Diagnosing sexually transmitted infections in resource‐constrained settings: challenges and ways forward

Abstract

Introduction Sexually transmitted infections (STIs) remain prevalent and are increasing in several populations. Appropriate STI diagnosis is crucial to prevent the transmission and sequelae of untreated infection. We reviewed the diagnostic accuracy of syndromic case management and existing point‐of‐care tests (POCTs), including those in the pipeline, to diagnose STIs in resource‐constrained settings. Methods We prioritized updating the systematic review and meta‐analysis of the diagnostic accuracy of vaginal discharge from 2001 to 2015 to include studies until 2018. We calculated the absolute effects of different vaginal flowcharts and the diagnostic performance of POCTs on important outcomes. We searched the peer‐reviewed literature for previously conducted systematic reviews and articles from 1990 to 2018 on the diagnostic accuracy of syndromic management of vaginal and urethral discharge, genital ulcer and anorectal infections. We conducted literature reviews from 2000 to 2018 on the existing POCTs and those in the pipeline. Results and discussions The diagnostic accuracy of urethral discharge and genital ulcer disease syndromes is relatively adequate. Asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections limit the use of vaginal discharge and anorectal syndromes. The pooled diagnostic accuracy of vaginal syndromic case management for CT/NG is low, resulting in high numbers of overtreatment and missed treatment. The absolute effect of POCTs was reduced overtreatment and missed treatment. Findings of the reviews on syndromic case management underscored the need for low‐cost and accurate POCTs for the identification, first, of CT/NG, and, second, of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) and NG and MG resistance/susceptibility testing. Near‐patient POCT molecular assays for CT/NG/TV are commercially available. The prices of these POCTs remain the barrier for uptake in resource‐constrained settings. This is driving the development of lower cost solutions. Conclusions The WHO syndromic case management guidelines should be updated to raise the quality of STI management through the integration of laboratory tests. STI screening strategies are needed to address asymptomatic STIs. POCTs that are accurate, rapid, simple and affordable are urgently needed in resource‐constrained settings to support the uptake of aetiological diagnosis and treatment.

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

“…The availability of those tests has the potential to improve the treatment and prevention of STIs globally. 10,60 However, although the available POC tests for syphilis have performed well, there is need for additional POC tests for C trachomatis and N gonorrhoeae, the 2 most common bacterial STIs worldwide. The number of those tests has increased, but there is considerable variability in their performance.…”

“…A number of molecular tests exist for the diagnosis of STIs, predominantly nucleic acid amplification tests (NAATs), and are primarily used in high-income countries and other wellresourced settings. 10 However, establishing an etiologic diagnosis for STIs is difficult in many low-resource settings, where diagnostic tests are typically unavailable because of prohibitive costs and a lack of equipment and trained personnel. 11 In response to the limited access to diagnostic testing in low-and middle-income countries, the WHO introduced syndromic case management for STIs, which continues to be used as the standard of care in most lowand middle-income countries.…”

Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance: An expert consensus

“…WHO has developed simplified flowcharts to guide implementation of the syndromic management [57], which is based on the identification of symptoms and signs and the provision of treatment to deal with most of the organisms responsible for producing STIs. A recent systematic review and modelling study on vaginal discharge, performed to inform the TPP development, showed that the pooled sensitivity and specificity of the WHO flowchart 1, consisting of the basic clinical procedures such as history taking including risk assessment, physical examination and bimanual palpation which allows for immediate treatment of CT and NG, is 27.9% (24.7 to 31.1) and 57.0% (56.1 to 58.0) respectively [58]. The absolute effect of differences in prevalence using the pooled sensitivities and specificities of the different vaginal discharge flowcharts reveal that the low diagnostic accuracy of vaginal syndromic case management results in a high number of false positives (lower specificity), leading to overtreatment.…”

Transforming and integrating STI surveillance to enhance global advocacy and investment in STI control

“…Robust national-level strategic information systems that incorporate STI case reporting, prevalence surveys, assessment of the aetiology of STI syndromes, and monitoring for antimicrobial resistance to gonorrhoea are needed to guide programming and clinical service delivery [7,16] (Box 1). As reported in this issue by Wi et al, most countries lack the basic capacity to diagnose and treat STIs let alone implement surveillance [17]. Yet potential stakeholders must first recognize the prevalence and impact of these infections from reliable surveillance data.…”