Test Code LAB7130 GASTROINTESTINAL PANEL PCR, STOOL
Useful for detection of
• Salmonella
• Shigella/EIEC
• Campylobacter
• STEC STx1 and Stx2 (Shiga toxin-producing E. coli)
• Yersinia enterocolitica
• Vibrio cholerae
• Vibrio parahaemolyticus
• Giardia
• Cryptosporidium
• Norovirus GI/GII
Specimen Type
Source: Stool in Cary-Blair Medium (stool transport media)
Specimen Volume: Fill to red line
Turnaround Time
STAT: 4 hours
Routine: 24 hours
Test Schedule
Daily
Sample Stability
Stool must be put in Cary Blair Medium within 1 hour of collection
Cary-Blair Medium:
Room Temp: 24 hours
Refrigerated: 4 days
Method
Cepheid GeneXpert Real-time PCR assay
Reference Ranges
Detected, Not Detected, or Indeterminant for the following targets:
• Salmonella
• Shigella/EIEC
• Campylobacter
• STEC STx1 and Stx2 (Shiga toxin-producing E. coli)
• Yersinia enterocolitica
• Vibrio cholerae
• Vibrio parahaemolyticus
• Giardia
• Cryptosporidium
• Norovirus GI/GII
Synonyms
GIP, GI, GI panel, gastro, gastrointestinal, feces, feces culture, stool, stool culture, pcr, pcr panel, GI PCR panel, diarrhea, stool pathogen, Salmonella, Shigella, Shiga toxin, Yersinia, campy, Campylobacter, Vibrio, Giardia, Crypto, Cryptosporidium, Norovirus, STEC, EIEC
CPT Code
87506
Specimen Rejection Criteria
- Incorrect or expired transport medium
- Any specimen that has leaked
- Improper storage conditions during transport
- Improper sample collection
Limitations
- All assay results should be used and interpreted in the context of a full clinical evaluation as an aid in the diagnosis of gastrointestinal infection.
- There is a risk of false positive values resulting from cross-contamination by target organisms, their nucleic acids, or the amplified product.
- There is a risk of false positive values resulting from non-specific signals in the assay.
- Analyte targets (virus, bacteria, or parasite nucleic acid sequences) may persist in vivo, independent of virus, bacteria, or parasite viability. Detection of analyte target(s) does not guarantee that the corresponding live organism(s) is present, or that the corresponding organism(s) is the causative agent for clinical symptoms.
- The detection of viral, bacterial, or parasitic sequences is dependent upon proper specimen collection, handling, transportation, storage, and preparation (including extraction). Failure to observe proper procedures in any one of these steps can lead to incorrect results.
- Underlying polymorphisms in primer-binding regions can affect the targets being detected and subsequently the test results returned.
- Salmonella: not all Salmonella serotypes were tested in validation studies.
- There is a risk of false negative values resulting from improperly collected, transported, or handled specimens.
- There is a risk of false negative values due to the presence of strain/species sequence variability in the targets of the assay, procedural errors, amplification inhibitors in specimens, or inadequate numbers of organisms for amplification.
- The performance of this test has not been established for monitoring treatment of infection with any of the targeted microorganisms.
- Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely when prevalence of disease is high. False positive test results are more likely when prevalence is low.
- The effect of interfering substances has only been evaluated for those listed in the labeling at its indicated amount or concentration. Interference by substances other than those described in the interfering substances section of the package insert can lead to erroneous results.
- There is a potential risk for non-determinate result or false negative results when over-filling the Cary Blair