Mycoplasma genitalium, Molecular Detection, PCR
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Rapid, sensitive, and specific identification of Mycoplasma genitalium from genitourinary and reproductive sources
Real-Time Polymerase Chain Reaction (PCR) Using LightCycler and Fluorescent Resonance Energy Transfer (FRET)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Mycoplasma genitalium PCR
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen source is required.
Submit only 1 of the following specimens:
Specimen Type: Swab
Sources: Cervix, urethra, urogenital, vaginal
Preferred: Dacron or rayon swab with aluminum or plastic shaft (does not need to be in transport media)
Acceptable: Swab in transport media: M5 (Supply T484), M4, or universal transport media
Specimen Volume: Entire specimen
Vaginal: Collect specimen by swabbing back and forth over mucosa surface to maximize recovery of cells.
Urethra or Cervical: Collect specimen by inserting swab 1 to 3 cm and rotating 360 degrees.
Specimen Type: Fluid
Sources: Amniotic, pelvic, prostatic secretion, reproductive drainage, semen
Preferred: Sterile container
Acceptable: Container with 3 mL of transport media: M5 (Supply T484), M4, or universal transport media
Specimen Volume: 1-2 mL
Specimen Type: Urine (kidney stones)
Container/Tube: Sterile container
Specimen Volume: 10 mL
Specimen Type: Tissue
Sources: Placenta, products of conception, genitourinary
Container/Tube: Sterile container
Specimen Volume: 5 mm
Collection Instructions: Submit only fresh tissue.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Pelvic Fluid, Amniotic Fluid, Prostatic Secretions, Semen, Reproductive Drainage-Fluid: 1 mL/Urine: 2 mL/Swab: 1 Swab
Wooden shaft, cotton swab
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Varies||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Mycoplasma genitalium causes acute and chronic non-gonococcal urethritis, cervicitis and pelvic inflammatory disease. Culture isolation is technically challenging; PCR is the diagnostic test of choice.
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.
A positive PCR result for the presence of a specific sequence found within the Mycoplasma genitalium tuf gene indicates the presence of Mycoplasma genitalium DNA in the specimen.
A negative PCR result indicates the absence of detectable Mycoplasma genitalium DNA in the specimen, but does not rule-out infection as false-negative results may occur due to the following; inhibition of PCR, sequence variability underlying the primers and/or probes, or the presence of Mycoplasma genitalium in quantities less than the limit of detection of the assay
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Interfering substances may affect the accuracy of this assay; results should always be interpreted in conjunction with clinical and epidemiological findings.
This test does not detect other mycoplasmas or ureaplasmas.
This assay was clinically validated in a blinded fashion using 399 archived specimens submitted for Mycoplasma hominis or Ureaplasma culture, 383 of which were in M4, M5, M6 or Universal Transport Medium (UTM). The specimens consisted of 349 genitourinary and 50 reproductive fluids or tissues. The results were compared to PCR results obtained using the method described by Jurstrand et al. (Journal of Medical Microbiology 2005;54:23-29). Compared to the method by Jurstrand et al, the Mayo PCR assay had 100% sensitivity and 100% specificity; however, only 1 positive specimen, a vaginal swab, was included in the analysis. That specimen was also tested by PCR by Dr. Kathleen A. Stellrecht at the Albany Medical Center (Journal of Clinical Microbiology 2004;42:1528-1533) and found to be positive. The limit of detection of the assay is 100 targets/mcL for all validated sources. Additional spiking studies (at the limit of detection of the assay) were performed using 30 or more of each of the following: genitourinary swabs, genitourinary fluid, and reproductive tissue/fluid. All results (except for 2) were as expected.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Stellrecht KA, Woron AM, Mishrik NG, Venezia RA: Comparison of multiplex PCR assay with culture detection of genital mycoplasmas. J Clin Microbiol 2004;42:1528-1533
2. Taylor-Robinson D, Jensen JS: Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Micro Rev 2011;24:498–514
Method Description Describes how the test is performed and provides a method-specific reference
This PCR method employs a target-specific detection system including primers, as well as fluorescent resonance energy transfer (FRET) hybridization probes designed for tuf of Mycoplasma genitalium. The LightCycler instrument amplifies and monitors target nucleic acid sequences by fluorescence during PCR cycling. This is an automated PCR system that can rapidly detect amplified product development. The detection of amplified products is based on the FRET principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3' end is excited by an external light source, which emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, on the 5' end. The acceptor fluorophore then emits light of a different wavelength that is measured with a signal that is proportional to the amount of specific PCR product. The process is completed in a closed-tube system. (Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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 U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|