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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

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Unemo, M, Hansen, M, Hadad, R, Puolakkainen, M, Westh, H, Rantakokko-Jalava, K, Thilesen, C, Cole, MJ, Boiko, I, Lan, PT, 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, vol. 20, no. 1, 419, pp. 1-6. https://doi.org/10.1186/s12879-020-05148-7

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Unemo, Magnus ; Hansen, Marit ; Hadad, Ronza ; Puolakkainen, Mirja ; Westh, Henrik ; Rantakokko-Jalava, Kaisu ; Thilesen, Carina ; Cole, Michelle J ; Boiko, Iryna ; Lan, Pham T ; Golparian, Daniel ; Ito, Shin ; Sundqvist, Martin. / Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants. In: BMC Infectious Diseases. 2020 ; Vol. 20, No. 1. pp. 1-6.

Bibtex

@article{733c0cba57aa4e0fb4f98b72dfd4d385,
title = "Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants",
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.",
keywords = "23S rRNA, Aptima combo 2, Chlamydia trachomatis, Finnish new variant, Surveillance, Validation",
author = "Magnus Unemo and Marit Hansen and Ronza Hadad and Mirja Puolakkainen and Henrik Westh and Kaisu Rantakokko-Jalava and Carina Thilesen and Cole, {Michelle J} and Iryna Boiko and Lan, {Pham T} and Daniel Golparian and Shin Ito and Martin Sundqvist",
year = "2020",
month = "6",
day = "16",
doi = "10.1186/s12879-020-05148-7",
language = "English",
volume = "20",
pages = "1--6",
journal = "BMC Infectious Diseases",
issn = "1471-2334",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

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

PY - 2020/6/16

Y1 - 2020/6/16

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.

AB - 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.

KW - 23S rRNA

KW - Aptima combo 2

KW - Chlamydia trachomatis

KW - Finnish new variant

KW - Surveillance

KW - Validation

UR - http://www.scopus.com/inward/record.url?scp=85086686721&partnerID=8YFLogxK

U2 - 10.1186/s12879-020-05148-7

DO - 10.1186/s12879-020-05148-7

M3 - Journal article

VL - 20

SP - 1

EP - 6

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

SN - 1471-2334

IS - 1

M1 - 419

ER -

ID: 60095952