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Epic Test Code LAB2107 Cryptosporidium molecular assay

Performing Location(s)

BMC

Specimen Type

Random Stool

Preferred Container

Stool sample in modified Carey Blair (ETM)

Volume Required

1 g or 5mL Stool

Storage Requirements

Ambient temperature- preferred for up to 4 days (15 - 25°C)

Transportation Needs

Deliver to the laboratory as soon as possible

Causes for Rejection

Mislabeled or unlabeled specimen
Stool in Proto-Fix,formalin, SAF, MIF, PVA
Unpreserved Specimen >2 hours at room temperature
Swab - Rectal, Stool
Frozen specimen
Improper Collection
Bloody stool
Mucus in stool
Non-stool sample

Limitations

Detected Cryptosporidium only

The detection of microbial DNA or RNA is dependent upon proper sample collection, handling, transportation, storage, and preparation. There is a risk of false-negative results due to the presence of strains with sequence variability or genetic rearrangements in the target regions of the assays.

This test is not recommended as a test of cure.

Repeat testing should not be performed on samples collected less than 7 days apart.

The presence of blood or mucous in the sample may interfere with testing. Sample should be rejected.

The following information is provided by the test manufacturer:
Cary Blair media, used for dilution and processing of clinical stools, is screened by manufacturers for viable organisms but may not be specifically tested for microbial nucleic acids.  The presence of nucleic acids at levels that can be detected by the FilmArray GI Panel may lead to false positive test results.  (BioFire Technical Notes FLM1-PRT-0239-01 and QS-339B-01.)
 

Cryptosporidium molecular assay information:
Cryptosporidium species
: Detects but does not differentiate approximately 23 different Cryptosporidium species, including the most common species (eg, C hominis and C parvum), as well as less common species (eg, C meleagridis, C felis, C canis, C cuniculus,  C muris, and C suis), but is not expected to detect the very rare species C bovis, C ryanae, and C xiaoi.

Information listed above concerning intestinal pathogens taken from: https://www.fda.gov/food/foodborne-pathogens/bad-bug-book-second-edition

(FilmArray Gastrointestinal [GI] Panel CE IVD, BioFire Diagnostics, LLC, Salt Lake City, Utah)

 

Reference Values

Population Units Reference Range
All Populations (none) Negative

 

Available STAT

No

Days of Analysis

All

Additional Information

Collection Instructions:

Ova and Parasite collection procedure

 

Other Information:

Cryptosporidium is a NYSDOH reportable communicable disease. The NYSDOH will be notified of all positive results.

Interpretation

A negative result should not rule-out infection in patients with a high pretest probability for gastrointestinal infection.
The assay does not test for all potential infectious agents of diarrheal disease.

If microscopic examination is warranted contact the Microbiology laboratory at 3707, for the order to be placed.
If microscopic examination is warranted it is imperative to place stool into the PROTO-FIX transport media IMMEDIATELY after passing; living parasites degrade within 1/2 hour.   Add stool to the vial until the liquid reaches the FILL LINE.   Cap specimen vial tightly and shake to mix well.    Refer the Microbiology Specimen Collection procedures on this site for specimen collection instructions.

For microsporidia testing use the miscellaneous (MISC) order code LAB101011: MAYO LCMSP and specify Microsporidia.  Microsporidia species, Molecular Detection, PCR order will be placed by CLP. Specimen requirements: unpreserved stool.

Methodology

Biofire

CPT Code

87328

Last Updated

26-Jun-19