Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens.

Adult Chlamydia Infections / diagnosis Chlamydia trachomatis / genetics Genitalia / microbiology Gonorrhea / diagnosis Homosexuality, Male Humans Male Neisseria gonorrhoeae / genetics Nucleic Acid Amplification Techniques / methods Real-Time Polymerase Chain Reaction / methods Sensitivity and Specificity
APTIMA Chlamydia trachomatis Extra-genital In-house real-time PCR Neisseria gonorrhoeae Urine

Journal

BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551

Informations de publication

Date de publication:
03 Jan 2019
Historique:
received: 17 05 2018
accepted: 18 12 2018
entrez: 5 1 2019
pubmed: 5 1 2019
medline: 12 2 2019
Statut: epublish

Résumé

Extra-genital Neisseria gonorrhoeae and Chlamydia trachomatis infections are mostly asymptomatic, and important reservoir sites of infection as they often go undetected and may be more difficult to eradicate with recommended therapeutic regimens. Commercial nucleic acid amplification tests (NAATs) have not received regulatory approval for the detection of N. gonorrhoeae and C. trachomatis in extra-genital specimens. The HOLOGIC® APTIMA Combo2 assay for N. gonorrhoeae and C. trachomatis has performed well in evaluations using extra-genital specimens. We assessed the performance of an in-house real-time duplex PCR assay for the detection of N. gonorrhoeae and C. trachomatis in urine and extra-genital specimens using the HOLOGIC® APTIMA assays as gold standard comparators. Urine, oropharyngeal and ano-rectal specimens were collected from each of 200 men-who-have-sex-with-men (MSM) between December 2011 and July 2012. For N. gonorrhoeae detection, the in-house PCR assay showed 98.5-100% correlation agreement with the APTIMA assays, depending on specimen type. Sensitivity for N. gonorrhoeae detection was 82.4% for ano-rectal specimens, 83.3% for oropharyngeal specimens, and 85.7% for urine; and specificity was 100% with all specimen types. The positive predictive value (PPV) for N. gonorrhoeae detection was 100% and the negative predictive value (NPV) varied with sample type, ranging from 98.5-99.5%. For C. trachomatis detection, correlation between the assays was 100% for all specimen types. The sensitivity, specificity, PPV and NPV of the in-house PCR assay was 100% for C. trachomatis detection, irrespective of specimen type. The in-house duplex real-time PCR assay showed acceptable performance characteristics in comparison with the APTIMA® assays for the detection of extra-genital N. gonorrhoeae and C. trachomatis.

Sections du résumé

BACKGROUND BACKGROUND
Extra-genital Neisseria gonorrhoeae and Chlamydia trachomatis infections are mostly asymptomatic, and important reservoir sites of infection as they often go undetected and may be more difficult to eradicate with recommended therapeutic regimens. Commercial nucleic acid amplification tests (NAATs) have not received regulatory approval for the detection of N. gonorrhoeae and C. trachomatis in extra-genital specimens. The HOLOGIC® APTIMA Combo2 assay for N. gonorrhoeae and C. trachomatis has performed well in evaluations using extra-genital specimens.
METHODS METHODS
We assessed the performance of an in-house real-time duplex PCR assay for the detection of N. gonorrhoeae and C. trachomatis in urine and extra-genital specimens using the HOLOGIC® APTIMA assays as gold standard comparators. Urine, oropharyngeal and ano-rectal specimens were collected from each of 200 men-who-have-sex-with-men (MSM) between December 2011 and July 2012.
RESULTS RESULTS
For N. gonorrhoeae detection, the in-house PCR assay showed 98.5-100% correlation agreement with the APTIMA assays, depending on specimen type. Sensitivity for N. gonorrhoeae detection was 82.4% for ano-rectal specimens, 83.3% for oropharyngeal specimens, and 85.7% for urine; and specificity was 100% with all specimen types. The positive predictive value (PPV) for N. gonorrhoeae detection was 100% and the negative predictive value (NPV) varied with sample type, ranging from 98.5-99.5%. For C. trachomatis detection, correlation between the assays was 100% for all specimen types. The sensitivity, specificity, PPV and NPV of the in-house PCR assay was 100% for C. trachomatis detection, irrespective of specimen type.
CONCLUSION CONCLUSIONS
The in-house duplex real-time PCR assay showed acceptable performance characteristics in comparison with the APTIMA® assays for the detection of extra-genital N. gonorrhoeae and C. trachomatis.

