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Test ID: MGRP    
Mycoplasma genitalium, Molecular Detection, PCR

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

Rapid, sensitive, and specific identification of Mycoplasma genitalium from genitourinary and reproductive sources

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

Mycoplasma genitalium causes acute and chronic nongonococcal 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.

Not applicable

Interpretation Provides information to assist in interpretation of the test results

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 or probes, or the presence of Mycoplasma genitalium in quantities below 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.

Supportive Data

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.(1) 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(2) 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 or fluid. All results (except for 2) were as expected.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Jurstrand M, Jensen JS, Fredlund H, et al: Detection of Mycoplasma genitalium in urogenital specimens by real-time PCR and by conventional PCR assay. J Med Microbiol 2005;54(Pt 1):23-29
2. 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

3. Taylor-Robinson D, Jensen JS: Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Micro Rev 2011;24:498-514