Multicentre Clinical Evaluation of a Molecular Diagnostic Assay to Identify Neisseria gonorrhoeae Infection and Detect Antimicrobial Resistance
•This assay bridges the gap between molecular diagnostic assays and antimicrobial resistance (AMR) detection in Neisseria gonorrhoeae (N. gonorrhoeae).•The high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) assay showed promising diagnostic performance for detecting N. gonorrhoeae infe...
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| Veröffentlicht in: | International journal of antimicrobial agents 2023-05, Vol.61 (5), p.106785-106785, Article 106785 |
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| creator | Xiu, Leshan Wang, Liqin Li, Yamei Hu, Lihua Huang, Jia Yong, Gang Wang, Youwei Cao, Wenling Dong, Yuan Gu, Weiming Peng, Junping |
| description | •This assay bridges the gap between molecular diagnostic assays and antimicrobial resistance (AMR) detection in Neisseria gonorrhoeae (N. gonorrhoeae).•The high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR.•40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.•This assay can be used to enhance AMR surveillance and inform treatment.
Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (N. gonorrhoeae) is an urgent threat to public health, with the emergence of highly resistant strains such as the FC428 clone. This study aimed to evaluate the high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) for diagnosing N. gonorrhoeae infection and detecting extended-spectrum cephalosporins and azithromycin resistance.
A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65–97.28) and a specificity of 96.44% (95% CI 94.17–97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57–97.50) for cefixime to 99.52% (95% CI 98.68–99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87–43.97) for azithromycin to 79.10% (95% CI 63.52–89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
[Display omitted] |
| doi_str_mv | 10.1016/j.ijantimicag.2023.106785 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2787214628</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0924857923000675</els_id><sourcerecordid>2787214628</sourcerecordid><originalsourceid>FETCH-LOGICAL-c377t-bbe4b49fe913e0ad7499f4e0f23a43dc096ca7aaf0dd3ddcbbe524e004b223a43</originalsourceid><addsrcrecordid>eNqNUU1v1DAQtRCILoW_gMyNS7Z24sTJcbUtsFILEoKzNbEny6yydrGTSvsr-pdxm1Jx5GTZfh8z7zH2QYq1FLK5OKzpAH6iI1nYr0tRVvm90W39gq1kq8tCd7J6yVaiK1XR1ro7Y29SOggh60rVr9lZ1XSyFa1esfubeZzIop8i8u1IPkuO_OoOxhkmCp6HgQO_CSPaeYTILwn2PqRM4ZuU4MSnwHcu02k48a9IKWEk4PvgQ4y_AgLynR_QPmqBd_wSp3zjm2X8GHrKft8xUZrAW3zLXg0wJnz3dJ6zn5-ufmy_FNffPu-2m-vCVlpPRd-j6lU3YF4UBTitum5QKIayAlU5K7rGggYYhHOVczbj6zL_C9WXj5Bz9nHRvY3h94xpMkdKFscRPIY5mVLnHKVqyjZDuwWap00p4mBuIx0hnowU5qEPczD_9GEe-jBLH5n7_slm7o_onpl_C8iA7QLAvOwdYTTJEuYgHMWck3GB_sPmD3Z5pi8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2787214628</pqid></control><display><type>article</type><title>Multicentre Clinical Evaluation of a Molecular Diagnostic Assay to Identify Neisseria gonorrhoeae Infection and Detect Antimicrobial Resistance</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><creator>Xiu, Leshan ; Wang, Liqin ; Li, Yamei ; Hu, Lihua ; Huang, Jia ; Yong, Gang ; Wang, Youwei ; Cao, Wenling ; Dong, Yuan ; Gu, Weiming ; Peng, Junping</creator><creatorcontrib>Xiu, Leshan ; Wang, Liqin ; Li, Yamei ; Hu, Lihua ; Huang, Jia ; Yong, Gang ; Wang, Youwei ; Cao, Wenling ; Dong, Yuan ; Gu, Weiming ; Peng, Junping</creatorcontrib><description>•This assay bridges the gap between molecular diagnostic assays and antimicrobial resistance (AMR) detection in Neisseria gonorrhoeae (N. gonorrhoeae).•The high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR.•40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.•This assay can be used to enhance AMR surveillance and inform treatment.
Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (N. gonorrhoeae) is an urgent threat to public health, with the emergence of highly resistant strains such as the FC428 clone. This study aimed to evaluate the high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) for diagnosing N. gonorrhoeae infection and detecting extended-spectrum cephalosporins and azithromycin resistance.
