Gastrointestinal Pathogen Panel molecular assay with 22 pathogens

CPT Code(s)

CPT 87507

Synonym(s)

Adenovirus, Astrovirus, Norovirus, Rotavirus, Sapovirus, Campylobacter, Clostridium difficile, Plesiomonas shigelloides, Salmonella, Vibrio, Yersinia enterocolitica, Enteroaggregative E. coli, EAEC, Enteropathogenic E. coli, EPEC, Enterotoxigenic E. coli, ETEC, Shiga-like toxin-producing E. coli, STEC, E. coli O157, Shigella/Enteroinvasive E. coli, EIEC, Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia.

Performed

Molecular Diagnostics Laboratory

Clinical Indication and Relevance

The assay is useful to detect adenovirus F40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus (genogroups I, II, IV and V), Campylobacter (C. jejuni/C. coli/C. upsaleiensis), Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC), Shiga-like toxin-producing E. coli (STEC) stx1/stx2 including E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica and/or Giardia lamblia.

Methodology

The assay uses polymerase chain reaction (PCR) on the BioFire FilmArray Torch System.

Minimum Specimen Requirements

Sample type

Collect liquid to soft stool specimen in a sterile cup.
Liquid to soft stool specimen transferred to Cary Blair or FecalSwab (modified Cary-Blair) transport medium.
Minimum sample volume of 0.2 mL

Specimen Labeling

The specimen must be labeled with two identifiers at the time of collection. Examples of acceptable identifiers include but are not limited to: patient name, date of birth, hospital medical record number, accession number. A location (e.g., hospital room number) is not an acceptable identifier. Collection date and collector’s identifier are required.
A completed requisition form should be submitted with every sample and, at minimum, the following is required: ordering physician name, phone number, fax number, and patient’s name, identifying number of patient, patient sex, patient date of birth specimen type, collection date, tests requested, provisional diagnosis or clinical rationale for test, and billing information.

Transport

Specimens can contain extremely high levels of virus or other organisms. Specimens
must be shipped and transported in accordance with applicable local, national and international transportation regulations. Maintain proper storage conditions of 2-8°C during shipping to ensure integrity of the specimen.

Stability

After collection, transfer to Cary Blair immediately. Sample can be stored at 2-8°C up to 24 hours before transferring to Cary Blair medium.
Once in Cary Blair medium, transport to the lab immediately for testing. Store at 2-8°C up to 72 hours.

Unacceptable Samples

Improperly labeled or incorrect patient identification, specimen leaked,
incorrect media, insufficient volume (less than 200 ul), rectal swabs, endoscopy stool aspirates, gastrointestinal contents or vomitus, stool sample in fixative, hard stools which rattle inside the container, specimen does not meet transport, storage or date of collection requirements.

Turnaround time

1-2 business days.