep A Twist Rapid Test Device (Throat Swab) is a rapid test to qualitatively detect the
presence of Strep A antigen 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 antigen in a throat swab specimen.
PRINCIPLE
The Strep A Twist Rapid Test Device (Throat Swab) is 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
generates a colored line in the test
line region. The presence of this colored 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.
REAGENTS
The test contains Strep A antibody coated particles and Strep A antibody coated on the membrane.
PRECAUTIONS
• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens and kits are handled.
• 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.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when
specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature can adversely affect results.