33447 - Gastrointestinal Panel Complete Pathogen (no. C. diff)

2 business days from receipt of specimen - performed Monday, Wednesday, Friday.

33447 - Gastrointestinal Panel Complete Pathogen (no C. difficile) – Is a qualitative in vitro test for the single or multiple detection of Adenovirus, Astrovirus, Norovirus GI, Norovirus GII, Rotavirus, Aeromonas spp., Campylobacter spp., Clostridium perfringens, Salmonella spp., Shigella spp./EIEC, Vibrio spp., Yersinia enterocolitica, Enteroaggregative E. coli (AEC), Enteropathogenic E. coli (EPEC), E. coli O157, Enterotoxigenic E. coli (ETEC), Shiga Toxin-producing E. coli (STEC), Blastocystis hominis, Cryptosporidium spp., Cyclospora cayetanensis, Dientamoeba fragilis, Entamoeba histolytica, Giardia lamblia

Assay Limitations

1. Positive results obtained using the Seegene assay are presumptive and must be confirmed with an FDA cleared or approved test or other acceptable reference method. All results should be used and interpreted in the context of a full clinical evaluation as an aid in the diagnosis of gastrointestinal infection.
   a. There is a risk of false positive values resulting from cross-contamination by target organisms, their nucleic acids or amplified product.
   b. There is a risk of false positive values resulting from non-specific signals in the assay.

2. 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.

3. As with any hybridization-based assay, underlying polymorphisms in primer-binding regions can affect the targets being detected and subsequently the calls made.

4. Campylobacter: the Seegene assay was designed to detect C. jejuni, C. coli and C. lari; however, some strains of Campylobacter fetus subsp. fetus may be detected, (Campylobacter fetus subsp. fetus (NCTC 10842, type strain [ATCC 27374]) at a concentration of 6 x10⁸ cfu/mL resulted in a positive call for Campylobacter).

5. Escherichia coli (Migula) Castellani and Chalmers strain CDC EDL 1284 [929-78] (serotype O124:NM [ATCC 43893]) (enteroinvasive) resulted in a positive call for Shigella.

6. Cryptosporidium: the Seegene GPP assay detects C. parvum and C. hominis only.

7. Giardia: Seegene GPP assay detects G. lamblia only (also known as G. intestinalis and G. duodenalis).

8. Primers for Shigella are expected to cross-react with enteroinvasive E. coli (EIEC) and Salmonella subterranean (at a concentration of 6 x 10⁸ cfu/mL). Enteroinvasive E. coli (strain CDC EDL 1284 [929-78], serotype O124:NM) cross-reacting with Shigella in the Seegene GPP kit is expected as EIEC is genetically, biochemically and physiologically closely related to Shigell. EIEC strains possess some of the biochemical characteristics of E. coli, but some strains can cause dysentery using the same method of invasion used by Shigella. Both Shigella and EIEC can be separated from other E. coli by PCR targeting the invasion plasmid antigen H (ipaH) gene. However, PCR alone cannot distinguish between Shigella from EIEC. Additional physiological and biochemical typing, and serological typing must be used in combination with the ipaH gene PCR to distinguish between Shigella and EIEC. EIEC also causes diarrhea predominantly in tropical countries with occasional cases reported in the US.

9. 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.

10. A target call of STEC stx1/stx2 may be from either Shigella dysenteriae or from STEC.

11. The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.

12. Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely prevalent when disease is high. False positive test results are more likely during periods when prevalence is low.

13. This test is a qualitative test and does not provide the quantitative value of detected organism present.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219.

Causes for Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Eurofins Viracor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1. Schlenker C, Surawicz CM. Emerging infections of the gastrointestinal tract. Best Pract Res Clin Gastroenterol. 2009;23(1);89-99.

2. Thom K, Forrest G. Gastrointestinal infections in immunocompromised hosts. Curr Opin Gastroenterol. 2006 Jan;22(1):18-23.

3. Fischer Walker CL, Sack D, Black RE. Etiology of diarrhea in older children, adolescents and adults: a systematic review. PLoS Negl Trop Dis. 2010 Aug 3;4(8);e768.

4. Patel A, Mamtani M, Dibley MJ, Badhoniya N, Kulkarni H. Therapeutic value of zinc supplementation in acute and persistent diarrhea: a systematic review. PLoS One. 2010 Apr 28;5(4):e10386.