Test Catalog

Test Id : LCMSP

Microsporidia species, Molecular Detection, PCR, Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection of Enterocytozoon bieneusi and Encephalitozoon species in fecal and urine specimens to support the clinical diagnosis of microsporidiosis

Highlights

This test is intended to be used for immunocompromised patients with persistent, watery diarrhea. See the Parasitic Investigation of Stool Specimens Algorithm.

 

This test is intended to be used for the detection of Enterocytozoon bieneusi and Encephalitozoon species DNA in fecal and urine specimens to support the clinical diagnosis of microsporidiosis. Other sources should be tested using MTBS / Microsporidia Stain, Varies.

 

A negative result indicates the absence of detectable DNA from Enterocytozoon bieneusi and Encephalitozoon species in the specimen, but does not rule out ongoing microsporidiosis. See Interpretation for more information.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Microsporidia PCR

Aliases
Lists additional common names for a test, as an aid in searching

Encephalitozoon

Enterocytozoon

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

For specimens other than feces or urine, MTBS / Microsporidia Stain, Varies should be ordered since it will detect other microsporidia that are not targeted by this assay.

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MSPS Specimen Source

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Unpreserved feces

Supplies: Stool container, Small (Random), 4 oz (T288); Stool Collection Kit, Random (T635)

Container/Tube: Fecal container (T288)

Specimen Volume: 5 g

 

Specimen Type: Preserved feces

Supplies: ECOFIX Stool Transport Vial (Kit) (T219); Stool Collection Kit, Random (T635)

Container/Tube: ECOFIX preservative

Specimen Volume: 5 g

 

Specimen Type: Urine

Container/Tube: Sterile container

Specimen Volume: 5 mL

Collection Instructions: Mid-stream, clean-catch, suprapubic aspirates and catheterization collections are acceptable. Please submit in a clean, sterile container free from preservatives. The first portion of the voided urine (first void) is also acceptable.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Client Test Request (T728)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Feces: 1 g

Urine: 0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Other Urine containing preservatives Prostate secretions and samples Feces in preservatives other than ECOFIX

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
Ambient 7 days
Frozen 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection of Enterocytozoon bieneusi and Encephalitozoon species in fecal and urine specimens to support the clinical diagnosis of microsporidiosis

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Microsporidia are highly specialized fungi that cause a wide variety of clinical syndromes in humans. The most common microsporidia are Enterocytozoon bieneusi and Encephalitozoon intestinalis, which infect the gastrointestinal tract and cause a diarrheal illness, and Encephalitozoon cuniculi and Encephalitozoon hellem that can infect the conjunctiva, respiratory tract, and genitourinary system. Human infections have been reported most frequently in patients with AIDS, but also can occur in other immunocompromised patients, including solid organ allograft recipients and, sporadically, immunocompetent hosts. Less commonly, other microsporidia such as Vittaforma corneae and Brachiola species can cause disseminated or organ-specific disease. This assay detects only the most common microsporidia, Enterocytozoon bieneusi and Encephalitozoon species, and not microsporidiosis due to other species.

 

See Parasitic Investigation of Stool Specimens Algorithm and Laboratory Testing for Infectious Causes of Diarrhea in Special Instructions for other diagnostic tests that may be of value in evaluating patients with diarrhea.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of Enterocytozoon bieneusi and Encephalitozoon species DNA and is consistent with an active or recent infection. Since microsporidia DNA may be present in feces or urine in the absence of clinical symptoms, results should be correlated with clinical presentation.

 

A negative result indicates absence of detectable DNA from Enterocytozoon bieneusi and Encephalitozoon species in the specimen, but does not always rule out ongoing microsporidiosis since the organism may be present at very low levels or may be sporadic.

 

Other tests to consider in the evaluation of a patient presenting with acute or chronic watery diarrhea include cultures or specific assays for bacterial, viral, and parasitic pathogens.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test only detects DNA from Enterocytozoon bieneusi and Encephalitozoon species and does not detect the less common microsporidia. These 2 genera are the most common causes of intestinal and renal microsporidiosis.

 

While this assay is designed to detect symptomatic infection with Enterocytozoon bieneusi and Encephalitozoon species, it may detect asymptomatic carriage and should only be used for patients with a clinical history and symptoms consistent with microsporidiosis.

Supportive Data

In a study using 205 clinical specimens and 254 spiked specimens, the Microsporidia PCR assay had 90% to 100% sensitivity and 100% specificity in all specimen types accepted for this assay. The limit of detection is between 500 to 5,000 target DNA copies/mL of specimen. When 10-fold dilutions of fresh stool specimens containing Enterocytozoon bieneusi spores were tested by both PCR and microscopy, PCR showed significantly greater sensitivity, with the ability to detect at Enterocytozoon bieneusi at 1 to 2 dilutions lower than microscopy.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Didier ES, Weiss LM: Microsporidiosis: Not just in AIDS patients. Curr Opin Infect Dis 2011;24 (5):490-495

2. Nagpal A, Pritt BS, Lorenz EC, et al: Disseminated microsporidiosis in a renal transplant recipient: case report and review of the literature. Transpl Infect Dis. 2013 Oct;15(5):526-532

3. Verweij JJ, Stensvold CR: Molecular Testing for Clinical Diagnosis and Epidemiological Investigations of Intestinal Parasitic Infections. Clin.Microbiol. Rev. April 2014;27:371-418

4. Wolk DM, Schneider SK, Wengenack NL, et al: Real-time PCR method for detection of Encephalitozoon intestinalis from stool specimens. J Clin Microbiol 2002 Nov;40(11):3922-3928

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Nucleic acid is extracted from feces and urine using the automated MagNA Pure bead-based system (Roche Molecular Systems). The extract is then transferred to individual self-contained capillary cuvettes for amplification. The LightCycler is a self-contained automated instrument that amplifies and monitors the development of target nucleic acid (amplicon) after each cycle of PCR.

 

The DNA target for PCR assay is the 18S rRNA gene of Enterocytozoon bieneusi, Encephalitozoon intestinalis, Encephalitozoon hellem, and Encephalitozoon cuniculi.

 

This assay utilizes 2 primers and 2 probes, which are specific for E bieneusi and 3 primers and 2 probes specific for Encephalitozoon species. The specific base pair DNA target sequence is first amplified by PCR using the target-specific primers. Amplicon is then detected during melting curve analysis using fluorescence resonance energy transfer (FRET) probes, which utilizes one hybridization probe with a donor fluorophore, fluorescein, at the 3' end and a second hybridization probe with an acceptor fluorophore, at the 5' end. Fluorescence is produced when the 2 probes anneal to the target sequence in close proximity to one another. The LC-Red 670 emits a measurable and quantifiable light signal at a specific wavelength when E bieneusi is present and the LC-Red 610 emits a measurable and quantifiable light signal in the presence of Encephalitozoon species.(Cockerill FR, Uhl FR: Applications and challenges of real-time PCR for the clinical microbiology laboratory. In Rapid Cycle Real-Time PCR. Edited by U Reischl, C Wittwer, F Cockerill. Springer, NY 2002

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 4 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87798

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
LCMSP Microsporidia PCR 94332-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
MSPS Specimen Source 31208-2
36744 Encephalitozoon species 94333-2
36745 Enterocytozoon bieneusi 94334-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports