{"id":40342,"date":"2021-04-05T11:56:58","date_gmt":"2021-04-05T15:56:58","guid":{"rendered":"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/?p=79"},"modified":"2022-04-13T10:07:50","modified_gmt":"2022-04-13T14:07:50","slug":"virion-biomedical-technologies","status":"publish","type":"post","link":"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/","title":{"rendered":"Cost-Effective HIV Viral Load Assay"},"content":{"rendered":"\n<div class=\"wp-block-image is-position-center-center\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"750\" height=\"300\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Viriotech-Logo-3.jpg\" alt=\"\" class=\"wp-image-973\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Viriotech-Logo-3.jpg 750w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Viriotech-Logo-3-300x120.jpg 300w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Problem Statement<\/h2>\n\n\n\n<p>Viriotech Biomedical Engineering is designing a cassette for a cost-effective human immunodeficiency virus (HIV) viral load assay. While there has been a steady global decrease in HIV mortality since the turn of the 21st century, sub-Saharan African communities remain disproportionately affected by HIV partly due to limited access to medical resources. Current technology requires patients to wait several days for expensive test results. This wait presents challenges in communities far from health clinics. Our mission is to design a cassette for an HIV viral load assay that allows us to provide quick, more affordable HIV testing for more people in low-resource communities. We are collaborating with Dr. Benjamin Miller and Jeffrey Beard at the University of Rochester Medical Center to develop this device. Our end-users are the healthcare workers in clinics. They will determine a patient\u2019s viral load based on a fluorescence readout. A patient\u2019s blood sample runs through multiple microfluidics paper layers that capture the viral RNA in a detection layer. This cassette incorporates a readout method that uses smartphone technology to determine HIV virion concentration in the blood. Our device has materials that withstand high temperature and humidity environments like in sub-Saharan Africa. Ultimately, this project impacts communities without essential resources in healthcare.<\/p>\n\n\n\n<figure class=\"wp-block-video aligncenter\"><video height=\"1080\" style=\"aspect-ratio: 1696 \/ 1080;\" width=\"1696\" autoplay controls loop src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/HIV_ASSAY_MK-VI-Active-Creo-Parametric-Student-Edition-for-educational-use-only-2021-05-05-10-49-50.mp4\"><\/video><\/figure>\n\n\n\n<div class=\"wp-block-coblocks-alert\"><p class=\"wp-block-coblocks-alert__title\">Intellectual Property Disclaimer<\/p><p class=\"wp-block-coblocks-alert__text\">Due to IP concerns, some specifications about the device have been omitted. <\/p><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Background<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-coblocks-accordion\">\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Aim<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Our aim is to design a cassette for a <strong>cost-effective<\/strong> and <strong>fast<\/strong> HIV viral load assay to increase testing <strong>accessibility<\/strong> in areas such as sub-Saharan Africa where HIV rates are highly prevalent.<\/p>\n\n\n\n<div class=\"wp-block-image is-style-default\"><figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/PROBLEM-STATEMENT.png\" alt=\"\" class=\"wp-image-971\" width=\"546\" height=\"135\"\/><\/figure><\/div>\n\n\n\n<p><\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">What is HIV\/AIDS?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The Human Immunodeficiency Virus (HIV) binds and targets CD4 receptors on T-cells, a type of immune cell that targets foreign invaders in the body. Without treatment, HIV can progress to acquired immunodeficiency syndrome (AIDS) where a patient is completely immunocompromised due to the high viral load of HIV.<\/p>\n\n\n\n<p>Since the first case of HIV in the 1920s, HIV\/AIDS was not declared an epidemic until the 1980s. Due to increasing awareness of the manner, there was a major expansion in research in HIV tests and treatments such as antiretroviral therapy (ART). ART prevents the progression of HIV into AIDS and transmission to others. <\/p>\n\n\n\n<p>By 2010, although manageable in most parts of the world due to accessible tests and treatments, new infections remain high in Eastern and Southern Africa. <\/p>\n\n\n\n<p>Below is a schematic of the lifecycle of HIV, from the moment it&nbsp;binds to a CD4 receptor<strong> <\/strong>and a coreceptor (CCR5 or CXCR4).