Limitations

• The FilmArray RP2plus has not been validated for testing of specimens other than nasopharyngeal swab (NPS) specimens in transport medium
• The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false positive or false negative values resulting from improperly collected, transported, or handled specimens.
• A negative FilmArray RP2plus result does not exclude the possibility of MERS-CoV, or other viral or bacterial 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 antiviral/antibacterial therapy or levels of organism in the specimen that are below the limit of detection for the test. Levels of MERS-CoV may be very low early in infection. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Negative results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. A negative MERS-CoV result in an asymptomatic individual does not rule out the possibility of future illness and does not demonstrate that the individual is not infectious
• There is a risk of false positive results due to cross-contamination by target organisms, their nucleic acids or amplified product. Particular attention should be given to the Laboratory Precautions noted under the Warnings and Precautions section.
• Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely during peak activity when prevalence of disease is high. False positive test results are more likely during periods when prevalence is moderate to low.
• Due to the genetic similarity between Human Rhinovirus and Enterovirus, the FilmArray RP2plus cannot reliably differentiate them. A FilmArray RP2plus Rhinovirus/Enterovirus Detected result should be followed-up using an alternate method (e.g. cell culture or sequence analysis) if differentiation between the viruses is required.