Item Brochure

INTENDED USE
The OSOM
®
Strep A Test is intended for the qualitative detection of Group A Streptococcal antigen from
throat swabs or confirmation of presumptive Group A Streptococcal colonies recovered from culture.
For laboratory and professional in vitro diagnostic use only.
SUMMARY AND EXPLANATION OF TEST
Group A Streptococcus is one of the most important causes of acute upper respiratory tract infection.
Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the
severity of symptoms and further complications such as rheumatic fever and glomerulonephritis
(1)
.
Conventional identification procedures for Group A Streptococcus from throat swabs involve the
isolation and subsequent identification of viable pathogens by techniques that require 24 to 48 hours
or longer
(2)
. The OSOM Strep A Test detects either viable or nonviable organisms directly from a throat
swab, providing results within 5 minutes.
PRINCIPLES OF TEST
The OSOM Strep A Test uses color immunochromatographic dipstick technology with rabbit antibodies
coated on the nitrocellulose membrane. In the test procedure, a throat swab is subjected to a chemical
extraction of a carbohydrate antigen unique to Group A Streptococcus. The Test Stick is then placed
in the extraction mixture and the mixture migrates along the membrane. If Group A Streptococcus is
present in the sample, it will form a complex with the anti-Group A Streptococcus antibody conjugated
color particles. The complex will then be bound by the anti-Group A Streptococcus capture antibody
and a visible blue Test Line will appear to indicate a positive result.
KIT CONTENTS AND STORAGE
50 Test Sticks
50 Test Tubes
50 Sterile Swabs
1 Reagent 1 (2 M Sodium Nitrite)
1 Reagent 2 (0.3 M Acetic Acid)
1 Positive Control (Nonviable Group A Streptococci, 0.1% Sodium Azide)
1 Negative Control (Nonviable Group C Streptococci, 0.1% Sodium Azide)
1 Directional Insert
Note: Two extra test sticks have been included in the kit for external QC testing. In addition, extra
components (swabs, tubes) have been provided for your convenience.
Store Test Sticks and reagents tightly capped at 15° – 30°C (59° – 86°F).
Do not use Test Sticks or reagents after expiration date.
MATERIALS REQUIRED BUT NOT PROVIDED
A timer or watch.
WARNINGS AND PRECAUTIONS
®
CLIA Complexity, testing from throat swabs: Waived
CLIA Complexity, testing from colonies recovered from culture: Moderate
Strep A Test
Component (s) Pictogram Signal Word Hazard Statement
Reagent 1
Sodium Nitrate
Warning/Oxidizer
H272: May intensify fire; oxidizer
H302: Harmful if swallowed
Precautionary
Statement (s)
P210 : Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P220: Keep/Store away from combustible materials.
P221: Take any precaution to avoid mixing with combustibles.
P264: Wash hands thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection
P301+P330+ P312: IF SWALLOWE D : Rinse mouth. Immediately call a POISON CENTER or doctor/ physician.
P501: Dispose of contents/container in accordance with local/regional/national/international regulations.
Reagent 2
Acetic Acid
Warning
H315 : Causes skin irritation
H319 : Causes serious eye irritation
Precautionary
Statement (s)
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection
P302+P352: If on skin: Wash with plenty of water. If skin irritation occurs: Get medical advice / attention.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P321: Specific treatment (see First Aid Measures on Safety Data Sheet).
P337+P313: If eye irritation persists get medical advice/attention.
P362+P364: Take off contaminated clothing and wash it before reuse
P501: Dispose of contents/container in accordance with local/regional/national/international regulations.