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. 2022 Jan 3:8:806605.
doi: 10.3389/fmed.2021.806605. eCollection 2021.

The Diagnostic Accuracy of Syndromic Management for Genital Ulcer Disease: A Systematic Review and Meta-Analysis

Andre J W Loh  1 , Ee Lynn Ting  1 , Teodora E Wi  2 , Philippe Mayaud  3 , Eric P F Chow  1   4   5 , Nancy Santesso  6 , Jane Falconer  7 , Richard Ofori-Asenso  8   9 , Jason J Ong  1   3   4
Affiliations

The Diagnostic Accuracy of Syndromic Management for Genital Ulcer Disease: A Systematic Review and Meta-Analysis

Andre J W Loh et al. Front Med (Lausanne). .

Abstract

Objectives: Genital Ulcer Disease (GUD) carries a significant disease burden globally. With limited access to diagnostics, the 2001 World Health Organization (WHO) sexually transmitted illnesses (STI) guidelines proposed a syndromic management algorithm that required a clinical decision to determine the management of GUD. We assessed the diagnostic accuracy of this algorithm. Methods: We conducted a systematic review (Prospero: CRD42020153294) using eight databases for publications between 1995 and January 2021 that reported primary data on the diagnostic accuracy of clinical diagnosis to identify aetiological agents of GUD. Titles and abstracts were independently assessed for eligibility, and data were extracted from full texts for sensitivity/specificity. A hierarchical logistic regression model was used to derive pooled sensitivity and specificity. We used GRADE to evaluate the certainty of evidence. Results: Of 24,857 articles, 151 full texts were examined and 29 included in the analysis. The majority were from middle-income countries [(14/29 (48%) lower middle, 10/29 (34%) upper middle)]. We pooled studies where molecular testing was using to confirm the aetiology of GUD: 9 studies (12 estimates) for herpes, 4 studies (7 estimates) for syphilis, and 7 studies (10 estimates) for chancroid. The pooled sensitivity and specificity of GUD for the detection of herpes was 43.5% [95% confidence interval (CI): 26.2-62.4], and 88.0% (95% CI: 67.0-96.3), respectively (high certainty evidence); and for syphilis were 52.8% (95% CI: 23.0-80.7), and 72.1% (95% CI: 28.0-94.5) (moderate certainty evidence); and for chancroid were 71.9% (95% CI: 45.9-88.5) and 53.1% (95% CI: 36.6-68.9) (moderate certainty evidence), respectively. Conclusion: Algorithms requiring a clinical diagnosis to determine and treat the aetiology of GUD have poor sensitivities for syphilis and herpes simplex virus, resulting in significant numbers of missed cases. There is an urgent need to improve access to affordable and efficient diagnostics (e.g., point-of-care tests) to be incorporated into GUD algorithms to better guide appropriate management. Systematic Review Registration: PROSPERO, identifier: CRD42020153294.

Keywords: chancroid; genital ulcer disease; herpes; syndromic algorithm; syphilis; systematic review and meta-analysis.

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Conflict of interest statement

RO-A is a current employee of Roche Products Ltd., UK. The views expressed in this article are his own and do not represent that of his employers. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
PRISMA flowchart.
Figure 2
Figure 2
Forest plot of the sensitivity and specificity of clinical diagnosis to detect herpes simplex virus in genital ulcer disease.
Figure 3
Figure 3
Forest plot of the sensitivity and specificity of clinical diagnosis to detect syphilis in genital ulcer disease.
Figure 4
Figure 4
Forest plot of the sensitivity and specificity of clinical diagnosis to detect chancroid in genital ulcer disease.
See this image and copyright information in PMC

References

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