Diagnostic Accuracy of Rapid Point-of-Care Tests for Detecting Active Syphilis: A Systematic Review and Meta-Analysis.

BACKGROUND

Syphilis represents an important cause of morbidity and mortality. Point-of-care (POC) test offers the advantages of diagnosing the condition and the possibility of starting treatment immediately.

METHODS

MEDLINE, Embase, CENTRAL, LILACS, World Health Organization International Clinical Trials Registry Platform, Web of Science, OpenGrey, and DARE were searched without language restrictions from inception to September 30, 2020. Diagnostic test accuracy studies that enrolled men and nonpregnant women of reproductive age under field conditions were analyzed. Only studies wherein all the patients had undergone a rapid POC test and those that included the reference standard (treponemal plus nontreponemal test) were eligible for inclusion. Studies were independently assessed for inclusion, data extraction, and bias risk. The data from these studies were extracted for meta-analyses. The quality of the evidence was assessed using the GRADE approach. Registration Prospero CRD42018107532.

RESULTS

Nine studies with 9666 participants were included. Nine POC brands were assessed. Sensitivities of the tests ranged from 0.67 to 1.00 and specificities from 0.93 to 1.00. The mean sensitivity and specificity of all the included studies was 0.86 (95% confidence interval, 0.79-0.91) and 0.98 (95% confidence interval, 0.96-0.99), respectively.

CONCLUSIONS

Based on the results of this systematic review, the POC test for syphilis showed good sensitivity and excellent specificity.