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; Mlisana, Koleka; Mindel, Adrian

doi:10.1136/bmjopen-2018-026888

Cited by 33 publications

(27 citation statements)

References 14 publications

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“…10 Still, studies done in these settings have shown that the use of NAAT-based POC tests is acceptable and feasible, but additional costeffectiveness studies will be essential to justify the investment by health systems. [28][29][30][31] Cost-effectiveness studies in high-income settings have demonstrated that the tests can be cost-effective in different testing scenarios. 18,51 Ensuring adherence to the ASSURED criteria is one way to maximize the impact of new POC tests.…”

Section: Resultsmentioning

confidence: 99%

“…29 Another study in South Africa demonstrated how the use of the assay could improve same-day treatment, facilitate expedited partner therapy, and reduce reinfection at 6 months. 30 A recent study in Rwanda established that the assay could be used to provide targeting screening to improve the WHO's syndromic treatment approach and resulted in a reduction in overtreatment of STIs. 31 The binx health io CT/NG Assay (binx health, Inc) is a rapid qualitative PCR-based diagnostic system that consists of a small, benchtop, fully integrated instrument that uses single-use, assay-specific cartridges.…”

Section: Naat-based Systemsmentioning

confidence: 99%

“…These aspects also make the assay appealing for use in low-resource settings, and studies have demonstrated its potential to improve diagnosis of T vaginalis infections in Rwanda and South Africa. 30,31 The timelines for the available POC tests for STIs and those under development are displayed in Figure 3. 42 ABILITY TO DETECT DRUG RESISTANCE The emergence and spread of antimicrobial resistance (AMR) in N gonorrhoeae is an urgent global public health concern, and N gonorrhoeae has been listed as a priority pathogen by the WHO.…”

Section: Trichomoniasismentioning

confidence: 99%

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Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments

Adamson

Loeffelholz²,

Klausner

2020

Archives of Pathology &Amp; Laboratory Medicine

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Context.— Sexually transmitted infections (STIs) are among the most common communicable diseases globally and are associated with significant morbidity and mortality worldwide. Point-of-care tests have the potential to revolutionize the prevention and control of STIs by enabling rapid diagnosis and early treatment of infections, thus interrupting transmission and preventing the sequelae of untreated infections. Currently, there are several point-of-care (POC) tests available for the diagnosis of Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections, although these tests differ with regard to their performance, turnaround time, and cost. Objective.— To provide an updated review of the POC tests available and under development for the diagnosis of T pallidum, C trachomatis, N gonorrhoeae, and T vaginalis infections, to discuss the context for which these tests might be used, and to highlight future directions for test development. Data Sources.— We reviewed the literature pertaining to the recent development and performance evaluations of POC tests for the diagnosis of syphilis, chlamydia, gonorrhea, and trichomonas. Conclusions.— Recently, there has been rapid development of new POC tests for STIs. Although there are inexpensive, rapid, and accurate POC tests available for syphilis, there are few such tests available for the diagnosis of chlamydia, gonorrhea, or trichomonas, and currently none with the ability to detect antimicrobial resistance in N gonorrhoeae. Research evaluating implementation strategies for the currently available tests and the development of additional POC tests that are rapid, accurate, and affordable are urgently needed to address the rising number of STIs worldwide.

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Section: Resultsmentioning

confidence: 99%

Section: Naat-based Systemsmentioning

confidence: 99%

Section: Trichomoniasismentioning

confidence: 99%

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Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments

Adamson

Loeffelholz²,

Klausner

2020

Archives of Pathology &Amp; Laboratory Medicine

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“… 16 The study included a cohort of young, non-pregnant, HIV-uninfected women attending the Prince Cyril Zulu Communicable Diseases Centre for sexual and reproductive services in Durban, South Africa. 17 Women were excluded from the study if they reported the use of antibiotics or HSV treatments within the past 7 days or had engaged in any form of sex work. A total of 251 enrolled women consenting to genital specimen collection were included in this secondary analysis of baseline data.…”

