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Evaluation of Six Commercial and Non-Commercial Colistin Resistance Diagnostics | medRxiv
<!DOCTYPE html> <html lang="en" dir="ltr" xmlns="http://www.w3.org/1999/xhtml" xmlns:mml="http://www.w3.org/1998/Math/MathML"> <head prefix="og: http://ogp.me/ns# article: http://ogp.me/ns/article# book: http://ogp.me/ns/book#" > <!--[if IE]><![endif]--> <link rel="dns-prefetch" href="//d33xdlntwy0kbs.cloudfront.net" /> <link rel="dns-prefetch" href="//cdn.jsdelivr.net" /> <link rel="dns-prefetch" href="//www.google.com" /> <link rel="dns-prefetch" href="//scholar.google.com" /> <link rel="dns-prefetch" href="//www.googletagmanager.com" /> <link rel="dns-prefetch" href="//rum-static.pingdom.net" /> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <link rel="shortcut icon" href="https://www.medrxiv.org/sites/default/files/images/favicon.ico" type="image/vnd.microsoft.icon" /> <meta name="viewport" content="width=device-width, initial-scale=1" /> <meta name="type" content="article" /> <meta name="category" content="article" /> <meta name="HW.identifier" content="/medrxiv/early/2024/03/22/2024.03.21.24304472.atom" /> <meta name="HW.pisa" content="medrxiv;2024.03.21.24304472v1" /> <meta name="DC.Format" content="text/html" /> <meta name="DC.Language" content="en" /> <meta name="DC.Title" content="Evaluation of Six Commercial and Non-Commercial Colistin Resistance Diagnostics" /> <meta name="DC.Identifier" content="10.1101/2024.03.21.24304472" /> <meta name="DC.Date" content="2024-03-22" /> <meta name="DC.Publisher" content="Cold Spring Harbor Laboratory Press" /> <meta name="DC.Rights" content="© 2024, Posted by Cold Spring Harbor Laboratory. This pre-print is available under a Creative Commons License (Attribution-NonCommercial-NoDerivs 4.0 International), CC BY-NC-ND 4.0, as described at http://creativecommons.org/licenses/by-nc-nd/4.0/" /> <meta name="DC.AccessRights" content="restricted" /> <meta name="DC.Description" content="Background Resistance to colistin, a last-reserve antibiotic used for treating drug-resistant infections, is increasing globally. This study evaluated six diagnostic tests designed to detect colistin-resistant pathogens. Methods PCR and broth microdilution assays (BMD) were used to respectively characterize the molecular mechanisms and phenotypic colistin resistance of 142 Gram-negative bacterial isolates and controls. The sensitivity, specificity, positive- and negative-predictive values, major (ME) and very major errors (VME), categorical and essential agreements (EA) of ComASP Colistin, CHROMagar COL- APSE , Rapid NP Test, Sensititre, MicroScan, and Vitek 2 were determined with these isolates; the BMD was used as gold standard. Results The Vitek 2, Sensititre, and ComASP tests were more efficient, albeit with concerning ME and VMEs and low EAs. Sensititre was 100% specific with 0% ME and 3.61% VME; Vitek 2 had the least VME (1.25% and 0%) and a low EA (57.50%). ComASP had an EA of 75.35%. MicroScan was highly sensitive (96.55%) but less specific (87.50%), with very below-accetable EAs (48.11%). The CHROMAgar COL- APSE efficiently identified the species with their unique colours but was the least specific (67.80%), with the highest ME (32.20%) and high VME (7.23%). The Rapid NP test had the highest VME (7.84%), producing results within 4 hours with 92.16% sensitivity and 96.08% specificity. Conclusion Vitek 2, MicroScan, ComASP colistin, and Sensititre are good for determining colistin resistance; the latter two tests are recommendable for low-resourced laboratories. The in-house Rapid NP test has short turnaround time with high efficiency for initial resistance screening. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was funded by a grant from the National Health Laboratory Service (NHLS) given to Dr. John Osei Sekyere under grant number GRANT004 94807 and GRANT004 94808. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Research Ethics Committee, Faculty of Health Sciences, University of Pretoria, under reference number 550/2020. The study complied with the ICH-GCP guidelines and the Helsinki declaration. