Limitations

1. These results are not intended to be used as the sole basis for diagnosis, treatment, or patient management decisions.
2. All assay results should be used and interpreted by a trained healthcare professional in the context of a full examination, laboratory and epidemiological findings, as an aid in the diagnosis of GI infection.
3. The performance of this test has not been evaluated for asymptomatic patients.
4. This test should not be performed using a Para-Pak C&S vial that has been overfilled. The overfilling of the vial may result in a failed test with an error indicating "Sample concentration too high".
5. The detection of viral, bacterial, or parasitic sequences is dependent on proper specimen collection, handling, transportation, storage, and preparation. Failure to adhere to the proper procedures in any of these steps may lead to incorrect results. There is a risk of false negative values resulting from improperly collected, transported, or handled specimens.
6. Positive results do not rule out co-infection with organisms not included in the panel. The agent(s) detected may not be the definitive cause of disease.
7. Not all agents of acute GI infection are detected by this assay.
8. This test should be used in conjunction with standard of care culture for organism recovery, serotyping, and/or AST when applicable.
9. The identification of multiple diarrheagenic E. coli pathotypes has historically relied upon phenotypic characteristics, such as adherence patterns or toxigenicity in tissue culture. This test targets genetic determinants characteristic of most pathogenic strains of these organisms but may not detect all strains have phenotypic characteristics of a pathotype.
10. Genetic virulence markers associated with diarrheagenic E. coli/Shigella pathotypes are often carried on mobile genetic elements that can be transferred horizontally between strains. Because of this, "detected" results for multiple diarrheagenic E. coli/Shigella may be due to co-infection with multiple pathotypes or due to the presence a single organism containing genes characteristic of multiple pathotypes.
11. This panel detectes EPEC through targeting the eae gene, which encodes the adhesin intimin. As some STEC also carry the eae gene, this panel cannot distinguish between STEC containing eae and a co-infection of EPEC and STEC. Therefore, the EPEC result is not applicable and not reported for specimens in which STEC has also been detected. In rare cases, STEC may be reported as EPEC when an STEC carrying eae (EHEC) is present in a specimen below the LoD of the STEC oligonucleotide design(s). Rare instances of other organisms carrying the eae gene have been documented; e.g., Escherichia albertii and Shigella boydii.
12. Shigella dysenteriae serotype 1 possesses a shiga toxin gene (stx) that is identical to the stx1 gene of STEC. More recently, stx genes have been found in other Shigella species. The detection of shigella and STEC analytes in the same specimen may indicate the presence of Shigella species such as S. dysenteriae. Rare instances of the detection of Shiga-like toxin genes in other genera/species have been reported.
13. E. coli O157 result is only reported as a specific serogroup identification in associates with STEC stx1/stx2. While non-STEC O157 strains have been detected in human stool, their role in disease has not been established. Serotype O157 EPEC have been identified and will be detected by this panel due to their carriage of the eae gene.
14. This panel cannot distinguish between infections with a single toxigenic STEC O157 or rare co-infections of STEC (non-O157) with a stx1/stx2 negative E. coli O157.
15. Negative results do not exclude the possibility of GI infection. Negative test results may occur from sequence variants in the region targeted by the assay, the presence of inhibitors, technical errors, sample mix-ups, or an infection caused by an organism not detected by the panel. Test results may also be affected by the use of certain medications (e.g., calcium carbonate), concurrent antimicrobial therapy, or levels of the organism in the sample that are below the limit of detection for the test. Negative results should not be used as the sole basis for diagnosis, treatment, or patient management decisions.
16. Organism and amplicon contamination may produce erroneous results for this test.
17. There is a risk of false-positive values resulting from cross-contamination by target organisms, their nucleic acids or the amplified product, or from non-specific signals in the assay.
18. There is a risk of false-negative values due to the presence of strains with sequence variability in the target regions of the oligonucleotides design.
19. Not all serotypes of Salmonella were tested in validation studies; however, representatives of the 20 most prevalent serotypes recently circulating in the US were evaluated during studies. In silico sequence analysis supports detection of all subspecies and serotypes of Salmonella.
20. The performance of this test was not evaluated for immunocompromised patients.
21. Underlying polymorphisms in the primer-binding regions can affect the targets being detected and subsequently the test results returned.
22. Positive and negative predictive values are highly dependent upon prevalence. False negative test results are more likely when disease prevalence is high. False positive test results are more likely when disease prevalence is low.
23. The effect of interfering substances has only been evaluated for the substances listed in the IFU. Interference by substances not tested (or different concentrations of those that were tested) may lead to erroneous results.
24. Cross-reactivity with GI organisms other than those listed in the IFU Specificity section may lead to erroneous results.
25. This is a qualitative test and does not provide the quantitative value of detected organisms.
26. Assay sensitivity for Cyclospora cayetenensis, Adenovirus F40/41, Entamoeba histolytica and STEC may be reduced up to 3.16-fold when using half-input sample volume workflow for "Sample concentration too high" errors repeat testing.
27. Due to the small number of positive specimens collected for certain analytes during the prospective clinical studies, performance characteristics for Cyclospora cayetenensis, Adenovirus 40/41, ETEC, Plesiomonas shigelloides, Shigella/EIEC, STEC, E. coli O157, Yersinia enterocolitica, Cryptosporidium, and Giardia lamblia were established additionally with retrospective clinical specimens. Performance characteristics of Astrovirus and Entamoeba histolytica were primarily established using contrived specimens.
28. If four or more distinct organisms are detected in a specimen, retesting is recommended to confirm the polymicrobial result.
29. Virus, bacterial and parasitic nucleic acid may persist in vivo independently of organism viability. Some organisms may be carried asymptomatically. Detection of organism targets does not imply that they corresponding organisms are infectious or the causative agents for clinical symptoms.
30. The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.
31. For ETEC, the assay is not predicted to detect carrier status of Heat-labile enterotoxin gene subtype LT-II and/or Heat-stable enterotoxin gene variant Stb e.
32. This assay is not predicted to detect Human Astrovirus types MLB1-3 and VA1-5.
33. The potential for competitive inhibition at high concentrations between on-panel analytes is unknown.