<\/p>\n\n\n\n<p><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"500\" class=\"wp-image-1405\" style=\"width: 500px;\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1.jpeg\" alt=\"\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1.jpeg 2560w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-300x300.jpeg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-1024x1024.jpeg 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-150x150.jpeg 150w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-768x768.jpeg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-1536x1536.jpeg 1536w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-2048x2048.jpeg 2048w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-1200x1200.jpeg 1200w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/HIV-life-cycle-graphic_overview-scaled-1-1980x1980.jpeg 1980w\" sizes=\"auto, (max-width: 500px) 100vw, 500px\" \/><\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Why is HIV important to address?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Below is a map of HIV prevalence worldwide. Although manageable in most parts of the world due to accessible tests and treatments, 54% of cases are in sub-Saharan Africa. <\/p>\n\n\n\n<p>In 2019, almost 21 million people in Eastern and Southern Africa were living with HIV. This is why our team and customers are focusing on this region. <\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"723\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-1024x723.png\" alt=\"\" class=\"wp-image-941\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-1024x723.png 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-300x212.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-768x542.png 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-1536x1084.png 1536w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-2048x1446.png 2048w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-1200x847.png 1200w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/hiv-death-rates-1980x1398.png 1980w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>M. Roser and H. Ritchie, \u201cHIV \/ AIDS,\u201d <em>Our World in Data<\/em>, 2018.<\/p>\n\n\n\n<p>&#8220;Global Statistics&#8221;, HIV.gov, 2021<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">What is a viral load?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Viral load is the gold standard for quantifying the levels of HIV in the blood and therefore determines the success of ART. <\/p>\n\n\n\n<p>By 2021 low to middle-income countries will need an estimated 30 million viral load tests. However, it is not just important to have more people on ART. These patients need to be continuously monitored. The 2013 World Health Organization Guidelines recommend viral load monitoring at six months after treatment initiation, at 12 months, and every 12 months thereafter.<\/p>\n\n\n\n<p>The schematic below shows how antiretroviral drugs (ARVs) target specific steps in the HIV replication cycle.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"850\" height=\"723\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/ARVs-target-specific-steps-in-the-HIV-replication-cycle.jpg\" alt=\"\" class=\"wp-image-1449\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/ARVs-target-specific-steps-in-the-HIV-replication-cycle.jpg 850w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/ARVs-target-specific-steps-in-the-HIV-replication-cycle-300x255.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/ARVs-target-specific-steps-in-the-HIV-replication-cycle-768x653.jpg 768w\" sizes=\"auto, (max-width: 850px) 100vw, 850px\" \/><figcaption>B. Yavuz et al., &#8220;Pharmaceutical Approaches to HIV Treatment and Prevention&#8221;,&nbsp;<em>Advanced Therapeutics<\/em>, vol. 1, no. 6, p. 1800054, 2018.<\/figcaption><\/figure>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">The Global HIV Market<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The global HIV therapeutics market will reach $27 billion by 2023. <\/p>\n\n\n\n<p>The HIV Market encompassing all testing, from diagnostic to viral load assays, exceeded 2.9 billion $ in 2017, out of which 20% is viral load assays.<\/p>\n\n\n\n<p>Below are two popular Viral Load technologies by Cepheid and Abbot.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"740\" height=\"440\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-09.25.37.png\" alt=\"\" class=\"wp-image-1527\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-09.25.37.png 740w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-09.25.37-300x178.png 300w\" sizes=\"auto, (max-width: 740px) 100vw, 740px\" \/><\/figure>\n\n\n\n<p>Why are these technologies not meeting the current need for more, cost-effective viral load assays?<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li>Require electricity, often not available in the clinics<\/li><li>Lack of transparency in their prices (apparatus price not listed online)<\/li><li>One test costs $38-131<\/li><\/ul>\n\n\n\n<p>Viral load assays with dried blood spots specifically targeted towards middle to low resource communities have prices ranging<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li>$25-44 without support<\/li><li>$17-29 with Doctors Without Borders and Unitaid personnel and funding support<\/li><\/ul>\n\n\n\n<p>\u201cHIV Diagnostics Market Forecasts\u201d, WHO, 2015<\/p>\n\n\n\n<p>P. Drain et al., &#8220;Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV\/AIDS Response&#8221;,&nbsp;<em>Clinical Microbiology Reviews<\/em>, vol. 32, no. 3, 2019.