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript" /> <meta name="DC.Contributor" content="Tumisho Mmatumelo Seipei Leshaba" /> <meta name="DC.Contributor" content="Masego Mmatli" /> <meta name="DC.Contributor" content="Lebogang Skosana" /> <meta name="DC.Contributor" content="Nontombi Marylucy Mbelle" /> <meta name="DC.Contributor" content="John Osei Sekyere" /> <meta name="article:published_time" content="2024-03-22" /> <meta name="citation_title" content="Evaluation of Six Commercial and Non-Commercial Colistin Resistance Diagnostics" /> <meta name="citation_abstract" lang="en" content="<h3>Abstract</h3> <h3>Background</h3> <p>Resistance to colistin, a last-reserve antibiotic used for treating drug-resistant infections, is increasing globally. This study evaluated six diagnostic tests designed to detect colistin-resistant pathogens.</p><h3>Methods</h3> <p>PCR and broth microdilution assays (BMD) were used to respectively characterize the molecular mechanisms and phenotypic colistin resistance of 142 Gram-negative bacterial isolates and controls. The sensitivity, specificity, positive- and negative-predictive values, major (ME) and very major errors (VME), categorical and essential agreements (EA) of ComASP Colistin, CHROMagar COL-<i>APSE</i>, Rapid NP Test, Sensititre, MicroScan, and Vitek 2 were determined with these isolates; the BMD was used as gold standard.</p><h3>Results</h3> <p>The Vitek 2, Sensititre, and ComASP tests were more efficient, albeit with concerning ME and VMEs and low EAs. Sensititre was 100% specific with 0% ME and 3.61% VME; Vitek 2 had the least VME (1.25% and 0%) and a low EA (57.50%). ComASP had an EA of 75.35%. MicroScan was highly sensitive (96.55%) but less specific (87.50%), with very below-accetable EAs (48.11%). The CHROMAgar COL-<i>APSE</i> efficiently identified the species with their unique colours but was the least specific (67.80%), with the highest ME (32.20%) and high VME (7.23%). The Rapid NP test had the highest VME (7.84%), producing results within 4 hours with 92.16% sensitivity and 96.08% specificity.</p><h3>Conclusion</h3> <p>Vitek 2, MicroScan, ComASP colistin, and Sensititre are good for determining colistin resistance; the latter two tests are recommendable for low-resourced laboratories. The in-house Rapid NP test has short turnaround time with high efficiency for initial resistance screening.</p>" /> <meta name="citation_journal_title" content="medRxiv" /> <meta name="citation_publisher" content="Cold Spring Harbor Laboratory Press" /> <meta name="citation_publication_date" content="2024/01/01" /> <meta name="citation_mjid" content="medrxiv;2024.03.21.24304472v1" /> <meta name="citation_id" content="2024.03.21.24304472v1" /> <meta name="citation_public_url" content="https://www.medrxiv.org/content/10.1101/2024.03.21.24304472v1" /> <meta name="citation_abstract_html_url" content="https://www.medrxiv.org/content/10.1101/2024.03.21.24304472v1.abstract" /> <meta name="citation_full_html_url" content="https://www.medrxiv.org/content/10.1101/2024.03.21.24304472v1.full" /> <meta name="citation_pdf_url" content="https://www.medrxiv.org/content/medrxiv/early/2024/03/22/2024.03.21.24304472.full.pdf" /> <meta name="citation_doi" content="10.1101/2024.03.21.24304472" /> <meta name="citation_num_pages" content="19" /> <meta name="citation_article_type" content="Article" /> <meta name="citation_firstpage" content="2024.03.21.24304472" /> <meta name="citation_author" content="Tumisho Mmatumelo Seipei Leshaba" /> <meta name="citation_author_institution" content="Department of Medical Microbiology, School of Medicine, University of Pretoria" /> <meta name="citation_author_orcid" content="http://orcid.org/0000-0003-1962-2435" /> <meta name="citation_author" content="Masego Mmatli" /> <meta name="citation_author_institution" content="Department of Medical Microbiology, School of Medicine, University of Pretoria" /> <meta name="citation_author_orcid" content="http://orcid.org/0000-0002-5238-454X" /> <meta name="citation_author" content="Lebogang Skosana" /> <meta name="citation_author_institution" content="Department of Medical Microbiology, School of Medicine, University of Pretoria" /> <meta name="citation_author_institution" content="Department of Medical Microbiology, Tshwane Academic Division, National Health Laboratory Service" /> <meta name="citation_author_orcid" content="http://orcid.org/0000-0002-5684-9930" /> <meta name="citation_author" content="Nontombi Marylucy Mbelle" /> <meta name="citation_author_institution" content="Department of Medical Microbiology, School of Medicine, University of Pretoria" /> <meta name="citation_author_orcid" content="http://orcid.org/0000-0001-8890-2663" /> <meta name="citation_author" content="John