A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65–97.28) and a specificity of 96.44% (95% CI 94.17–97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57–97.50) for cefixime to 99.52% (95% CI 98.68–99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87–43.97) for azithromycin to 79.10% (95% CI 63.52–89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
[Display omitted]</description><identifier>ISSN: 0924-8579</identifier><identifier>EISSN: 1872-7913</identifier><identifier>DOI: 10.1016/j.ijantimicag.2023.106785</identifier><identifier>PMID: 36918087</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Anti-Bacterial Agents - pharmacology ; Anti-Bacterial Agents - therapeutic use ; Antimicrobial resistance ; Azithromycin - pharmacology ; Azithromycin - therapeutic use ; Cefixime - pharmacology ; Ceftriaxone - pharmacology ; Ceftriaxone - therapeutic use ; Clinical evaluation ; Drug Resistance, Bacterial ; FC428 clone ; Gonorrhea - drug therapy ; High-resolution melting ; Humans ; Microbial Sensitivity Tests ; Molecular diagnostics ; Neisseria gonorrhoeae ; Pathology, Molecular</subject><ispartof>International journal of antimicrobial agents, 2023-05, Vol.61 (5), p.106785-106785, Article 106785</ispartof><rights>2023 Elsevier Ltd and International Society of Antimicrobial Chemotherapy</rights><rights>Copyright © 2023 Elsevier Ltd and International Society of Antimicrobial Chemotherapy. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c377t-bbe4b49fe913e0ad7499f4e0f23a43dc096ca7aaf0dd3ddcbbe524e004b223a43</citedby><cites>FETCH-LOGICAL-c377t-bbe4b49fe913e0ad7499f4e0f23a43dc096ca7aaf0dd3ddcbbe524e004b223a43</cites><orcidid>0000-0001-7959-5286 ; 0000-0003-0391-1742</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijantimicag.2023.106785$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36918087$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Xiu, Leshan</creatorcontrib><creatorcontrib>Wang, Liqin</creatorcontrib><creatorcontrib>Li, Yamei</creatorcontrib><creatorcontrib>Hu, Lihua</creatorcontrib><creatorcontrib>Huang, Jia</creatorcontrib><creatorcontrib>Yong, Gang</creatorcontrib><creatorcontrib>Wang, Youwei</creatorcontrib><creatorcontrib>Cao, Wenling</creatorcontrib><creatorcontrib>Dong, Yuan</creatorcontrib><creatorcontrib>Gu, Weiming</creatorcontrib><creatorcontrib>Peng, Junping</creatorcontrib><title>Multicentre Clinical Evaluation of a Molecular Diagnostic Assay to Identify Neisseria gonorrhoeae Infection and Detect Antimicrobial Resistance</title><title>International journal of antimicrobial agents</title><addtitle>Int J Antimicrob Agents</addtitle><description>•This assay bridges the gap between molecular diagnostic assays and antimicrobial resistance (AMR) detection in Neisseria gonorrhoeae (N. gonorrhoeae).•The high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR.•40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.•This assay can be used to enhance AMR surveillance and inform treatment.
Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (N. gonorrhoeae) is an urgent threat to public health, with the emergence of highly resistant strains such as the FC428 clone. This study aimed to evaluate the high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) for diagnosing N. gonorrhoeae infection and detecting extended-spectrum cephalosporins and azithromycin resistance.