<\/p>\n\n\n\n<p>\u201cHow Low Can We Go?\u201d, MSF.org, 2013<\/p>\n<\/div><\/details><\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons alignfull is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">Problem statement<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--2\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">background<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--3\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/2\/\">Team members<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--4\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/3\/\">Cassette design<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--5\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/4\/\">testing &amp; Injection molding<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--6\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">next steps<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--7\"><a class=\"wp-block-button__link has-secondary-color has-background-background-color has-text-color has-background\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/5\/\">FAQ and covid-19<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--8\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">Customer Feedback &amp; AcknowledgmentS<\/a><\/div>\n<\/div>\n\n\n\n<!--nextpage-->\n\n\n\n<h1 class=\"wp-block-heading\">Meet the Team<\/h1>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-center is-image-fill\" style=\"grid-template-columns:22% auto\"><figure class=\"wp-block-media-text__media\" style=\"background-image:url(https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/04\/Sarah-1-843x1024.jpg);background-position:39% 49%\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/04\/Sarah-1-843x1024.jpg\" alt=\"\" class=\"wp-image-952 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">Sarah Kintzel <\/p>\n\n\n\n<p>skintzel@u.rochester.edu<\/p>\n\n\n\n<p>she\/her\/hers<\/p>\n\n\n<div class=\"wp-block-coblocks-social wp-block-coblocks-social-profiles has-colors\"><ul><li><a href=\"https:\/\/www.linkedin.com\/in\/sarahkintzel-21\/\" title=\"Linkedin\" class=\"wp-block-button__link wp-block-coblocks-social__button wp-block-coblocks-social__button--linkedin has-padding\" style=\"border-radius:40px\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"wp-block-coblocks-social__icon\"><\/span><span class=\"wp-block-coblocks-social__text\">Linkedin<\/span><\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-center is-image-fill\" style=\"grid-template-columns:22% auto\"><figure class=\"wp-block-media-text__media\" style=\"background-image:url(https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/Leonor-Teles1-768x1024.jpg);background-position:50% 50%\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/Leonor-Teles1-768x1024.jpg\" alt=\"\" class=\"wp-image-935 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">Leonor Teles<\/p>\n\n\n\n<p>lteles@u.rochester.edu<\/p>\n\n\n\n<p>she\/her\/hers<\/p>\n\n\n<div class=\"wp-block-coblocks-social wp-block-coblocks-social-profiles has-colors\"><ul><li><a href=\"http:\/\/linkedin.com\/in\/leonor-teles-5898bb181\" title=\"Linkedin\" class=\"wp-block-button__link wp-block-coblocks-social__button wp-block-coblocks-social__button--linkedin has-padding\" style=\"border-radius:40px\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"wp-block-coblocks-social__icon\"><\/span><span class=\"wp-block-coblocks-social__text\">Linkedin<\/span><\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-center\" style=\"grid-template-columns:23% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/dylan.jpg\" alt=\"\" class=\"wp-image-1006 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-text-align-left has-large-font-size\">Dylan Manuele <\/p>\n\n\n\n<p>dmanuele@u.rochester.edu<\/p>\n\n\n\n<p>he\/him\/his<\/p>\n\n\n<div class=\"wp-block-coblocks-social wp-block-coblocks-social-profiles has-colors\"><ul><li><a href=\"https:\/\/www.linkedin.com\/in\/dylan-manuele\" title=\"Linkedin\" class=\"wp-block-button__link wp-block-coblocks-social__button wp-block-coblocks-social__button--linkedin has-padding\" style=\"border-radius:40px\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"wp-block-coblocks-social__icon\"><\/span><span class=\"wp-block-coblocks-social__text\">Linkedin<\/span><\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile is-vertically-aligned-center is-image-fill\" style=\"grid-template-columns:24% auto\"><figure class=\"wp-block-media-text__media\" style=\"background-image:url(https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screen-Shot-2020-10-19-at-10.53.04-PM.png);background-position:54% 52%\"><img loading=\"lazy\" decoding=\"async\" width=\"938\" height=\"704\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screen-Shot-2020-10-19-at-10.53.04-PM.png\" alt=\"\" class=\"wp-image-992 size-full\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screen-Shot-2020-10-19-at-10.53.04-PM.png 938w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screen-Shot-2020-10-19-at-10.53.04-PM-300x225.