Identifiants

DOI: 10.1186/s12879-018-3629-0 PMID: 30606127 PMC: PMC6318993
pubmed: 30606127
doi: 10.1186/s12879-018-3629-0
pii: 10.1186/s12879-018-3629-0
pmc: PMC6318993
doi:

Types de publication

Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

6

Subventions

Organisme : United States Agency for International Development
ID : AID-674-A-12-00015

Références

Sex Transm Infect. 2002 Jun;78(3):190-3
pubmed: 12238651
J Clin Microbiol. 2003 Jan;41(1):304-9
pubmed: 12517865
J Clin Microbiol. 2004 Jul;42(7):3089-93
pubmed: 15243065
Clin Infect Dis. 2005 Jul 1;41(1):67-74
pubmed: 15937765
Clin Infect Dis. 2006 Nov 15;43(10):1284-9
pubmed: 17051493
Sex Transm Infect. 2006 Dec;82(6):515
pubmed: 17151040
Int J STD AIDS. 2007 Dec;18(12):871-2
pubmed: 18073027
Can J Infect Dis Med Microbiol. 2005 Jan;16(1):39-44
pubmed: 18159527
Sex Transm Dis. 2008 Jul;35(7):637-42
pubmed: 18520976
Sex Transm Infect. 2009 Jun;85(3):182-6
pubmed: 19126571
J Clin Microbiol. 2009 Apr;47(4):902-7
pubmed: 19193848
Expert Opin Pharmacother. 2009 Mar;10(4):555-77
pubmed: 19284360
Clin Infect Dis. 2009 May 1;48(9):1237-43
pubmed: 19323630
J Clin Microbiol. 2009 Jun;47(6):1657-62
pubmed: 19369445
Int J STD AIDS. 2009 May;20(5):315-9
pubmed: 19386967
Sex Transm Infect. 2009 Jun;85(3):159-60
pubmed: 19478103
MMWR Morb Mortal Wkly Rep. 2009 Jul 10;58(26):716-9
pubmed: 19590491
J Clin Microbiol. 2010 May;48(5):1827-32
pubmed: 20335410
Sex Transm Dis. 2010 Sep;37(9):566-70
pubmed: 20502394
Sex Transm Dis. 2010 Dec;37(12):771-6
pubmed: 20585275
Sex Health. 2011 Mar;8(1):9-11
pubmed: 21371376
J Clin Microbiol. 2011 May;49(5):1970-1
pubmed: 21411585
Antimicrob Agents Chemother. 2011 Jul;55(7):3538-45
pubmed: 21576437
BMC Infect Dis. 2011 Jul 26;11:203
pubmed: 21791061
J Clin Microbiol. 2012 Jun;50(6):2005-8
pubmed: 22493338
Sex Transm Dis. 2012 Jul;39(7):543-9
pubmed: 22706217
BMC Public Health. 2013 Nov 25;13:1093
pubmed: 24274101
Clin Infect Dis. 2014 Jun;58(11):1564-70
pubmed: 24647015
Clin Microbiol Rev. 2014 Jul;27(3):587-613
pubmed: 24982323
Euro Surveill. 2014 Jul 31;19(30):null
pubmed: 25108533
PLoS One. 2015 Sep 29;10(9):e0138315
pubmed: 26418464
Sex Transm Dis. 2016 Feb;43(2):105-9
pubmed: 26766527

Auteurs

Johanna M E Venter (JME)

Centre for HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases (NICD), National Health Laboratory Service (NHLS), Johannesburg, South Africa. LLZEV@NICD.AC.ZA.
ORCID: 0000-0001-9725-9606

Precious M Mahlangu (PM)

Centre for HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases (NICD), National Health Laboratory Service (NHLS), Johannesburg, South Africa.

Etienne E Müller (EE)

Centre for HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases (NICD), National Health Laboratory Service (NHLS), Johannesburg, South Africa.

David A Lewis (DA)

Western Sydney Sexual Health Centre, Western Sydney Local Health District, Parramatta, Australia.
Marie Bashir Institute for Infectious Diseases and Biosecurity & Sydney Medical School, Westmead, University of Sydney, Sydney, Australia.

Kevin Rebe (K)

Anova Health Institute, Johannesburg, Cape Town, South Africa.
Division of Infectious Diseases and HIV Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.

Helen Struthers (H)

Anova Health Institute, Johannesburg, Cape Town, South Africa.
Division of Infectious Diseases and HIV Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.

James McIntyre (J)

Anova Health Institute, Johannesburg, Cape Town, South Africa.
Division of Epidemiology & Biostatistics, School of Public & Family Medicine, University of Cape Town, Cape Town, South Africa.

Ranmini S Kularatne (RS)

Centre for HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases (NICD), National Health Laboratory Service (NHLS), Johannesburg, South Africa.
Department of Clinical Microbiology & Infectious Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Maladies urogénitales › Maladies génitales › Infections à Chlamydia › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Bactéries › Bactéries à Gram négatif › Chlamydiales › Chlamydiaceae › Chlamydia › Chlamydia trachomatis › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Appareil urogénital › Système génital › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Maladies urogénitales › Maladies génitales › Gonorrhée › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Sexualité › Homosexualité › Homosexualité masculine › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Bactéries › Proteobacteria › Betaproteobacteria › Neisseriaceae › Neisseria › Neisseria gonorrhoeae › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques d'amplification d'acides nucléiques › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques d'amplification d'acides nucléiques › Réaction de polymérisation en chaîne › Réaction de polymérisation en chaine en temps réel › Comparison of an in-house real-time duplex PCR...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Sensibilité et spécificité › Comparison of an in-house real-time duplex PCR...