Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: A cross-sectional study

Nigel Garrett, Nireshni Mitchev, Farzana Osman, Jessica Naidoo, Jienchi Dorward, Ravesh Singh, Hope Ngobese, Anne Marie Rompalo, Koleka Mlisana, Adrian Mindel

Research output: Contribution to journalArticle

Abstract

Objectives Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- A nd middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and OSOM Trichomonas vaginalis (TV) Test as part of a STI care model for young women in South Africa. Design Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017. Setting One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa Participants 247 women, aged 18-40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded. Outcomes Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay. Results We obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2-7.5) and TV 3.2% (1.0-5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6-99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0-100) and 100% (100-100). Conclusion The Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.

Original languageEnglish (US)
Article numbere026888
JournalBMJ Open
Volume9
Issue number2
DOIs
StatePublished - Feb 1 2019

Fingerprint

Point-of-Care Systems
Trichomonas
Neisseria gonorrhoeae
Chlamydia trachomatis
Trichomonas vaginalis
Sexually Transmitted Diseases
South Africa
Cross-Sectional Studies
HIV
Public Facilities
Sensitivity and Specificity
Asymptomatic Infections
Cost-Benefit Analysis
Cohort Studies
Prospective Studies
Delivery of Health Care

Keywords

  • point-of-care testing
  • sexually transmitted infections
  • South Africa
  • Xpert CT/NG

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa : A cross-sectional study. / Garrett, Nigel; Mitchev, Nireshni; Osman, Farzana; Naidoo, Jessica; Dorward, Jienchi; Singh, Ravesh; Ngobese, Hope; Rompalo, Anne Marie; Mlisana, Koleka; Mindel, Adrian.

In: BMJ Open, Vol. 9, No. 2, e026888, 01.02.2019.

Research output: Contribution to journalArticle

Garrett, Nigel ; Mitchev, Nireshni ; Osman, Farzana ; Naidoo, Jessica ; Dorward, Jienchi ; Singh, Ravesh ; Ngobese, Hope ; Rompalo, Anne Marie ; Mlisana, Koleka ; Mindel, Adrian. / Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa : A cross-sectional study. In: BMJ Open. 2019 ; Vol. 9, No. 2.
@article{9d977a410d934e76b02607ee7d633a21,
title = "Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: A cross-sectional study",
abstract = "Objectives Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- A nd middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and OSOM Trichomonas vaginalis (TV) Test as part of a STI care model for young women in South Africa. Design Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017. Setting One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa Participants 247 women, aged 18-40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded. Outcomes Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay. Results We obtained vaginal swabs from 247 women and found 96.8{\%} (239/247) concordance between Xpert and Anyplex for CT and 100{\%} (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0{\%} (95{\%} CI 10.5 to 19.4), NG 4.9{\%} (2.2-7.5) and TV 3.2{\%} (1.0-5.4). Sensitivity and specificity of Xpert CT/NG were 100{\%} (100-100) and 97.6{\%} (95.6-99.7) for CT and 100{\%} (100-100) and 100{\%} (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0{\%} (45.0-100) and 100{\%} (100-100). Conclusion The Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.",
keywords = "point-of-care testing, sexually transmitted infections, South Africa, Xpert CT/NG",
author = "Nigel Garrett and Nireshni Mitchev and Farzana Osman and Jessica Naidoo and Jienchi Dorward and Ravesh Singh and Hope Ngobese and Rompalo, {Anne Marie} and Koleka Mlisana and Adrian Mindel",
year = "2019",
month = "2",
day = "1",
doi = "10.1136/bmjopen-2018-026888",
language = "English (US)",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "2",

}

TY - JOUR

T1 - Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa

T2 - A cross-sectional study

AU - Garrett, Nigel

AU - Mitchev, Nireshni

AU - Osman, Farzana

AU - Naidoo, Jessica

AU - Dorward, Jienchi

AU - Singh, Ravesh

AU - Ngobese, Hope

AU - Rompalo, Anne Marie

AU - Mlisana, Koleka

AU - Mindel, Adrian

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Objectives Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- A nd middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and OSOM Trichomonas vaginalis (TV) Test as part of a STI care model for young women in South Africa. Design Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017. Setting One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa Participants 247 women, aged 18-40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded. Outcomes Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay. Results We obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2-7.5) and TV 3.2% (1.0-5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6-99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0-100) and 100% (100-100). Conclusion The Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.

AB - Objectives Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- A nd middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and OSOM Trichomonas vaginalis (TV) Test as part of a STI care model for young women in South Africa. Design Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017. Setting One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa Participants 247 women, aged 18-40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded. Outcomes Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay. Results We obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2-7.5) and TV 3.2% (1.0-5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6-99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0-100) and 100% (100-100). Conclusion The Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.

KW - point-of-care testing

KW - sexually transmitted infections

KW - South Africa

KW - Xpert CT/NG

UR - http://www.scopus.com/inward/record.url?scp=85061154516&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85061154516&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2018-026888

DO - 10.1136/bmjopen-2018-026888

M3 - Article

C2 - 30782948

AN - SCOPUS:85061154516

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 2

M1 - e026888

ER -