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screen-Shot-2020-10-19-at-10.53.04-PM-768x576.png 768w\" sizes=\"auto, (max-width: 938px) 100vw, 938px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">Gillian Mair<\/p>\n\n\n\n<p>gmair@u.rochester.edu<\/p>\n\n\n\n<p>she\/her\/hers<\/p>\n\n\n<div class=\"wp-block-coblocks-social wp-block-coblocks-social-profiles has-colors\"><ul><li><a href=\"http:\/\/linkedin.com\/in\/gillian-mair-684208196\" title=\"Linkedin\" class=\"wp-block-button__link wp-block-coblocks-social__button wp-block-coblocks-social__button--linkedin has-padding\" style=\"border-radius:40px\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"wp-block-coblocks-social__icon\"><\/span><span class=\"wp-block-coblocks-social__text\">Linkedin<\/span><\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile is-image-fill\" style=\"grid-template-columns:25% auto\"><figure class=\"wp-block-media-text__media\" style=\"background-image:url(https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/rachel.png);background-position:50% 50%\"><img loading=\"lazy\" decoding=\"async\" width=\"624\" height=\"764\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/rachel.png\" alt=\"\" class=\"wp-image-1007 size-full\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/rachel.png 624w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/rachel-245x300.png 245w\" sizes=\"auto, (max-width: 624px) 100vw, 624px\" \/><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">Qing (Rachel) Zhu<\/p>\n\n\n\n<p>qzhu13@u.rochester.edu<\/p>\n\n\n\n<p>she\/her\/hers<\/p>\n\n\n<div class=\"wp-block-coblocks-social wp-block-coblocks-social-profiles has-colors\"><ul><li><a href=\"http:\/\/linkedin.com\/in\/qing-zhu-rachel\" title=\"Linkedin\" class=\"wp-block-button__link wp-block-coblocks-social__button wp-block-coblocks-social__button--linkedin has-padding\" style=\"border-radius:40px\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"wp-block-coblocks-social__icon\"><\/span><span class=\"wp-block-coblocks-social__text\">Linkedin<\/span><\/a><\/li><\/ul><\/div><\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion\">\n<div class=\"wp-block-coblocks-accordion-item\"><\/div>\n<\/div>\n\n\n\n<figure class=\"wp-block-pullquote is-style-default\"><blockquote><p>Together we are dedicated to designing and providing more accessible healthcare to low resource communities.<\/p><cite>Viriotech Biomedical Engineering<\/cite><\/blockquote><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Rice 360\u00ba Design Competition<\/h2>\n\n\n\n<p>Viriotech Biomedical Engineering was a <strong>semifinalist<\/strong> in this design <a rel=\"noreferrer noopener\" href=\"https:\/\/www.rice360.rice.edu\/design-competition\" target=\"_blank\">competition<\/a>. Below is the submission video, developed during an earlier stage of the device. <\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-4-3 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"wp-embed\"><div class=\"wp-embed-wrap\"><iframe loading=\"lazy\" title=\"Viriotech Biomedical HIV Assay Competition Video\" width=\"1062\" height=\"797\" src=\"https:\/\/www.youtube.com\/embed\/-2Nd-8TYVR0?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" allowfullscreen><\/iframe><\/div><\/div>\n<\/div><\/figure>\n\n\n\n<figure class=\"wp-block-image alignwide size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"300\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Hajim_Logo-H-4-1024x300.jpg\" alt=\"\" class=\"wp-image-1473\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Hajim_Logo-H-4-1024x300.jpg 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Hajim_Logo-H-4-300x88.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Hajim_Logo-H-4-768x225.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Hajim_Logo-H-4.jpg 1063w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<div class=\"wp-block-buttons alignfull is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--9\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">Problem statement<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--10\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">background<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--11\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/2\/\">Team members<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--12\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/3\/\">Cassette design<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--13\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/4\/\">testing &amp; Injection molding<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--14\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">next steps<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--15\"><a class=\"wp-block-button__link has-secondary-color has-background-background-color has-text-color has-background\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/5\/\">FAQ and covid-19<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--16\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">Customer Feedback &amp; AcknowledgmentS<\/a><\/div>\n<\/div>\n\n\n\n<!