Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial

Ian Boostrom; Yohan Bala; Jelena Minic Vasic; Jelena Gluvakov; Emmanuel Chanard; Andrew H. Barratt; Kirsty Sands; Edward Portal; Laurence Devigne; Lucy C. Jones; Owen B. Spiller

doi:10.1093/jac/dkab320

Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial

Ian Boostrom, Yohan Bala, Jelena Minic Vasic, Jelena Gluvakov, Emmanuel Chanard, Andrew H. Barratt, Kirsty Sands, Edward Portal, Laurence Devigne, Lucy C. Jones, Owen B. Spiller^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

690 Downloads (Pure)

Abstract

Objectives: To evaluate the accuracy, susceptibility and specificity of MYCOPLASMA IST3, the next generation of the most popular culture-based in vitro diagnostic device designed to detect, identify and test the susceptibility of urogenital mycoplasma infections.

Methods: MYCOPLASMA IST3 was evaluated against culture- and molecular-based gold standard methodologies to detect, identify, enumerate and determine antimicrobial resistance for Mycoplasma hominis and Ureaplasma species in 516 clinical samples collected across France, Serbia and the UK. Sample types included vulvovaginal/endocervical or urethral swabs (dry swab or eSwab((R))), semen and urine samples, which included blinded analysis following addition of a panel of 80 characterized control strains.

Results: Overall species identification was excellent for both Ureaplasma spp. (98.4% sensitivity, 99.7% specificity) and M. hominis (95.7% sensitivity, 100% specificity) relative to combined colony morphology on agar and quantitative PCR standards. Non-dilution-based bacterial load estimation by the assay was accurate between 83.7% (M. hominis) and 86.3% (Ureaplasma spp.) of the time (increased to 94.2% and 100%, respectively, if 10-fold variance was allowed) relative to colonies counted on agar. Resistance accuracy for Ureaplasma spp. varied from gold standards for only 11/605 of individual tests (major error rate=1.8%) and for 14/917 individual tests for M. hominis (major error rate=1.5%).

Conclusions: The redesigned MYCOPLASMA IST3 assay eliminated previous shortcomings by providing independent accurate resistance screening of M. hominis and Ureaplasma species, even in mixed infections, with CLSI-compliant thresholds. Specificity, sensitivity and enumeration estimates correlated closely with the confirmatory methods.

Original language	English
Pages (from-to)	3175-3182
Number of pages	8
Journal	Journal of Antimicrobial Chemotherapy
Volume	76
Issue number	12
Early online date	3 Sept 2021
DOIs	https://doi.org/10.1093/jac/dkab320
Publication status	Published - 1 Dec 2021

Bibliographical note

Funding Information: A.H.B. was supported by the Knowledge Economy Skills Scholarship 2 (KESS2) programme of funding (grant #80815) for his MPhil under the supervision of O.B.S. and L.C.J. Partial funding support for this project was
provided by bioMérieux to O.B.S. and I.B.

Open Access: This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected]

Publisher Copyright: © The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.

Citation: Ian Boostrom, Yohan Bala, Jelena Minic Vasic, Jelena Gluvakov, Emmanuel Chanard, Andrew H Barratt, Kirsty Sands, Edward Portal, Laurence Devigne, Lucy C Jones, Owen B Spiller, Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial, Journal of Antimicrobial Chemotherapy, Volume 76, Issue 12, December 2021, Pages 3175–3182,

DOI: https://doi.org/10.1093/jac/dkab320

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1093/jac/dkab320Licence: CC BY-NC

Boostrom2021EvaluationOfTheMYCOPLASMAIST3UrogenitalMycoplasmaJAntimicrobChemotherFinal published version, 246 KBLicence: CC BY-NC