Osei Sekyere" /> <meta name="citation_author_institution" content="Department of Medical Microbiology, School of Medicine, University of Pretoria" /> <meta name="citation_author_institution" content="Department of Dermatology, School of Medicine, University of Pretoria" /> <meta name="citation_author_institution" content="Institute of Biomarker Research, Medical Diagnostic Laboratories, Genesis Biotechnology Group" /> <meta name="citation_author_email" content="j.oseisekyere@up.ac.za" /> <meta name="citation_author_email" content="jod14139@gmail.com" /> <meta name="citation_author_orcid" content="http://orcid.org/0000-0002-9508-984X" /> <meta name="citation_reference" content="Mmatli M, Mbelle NM, Maningi NE, Osei Sekyere J. 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Eur J Clin Microbiol Infect Dis 2021;40:1749–53. 10.1007/S10096-021-04182-W." /> <meta name="twitter:title" content="Evaluation of Six Commercial and Non-Commercial Colistin Resistance Diagnostics" /> <meta name="twitter:site" content="@medrxivpreprint" /> <meta name="twitter:card" content="summary" /> <meta name="twitter:image" content="https://www.medrxiv.org/sites/default/files/images/medrxiv_logo_homepage7-5-small-test-up.png" /> <meta name="twitter:description" content="Background Resistance to colistin, a last-reserve antibiotic used for treating drug-resistant infections, is increasing globally. This study evaluated six diagnostic tests designed to detect colistin-resistant pathogens. Methods PCR and broth microdilution assays (BMD) were used to respectively characterize the molecular mechanisms and phenotypic colistin resistance of 142 Gram-negative bacterial isolates and controls. The sensitivity, specificity, positive- and negative-predictive values, major (ME) and very major errors (VME), categorical and essential agreements (EA) of ComASP Colistin, CHROMagar COL- APSE , Rapid NP Test, Sensititre, MicroScan, and Vitek 2 were determined with these isolates; the BMD was used as gold standard. Results The Vitek 2, Sensititre, and ComASP tests were more efficient, albeit with concerning ME and VMEs and low EAs. Sensititre was 100% specific with 0% ME and 3.61% VME; Vitek 2 had the least VME (1.25% and 0%) and a low EA (57.50%). ComASP had an EA of 75.35%. MicroScan was highly sensitive (96.55%) but less specific (87.50%), with very below-accetable EAs (48.11%). The CHROMAgar COL- APSE efficiently identified the species with their unique colours but was the least specific (67.80%), with the highest ME (32.20%) and high VME (7.23%). The Rapid NP test had the highest VME (7.84%), producing results within 4 hours with 92.16% sensitivity and 96.08% specificity. Conclusion Vitek 2, MicroScan, ComASP colistin, and Sensititre are good for determining colistin resistance; the latter two tests are recommendable for low-resourced laboratories. The in-house Rapid NP test has short turnaround time with high efficiency for initial resistance screening. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was funded by a grant from the National Health Laboratory Service (NHLS) given to Dr. John Osei Sekyere under grant number GRANT004 94807 and GRANT004 94808. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Research Ethics Committee, Faculty of Health Sciences, University of Pretoria, under reference number 550/2020. The study complied with the ICH-GCP guidelines and the Helsinki declaration. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript" /> <meta name="og-title" property="og:title" content="Evaluation of Six Commercial and Non-Commercial Colistin Resistance Diagnostics" /> <meta name="og-url" property="og:url" content="https://www.medrxiv.org/content/10.1101/2024.03.21.24304472v1" /> <meta name="og-site-name" property="og:site_name" content="medRxiv" /> <meta name="og-description" property="og:description" content="Background Resistance to colistin, a last-reserve antibiotic used for treating drug-resistant infections, is increasing globally. This study evaluated six diagnostic tests designed to detect colistin-resistant pathogens. Methods PCR and broth microdilution assays (BMD) were used to respectively characterize the molecular mechanisms and phenotypic colistin resistance of 142 Gram-negative bacterial isolates and controls. The sensitivity, specificity, positive- and negative-predictive values, major (ME) and very major errors (VME), categorical and essential agreements (EA) of