--nextpage-->\n\n\n\n<p style=\"font-size:74px\">HIV Assay Cassette Design<\/p>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\" style=\"grid-template-columns:53% auto\"><figure class=\"wp-block-media-text__media\"><video controls src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Voice-over.mp4\"><\/video><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\"><strong>Customer Scenario<\/strong><\/p>\n\n\n\n<p>In the clinic, about 1 mL of blood is drawn and taken to the lab for testing. The healthcare worker opens the cassette, inserts the blood sample with the assay reagents, and seals the device to contain infectious materials. Inside the cassette, the blood sample runs through porous layers where viral material can be exposed and analyzed to assess viral load. Within 30 minutes, the test results are available to the patient.<\/p>\n<\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Workflow<\/h2>\n\n\n\n<p>The diagram below demonstrates the workflow that healthcare workers will experience in the clinic when using the HIV viral load assay. Please review our customer scenario video to see how this device will work in the clinic.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"944\" height=\"303\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-10.40.18.png\" alt=\"\" class=\"wp-image-1534\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-10.40.18.png 944w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-10.40.18-300x96.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Screenshot-2021-05-06-at-10.40.18-768x247.png 768w\" sizes=\"auto, (max-width: 944px) 100vw, 944px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Device Requirements<\/h2>\n\n\n\n<ul class=\"is-style-checkbox has-large-font-size wp-block-list\"><li>Inexpensive<\/li><li>Efficient<\/li><li>Effective<\/li><li>Stable<\/li><li>Mass Producible <\/li><\/ul>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><thead><tr><th class=\"has-text-align-center\" data-align=\"center\">Requirements<\/th><th class=\"has-text-align-center\" data-align=\"center\">Metrics<\/th><\/tr><\/thead><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\">Cost (USD)<\/td><td class=\"has-text-align-center\" data-align=\"center\">$10 \u00b1 $5 per unit<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Time before receiving results (min)<\/td><td class=\"has-text-align-center\" data-align=\"center\">30 &#8211; 90 min<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Blood required (\u03bcL)<\/td><td class=\"has-text-align-center\" data-align=\"center\">750 \u00b1 10 \u03bcL<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Effective diagnosis (%)<\/td><td class=\"has-text-align-center\" data-align=\"center\">90 &#8211; 100%<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Shelf life (months)<\/td><td class=\"has-text-align-center\" data-align=\"center\">6+ months<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Temperature (\u00b0C)<\/td><td class=\"has-text-align-center\" data-align=\"center\">20-50 \u00b0C<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Humidity (%)<\/td><td class=\"has-text-align-center\" data-align=\"center\">50-90%<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Number of parts<\/td><td class=\"has-text-align-center\" data-align=\"center\">2 \u00b1 1 parts<\/td><\/tr><\/tbody><\/table><figcaption>Here are the top device requirements outlined by our customers with included metrics.<\/figcaption><\/figure>\n\n\n\n<h2 class=\"has-text-align-left wp-block-heading\">Cassette CAD &amp; 3D Printed Model<\/h2>\n\n\n\n<div class=\"wp-block-coblocks-gallery-masonry\"><div class=\"coblocks-gallery has-no-alignment has-caption-style-dark has-gutter\"><ul class=\"has-grid-xlrg has-gutter-15 has-gutter-mobile-15\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img loading=\"lazy\" decoding=\"async\" width=\"960\" height=\"540\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Virtual-Design-Day-Website-1.png\" alt=\"\" data-id=\"959\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/virtual-design-day-website-1\/\" class=\"wp-image-959\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Virtual-Design-Day-Website-1.png 960w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Virtual-Design-Day-Website-1-300x169.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Virtual-Design-Day-Website-1-768x432.png 768w\" sizes=\"auto, (max-width: 960px) 100vw, 960px\" \/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"894\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-1024x894.jpg\" alt=\"\" data-id=\"1244\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/img_2813-1\/\" class=\"wp-image-1244\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-1024x894.jpg 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-300x262.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-768x671.