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Test Id : TBSP

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Mycobacterium tuberculosis Complex Species Identification, PCR, Varies

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Overview

Test Catalog

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

Determining the species of a Mycobacterium tuberculosis complex culture isolate

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
RTBSP Id, Mtb Speciation, PCR No, (Bill Only) Yes

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

When this test is ordered, species identification will always be performed at an additional charge.

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

Real-Time Polymerase Chain Reaction (PCR)

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

M tuberculosis species ID, PCR

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

Acid-Fast Bacilli (AFB)

AFB (Acid-Fast Bacilli)

Bacillus, Acid-Fast

MTB (Mycobacterium tuberculosis)

Mycobacterium tuberculosis (MTB)

TB (Tuberculosis)

Tubercle Bacilli: Mycobacterium tuberculosis

Tuberculosis (TB)

MTB Complex Species

Species Identification

Tuberculosis Complex Species

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

When this test is ordered, species identification will always be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This test should be used to identify the species within the Mycobacterium tuberculosis complex from a known M tuberculosis complex isolate.

 

For identification of M tuberculosis complex from isolate growth, order CTBID / Culture Referred for Identification, Mycobacterium and Nocardia, Varies.

 

For rapid identification of M tuberculosis complex directly from a specimen, order MTBRP / Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Varies or MTBXS / Mycobacterium tuberculosis Complex, Molecular Detection and Rifampin Resistance, PCR, Sputum.

Shipping Instructions

1. For shipping information see Infectious Specimen Shipping Guidelines.

2. Place specimen in a large infectious container and label as an etiologic agent/infectious substance.

Necessary Information

Specimen source and suspected organism identification are required.

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

Specimen Type: Mycobacterium tuberculosis complex isolate growing in pure culture

Supplies: Infectious Container, Large (T146)

Container/Tube: Growth on solid slant media, eg, Middlebrook 7H10, 7H11 and Lowenstein Jensen; growth in broth medium, eg, Mycobacteria Growth Indicator Tube, 7H9 broth BACT/ALERT MP or VersaTREK

Specimen Volume: Isolate with visible growth on solid media; if broth is sent, 3 mL or more of broth culture

Collection Instructions:

1. Bacterial organism must be submitted in pure culture, actively growing. Do not submit mixed cultures.

2. Place specimen in a large infectious container and label as an etiologic agent/infectious substance.

Additional Information: If subculture to Middlebrook agar medium is needed to ensure purity, turnaround time for results may be delayed.

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

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

Agar plate
Mixed culture 		Reject

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 Ambient (preferred)
Refrigerated

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

Determining the species of a Mycobacterium tuberculosis complex culture isolate

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

When this test is ordered, species identification will always be performed at an additional charge.

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

This assay provides a species-level identification of microbiologic culture isolates previously identified to be a member of the Mycobacterium tuberculosis complex. Species level identification can be important for patient care or for epidemiologic investigations. For example, the species-level identification of Mycobacterium bovis bacillus Calmette-Guerin (BCG) can assist with identification of disseminated infections following use of the vaccine as an adjuvant during chemotherapy.

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.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

This assay can differentiate the most common species within the Mycobacterium tuberculosis complex, which are, M tuberculosis, Mycobacterium bovis, Mycobacterium bovis bacillus Calmette-Guerin (BCG; the vaccine strain), Mycobacterium canettii, Mycobacterium caprae, Mycobacterium microti, and Mycobacterium pinnepedii.. This assay cannot distinguish Mycobacterium africanum from Mycobacterium mungi so if that result is obtained, the organism will be reported as M africanum/M mungi.

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

Only isolates of Mycobacterium tuberculosis complex should be submitted and they must be in pure culture. Nontuberculous mycobacteria should not be submitted. Mixed cultures will result in a delay because the M tuberculosis complex organism must be isolated prior to performing the polymerase chain reaction assay.

 

This assay has not been verified for the direct detection of M tuberculosis complex from clinical specimens. It is intended for use on microbiologic culture isolates already identified as M tuberculosis complex.

Supportive Data

Type strains of Mycobacterium tuberculosis complex members were tested using the species identification polymerase chain reaction (PCR) assay and all were identified correctly. Type strains tested were M tuberculosis ATCC 27294, Mycobacterium bovis ATCC 19210, M bovis BCG ATCC 101472, Mycobacterium africanum ATCC 25240, Mycobacterium microti ATCC 19422, Mycobacterium caprae ATCC BAA 824, Mycobacterium pinnipedii ATCC BAA 688.

 

In addition, a clinical isolate of Mycobacterium canettii, identified by whole genome sequencing at the New York State Department of Health Wadsworth Center, was tested and confirmed to be M canettii by the M tuberculosis complex species identification PCR assay.

 

As part of the verification of this assay, 78 M tuberculosis complex isolates with the species identified at a reference laboratory were tested using the species identification PCR assay. All 78 isolates were correctly identified to the species level.

 

Table. Species reported by reference laboratory

LC 480 PCR results

 

M tuberculosis

M bovis

M bovis BCG

M africanium

M tuberculosis

53

 

 

 

M bovis

 

4

 

 

M bovis BCG

 

 

14

 

M africanium

 

 

 

7

 

Although the species identification test can be used only for mycobacterial isolates already identified as M tuberculosis complex, 159 other Mycobacterium species isolates were tested to determine whether any nontuberculous mycobacteria would be positive in the test. No nontuberculous mycobacteria were positive in the M tuberculosis complex species identification PCR assay.

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

Fitzgerald DW, Sterling TR, Haas DW. Mycobacterium tuberculosis. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:2985-3021

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

The method uses real-time polymerase chain reaction on the LightCycler 480 platform with Mycobacterium tuberculosis complex-specific primers coupled with fluorescence resonance energy transfer (FRET) probes to differentiate the members of the complex to the species level. The probes target specific regions of difference (RD) within the M tuberculosis complex genome. Detection of the presence or absence of these RD allows for differentiation of the species within the M tuberculosis complex.(Halse TA, Escuyer VE, Musser KA. Evaluation of a single tube multiplex real-time PCR for differentiation of members of the Mycobacterium tuberculosis complex in clinical specimens. J Clin Microbiol. 2011;49:2562-2567; Warshauer DM, Salfinger M, Desmond E, and Lin S-Y G. Mycobacterium tuberculosis complex. In: Carroll KC, Pfaller MA, Landry ML, et al, eds. Manual of Clinical Microbiology. 12th edition, ASM Press; 2019:576-594)

 

The RD's expected for each species within the M tuberculosis complex are shown in the table below. "+" indicates the region is present and "-" indicates the region is absent.

 

Expected RD signature patterns

RD1

RD4

RD9

RD12

RD9-2

Mycobacterium tuberculosis

+

+

+

+

+

Mycobacterium bovis

+

-

-

-

+

Mycobacterium bovis BCG

-

-

-

-

+

Mycobacterium africanum

+

+

-

+

+

Mycobacterium canettii

+

+

+

-

+

Mycobacterium caprae

+

+

-

-

+

Mycobacterium microti

-

+

-

+

+

Mycobacterium mungi

+

+

-

+

+

Mycobacterium pinnepedii

+

+

-

-

+

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.

Monday 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.

7 to 14 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 year

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 account representative. 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

87150

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
TBSP M tuberculosis species ID, PCR 94576-6
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.
TBSP M tuberculosis species ID, PCR 94576-6

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 | PHP Pdf | CMS 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