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
作者
Garrett, Nigel [1 ,2 ]
Mitchev, Nireshni [3 ]
Osman, Farzana [1 ]
Naidoo, Jessica [1 ]
Dorward, Jienchi [1 ]
Singh, Ravesh [3 ,4 ]
Ngobese, Hope [5 ]
Rompalo, Anne [6 ]
Mlisana, Koleka [3 ,4 ]
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.
引用
收藏
页数:5
相关论文
共 18 条
  • [1] [Anonymous], 2015, 2015 SEX TRANSM DIS
  • [2] [Anonymous], ANN NUMB GENEXPERT M
  • [3] [Anonymous], LET OUR ACT COUNT S
  • [4] [Anonymous], 2015, South African Water Quality Guidelines: Domestic Use, Vsecond, P1
  • [5] Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation
    Causer, Louise M.
    Guy, Rebecca J.
    Tabrizi, Sepehr N.
    Whiley, David M.
    Speers, David John
    Ward, James
    Tangey, Annie
    Badman, Steven G.
    Hengel, Belinda
    Natoli, Lisa Jane
    Anderson, David A.
    Wand, Handan
    Wilson, David
    Regan, David G.
    Shephard, Mark
    Donovan, Basil
    Fairley, Christopher K.
    Kaldor, John M.
    [J]. SEXUALLY TRANSMITTED INFECTIONS, 2018, 94 (05) : 340 - +
  • [6] Beyond syndromic management: Opportunities for diagnosis-based treatment of sexually transmitted infections in low-and middle-income countries
    Garrett, Nigel J.
    Osman, Farzana
    Maharaj, Bhavna
    Naicker, Nivashnee
    Gibbs, Andrew
    Norman, Emily
    Samsunder, Natasha
    Ngobese, Hope
    Mitchev, Nireshni
    Singh, Ravesh
    Karim, Salim S. Abdool
    Kharsany, Ayesha B. M.
    Mlisana, Koleka
    Rompalo, Anne
    Mindel, Adrian
    [J]. PLOS ONE, 2018, 13 (04):
  • [7] Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
    Gaydos, Charlotte A.
    Van der Pol, Barbara
    Jett-Goheen, Mary
    Barnes, Mathilda
    Quinn, Nicole
    Clark, Carey
    Daniel, Grace E.
    Dixon, Paula B.
    Hook, Edward W., III
    [J]. JOURNAL OF CLINICAL MICROBIOLOGY, 2013, 51 (06) : 1666 - 1672
  • [8] Reproductive-tract infections in women in low-income, low-prevalence situations: assessment of syndromic management in Matlab, Bangladesh
    Hawkes, S
    Morison, L
    Foster, S
    Gausia, K
    Chakraborty, J
    Peeling, RW
    Mabey, D
    [J]. LANCET, 1999, 354 (9192) : 1776 - 1781
  • [9] Performance of rapid immunochromatographic assay in the diagnosis of Trichomoniasis vaginalis
    Hegazy, Mamdouh M.
    El-Tantawy, Nora L.
    Soliman, Mohamed M.
    El-Sadeek, Ehaab S.
    El-Nagar, Hassan S.
    [J]. DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE, 2012, 74 (01) : 49 - 53
  • [10] NON-ULCERATIVE SEXUALLY-TRANSMITTED DISEASES AS RISK-FACTORS FOR HIV-1 TRANSMISSION IN WOMEN - RESULTS FROM A COHORT STUDY
    LAGA, M
    MANOKA, A
    KIVUVU, M
    MALELE, B
    TULIZA, M
    NZILA, N
    GOEMAN, J
    BEHETS, F
    BATTER, V
    ALARY, M
    HEYWARD, WL
    RYDER, RW
    PIOT, P
    [J]. AIDS, 1993, 7 (01) : 95 - 102