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-1536x1341.jpg 1536w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-2048x1789.jpg 2048w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-1200x1048.jpg 1200w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/IMG_2813-1-1980x1729.jpg 1980w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/IMG_2814-1024x768.jpg\" alt=\"\" data-id=\"1245\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/img_2814\/\" class=\"wp-image-1245\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/IMG_2815-1024x768.jpg\" alt=\"\" data-id=\"1246\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/img_2815\/\" class=\"wp-image-1246\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/PXL_20210504_201447721-1024x768.jpg\" alt=\"\" data-id=\"1247\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/pxl_20210504_201447721\/\" class=\"wp-image-1247\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/PXL_20210504_201417704-1024x768.jpg\" alt=\"\" data-id=\"1248\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/pxl_20210504_201417704\/\" class=\"wp-image-1248\"\/><\/figure><\/li><\/ul><\/div><\/div>\n\n\n\n<p>As shown in the figures, the cassette features two lids in different sizes with a blood inlet. In clinical settings, medical workers should collect about 1 mL of blood from patients and apply it to the inlet through lid #1. After 30 minutes, an image is taken with a phone through lid #2 for the result.<\/p>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\">L-TOE CAD &amp; 3D Printed Model<\/h2>\n\n\n\n<div class=\"wp-block-coblocks-gallery-masonry\"><div class=\"coblocks-gallery has-no-alignment has-caption-style-dark has-gutter\"><ul class=\"has-grid-xlrg has-gutter-15 has-gutter-mobile-15\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img loading=\"lazy\" decoding=\"async\" width=\"804\" height=\"540\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/LTOE-1.png\" alt=\"\" data-id=\"964\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/ltoe-1\/\" class=\"wp-image-964\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/LTOE-1.png 804w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/LTOE-1-300x201.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/LTOE-1-768x516.png 768w\" sizes=\"auto, (max-width: 804px) 100vw, 804px\" \/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/PXL_20210504_201501479-768x1024.jpg\" alt=\"\" data-id=\"1252\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/pxl_20210504_201501479\/\" class=\"wp-image-1252\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/IMG_2819-1024x768.jpg\" alt=\"\" data-id=\"1255\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/img_2819\/\" class=\"wp-image-1255\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/IMG_2817-1024x768.jpg\" alt=\"\" data-id=\"1256\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/img_2817\/\" class=\"wp-image-1256\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/PXL_20210506_230347116-768x1024.jpg\" alt=\"\" data-id=\"1925\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/pxl_20210506_230347116\/\" class=\"wp-image-1925\"\/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img decoding=\"async\" src=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/wp-content\/uploads\/2021\/05\/IMG_2818-1024x768.jpg\" alt=\"\" data-id=\"1257\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/img_2818\/\" class=\"wp-image-1257\"\/><\/figure><\/li><\/ul><\/div><\/div>\n\n\n\n<p>The figures demonstrate the Light-Tight Optical Enclosure (L-TOE) that will be used to take the image for the result. At the bottom of the device, there is a sunken part in the shape of the cassette with lid #2 open. The cassette can be slide in through the gap on the side of the top half of L-TOE. The phone can be secured in place on top of the device. In the future, the L-TOE will be manufacturing using cardboard.<\/p>\n\n\n\n<h2 class=\"has-text-align-left wp-block-heading\">Life Cycle<\/h2>\n\n\n\n<figure class=\"wp-block-image alignwide size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"960\" height=\"465\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/life-cycle.jpg\" alt=\"\" class=\"wp-image-1679\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/life-cycle.jpg 960w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/life-cycle-300x145.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/life-cycle-768x372.jpg 768w\" sizes=\"auto, (max-width: 960px) 100vw, 960px\" \/><figcaption>The HIV viral load assay goes through many phases in its life cycle from production and transport to use in a clinical setting. The life cycle of the device is divided into two main phases: preclinical care (orange) and clinician care (green). Preclinical care pertains to the life of the product in the manufacturing and shipment stages. Clinician care pertains to the clinical uses of the device. The clinics would also have biohazard waste disposal, further ensuring safety.