Gastrointestinal Profile, Stool, PCR

Test Code

18296

CPT Codes
87507<br>Restricted Client Code

Includes

Adenovirus F 40/41
Astrovirus
C difficile toxin A/B
Campylobacter
Cryptosporidium
Cyclospora cayetanensis
E coli O157
Entamoeba histolytica
Enteroaggregative E coli
Enteropathogenic E coli
Enterotoxigenic E coli
Giardia lamblia
Norovirus GI/GII
Plesiomonas shigelloides
Rotavirus A
Salmonella
Sapovirus
Shiga-toxin-producing E coli
Shigella/Enteroinvasive E coli
Vibrio
Vibrio cholerae
Yersinia enterocolitica

Preferred Specimen

Stool placed in a stool culture transport vial (Para-Pak® C&S orange). Add stool until level in Para-Pak vial is at fill-line on vial label. Do not over fill.

Instructions

Introduce stool into orange Para-Pak vial in small amounts such that level does not exceed fill-line on label. Cap securely and shake vial to distribute sample into the Cary-Blair preservative.

If possible, allow patient to urinate before collecting stool specimen so as to avoid contaminating the stool specimen with urine. Catch the stool specimen in a clean, empty wide-mouthed container or place plastic wrap over the opening of the toilet bowl to prevent the stool specimen from falling into the bowl. Do not mix urine or water with the stool specimen.

For diaper collected specimens, line the diaper with plastic wrap. Do not submit the diaper. Place small amounts of the stool specimen into the orange-labeled Para-Pak vial using the spoon affixed to the Para-Pak vial cap, taking care not to let the volume in the vial exceed the RED fill-line indicated on the vial label. Cap the Para-Pak vial and shake the vial 10 times to ensure complete distribution of the stool into the preservative.

The stool specimen must be placed into the Para-Pak vial within one hour of the stools production for optimum results. Label the Para-Pak vial with the patient's name, date of birth, date of collection and time of collection. Be sure the Para-Pak vial cap is securely in place and that the vial is not leaking.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 4 days
Refrigerated: 7 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimen not received in Cary-Blair preservative medium • Specimen vial leaking • Specimen >96 hours since collection • Frozen specimen • Rectal swab • Specimen below fill line on container (underfilled) • Container overfilled above the line on label

Methodology
Polymerase Chain Reaction (PCR)

Setup Schedule

Set up: Varies; Report available: 3-4 days

Reference Range

Not Detected

Clinical Significance

Test includes: Adenovirus F 40/41; astrovirus; Campylobacter; Clostridium difficile toxin A/B; Cryptosporidium; Cyclospora cayetanensis; E coli O157; Entamoeba histolytica; enteroaggregative E coli (EAEC); enteropathogenic E coli (EPAC); enterotoxigenic E coli (ETEC) lt/st; Giardia lamblia; norovirus GI/GII; Plesiomonas shigelloides; rotavirus A; Salmonella; Sapovirus; Shiga-like toxin-producing E coli (STEC) stx1/stx2; Shigella/enteroinvasive E coli (EIEC); Vibrio; Vibrio cholerae; Yersinia enterocolitica.

Gastrointestinal disease can be caused by many agents, including bacteria, viruses, and parasites. Culture for bacteria will not pick up the viruses or parasites. Tests for parasites will not be detect the viruses or the bacteria. This GI profile is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of nucleic acids from multiple bacteria, viruses and parasites directly from stool samples in Cary-Blair transport media obtained from individuals with signs and/or symptoms or gastrointestinal infection.

Limitations: The performance of this test has not been established for patients without signs and symptoms of gastrointestinal illness. Virus, bacteria and parasite nucleic acid may persist in vivo independently of organism viability. Additonally, some organisms may be carried asymptomatically. Detection of organism targets does not imply that the corresponding oragnisms are infectious or are the causative agents for clinical symptoms. The detection of organism nucleic acid is dependent upon proper sample 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 and false-negative results caused by improperly collected, transported and/or handled specimens.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.