Product Manual

ManualsBrandsQuidel ManualsRapid TestsSofia Strep A Test Kit, 25/kt

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Sofia Strep A FIA

INTENDED USE

The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat

swabs of symptomatic patients. All negative test results should be confirmed by bacterial culture because negative results

do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for

professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.

SUMMARY AND EXPLANATION

Group A Streptococcus is one of the most common 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 serious

complications such as rheumatic fever and glomerulonephritis.

1, 2

Conventional procedures for identification of Group A

Streptococcus from throat swabs involve the culture, isolation, and subsequent identification of viable pathogen at 24 to

48 hours or longer for results.

3, 4

PRINCIPLE OF THE TEST

The Sofia Strep A FIA employs immunofluorescence technology that is used with the Sofia analyzer (Sofia) to detect

Group A Streptococcal antigen.

The Sofia Strep A FIA involves the extraction of the antigenic components of the Group A Streptococcus (GAS) bacteria.

The patient’s Swab specimen is placed in the Reagent Tube containing the Reagent Solution, during which time the

bacterial antigens are extracted, making them more accessible to the specific antibodies. An aliquot of the extracted

specimen is dispensed into the Cassette sample well. From the sample well, the specimen migrates through a test strip

containing various unique chemical environments. If Group A Streptococcal antigens are present, they will be bound

by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles

containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected

by Sofia. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor

detected by Sofia.

Note: Depending upon the user’s choice, the Cassette, now containing the specimen, is either placed directly inside Sofia

for automatically timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed

development and then placed into Sofia (READ NOW Mode).

Sofia scans, measures, and interprets the immunofluorescent signal, using on-board method-specific algorithms. Sofia will

then report the test results to the user (Positive, Negative, or Invalid) on its display screen, and it can print out the results via

an integrated printer or transmit the results via an LIS connection.

FOR USE WITH SOFIA ONLY

Summary of content (15 pages)

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FOR USE WITH SOFIA ONLY INTENDED USE The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.
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REAGENTS AND MATERIALS SUPPLIED 25-Test Kit:  Individually Packaged Cassettes (25): Polyclonal rabbit anti-Group A Streptococcus antibodies  Reagent Tubes (25)  Reagent Solution Bottles (25): 4M Sodium Nitrite and 0.
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 Do not write on the barcode of the Cassette. This is used by Sofia to identify the type of test being run and to identify the individual Cassette so as to prevent a second read of the Cassette by the same Sofia.  Once a Cassette has been successfully scanned by Sofia, do not attempt to scan the Cassette again in the same Sofia. The barcode on the Cassette contains a unique identifier that will prevent Sofia from performing a second read on a previously scanned Cassette.
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Built-in Procedural Controls The Sofia Strep A FIA contains two built-in procedural control features. The manufacturer’s recommendation for daily control is to document these built-in procedural controls for the first sample tested each day. A control of the extraction procedure is provided by a color change from clear to green as the Reagent Solution is mixed. The color change is an indication of Reagent Solution integrity and is also an indication that the extraction procedure was performed correctly.
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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, cottontipped or wooden shaft swabs. Collect throat specimens by standard clinical methods. Depress the tongue with a tongue blade or spoon.
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3. Vigorously shake the Bottle 5 times to mix the Solutions. Solution should turn green after the ampoule is broken. 4. Remove the cap. Holding Bottle vertically, fill the Reagent Tube to the line [approximately 6 drops]. Fill to Line 5. Immediately add the patient Swab sample to the Reagent Tube. Vigorously mix the solutions by plunging the Swab 5 times in an up and down motion in the Tube. NOTE: Best results are obtained when the specimen is vigorously extracted in the solution.
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8. Express as much liquid as possible from the Swab by squeezing the sides of the Tube as the Swab is withdrawn. Discard the Swab in accordance with your biohazard waste disposal protocol. 9. Fill the provided Yellow 100 µL Fixed Volume Pipette with the sample: Squeeze here To fill the Fixed Volume Pipette with the sample: a) FIRMLY squeeze the top bulb. b) Still squeezing, place the Pipette tip into the sample.
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Tips for Batch Testing In order to make batch testing easier, the user can prepare one or more Reagent Solution Bottles in advance of testing samples. The user can break the ampoule inside each Reagent Solution Bottle, shake to mix the solutions, and then store the capped Bottles on the bench top at room temperature for up to 12 hours without loss of activity before using with Swab sample(s).
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5. Sofia will start automatically and display the progress as shown in example below. In the WALK AWAY Mode, the test results will be displayed on the screen in approximately 5 minutes. In the READ NOW Mode, the test results will be displayed on the screen in less than 1 minute. See “Interpretation of Results” section. For example: This display shows that the test in WALK AWAY mode has 4 minutes, 13 seconds remaining. Sofia will read and display the results in about 5 minutes.
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LIMITATIONS n The contents of this kit are to be used for the qualitative detection of Group A Streptococcal antigens from throat Swab specimens. n The test detects both viable and nonviable Group A Streptococcus bacteria and may yield a positive result in the absence of living organisms. n Respiratory infections, including pharyngitis, can be caused by Streptococcus from serogroups other than Group A, as well as other pathogens.
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Table 3a Sofia Strep A FIA Results: READ NOW Mode Culture Pos Neg Sofia Pos 100 23 Sofia Neg 12 549 Total: 112 572 Total: 123 561 684 Sens. = 89.3% (100/112) (95% CI: 82.2%-93.8%) Spec. = 96.0% (549/572) (95% CI: 94.0%-97.3%) PPV = 81.3% (100/123) NPV = 97.9% (549/561) Prev. = 16.4% (112/684) Table 3b Sofia Strep A FIA Results: WALK AWAY Mode Culture Pos Neg Total: Sofia Pos 16 1 17 Sofia Neg 0 35 35 Total: 16 36 52 Sens. = 100% (16/16) (95% CI: 80.6%-100%) Spec. = 97.2% (35/36) (95% CI: 85.8%-99.
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Limit of Detection The limit of detection (LOD) for the Sofia Strep A FIA was determined using three (3) strains of Group A Streptococcus pyogenes. The LOD ranged from 9x103-2x104 colony forming units (cfu)/test (Table 6). Table 6 Sofia Strep A FIA Limits of Detection for Three Streptococcus pyogenes Strains Strain Bruno [CIP 104226] CDC-SS-1402 CDC-SS-1460 Minimum Detectable Level* 1.86x104 cfu/test 9.24x103 cfu/test 2.
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Analytical Specificity Cross Reactivity The cross reactivity of the Sofia Strep A FIA was evaluated with a total of 61 non-Group A Streptococcus bacterial and fungal microorganisms, and 26 viral isolates. None of the organisms or viruses listed below in Table 8 showed any sign of cross reactivity in the assay.
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Interfering Substances Several over-the-counter (OTC) products, whole blood, and blood agar were evaluated and did not interfere with the Sofia Strep A FIA at the levels tested (Table 9).
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20231 – Sofia Strep A FIA – 25 Tests (multi-language) 20253 – Sofia Strep A FIA – 25 Tests MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Quidel Corporation 10165 McKellar Court San Diego, CA 92121 USA quidel.