<\/figcaption><\/figure>\n\n\n\n<div class=\"wp-block-buttons alignfull is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--17\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">Problem statement<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--18\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">background<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--19\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/2\/\">Team members<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--20\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/3\/\">Cassette design<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--21\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/4\/\">testing &amp; Injection molding<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--22\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">next steps<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--23\"><a class=\"wp-block-button__link has-secondary-color has-background-background-color has-text-color has-background\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/5\/\">FAQ and covid-19<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--24\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">Customer Feedback &amp; AcknowledgmentS<\/a><\/div>\n<\/div>\n\n\n\n<!--nextpage-->\n\n\n\n<p class=\"has-text-align-center has-primary-color has-text-color\" style=\"font-size:74px;line-height:1.1\">Testing &amp; Scale-up<\/p>\n\n\n\n<p>To further understand and gauge the device, Viriotech tested the cassette in three categories: evaporation, sealability, and usability.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>Evaporation<\/strong><\/p>\n\n\n\n<p>The HIV assay runs on capillary action, so enough blood must run through the layers during the test. Evaporation tests were done to ensure the cassette protected the fluid from the environment. The figure below shows (1) the percent difference in the weight of the layers after 50 minutes and (2) the fluctuations of the weight over time. Four-layer assemblies were used for the tests in two environments: enclosed within the cassette and open\/exposed to the environment. Results show that the evaporation rate is lower in the enclosed layers. The data demonstrate that our cassette prevents the evaporation of blood samples, but not perfectly. Nonetheless, we estimate that a less than 2% weight change does not harm the final viral result.<\/p>\n\n\n\n<div class=\"wp-block-coblocks-gallery-stacked aligncenter\"><ul class=\"coblocks-gallery has-fullwidth-images\"><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img loading=\"lazy\" decoding=\"async\" width=\"560\" height=\"420\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/percentdifference.jpg\" alt=\"\" data-id=\"1597\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/percentdifference\/\" class=\"wp-image-1597 has-shadow-none\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/percentdifference.jpg 560w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/04\/percentdifference-300x225.jpg 300w\" sizes=\"auto, (max-width: 560px) 100vw, 560px\" \/><\/figure><\/li><li class=\"coblocks-gallery--item\"><figure class=\"coblocks-gallery--figure\"><img loading=\"lazy\" decoding=\"async\" width=\"560\" height=\"420\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/evaporation-test.jpg\" alt=\"\" data-id=\"1601\" data-imglink=\"\" data-link=\"https:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/attachment\/evaporation-test\/\" class=\"wp-image-1601 has-shadow-none\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/evaporation-test.jpg 560w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/evaporation-test-300x225.jpg 300w\" sizes=\"auto, (max-width: 560px) 100vw, 560px\" \/><\/figure><\/li><\/ul><\/div>\n\n\n\n<p><strong>Sealability<\/strong><\/p>\n\n\n\n<p>The sealability of the device is currently being tested in the following conditions:&nbsp;<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li>Bumped cassette (moving left and right, up and down, forward and back, pitch, roll, and yaw)<\/li><li>Dropped cassette (0-6 feet with intervals of 0.5 feet) onto a floor of different textures (granite, wood, mud).<\/li><li>Slide rotator test: fill cassette with 750 uL of water, close lids, and rotate the cassette at four different speeds (20 rpm, 40 rpm, 60 rpm, &amp; 80 rpm) for 30 seconds, and then check for any leaks.<\/li><\/ul>\n\n\n\n<p>Results from the slide rotator test:<\/p>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\"><figure class=\"wp-block-media-text__media\"><video controls src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/PXL_20210506_222325687.ACTIVE-4.mp4\"><\/video><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">20 RPM<\/p>\n\n\n\n<p>Results: No leaks<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\"><figure class=\"wp-block-media-text__media\"><video controls src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/PXL_20210506_222533788.ACTIVE-2.mp4\"><\/video><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">40 RPM<\/p>\n\n\n\n<p>Results: No leaks<\/p>\n\n\n\n<p><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\"><figure class=\"wp-block-media-text__media\"><video controls src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/PXL_20210506_222634874.ACTIVE-2.mp4\"><\/video><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">60 RPM<\/p>\n\n\n\n<p>Results: No leaks<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\"><figure class=\"wp-block-media-text__media\"><video controls src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/PXL_20210506_222754362.ACTIVE-2.mp4\"><\/video><\/figure><div class=\"wp-block-media-text__content\">\n<p class=\"has-large-font-size\">80 RPM<\/p>\n\n\n\n<p>Results: No leaks<\/p>\n<\/div><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>Usability<\/strong><\/p>\n\n\n\n<p>The usability of the device and the L-TOE were determined by peers who are either experienced with clinical work or are not. They were each handed the cassette and the L-TOE without any instructions, and then asked to assemble the cassette with the L-TOE. Here are the results before and after using the protocol.