Gastrointestinal Pathogen Panel

As with all PCR testing methods there is a risk of false positive or false negative values resulting from improperly collected, transported or handled specimens. A negative FilmArray RP2 result does not exclude the possibility of gastrointestinal infection. Negative test results may occur from the presence of sequence variants in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up or an infection caused by an organism not detected by the panel. Test results may also be affected by concurrent antibacterial therapy or levels of organism in the specimen that are below the limit of detection for the test. Negative results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. False negative results are more likely during peak activity when prevalence of disease is high. The risk of a false positive is more likely during periods when prevalence is moderate to low. A false positive can also occur due to cross-contamination by target organisms, their nucleic acids or amplified product. Erroneous results due to cross-reactivity with organisms that were not evaluated or new variant sequences that emerge is also possible. This test is not intended or evaluated for use on samples collected from patients who are immunocompromised.