Cyclospora cayetanensis
This test is a nucleic acid, PCR assay intended for the qualitative detection of Cyclospora cayetanensis in human stool specimens from individuals with signs and symptoms of gastrointestinal infection. Detection of C. cayetanensis nucleic acid may aid diagnosis when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information.
About Gastrointestinal Infections
Gastrointestinal infections in both pediatric and adult patients account for significant morbidity and mortality worldwide.2 In addition, immunocompromised hosts, including HIV patients, solid-organ transplant recipients or patients requiring therapy for chronic inflammatory diseases are susceptible to gastrointestinal infections.3 Mild diarrhea can lead to absenteeism from school or work and may require treatment by a health care provider. Patients with severe diarrhea may be hospitalized and some may develop more serious sequelae such as Guillain-Barré syndrome and hemolytic uremic syndrome (HUS), and in some cases death.4 Nearly three percent of neonatal mortality and 17 percent of under-five child mortality is attributable to diarrhea.5 Diarrheal disease can be caused by a number of pathogens including viruses, bacteria, and parasites. Presentations of gastroenteritis with an unidentified source pose a challenge to health care providers, as the same clinical presentation can be caused by different etiologies. Knowing the identity of the causal agent in symptomatic (both acute and chronic gastroenteritis) adult and pediatric patients can aid in diagnosis and patient management.1
ProcedureThe Cyclospora cayetanensis assay is a real-time PCR test for amplification and detection of Cyclospora cayetanensis target nucleic acid. An internal positive control is included to detect possible PCR inhibitors in the patient specimen. Uracil-DNA glycosylase (UDG) is utilized to help prevent carryover contamination by amplicon products from previously run specimens.
SpecificityDetects Cyclospora cayetanensis
2 business days from receipt of specimen - performed Monday, Wednesday, and Friday.
| Specimen Type | Test Code | CPT Code | NY Approved | Volume | Assay Range | Special Instructions |
|---|---|---|---|---|---|---|
| fecal | 33648 | 87507 | No | Size of pea, or 2 mL liquid stool |
Detected/ Not Detected |
• Collect and place in a sterile, screw top tube. • Store frozen and ship on dry ice for overnight delivery. • Samples are stable frozen for 14 days. |
Assay Limitations
- Positive results obtained using the 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. - Analyte targets may persist in vivo, independent of 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.
- As with any hybridization-based assay, underlying polymorphisms in primer-binding regions can affect the targets being detected and subsequently the calls made.
- 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 panel organisms.
- 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.
- This test is a qualitative test and does not provide the quantitative value of detected organism present.
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- Specimen should be shipped on dry ice for overnight delivery to Eurofins Viracor. Friday shipments must be labeled for Saturday delivery.
- Specimens beyond the acceptable time from collection, or specimen types other than those listed below, are not accepted and may be rejected.
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- Schlenker C, Surawicz CM. Emerging infections of the gastrointestinal tract. Best Pract Res Clin Gastroenterol. 2009;23(1):89-99.
- Thom K, Forrest G. Gastrointestinal infections in immunocompromised hosts. Curr Opin Gastroenterol. 2006;22(1):18-23.
- Fischer Walker CL, Sack D, Black RE. Etiology of diarrhea in older children, adolescents and adults: a systematic review. PLoS Negl Trop Dis. 2010;4(8):e768.
- Seegene Inc. Novaplex GI-Parasite Assay: Multiplex real-time PCR system for detection of gastrointestinal parasites - Instructions for Use. Version 1.0. 2021.