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Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants.
BMC Infect Dis. 2020 Jun 16; 20(1):419.BI

Abstract

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, and Candida-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.

Authors+Show Affiliations

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, SE-701 85, Örebro, Sweden. magnus_unemo@yahoo.com.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, SE-701 85, Örebro, Sweden.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, SE-701 85, Örebro, Sweden.Department of Virology and Immunology, University of Helsinki and Helsinki University Hospital, HUSLAB, Helsinki, Finland.Department of Clinical Medicine, Faculty of Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Department of Clinical Microbiology, Hvidovre University Hospital, Hvidovre, Denmark.Department of Clinical Microbiology, Turku University Hospital, Turku, Finland.Department of Microbiology, Unilabs Laboratory Medicine, Skien, Norway.National Infection Service, Public Health England, London, UK.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, SE-701 85, Örebro, Sweden. Department of Functional and Laboratory Diagnostics, I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine.Hanoi Medical University, National Hospital of Dermatology and Venereology, Hanoi, Vietnam.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, SE-701 85, Örebro, Sweden.iClinic, Sendai, Japan.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, SE-701 85, Örebro, Sweden.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

32546213

Citation

Unemo, Magnus, et al. "Sensitivity, Specificity, Inclusivity and Exclusivity of the Updated Aptima Combo 2 Assay, Which Provides Detection Coverage of the New Diagnostic-escape Chlamydia Trachomatis Variants." BMC Infectious Diseases, vol. 20, no. 1, 2020, p. 419.
Unemo M, Hansen M, Hadad R, et al. Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants. BMC Infect Dis. 2020;20(1):419.
Unemo, M., Hansen, M., Hadad, R., Puolakkainen, M., Westh, H., Rantakokko-Jalava, K., Thilesen, C., Cole, M. J., Boiko, I., Lan, P. T., Golparian, D., Ito, S., & Sundqvist, M. (2020). Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants. BMC Infectious Diseases, 20(1), 419. https://doi.org/10.1186/s12879-020-05148-7
Unemo M, et al. Sensitivity, Specificity, Inclusivity and Exclusivity of the Updated Aptima Combo 2 Assay, Which Provides Detection Coverage of the New Diagnostic-escape Chlamydia Trachomatis Variants. BMC Infect Dis. 2020 Jun 16;20(1):419. PubMed PMID: 32546213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants. AU - Unemo,Magnus, AU - Hansen,Marit, AU - Hadad,Ronza, AU - Puolakkainen,Mirja, AU - Westh,Henrik, AU - Rantakokko-Jalava,Kaisu, AU - Thilesen,Carina, AU - Cole,Michelle J, AU - Boiko,Iryna, AU - Lan,Pham T, AU - Golparian,Daniel, AU - Ito,Shin, AU - Sundqvist,Martin, Y1 - 2020/06/16/ PY - 2020/05/13/received PY - 2020/06/11/accepted PY - 2020/6/18/entrez PY - 2020/6/18/pubmed PY - 2020/6/27/medline KW - 23S rRNA KW - Aptima combo 2 KW - Chlamydia trachomatis KW - Finnish new variant KW - Surveillance KW - Validation SP - 419 EP - 419 JF - BMC infectious diseases JO - BMC Infect. Dis. VL - 20 IS - 1 N2 - 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, and Candida-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. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/32546213/Sensitivity,_specificity,_inclusivity_and_exclusivity_of_the_updated_Aptima_Combo_2_assay,_which_provides_detection_coverage_of_the_new_diagnostic-escape_Chlamydia_trachomatis_variants L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-020-05148-7 DB - PRIME DP - Unbound Medicine ER -