Cite this

@article{c9cce0a000964adb90944fbc26af89e8,

title = "Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial",

abstract = "Objectives: To evaluate the accuracy, susceptibility and specificity of MYCOPLASMA IST3, the next generation of the most popular culture-based in vitro diagnostic device designed to detect, identify and test the susceptibility of urogenital mycoplasma infections.Methods: MYCOPLASMA IST3 was evaluated against culture- and molecular-based gold standard methodologies to detect, identify, enumerate and determine antimicrobial resistance for Mycoplasma hominis and Ureaplasma species in 516 clinical samples collected across France, Serbia and the UK. Sample types included vulvovaginal/endocervical or urethral swabs (dry swab or eSwab((R))), semen and urine samples, which included blinded analysis following addition of a panel of 80 characterized control strains.Results: Overall species identification was excellent for both Ureaplasma spp. (98.4% sensitivity, 99.7% specificity) and M. hominis (95.7% sensitivity, 100% specificity) relative to combined colony morphology on agar and quantitative PCR standards. Non-dilution-based bacterial load estimation by the assay was accurate between 83.7% (M. hominis) and 86.3% (Ureaplasma spp.) of the time (increased to 94.2% and 100%, respectively, if 10-fold variance was allowed) relative to colonies counted on agar. Resistance accuracy for Ureaplasma spp. varied from gold standards for only 11/605 of individual tests (major error rate=1.8%) and for 14/917 individual tests for M. hominis (major error rate=1.5%).Conclusions: The redesigned MYCOPLASMA IST3 assay eliminated previous shortcomings by providing independent accurate resistance screening of M. hominis and Ureaplasma species, even in mixed infections, with CLSI-compliant thresholds. Specificity, sensitivity and enumeration estimates correlated closely with the confirmatory methods.",

author = "Ian Boostrom and Yohan Bala and Vasic, {Jelena Minic} and Jelena Gluvakov and Emmanuel Chanard and Barratt, {Andrew H.} and Kirsty Sands and Edward Portal and Laurence Devigne and Jones, {Lucy C.} and Spiller, {Owen B.}",

note = "Funding Information: A.H.B. was supported by the Knowledge Economy Skills Scholarship 2 (KESS2) programme of funding (grant #80815) for his MPhil under the supervision of O.B.S. and L.C.J. Partial funding support for this project was provided by bioM{\'e}rieux to O.B.S. and I.B. Open Access: This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected] Publisher Copyright: {\textcopyright} The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. Citation: Ian Boostrom, Yohan Bala, Jelena Minic Vasic, Jelena Gluvakov, Emmanuel Chanard, Andrew H Barratt, Kirsty Sands, Edward Portal, Laurence Devigne, Lucy C Jones, Owen B Spiller, Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial, Journal of Antimicrobial Chemotherapy, Volume 76, Issue 12, December 2021, Pages 3175–3182, DOI: https://doi.org/10.1093/jac/dkab320",

year = "2021",

month = dec,

day = "1",

doi = "10.1093/jac/dkab320",

language = "English",

volume = "76",

pages = "3175--3182",

journal = "Journal of Antimicrobial Chemotherapy",

issn = "0305-7453",

publisher = "Oxford University Press",

number = "12",

}

TY - JOUR

T1 - Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial

AU - Boostrom, Ian

AU - Bala, Yohan

AU - Vasic, Jelena Minic

AU - Gluvakov, Jelena

AU - Chanard, Emmanuel

AU - Barratt, Andrew H.

AU - Sands, Kirsty

AU - Portal, Edward

AU - Devigne, Laurence

AU - Jones, Lucy C.

AU - Spiller, Owen B.

N1 - Funding Information: A.H.B. was supported by the Knowledge Economy Skills Scholarship 2 (KESS2) programme of funding (grant #80815) for his MPhil under the supervision of O.B.S. and L.C.J. Partial funding support for this project was provided by bioMérieux to O.B.S. and I.B. Open Access: This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected] Publisher Copyright: © The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. Citation: Ian Boostrom, Yohan Bala, Jelena Minic Vasic, Jelena Gluvakov, Emmanuel Chanard, Andrew H Barratt, Kirsty Sands, Edward Portal, Laurence Devigne, Lucy C Jones, Owen B Spiller, Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial, Journal of Antimicrobial Chemotherapy, Volume 76, Issue 12, December 2021, Pages 3175–3182, DOI: https://doi.org/10.1093/jac/dkab320

