Product Manual

Page 5 of 15
Sofia Strep A FIA
If a culture is desired, lightly streak the Swab on a 5% sheep blood agar plate before using the Swab in the Sofia Strep A
FIA. Do not perform the Strep A FIA before streaking the Swab, as the Reagent Solution will destroy the bacteria on the
Swab, thereby rendering the organism incapable of successful culturing. Alternatively, two throat Swab specimens can be
obtained; in this case one can be used separately for culture and the other for the Sofia Strep A FIA.
TEST PROCEDURE
Important:
 All specimens must be at room temperature (15°C to 30°C) before beginning the test.
 Gloves should be worn when handling human samples.
 Do not use the Reagent Solution if it is green prior to breaking the ampoule.
 Do not open the foil pouch of the test Cassette until it is ready for immediate use.
Expiration date: Check expiration on outer box before using. Do not use any test Cassette past the expiration date on the label.
1. Verify that Sofia is set to the desired Mode: WALK AWAY or READ NOW. See the “Using Sofia”
section for more information.
SPECIMEN COLLECTION AND HANDLING
SPECIMEN COLLECTION
Use the Rayon-tipped Swabs provided in the kit to collect throat specimens. The performance claims listed in the
Performance Characteristics section were obtained with the Swabs provided in the kit. Do not use calcium alginate, cotton-
tipped or wooden shaft swabs. Collect throat specimens by standard clinical methods. Depress the tongue with a tongue
blade or spoon. Rub the Swab on the back of the throat, both of the tonsils, the uvula and the posterior pharynx. Be careful
not to touch the tongue, sides or top of the mouth with the Swab. Consult standard reference procedures such as the
collection method described by Facklam.
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SPECIMEN TRANSPORT AND STORAGE
It is recommended that Swab specimens be processed as soon as possible after collection. Swabs can be held in any clean,
dry plastic tube or sleeve up to 24 hours at room temperature (15°C to 30°C), or refrigerated (2°C to 8°C) up to 48 hours.
The following transport media and storage conditions have been tested and are also acceptable (Table 1):
Table 1
Recommended Transport Media
*These transport media systems preserve the sample on the Swab tip via contact with a media-moistened sponge.
2. Squeeze ONCE to break the glass ampoule inside the Reagent Solution Bottle prior to
running the assay.
Transport Media
Recommended Storage Condition
2°C to 8°C Ambient Temperature
BD BBL CultureSwab with Liquid Stuarts Media (#220109)* 48 hours 24 hours
Remel BactiSwab with Liquid Amies Media (#R723095)*
48 hours
24 hours