ComASP Colistin, CHROMagar COL- APSE , Rapid NP Test, Sensititre, MicroScan, and Vitek 2 were determined with these isolates; the BMD was used as gold standard. Results The Vitek 2, Sensititre, and ComASP tests were more efficient, albeit with concerning ME and VMEs and low EAs. Sensititre was 100% specific with 0% ME and 3.61% VME; Vitek 2 had the least VME (1.25% and 0%) and a low EA (57.50%). ComASP had an EA of 75.35%. MicroScan was highly sensitive (96.55%) but less specific (87.50%), with very below-accetable EAs (48.11%). The CHROMAgar COL- APSE efficiently identified the species with their unique colours but was the least specific (67.80%), with the highest ME (32.20%) and high VME (7.23%). The Rapid NP test had the highest VME (7.84%), producing results within 4 hours with 92.16% sensitivity and 96.08% specificity. Conclusion Vitek 2, MicroScan, ComASP colistin, and Sensititre are good for determining colistin resistance; the latter two tests are recommendable for low-resourced laboratories. The in-house Rapid NP test has short turnaround time with high efficiency for initial resistance screening. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was funded by a grant from the National Health Laboratory Service (NHLS) given to Dr. John Osei Sekyere under grant number GRANT004 94807 and GRANT004 94808. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Research Ethics Committee, Faculty of Health Sciences, University of Pretoria, under reference number 550/2020. The study complied with the ICH-GCP guidelines and the Helsinki declaration. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript" /> <meta name="og-type" property="og:type" content="article" /> <meta name="og-image" property="og:image" content="https://www.medrxiv.org/sites/default/files/images/medrxiv_logo_homepage7-5-small-test-up.png" /> <meta name="citation_date" content="2024-03-22" /> <link rel="alternate" type="text/plain" title="Full Text (Plain)" href="/content/10.1101/2024.03.21.24304472v1.full.txt" /> <link rel="alternate" type="application/vnd.ms-powerpoint" title="Powerpoint" href="/content/10.1101/2024.03.21.24304472v1.ppt" /> <link rel="alternate" type="application/pdf" title="Full Text (PDF)" href="/content/10.1101/2024.03.21.24304472v1.full.pdf" /> <meta name="description" content="medRxiv - The Preprint Server for Health Sciences" /> <meta name="generator" content="Drupal 7 (http://drupal.org)" /> <link rel="canonical" href="https://www.medrxiv.org/content/10.1101/2024.03.21.24304472v1" /> <link rel="shortlink" 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data-apath="/medrxiv/early/2024/03/22/2024.03.21.24304472.atom" data-hw-author-tooltip-instance=""><div class="highwire-cite highwire-cite-highwire-article highwire-citation-medrxiv-article-top clearfix has-author-tooltip" > <h1 class="highwire-cite-title" id="page-title">Evaluation of Six Commercial and Non-Commercial Colistin Resistance Diagnostics</h1> <div class="highwire-cite-authors" ><span class="highwire-citation-authors"><span class="highwire-citation-author first hw-author-orcid-logo-wrapper" data-delta="0"><a href="http://orcid.org/0000-0003-1962-2435" target="_blank" class="hw-author-orcid-logo link-icon-only link-icon"><span class="hw-icon-orcid hw-icon-color-orcid"></span> <span class="title element-invisible">View ORCID Profile</span></a><span class="nlm-given-names">Tumisho Mmatumelo Seipei</span> <span class="nlm-surname">Leshaba</span></span>, <span class="highwire-citation-author hw-author-orcid-logo-wrapper" data-delta="1"><a href="http://orcid.org/0000-0002-5238-454X" target="_blank" class="hw-author-orcid-logo link-icon-only link-icon"><span class="hw-icon-orcid hw-icon-color-orcid"></span> <span class="title element-invisible">View ORCID Profile</span></a><span class="nlm-given-names">Masego</span> <span class="nlm-surname">Mmatli</span></span>, <span class="highwire-citation-author hw-author-orcid-logo-wrapper" data-delta="2"><a href="http://orcid.org/0000-0002-5684-9930" target="_blank" class="hw-author-orcid-logo link-icon-only link-icon"><span class="hw-icon-orcid hw-icon-color-orcid"></span> <span class="title element-invisible">View ORCID Profile</span></a><span class="nlm-given-names">Lebogang</span> <span class="nlm-surname">Skosana</span></span>, <span class="highwire-citation-author hw-author-orcid-logo-wrapper" data-delta="3"><a href="http://orcid.org/0000-0001-8890-2663" target="_blank" class="hw-author-orcid-logo