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Sökning: WFRF:(Thilesen Carina) > (2020) > Sensitivity, specif...

Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants

Unemo, Magnus, 1970- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology
Hansen, Marit (författare)
World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
Hadad, Ronza, 1984- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology
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Puolakkainen, Mirja (författare)
Department of Virology and Immunology, University of Helsinki, Helsinki University Hospital, HUSLAB, Helsinki, Finland
Westh, Henrik (författare)
Department of Clinical Medicine, Faculty of Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Microbiology, Hvidovre University Hospital, Hvidovre, Denmark
Rantakokko-Jalava, Kaisu (författare)
Department of Clinical Microbiology, Turku University Hospital, Turku, Finland
Thilesen, Carina (författare)
Department of Microbiology, Unilabs Laboratory Medicine, Skien, Norway
Cole, Michelle J. (författare)
National Infection Service, Public Health England, London, United Kingdom
Boiko, Iryna (författare)
World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Department of Functional and Laboratory Diagnostics, I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine
Lan, Pham T. (författare)
Hanoi Medical University, National Hospital of Dermatology and Venereology, Hanoi, Viet Nam
Golparian, Daniel, 1984- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology
Ito, Shin (författare)
iClinic, Sendai, Miyagi, Japan
Sundqvist, Martin, 1974- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology
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 (creator_code:org_t)
2020-06-16
2020
Engelska.
Ingår i: BMC Infectious Diseases. - : BioMed Central. - 1471-2334. ; 20:1
Relaterad länk:
https://doi.org/10.1...
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https://bmcinfectdis...
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Background: Four new variants of Chlamydia trachomatis (nvCTs), detected in several countries, cause false-negative or equivocal results using the Aptima Combo 2 assay (AC2; Hologic). We evaluated the clinical sensitivity and specificity, as well as the analytical inclusivity and exclusivity of the updated AC2 for the detection of CT and Neisseria gonorrhoeae (NG) on the automated Panther system (Hologic).Methods: We examined 1004 clinical AC2 samples and 225 analytical samples spiked with phenotypically and/or genetically diverse NG and CT strains, and other potentially cross-reacting microbial species. The clinical AC2 samples included CT wild type (WT)-positive (n = 488), all four described AC2 diagnostic-escape nvCTs (n = 170), NG-positive (n = 214), and CT/NG-negative (n = 202) specimens.Results: All nvCT-positive samples (100%) and 486 (99.6%) of the CT WT-positive samples were positive in the updated AC2. All NG-positive, CT/NG-negative, Trichomonas vaginalis (TV)-positive, bacterial vaginosis-positive, andCandida-positive AC2 specimens gave correct results. The clinical sensitivity and specificity of the updated AC2 for CT detection was 99.7 and 100%, respectively, and for NG detection was 100% for both. Examining spiked samples, the analytical inclusivity and exclusivity were 100%, i.e., in clinically relevant concentrations of spiked microbe.Conclusions: The updated AC2, including two CT targets and one NG target, showed a high sensitivity, specificity, inclusivity and exclusivity for the detection of CT WT, nvCTs, and NG. The updated AC2 on the fully automated Panther system offers a simple, rapid, high-throughput, sensitive, and specific diagnosis of CT and NG, which can easily be combined with detection of Mycoplasma genitalium and TV.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

Nyckelord

Finnish new variant
Chlamydia trachomatis
Aptima combo 2
23S rRNA
Validation
Surveillance

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