Abstract
Sexually transmitted infections (STIs) impose major health and economic burden worldwide. This systematic review evaluated challenges (implementational/logistical/technological/supply-chain/laboratory-related) faced during multiplexed, point-of-care test deployment.
Background:
Sexually transmitted infections (STIs) impose major health and economic burden worldwide. This systematic review aimed to evaluate challenges (implementational/logistical/technological/supply-chain/laboratory-related) faced during multiplexed, point-of-care test deployment.
Method:
Two reviewers independently searched Pubmed and Embase; 419 results were retrieved. Eligible studies utilizing multiplexed, rapid tests to detect several STIs were included. This work-in-progress report describes barriers collected thus far.
Results:
Of 419 citations screened, seven are currently included. All were observational studies, conducted in USA (n=3), UK (n=2), South Korea (n=1) and Central African Republic (n=1). The most common STIs screened were Hepatitis B, HIV, syphilis, Trichomonas vaginalis, Chlamydia trachomatis, herpesvirus and Lymphogranuloma venereum (LGV). Populations screened included individuals with LGV-associated anorectal symptoms; with suspicion or presence of active HBV, syphilis and HIV; and attending STI clinics.
Multiplex-PCR was unable to 1-distinguish between co-infections caused by different LGV strains and 2-reveal all serovar variants (n=1). The LightCycler instrument could not detect HPV-45 (n=1). INSTI-multiplex could not differentiate between active and prior syphilis infection and had limited utility in clinics (vs. outreach settings) (n=1). Multiplexed, point-of-care tests were costlier than standard-of-care screening (n=1). Low diagnostic accuracy and precision were reported, particularly for HIV, Trichomonas vaginalis and herpesvirus detection (n=2). Additionally, STDetect DNA chip was associated with time-consuming, cumbersome procedures (n=1).
Conclusion:
Multiplexed, point-of-care tests offer tremendous potential in STI diagnostics. However, poor diagnostic accuracy and a lack of resources for their optimal operationalization impede their full utilization. By identifying real-world challenges, this review can help facilitate deployment of multiplexed point-of-care screening worldwide.