link-icon-only link-icon"><span class="hw-icon-orcid hw-icon-color-orcid"></span> <span class="title element-invisible">View ORCID Profile</span></a><span class="nlm-given-names">Nontombi Marylucy</span> <span class="nlm-surname">Mbelle</span></span>, <span class="highwire-citation-author hw-author-orcid-logo-wrapper" data-delta="4"><a href="http://orcid.org/0000-0002-9508-984X" target="_blank" class="hw-author-orcid-logo link-icon-only link-icon"><span class="hw-icon-orcid hw-icon-color-orcid"></span> <span class="title element-invisible">View ORCID Profile</span></a><span class="nlm-given-names">John Osei</span> <span class="nlm-surname">Sekyere</span></span></span></div> <div class="highwire-cite-metadata" ><span class="highwire-cite-metadata-doi highwire-cite-metadata"><span class="label">doi:</span> https://doi.org/10.1101/2024.03.21.24304472 </span></div> </div> <div id="hw-article-author-popups-node-783150--21750529565" style="display: none;"><div class="author-tooltip-0"><div class="author-tooltip-name">Tumisho Mmatumelo Seipei Leshaba </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>a</span><span class='nlm-institution'>Department of Medical Microbiology, School of Medicine, University of Pretoria</span>, <span class='nlm-country'>South Africa</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Tumisho%2BMmatumelo%2BSeipei%2BLeshaba%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Leshaba%20TM&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link"><a href="/search/author1%3ATumisho%2BMmatumelo%2BSeipei%2BLeshaba%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li><li class="author-orcid-link last"><a href="http://orcid.org/0000-0003-1962-2435" target="_blank" class="" data-icon-position="" data-hide-link-title="0">ORCID record for Tumisho Mmatumelo Seipei Leshaba</a></li></ul></div><div class="author-tooltip-1"><div class="author-tooltip-name">Masego Mmatli </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>a</span><span class='nlm-institution'>Department of Medical Microbiology, School of Medicine, University of Pretoria</span>, <span class='nlm-country'>South Africa</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Masego%2BMmatli%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Mmatli%20M&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link"><a href="/search/author1%3AMasego%2BMmatli%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li><li class="author-orcid-link last"><a href="http://orcid.org/0000-0002-5238-454X" target="_blank" class="" data-icon-position="" data-hide-link-title="0">ORCID record for Masego Mmatli</a></li></ul></div><div class="author-tooltip-2"><div class="author-tooltip-name">Lebogang Skosana </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>a</span><span class='nlm-institution'>Department of Medical Microbiology, School of Medicine, University of Pretoria</span>, <span class='nlm-country'>South Africa</span></div><div class='author-affiliation'><span class='nlm-sup'>b</span><span class='nlm-institution'>Department of Medical Microbiology, Tshwane Academic Division, National Health Laboratory Service</span>, Pretoria, <span class='nlm-country'>South Africa</span></div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Lebogang%2BSkosana%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Skosana%20L&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link"><a href="/search/author1%3ALebogang%2BSkosana%2B" rel="nofollow" class="" data-icon-position="" 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Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Mbelle%20NM&link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link"><a href="/search/author1%3ANontombi%2BMarylucy%2BMbelle%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li><li class="author-orcid-link last"><a href="http://orcid.org/0000-0001-8890-2663" target="_blank" class="" data-icon-position="" data-hide-link-title="0">ORCID record for Nontombi Marylucy Mbelle</a></li></ul></div><div class="author-tooltip-4"><div class="author-tooltip-name">John Osei Sekyere </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>a</span><span class='nlm-institution'>Department of Medical Microbiology, School of Medicine, University of 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pane-highwire-panel-tabs-container" > <div class="pane-content"> <div