BD Veritor System Bedienungsanleitung Seite 91

INTERPRETATION OF RESULTS
Due to the technologies incorporated in the BD Veritor System, operators should not attempt to interpret assay results
visually from the test strip contained within the BD Veritor System Strep A assay device. The BD Veritor System Instrument
must perform interpretation of results of all BD Veritor Assays.
Instrument Display
STREP: +
STREP: -
CONTROL INVALID
Invalid Test If the test is invalid, the BD Veritor System Instrument will display "CONTROL INVALID" and the test or
control must then be repeated. If "CONTROL INVALID" reading results, contact BD.
REPORTING OF RESULTS
Positive Test Positive for the presence of Strep A antigen. A positive result may occur in the absence of viable bacteria.
Negative Test Negative for the presence of Strep A antigen. Infection due to Strep A cannot be ruled-out because the
antigen present in the sample may be below the detection limit of the test. Culture confirmation of
negative samples is recommended.
Invalid Test Test result is inconclusive. Do not report results.
QUALITY CONTROL:
To utilize the Analyzer's QC documentation capability, specimen barcode scanning must be enabled on an
Analyzer equipped with either an InfoScan or InfoSync module. Please refer to the Analyzer Instructions
Each BD Veritor System Group A Strep device contains both positive and negative internal/procedural controls:
1. The internal positive control validates the immunological integrity of the device, proper reagent function, and verifies
correct test procedure.
2. The membrane area surrounding the test lines functions as a background check on the assay device.
The BD Veritor System Instrument evaluates the positive and negative internal/procedural controls after insertion of
the BD Veritor System test device. The BD Veritor System Instrument will prompt the operator should a quality issue
occur. Failure of the internal/procedural controls will generate an invalid test result. NOTE: The internal controls do
not assess proper sample collection.
External Positive and Negative Controls:
Strep A Positive and Strep A Negative control swabs are supplied with each kit to ensure that the test reagents work
properly and that the test procedure is performed correctly. Prepare and test kit control swabs using the same workflow
procedure as used for patient specimen swabs.
Your laboratory's standard Quality Control procedures and applicable local, state and/or federal regulations or accreditation
requirements dictate the performance of external quality control procedures.
BD recommends controls be run once for:
• each new kit lot,
• each new operator,
• each new shipment of test kits,
• and at periodic intervals as required by your facility.
If the kit controls do not perform as expected, do not report patient results. Contact BD Technical Services
at 1.800.638.8663.
LIMITATIONS OF THE PROCEDURE
1. This test will indicate the presence of Strep A antigen in the throat swab specimen from both viable and non-viable
group A Streptococcus bacteria. It does not determine the qualitative concentration of Strep A antigen.
2. Respiratory infections can be caused by Streptococci of serogroups other than A as well as other pathogens. This test
does not differentiate between carriers and infected individuals.
3. Excess blood or mucus on the swab specimen may interfere with test performance.
4. Avoid touching the tongue, cheeks, and teeth
collecting specimens.
5. False negative results can occur from inadequate or improper specimen collection, or from antigen levels that are below
the limit of detection for this test.
6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to
the physician.
Interpretation
Positive Test for Strep A (Strep A antigen present)
Negative Test for Strep A (no antigen detected)
Control line error. Repeat the test.
for Use, section 4, to choose or change this configuration.
9 and any bleeding areas of the mouth with the swab when
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