• Do not use test if pouch is damaged.
• Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large
volumes of water.
• The positive and negative controls contain sodium azide (NaN3) as a preservative.
• Do not interchange kit reagents.
• Do not interchange reagent bottle caps.
• Do not interchange external control solution bottle caps.
• Be careful not to topple the swab out of the extraction chamber during the extraction step. If the
swab has been toppled, repeat the test with a new test and swab.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The
test and reagents are stable through the expiration date printed on the sealed pouch. The test
must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration
date.
SPECIMEN COLLECTION AND PREPARATION
• Collect the throat swab specimen with the sterile swab that is provided in the kit. Transport
swabs containing modified Stuart's or Amies medium can also be used with this product. Swab
the posterior pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and
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teeth with the swab.
• Testing should be performed immediately after the specimens have been collected. Swab
specimens may be stored in a clean, dry plastic tube for up to 8 hours at room temperature or
72 hours at 2-8°C.
• If a culture is desired, lightly roll the swab tip onto a Group A selective (GAS) blood agar plate
before using the swab in the Strep A Twist Rapid Test Device (Throat Swab).
MATERIALS
Materials Provided
• Test devices
• Strep A Reagent A
(2M Sodium Nitrite)
• Strep A Reagent B
(0.4M Acetic Acid)
• Strep A Positive control
(Non-viable Strep A; 0.09% NaN3)
• Strep A Negative control
(Non-viable Strep C; 0.09% NaN3)
Materials Required But Not Provided
• Timer
ENGLISH
• Package insert
R25 Toxic if swallowed
S1/2 Keep locked up and out of the reach of children
S45 In case of accident or if you feel unwell, seek
medical advice immediately (show the label where
possible)
S60 This material and its container must be disposed
of as hazardous waste
Safety data sheet available for professional users on
request
• Sterile swabs
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