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
被引:35
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Garrett, Nigel
[1
,2
]
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Mitchev, Nireshni
[3
]
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Osman, Farzana
[1
]
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Naidoo, Jessica
[1
]
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Dorward, Jienchi
[1
]
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Singh, Ravesh
[3
,4
]
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Ngobese, Hope
[5
]
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Rompalo, Anne
[6
]
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Mlisana, Koleka
[3
,4
]
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Mindel, Adrian
[1
]
机构:
[1] Ctr AIDS Programme South Africa CAPRISA, Durban, South Africa
[2] Univ KwaZulu Natal, Sch Nursing & Publ Hlth, Discipline Publ Hlth Med, Durban, South Africa
[3] Univ KwaZulu Natal, Dept Microbiol, Durban, South Africa
[4] Natl Hlth Lab Serv, Durban, South Africa
[5] EThekwini Municipal, Prince Cyril Zulu Communicable Dis Ctr, Durban, South Africa
[6] Johns Hopkins Sch Med, Med, Baltimore, MD USA
来源:
BMJ OPEN
|
2019年
/
9卷
/
02期
基金:
英国医学研究理事会;
关键词:
CHLAMYDIA;
PERFORMANCE;
MANAGEMENT;
VAGINALIS;
D O I:
10.1136/bmjopen-2018-026888
中图分类号:
R5 [内科学];
学科分类号:
1002 ;
100201 ;
摘要:
Objectives Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate pointof- care assays may improve STI care in low-and 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% (45.0100) 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.
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[Anonymous], ANN NUMB GENEXPERT M
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[Anonymous], LET OUR ACT COUNT S
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[Anonymous], 2015, South African Water Quality Guidelines: Domestic Use, Vsecond, P1
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Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Causer, Louise M.
Guy, Rebecca J.
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Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Guy, Rebecca J.
Tabrizi, Sepehr N.
论文数: 0引用数: 0
h-index: 0
机构:
Royal Womens Hosp, Div Microbiol, Parkville, Vic, Australia
Univ Melbourne, Murdoch Childrens Res Inst, Dept Obstet & Gynaecol, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Tabrizi, Sepehr N.
Whiley, David M.
论文数: 0引用数: 0
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Univ Queensland, Ctr Clin Res, Herston, Qld, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Whiley, David M.
Speers, David John
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h-index: 0
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PathWest Lab Med, Dept Microbiol, Perth, WA, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Speers, David John
Ward, James
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h-index: 0
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South Australian Hlth & Med Res Inst, Infect Dis, Aboriginal Hlth, Adelaide, SA, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Ward, James
Tangey, Annie
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Univ New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Ngaanyatjarra Hlth Serv, Sexual Hlth, Alice Springs, NT, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Tangey, Annie
Badman, Steven G.
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Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Badman, Steven G.
Hengel, Belinda
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h-index: 0
机构:
Apunipima Cape York Hlth Council, Sexual Hlth, Bungalow, Qld, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Hengel, Belinda
Natoli, Lisa Jane
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Burnet Inst, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Natoli, Lisa Jane
Anderson, David A.
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Burnet Inst, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Anderson, David A.
Wand, Handan
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Wand, Handan
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Regan, David G.
Shephard, Mark
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机构:
Flinders Univ S Australia, Int Ctr Point Care Testing, Adelaide, SA, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Shephard, Mark
Donovan, Basil
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Univ New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Sydney Sexual Hlth Ctr, Sydney, NSW, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Donovan, Basil
Fairley, Christopher K.
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机构:
Monash Univ, Cent Clin Sch, Melbourne, Vic, Australia
Melbourne Sexual Hlth Ctr, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Fairley, Christopher K.
Kaldor, John M.
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h-index: 0
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Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Univ KwaZulu Natal, Sch Nursing & Publ Hlth, Discipline Publ Hlth Med, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Garrett, Nigel J.
Osman, Farzana
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Osman, Farzana
Maharaj, Bhavna
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Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Maharaj, Bhavna
Naicker, Nivashnee
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Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Naicker, Nivashnee
Gibbs, Andrew
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机构:
South African Med Res Council, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Gibbs, Andrew
Norman, Emily
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h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Columbia Univ, Dept Epidemiol, New York, NY USACtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Norman, Emily
Samsunder, Natasha
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Samsunder, Natasha
Ngobese, Hope
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h-index: 0
机构:
Prince Cyril Zulu Communicable Dis Ctr, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Ngobese, Hope
Mitchev, Nireshni
论文数: 0引用数: 0
h-index: 0
机构:
Univ KwaZulu Natal, Dept Microbiol, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Mitchev, Nireshni
Singh, Ravesh
论文数: 0引用数: 0
h-index: 0
机构:
Univ KwaZulu Natal, Dept Microbiol, Durban, South Africa
Natl Hlth Lab Serv, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Singh, Ravesh
Karim, Salim S. Abdool
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Columbia Univ, Dept Epidemiol, New York, NY USACtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Karim, Salim S. Abdool
Kharsany, Ayesha B. M.
