Will a quadruple multiplexed point-of-care screening strategy for HIV-related co-infections be feasible and impact detection of new co-infections in at-risk populations? Results from cross-sectional studies

Abstract

ObjectivesMultiplexed point-of-care (POC) devices can rapidly screen for HIV-related co-infections (eg, hepatitis C (HCV), hepatitis B (HBV), syphilis) in one patient visit, but global evidence for this approach remains limited. This study aimed to evaluate a multiplex POC testing strategy to expedite screening for HIV-related co-infections in at-risk populations.MethodsA multiplex strategy was developed with two subsequent versions of an investigational device Miriad. It was evaluated in two non-comparable settings and populations in two countries for feasibility of conduct, detection of new infections, preference and accuracy. Version 1 was evaluated in 375 sexually transmitted disease clinic attendees in Mumbai, India; version 2 was evaluated in 119 injection drug users in Montreal, Canada.ResultsFeasibility (completion rate) of the multiplex strategy was high (86.1% Mumbai; 92.4% Montreal). A total of 170 new infections were detected in Mumbai (56 HIV, 75 HBV, 37 syphilis, 2 HCV) versus 2 in Montreal. Preference was 60% in Mumbai and 97% in Montreal. Miriad version 1 specificities were high: HIV 99.7% (98.3% to 100%), HBV 99.3% (97.6% to 99.9%), HCV 99.7% (98.5% to 99.9%), syphilis 85.2% (80.9% to 88.8%); sensitivities were as follows: HIV 100% (94.8% to 100%), HBV 13.3% (6.6% to 23.2%), HCV 50% (1.3% to 98.7%), syphilis 86.1% (70.5% to 95.3%). With version 2, specificities improved: HIV 100% (97.2% to 100%), HBV 100% (97.3% to 100%), HCV 85.3% (73.8% to 93.0%), syphilis 98.1% (93.3% to 99.8%); sensitivities were: HIV 100% (47.3% to 100%), HCV 80.4% (66.1% to 90.6%), syphilis 100% (22.4% to 100%).ConclusionsA quad multiplex POC strategy for HIV and co-infections was feasible to operationalise and preferred by patients in both settings. Many new infections were identified in Mumbai and accuracy improved with version 2 of the assay. Such a strategy will help expedite screening for co-infections, particularly where baseline screening is low. These findings are valuable to practitioners, researchers, policymakers and funders involved in initiatives for all four diseases with implications for scale-up.

Multiplexed testing for HIV and related bacterial and viral co-infections at the point-of-care:quo vadis?

“…Also, recent data suggest that POC tests are comparably accurate to first-line conventional laboratory tests [26]. But while trials for FDA approvals on multiplexed biomarker-based, gene-based and DNA-based devices are currently underway in the US, research data on the feasibility of multiplexed strategies implementation are very limited [20]. Piloting these technologies in simulated environments or in real-world settings can help prepare them for a successful implementation and uptake of these multiplexed devices.…”

“…While a combined, simultaneous or multiplexed HIV, HBV, HCV and syphilis POC screening strategy is gaining traction [20], other infections that are on the rise in at-risk populations are also becoming mainstream. For example, POC tests and platform screening tests for related viral infections such as HPV and HSV, as well as related bacterial infections such as TV, CT and GC are beginning to transform the diagnostic landscape, with a hope to catalyze a change.…”

Multiplexed Point-of-Care Assays for HIV and Co-Infections for Resource Constrained Settings: A Perspective

“…But as data on real world performance and impact measures from ongoing studies emerge, a full evaluation of their risks, benefits and challenges will be informative to policy makers and providers." [15]. For this reason, health professionals in endemic settings need to turn to testing algorithms and protocols to decide on the confirmatory test that can resolve the ambiguity and discriminate past from recent infection.…”

Transformative Innovations in Reproductive, Maternal, Newborn, and Child Health over the Next 20 Years

“…Innovations in diagnostics might include simplified, rapid, multiplexed point-of-care tests [ 22 ], especially those that definitively identify and differentiate bacterial and viral sepsis [ 23 – 25 ], or routine use of biomarkers in low-resource settings to identify which women might experience premature labor [ 26 ] or predict who might suffer from preeclampsia/eclampsia [ 27 , 28 ]. Similarly, screening tests such as genome sequencing [ 29 ] may allow for more rapid and accurate identification of high-risk disease conditions [ 30 – 32 ].…”