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

Pai, Nitika Pant; Daher, Jana

doi:10.1586/14737159.2015.1021335

Cited by 13 publications

(7 citation statements)

References 33 publications

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“…The quadruplex test thereby simplifies specimen acquisition and workup for symptomatic patients. This capability could be leveraged in turn to forestall disease progression; potential loss of patients to care if testing is performed stepwise; and further transmission [ [15] , [16] , [17] ].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Matysiak,

Cheng,

Kirby

2023

Practical Laboratory Medicine

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Matysiak,

Cheng,

Kirby

2023

Practical Laboratory Medicine

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“…Furthermore, prevention of mother-to-child transmission of HBV is a priority in sub-Saharan Africa [56], and adapted screening strategies for HBV infection as well HIV infection in pregnant women are needed [57]. As twin epidemics in key populations, combination integrated multi-disease assays that allow for multiplex testing of HIV, HBV and HCV infections using a single sample would improve the efficiency of screening programs and outcomes in linkage-to-care [2,8,10,51,58].…”

Section: Discussionmentioning

confidence: 99%

“…Ultimately, the acceptability of rapid, multiplex self-tests in sub-Saharan Africa will depend on the concerned groups of population (key populations, symptomatic patients, voluntary blood donors, etc. ), their usefulness in clinical decision-making, their analytical performances and cost, and their ability to be integrated into the health care systems [51].…”

Section: Substudymentioning

confidence: 99%

Self-testing for HIV, HBV, and HCV using finger-stick whole-blood multiplex immunochromatographic rapid test: A pilot feasibility study in sub-Saharan Africa

et al. 2021

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Background The burden of HIV, HBV, and HCV infections remains disproportionately high in sub-Saharan Africa, with high rates of co-infections. Multiplex rapid diagnostic tests for HIV, HBV and HCV serological testing with high analytical performances may improve the “cascade of screening” and quite possibly the linkage-to-care with reduced cost. Based on our previous field experience of HIV self-testing, we herein aimed at evaluating the practicability and acceptability of a prototype finger-stick whole-blood Triplex HIV/HCV/HBsAg self-test as a simultaneous serological screening tool for HIV, HBV, and HCV in the Democratic Republic of the Congo (DRC). Methods A cross-sectional multicentric study consisting of face-to-face, paper-based, and semi-structured questionnaires with a home-based and facility-based recruitment of untrained adult volunteers at risk of HIV, HBV, and HCV infections recruited from the general public was conducted in 2020 in urban and rural areas in the DRC. The practicability of the Triplex self-test was assessed by 3 substudies on the observation of self-test manipulation including the understanding of the instructions for use (IFU), on the interpretation of Triplex self-test results and on its acceptability. Results A total of 251 volunteers (mean age, 28 years; range, 18–49; 154 males) were included, from urban [160 (63.7%)] and rural [91 (36.3%)] areas. Overall, 242 (96.4%) participants performed the Triplex self-test and succeeded in obtaining a valid test result with an overall usability index of 89.2%. The correct use of the Triplex self-test was higher in urban areas than rural areas (51.2% versus 16.5%; aOR: 6.9). The use of video IFU in addition to paper-based IFU increased the correct manipulation and interpretation of the Triplex self-test. A total of 197 (78.5%) participants correctly interpreted the Triplex self-test results, whereas 54 (21.5%) misinterpreted their results, mainly the positive test results harboring low-intensity band (30/251; 12.0%), and preferentially the HBsAg band (12/44; 27.3%). The rates of acceptability of reuse, distribution of the Triplex self-test to third parties (partner, friend, or family member), linkage to the health care facility for confirmation of results and treatment, and confidence in the self-test results were very high, especially among participants from urban areas. Conclusions This pilot study shows evidence for the first time in sub-Saharan Africa on good practicability and high acceptability of a prototype Triplex HIV/HCV/HBsAg self-test for simultaneous diagnosis of three highly prevalent chronic viral infections, providing the rational basis of using self-test harboring four bands of interest, i.e. the control, HIV, HCV, and HBsAg bands. The relatively frequent misinterpretation of the Triplex self-test points however the necessity to improve the delivery of this prototype Triplex self-test probably in a supervised setting. Finally, these observations lay the foundations for the potential large-scale use of the Triplex self-test in populations living in sub-Saharan Africa at high risk for HIV, HBV, and HCV infections.

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“…Therefore, factors such as accuracy and access must be considered when deciding how multiplex devices will be evaluated. 48,71 The current environment may also not be ideal to newly developed assays. As the field continues to move forward at a rapid pace, questions are emerging regarding quality management.…”

Section: Regulatory Challenges Of New Technology Pocsmentioning

confidence: 99%

Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection—Clinical Trial Group Programmatic Meeting

Cristillo¹,

Bristow²,

Peeling³

et al. 2017

Sexual Trans Dis

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The goal of the Point-of-Care (POC) Sexually Transmitted Infection (STI) Diagnostics meeting was to review the state-of-the art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, non-profit and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, Human Papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations and future areas of development. Key points of the meeting are as follows: (i)while some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed and new technologies can be used to improve diagnostic testing, test uptake and treatment; (iii) efficient deployment of self-testing in supervised (i.e., pharmacies, clinics etc.) and/or unsupervised (i.e., home, offices etc.) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies and (v) questions regarding quality management are emerging including the mechanism by which poor performing diagnostics are removed from the market and quality assurance of self-testing is ensured.

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

Cited by 13 publications

References 33 publications

Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Evaluation of the Abbott Alinity m STI assay for diagnosis of the primary causes of sexually transmitted infections in the United States

Self-testing for HIV, HBV, and HCV using finger-stick whole-blood multiplex immunochromatographic rapid test: A pilot feasibility study in sub-Saharan Africa

Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection—Clinical Trial Group Programmatic Meeting

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