PY - 2021/12/1

Y1 - 2021/12/1

N2 - Objectives: To evaluate the accuracy, susceptibility and specificity of MYCOPLASMA IST3, the next generation of the most popular culture-based in vitro diagnostic device designed to detect, identify and test the susceptibility of urogenital mycoplasma infections.Methods: MYCOPLASMA IST3 was evaluated against culture- and molecular-based gold standard methodologies to detect, identify, enumerate and determine antimicrobial resistance for Mycoplasma hominis and Ureaplasma species in 516 clinical samples collected across France, Serbia and the UK. Sample types included vulvovaginal/endocervical or urethral swabs (dry swab or eSwab((R))), semen and urine samples, which included blinded analysis following addition of a panel of 80 characterized control strains.Results: Overall species identification was excellent for both Ureaplasma spp. (98.4% sensitivity, 99.7% specificity) and M. hominis (95.7% sensitivity, 100% specificity) relative to combined colony morphology on agar and quantitative PCR standards. Non-dilution-based bacterial load estimation by the assay was accurate between 83.7% (M. hominis) and 86.3% (Ureaplasma spp.) of the time (increased to 94.2% and 100%, respectively, if 10-fold variance was allowed) relative to colonies counted on agar. Resistance accuracy for Ureaplasma spp. varied from gold standards for only 11/605 of individual tests (major error rate=1.8%) and for 14/917 individual tests for M. hominis (major error rate=1.5%).Conclusions: The redesigned MYCOPLASMA IST3 assay eliminated previous shortcomings by providing independent accurate resistance screening of M. hominis and Ureaplasma species, even in mixed infections, with CLSI-compliant thresholds. Specificity, sensitivity and enumeration estimates correlated closely with the confirmatory methods.

AB - Objectives: To evaluate the accuracy, susceptibility and specificity of MYCOPLASMA IST3, the next generation of the most popular culture-based in vitro diagnostic device designed to detect, identify and test the susceptibility of urogenital mycoplasma infections.Methods: MYCOPLASMA IST3 was evaluated against culture- and molecular-based gold standard methodologies to detect, identify, enumerate and determine antimicrobial resistance for Mycoplasma hominis and Ureaplasma species in 516 clinical samples collected across France, Serbia and the UK. Sample types included vulvovaginal/endocervical or urethral swabs (dry swab or eSwab((R))), semen and urine samples, which included blinded analysis following addition of a panel of 80 characterized control strains.Results: Overall species identification was excellent for both Ureaplasma spp. (98.4% sensitivity, 99.7% specificity) and M. hominis (95.7% sensitivity, 100% specificity) relative to combined colony morphology on agar and quantitative PCR standards. Non-dilution-based bacterial load estimation by the assay was accurate between 83.7% (M. hominis) and 86.3% (Ureaplasma spp.) of the time (increased to 94.2% and 100%, respectively, if 10-fold variance was allowed) relative to colonies counted on agar. Resistance accuracy for Ureaplasma spp. varied from gold standards for only 11/605 of individual tests (major error rate=1.8%) and for 14/917 individual tests for M. hominis (major error rate=1.5%).Conclusions: The redesigned MYCOPLASMA IST3 assay eliminated previous shortcomings by providing independent accurate resistance screening of M. hominis and Ureaplasma species, even in mixed infections, with CLSI-compliant thresholds. Specificity, sensitivity and enumeration estimates correlated closely with the confirmatory methods.

UR - http://www.scopus.com/inward/record.url?scp=85119608283&partnerID=8YFLogxK

U2 - 10.1093/jac/dkab320

DO - 10.1093/jac/dkab320

M3 - Article

C2 - 34477840

AN - SCOPUS:85119608283

SN - 0305-7453

VL - 76

SP - 3175

EP - 3182

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

IS - 12

ER -

Evaluation of the MYCOPLASMA IST3 urogenital mycoplasma assay in an international multicentre trial

Abstract

Bibliographical note

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this