Section: Methodsmentioning

confidence: 99%

“…Protected by copyright. 17 Women were excluded from the study if they reported the use of antibiotics or HSV treatments within the past 7 days or had engaged in any form of sex work. A total of 251 enrolled women consenting to genital specimen collection were included in this secondary analysis of baseline data.…”

Section: Participants and Specimen Collectionmentioning

confidence: 99%

Genital HSV-1 DNA detection is associated with a low inflammatory profile in HIV-uninfected South African women

et al. 2020

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ObjectivesGenital herpes simplex virus (HSV) infections are common in South Africa and worldwide. While HSV-2 is known to cause genital lesions, HSV-1 is better known to cause oral infections. Due to the global rise in genital HSV-1 infections, we aimed to compare the genital cytokine environment associated with HSV-1 and HSV-2 infections and their relation to the proinflammatory genital immune environment associated with HIV risk in African women.MethodsHSV-1 and HSV-2 DNA were detected by quantitative real-time PCR in menstrual cup specimens collected from 251 HIV-negative women participating in the CAPRISA 083 study in Durban, South Africa. HSV shedding was defined as detection at >150 copies/mL. Forty-eight cytokines were measured in genital fluid by multiplexed ELISA, and multivariable regression models determined associations between genital cytokines and HSV DNA detection.ResultsHSV-1 DNA detection (24/251 (9.6%)) and shedding (13/24 (54.2%)) was more common than HSV-2 (detection in 14/251 (5.6%), shedding in 0/14). None of the women with detectable HSV had evidence of genital lesions. HSV-2 DNA detection was associated with increased interleukin (IL)−18 and decreased cutaneous T-cell attracting chemokine concentrations, but only in univariable analysis. By contrast, in both univariable and multivariable analyses, the detection of HSV-1 DNA was associated with reduced concentrations of granulocyte-colony stimulating factor, IL-7, IL-4, platelet-derived growth factor-ββ and five proinflammatory cytokines associated with HIV risk: IL-6, IL-1β, macrophage inflammatory protein (MIP)−1α, MIP-1β and tumour necrosis factor-α.ConclusionsThat HSV-1 DNA was more commonly detected and shed than HSV-2 emphasises the need for clinical screening of both viruses, not just HSV-2 in young women. Efforts to reduce genital inflammation may need to consider implementing additional strategies to mitigate a rise in HSV replication.

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Highly‐Specific Single‐Stranded Oligonucleotides and Functional Nanoprobes for Clinical Determination of Chlamydia Trachomatis and Neisseria Gonorrhoeae Infections

Dighe,

Moitra,

Gunaseelan

et al. 2023

Advanced Science

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Early detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is the key to controlling the spread of these bacterial infections. An important step in developing biosensors involves identifying reliable sensing probes against specific genetic targets for CT and NG. Here, the authors have designed single‐stranded oligonucleotides (ssDNAs) targeting mutually conserved genetic regions of cryptic plasmid and chromosomal DNA of both CT and NG. The 5′‐ and 3′‐ ends of these ssDNAs are differentially functionalized with thiol groups and coupled with gold nanoparticles (AuNP) to develop absorbance‐based assay. The AuNPs agglomerate selectively in the presence of its target DNA sequence and demonstrate a change in their surface plasmon resonance. The optimized assay is then used to detect both CT and NG DNA extracted from 60 anonymized clinical samples with a clinical sensitivity of ∼100%. The limit of detection of the assays are found to be 7 and 5 copies/µL for CT and NG respectively. Furthermore, it can successfully detect the DNA levels of these two bacteria without the need for DNA extraction and via a lateral flow‐based platform. These assays thus hold the potential to be employed in clinics for rapid and efficient monitoring of sexually transmitted infections.

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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

Cited by 33 publications

References 14 publications

Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments

Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments

Genital HSV-1 DNA detection is associated with a low inflammatory profile in HIV-uninfected South African women

Highly‐Specific Single‐Stranded Oligonucleotides and Functional Nanoprobes for Clinical Determination of Chlamydia Trachomatis and Neisseria Gonorrhoeae Infections

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