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h-index: 0
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Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Kharsany, Ayesha B. M.
Mlisana, Koleka
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机构:
Univ KwaZulu Natal, Dept Microbiol, Durban, South Africa
Natl Hlth Lab Serv, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Mlisana, Koleka
Rompalo, Anne
论文数: 0引用数: 0
h-index: 0
机构:
Johns Hopkins Univ, Baltimore, MD USACtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Rompalo, Anne
Mindel, Adrian
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Causer, Louise M.
Guy, Rebecca J.
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Guy, Rebecca J.
Tabrizi, Sepehr N.
论文数: 0引用数: 0
h-index: 0
机构:
Royal Womens Hosp, Div Microbiol, Parkville, Vic, Australia
Univ Melbourne, Murdoch Childrens Res Inst, Dept Obstet & Gynaecol, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Tabrizi, Sepehr N.
Whiley, David M.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Queensland, Ctr Clin Res, Herston, Qld, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Whiley, David M.
Speers, David John
论文数: 0引用数: 0
h-index: 0
机构:
PathWest Lab Med, Dept Microbiol, Perth, WA, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Speers, David John
Ward, James
论文数: 0引用数: 0
h-index: 0
机构:
South Australian Hlth & Med Res Inst, Infect Dis, Aboriginal Hlth, Adelaide, SA, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Ward, James
Tangey, Annie
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Ngaanyatjarra Hlth Serv, Sexual Hlth, Alice Springs, NT, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Tangey, Annie
Badman, Steven G.
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Badman, Steven G.
Hengel, Belinda
论文数: 0引用数: 0
h-index: 0
机构:
Apunipima Cape York Hlth Council, Sexual Hlth, Bungalow, Qld, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Hengel, Belinda
Natoli, Lisa Jane
论文数: 0引用数: 0
h-index: 0
机构:
Burnet Inst, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Natoli, Lisa Jane
Anderson, David A.
论文数: 0引用数: 0
h-index: 0
机构:
Burnet Inst, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Anderson, David A.
Wand, Handan
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Wand, Handan
Wilson, David
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Wilson, David
Regan, David G.
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Regan, David G.
Shephard, Mark
论文数: 0引用数: 0
h-index: 0
机构:
Flinders Univ S Australia, Int Ctr Point Care Testing, Adelaide, SA, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Shephard, Mark
Donovan, Basil
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Sydney Sexual Hlth Ctr, Sydney, NSW, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Donovan, Basil
Fairley, Christopher K.
论文数: 0引用数: 0
h-index: 0
机构:
Monash Univ, Cent Clin Sch, Melbourne, Vic, Australia
Melbourne Sexual Hlth Ctr, Melbourne, Vic, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
Fairley, Christopher K.
Kaldor, John M.
论文数: 0引用数: 0
h-index: 0
机构:
Univ New South Wales, Kirby Inst, Sydney, NSW 2052, AustraliaUniv New South Wales, Kirby Inst, Sydney, NSW 2052, Australia
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Univ KwaZulu Natal, Sch Nursing & Publ Hlth, Discipline Publ Hlth Med, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Garrett, Nigel J.
Osman, Farzana
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Osman, Farzana
Maharaj, Bhavna
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Maharaj, Bhavna
Naicker, Nivashnee
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Naicker, Nivashnee
Gibbs, Andrew
论文数: 0引用数: 0
h-index: 0
机构:
South African Med Res Council, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Gibbs, Andrew
Norman, Emily
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Columbia Univ, Dept Epidemiol, New York, NY USACtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Norman, Emily
Samsunder, Natasha
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Samsunder, Natasha
Ngobese, Hope
论文数: 0引用数: 0
h-index: 0
机构:
Prince Cyril Zulu Communicable Dis Ctr, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Ngobese, Hope
Mitchev, Nireshni
论文数: 0引用数: 0
h-index: 0
机构:
Univ KwaZulu Natal, Dept Microbiol, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Mitchev, Nireshni
Singh, Ravesh
论文数: 0引用数: 0
h-index: 0
机构:
Univ KwaZulu Natal, Dept Microbiol, Durban, South Africa
Natl Hlth Lab Serv, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Singh, Ravesh
Karim, Salim S. Abdool
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Columbia Univ, Dept Epidemiol, New York, NY USACtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Karim, Salim S. Abdool
Kharsany, Ayesha B. M.
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Kharsany, Ayesha B. M.
Mlisana, Koleka
论文数: 0引用数: 0
h-index: 0
机构:
Univ KwaZulu Natal, Dept Microbiol, Durban, South Africa
Natl Hlth Lab Serv, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Mlisana, Koleka
Rompalo, Anne
论文数: 0引用数: 0
h-index: 0
机构:
Johns Hopkins Univ, Baltimore, MD USACtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa
Rompalo, Anne
Mindel, Adrian
论文数: 0引用数: 0
h-index: 0
机构:
Ctr AIDS Programme Res South Africa CAPRISA, Durban, South AfricaCtr AIDS Programme Res South Africa CAPRISA, Durban, South Africa