Item Brochure

INTENDED USE
The OSOM
®
Ultra Strep A Test is a color immunochromatographic assay intended for the qualitative
detection of Group A Streptococcal antigen directly from throat swab specimens. 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 18 to 24 hours
or longer
(2)
. The OSOM Ultra Strep A Test detects either viable or nonviable organisms directly from a
throat swab, providing results within 7 minutes.
PRINCIPLES OF TEST
The OSOM Ultra Strep A Test is a color immunochromatographic assay using Dual Label Technology
(DLT)**. DLT uses antibody labeled color particles coated at two separate locations in the test device.
DLT allows greater sensitivity than the conventional single label technology without sacrificing specificity.
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 complexes
with the anti-Group A Streptococcus antibody conjugated color particles located at two separate
locations on the Test Stick. 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. A red Control Line will also
appear to indicate the test is valid.
KIT CONTENTS AND STORAGE
Contents:
25 Test Sticks Coated with Rabbit Anti-Group A Streptococcus
25 Test Tubes
25 Sterile Swabs
25 Extraction Reagent Bottles (2 M Sodium Nitrite and One Ampule with 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 Workstation
1 Directional Insert
Note: 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.
• Store Extraction Reagent Bottles inside the box. Avoid exposure to light.
• Avoid dropping Extraction Reagent Bottles as this may cause ampule breakage.
MATERIALS REQUIRED BUT NOT PROVIDED
A timer or a watch.
WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use
• Follow your laboratory safety guidelines in the collection, handling, storage and disposal of controls,
patient specimens and all items exposed to patient specimens
(3).
®
CLIA Complexity: Waived
Ultra Strep A Test
*NOTE: Adding more then 6 drops during step 2 may provide erroneous results.
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.P2 21: 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 SWAL LOWED: 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.