data-panels-ajax-tab-preloaded="biorxiv_tab_art" id="panels-ajax-tab-container-highwire_article_tabs" class="panels-ajax-tab-container"><div class="panels-ajax-tab-loading" style ="display:none"><img class="loading" src="https://www.medrxiv.org/sites/all/modules/contrib/panels_ajax_tab/images/loading.gif" alt="Loading" title="Loading" /></div><div class="panels-ajax-tab-wrap-biorxiv_tab_art"><div class="panel-display panel-1col clearfix" > <div class="panel-panel panel-col"> <div><div class="panel-pane pane-highwire-markup" > <div class="pane-content"> <div class="highwire-markup"><div xmlns="http://www.w3.org/1999/xhtml" data-highwire-cite-ref-tooltip-instance="highwire_reflinks_tooltip" class="content-block-markup" xmlns:xhtml="http://www.w3.org/1999/xhtml"><div class="article abstract-view "><span class="highwire-journal-article-marker-start"></span><div class="section abstract" id="abstract-1"><h2 class="">Abstract</h2><div id="sec-1" class="subsection"><p id="p-3"><strong>Background</strong> Resistance to colistin, a last-reserve antibiotic used for treating drug-resistant infections, is increasing globally. This study evaluated six diagnostic tests designed to detect colistin-resistant pathogens.</p></div><div id="sec-2" class="subsection"><p id="p-4"><strong>Methods</strong> PCR and broth microdilution assays (BMD) were used to respectively characterize the molecular mechanisms and phenotypic colistin resistance of 142 Gram-negative bacterial isolates and controls. The sensitivity, specificity, positive- and negative-predictive values, major (ME) and very major errors (VME), categorical and essential agreements (EA) of ComASP Colistin, CHROMagar COL-<em>APSE</em>, Rapid NP Test, Sensititre, MicroScan, and Vitek 2 were determined with these isolates; the BMD was used as gold standard.</p></div><div id="sec-3" class="subsection"><p id="p-5"><strong>Results</strong> The Vitek 2, Sensititre, and ComASP tests were more efficient, albeit with concerning ME and VMEs and low EAs. Sensititre was 100% specific with 0% ME and 3.61% VME; Vitek 2 had the least VME (1.25% and 0%) and a low EA (57.50%). ComASP had an EA of 75.35%. MicroScan was highly sensitive (96.55%) but less specific (87.50%), with very below-accetable EAs (48.11%). The CHROMAgar COL-<em>APSE</em> efficiently identified the species with their unique colours but was the least specific (67.80%), with the highest ME (32.20%) and high VME (7.23%). The Rapid NP test had the highest VME (7.84%), producing results within 4 hours with 92.16% sensitivity and 96.08% specificity.</p></div><div id="sec-4" class="subsection"><p id="p-6"><strong>Conclusion</strong> Vitek 2, MicroScan, ComASP colistin, and Sensititre are good for determining colistin resistance; the latter two tests are recommendable for low-resourced laboratories. The in-house Rapid NP test has short turnaround time with high efficiency for initial resistance screening.</p></div></div><h3>Competing Interest Statement</h3><p id="p-7">The authors have declared no competing interest.</p><h3>Funding Statement</h3><p id="p-8">This work was funded by a grant from the National Health Laboratory Service (NHLS) given to Dr. John Osei Sekyere under grant number GRANT004 94807 and GRANT004 94808.</p><h3>Author Declarations</h3><p id="p-9">I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.</p><p id="p-10">Yes</p><p id="p-11">The details of the IRB/oversight body that provided approval or exemption for the research described are given below:</p><p id="p-12">The study was approved by the Research Ethics Committee, Faculty of Health Sciences, University of Pretoria, under reference number 550/2020. The study complied with the ICH-GCP guidelines and the Helsinki declaration.</p><p id="p-13">I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.</p><p id="p-14">Yes</p><p id="p-15">I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).</p><p id="p-16">Yes</p><p id="p-17">I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.</p><p id="p-18">Yes</p><div class="section data-availability" id="sec-25"><h2 class="">Data Availability</h2><p id="p-51">All data produced in the present work are contained in the manuscript</p></div><span class="highwire-journal-article-marker-end"></span></div><span class="related-urls"></span></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-biorxiv-copyright" > <div class="pane-content"> <div class="field field-name-field-highwire-copyright 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