Interpretive Data

• Additional testing by culture methods may be warranted is the Xpress Strep A result is negative and clinical symptoms persist or if there is an outbreak of acute rheumatic fever (ARF).
• Because the detection of GAS is dependent on the organism’s DNA being present in the sample, reliable results are dependent on proper sample collection, handling and storage.
• This assay provides qualitative results and does not provide the quantitative value of organism detected in the specimen.
• A negative result does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, sample mix-up, or because the number of organisms in the sample is below the limit of detection of the test. A negative test does not preclude a Strep A infection and should not be used as the sole basis for treatment or other patient management decisions.
• This test does not differentiate asymptomatic carriers of GAS from those exhibiting streptococcal infection. Results should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
• This test has not been evaluated for patients without signs and symptoms of pharyngitis.
• This test cannot be used to rule out pharyngitis caused by other bacterial or vial pathogens aside from GAS.