A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65–97.28) and a specificity of 96.44% (95% CI 94.17–97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57–97.50) for cefixime to 99.52% (95% CI 98.68–99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87–43.97) for azithromycin to 79.10% (95% CI 63.52–89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
[Display omitted]</description><subject>Anti-Bacterial Agents - pharmacology</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antimicrobial resistance</subject><subject>Azithromycin - pharmacology</subject><subject>Azithromycin - therapeutic use</subject><subject>Cefixime - pharmacology</subject><subject>Ceftriaxone - pharmacology</subject><subject>Ceftriaxone - therapeutic use</subject><subject>Clinical evaluation</subject><subject>Drug Resistance, Bacterial</subject><subject>FC428 clone</subject><subject>Gonorrhea - drug therapy</subject><subject>High-resolution melting</subject><subject>Humans</subject><subject>Microbial Sensitivity Tests</subject><subject>Molecular diagnostics</subject><subject>Neisseria gonorrhoeae</subject><subject>Pathology, Molecular</subject><issn>0924-8579</issn><issn>1872-7913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUU1v1DAQtRCILoW_gMyNS7Z24sTJcbUtsFILEoKzNbEny6yydrGTSvsr-pdxm1Jx5GTZfh8z7zH2QYq1FLK5OKzpAH6iI1nYr0tRVvm90W39gq1kq8tCd7J6yVaiK1XR1ro7Y29SOggh60rVr9lZ1XSyFa1esfubeZzIop8i8u1IPkuO_OoOxhkmCp6HgQO_CSPaeYTILwn2PqRM4ZuU4MSnwHcu02k48a9IKWEk4PvgQ4y_AgLynR_QPmqBd_wSp3zjm2X8GHrKft8xUZrAW3zLXg0wJnz3dJ6zn5-ufmy_FNffPu-2m-vCVlpPRd-j6lU3YF4UBTitum5QKIayAlU5K7rGggYYhHOVczbj6zL_C9WXj5Bz9nHRvY3h94xpMkdKFscRPIY5mVLnHKVqyjZDuwWap00p4mBuIx0hnowU5qEPczD_9GEe-jBLH5n7_slm7o_onpl_C8iA7QLAvOwdYTTJEuYgHMWck3GB_sPmD3Z5pi8</recordid><startdate>202305</startdate><enddate>202305</enddate><creator>Xiu, Leshan</creator><creator>Wang, Liqin</creator><creator>Li, Yamei</creator><creator>Hu, Lihua</creator><creator>Huang, Jia</creator><creator>Yong, Gang</creator><creator>Wang, Youwei</creator><creator>Cao, Wenling</creator><creator>Dong, Yuan</creator><creator>Gu, Weiming</creator><creator>Peng, Junping</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7959-5286</orcidid><orcidid>https://orcid.org/0000-0003-0391-1742</orcidid></search><sort><creationdate>202305</creationdate><title>Multicentre Clinical Evaluation of a Molecular Diagnostic Assay to Identify Neisseria gonorrhoeae Infection and Detect Antimicrobial Resistance</title><author>Xiu, Leshan ; 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Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (N. gonorrhoeae) is an urgent threat to public health, with the emergence of highly resistant strains such as the FC428 clone. This study aimed to evaluate the high-resolution melting assay of N. gonorrhoeae AMR (HRM-NG-AMR) for diagnosing N. gonorrhoeae infection and detecting extended-spectrum cephalosporins and azithromycin resistance.
A multicentre collection of 1488 samples, including 770 isolates and 718 urogenital swabs, was used to evaluate the performance of the HRM-NG-AMR assay. The presence of N. gonorrhoeae was confirmed by culture. Minimum inhibitory concentrations of antibiotics against the tested isolates were determined using the agar dilution method.
Regarding N. gonorrhoeae identification, HRM-NG-AMR had a sensitivity of 95.15% (95% CI 91.65–97.28) and a specificity of 96.44% (95% CI 94.17–97.89) using culture as standard. Regarding AMR detection, the specificity ranged from 96.29% (95% CI 94.57–97.50) for cefixime to 99.52% (95% CI 98.68–99.85) for azithromycin. Additionally, the sensitivity ranged from 31.34% (95% CI 20.87–43.97) for azithromycin to 79.10% (95% CI 63.52–89.42) for ceftriaxone. It was determined that 664 of 672 (98.81%) and 615 of 672 (91.52%) N. gonorrhoeae isolates were susceptible to ceftriaxone and cefixime, respectively, by detecting non-mosaic penA. Lastly, 40 genotypic FC428-related strains with the penA-60.001 allele were accurately identified.
The HRM-NG-AMR assay showed promising diagnostic performance for detecting N. gonorrhoeae infection and predicting AMR. This study aimed to evaluate the application of this assay in the clinical setting to enhance AMR surveillance and treatment intervention.
[Display omitted]</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>36918087</pmid><doi>10.1016/j.ijantimicag.2023.106785</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-7959-5286</orcidid><orcidid>https://orcid.org/0000-0003-0391-1742</orcidid></addata></record> |
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| ispartof | International journal of antimicrobial agents, 2023-05, Vol.61 (5), p.106785-106785, Article 106785 |
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| subjects | Anti-Bacterial Agents - pharmacology Anti-Bacterial Agents - therapeutic use Antimicrobial resistance Azithromycin - pharmacology Azithromycin - therapeutic use Cefixime - pharmacology Ceftriaxone - pharmacology Ceftriaxone - therapeutic use Clinical evaluation Drug Resistance, Bacterial FC428 clone Gonorrhea - drug therapy High-resolution melting Humans Microbial Sensitivity Tests Molecular diagnostics Neisseria gonorrhoeae Pathology, Molecular |
| title | Multicentre Clinical Evaluation of a Molecular Diagnostic Assay to Identify Neisseria gonorrhoeae Infection and Detect Antimicrobial Resistance |
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