<\/p>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td><strong>Feedback<\/strong><\/td><td><strong>Clinical Work Experience<\/strong><\/td><td><strong>No Clinical Work Experience <\/strong><\/td><\/tr><tr><td>Usability<\/td><td>9\/10<\/td><td>7.5\/10<\/td><\/tr><tr><td>Number of mistakes made before provided protocol in previous prototype<\/td><td>1: fitting in L-TOE<\/td><td>2: add blood into inlet incorrectly &amp; not properly fitting in L-TOE<\/td><\/tr><tr><td>Number of mistakes made before provided protocol in most recent, presented prototype<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>Time taken to understand how to fit the cassette into the L-TOE without protocol\/steps<\/td><td>2-3 minutes<\/td><td>5-8 minutes<\/td><\/tr><\/tbody><\/table><figcaption>Sample: 6 peers (3 with clinical work, 3 without)<\/figcaption><\/figure>\n\n\n\n<p style=\"font-size:25px\">Other Observations:<\/p>\n\n\n\n<ul id=\"block-32af6aa3-04d2-4a80-8fad-820360cd3dd1\" class=\"is-style-checkbox wp-block-list\"><li>Peers memorized the whole protocol immediately with no mistakes made afterwards<\/li><\/ul>\n\n\n\n<p>This feedback, mainly on the L-TOE, led us to implement the most recent changes to the device, as featured on the <a rel=\"noreferrer noopener\" href=\"http:\/\/seniordesign.digitalscholar.rochester.edu\/bme2021\/2021\/virion-biomedical-technologies\/3\/(opens in a new tab)\" target=\"_blank\">Cassette Design page<\/a>.<\/p>\n\n\n\n<p>Additionally, the team met with experts in the field to ensure the device has an intuitive workflow and will in fact be used in the setting. These experts include doctors focused on HIV treatment and testing and others working directly in low-resource communities in Eastern Africa. They have encouraged us to create a pictographic pamphlet to prevent language barriers that we will be including in our final report and presentation.<\/p>\n\n\n\n<div class=\"wp-block-coblocks-accordion\">\n<div class=\"wp-block-coblocks-accordion-item\"><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Injection Molding<\/h2>\n\n\n\n<p>The cassette will be mass-produced via injection molding which is a mold to shape the plastic, polypropylene, into the cassette design. To get an estimation of the cost of injection molding, the team reached out to ProtoLabs with our CAD drawings of the prototype. The following figure shows the quote from ProtoLabs. The estimated cost of each device is $3.04, while a mold with an unlimited mold life costs $12,025. Overall, it would cost $13,545 to injection mold 500 units. The mold, the most costly component, has an unlimited life and thus would only be an initia, required investment by the manufacturers.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"395\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-1024x395.jpg\" alt=\"\" class=\"wp-image-1230\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-1024x395.jpg 1024w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-300x116.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-768x297.jpg 768w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-1536x593.jpg 1536w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-1200x463.jpg 1200w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS-1980x764.jpg 1980w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Image-from-iOS.jpg 2010w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<div class=\"wp-block-buttons alignfull is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--25\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">Problem statement<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--26\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">background<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--27\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/2\/\">Team members<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--28\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/3\/\">Cassette design<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--29\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/4\/\">testing &amp; Injection molding<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--30\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">next steps<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--31\"><a class=\"wp-block-button__link has-secondary-color has-background-background-color has-text-color has-background\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/5\/\">FAQ and covid-19<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--32\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">Customer Feedback &amp; AcknowledgmentS<\/a><\/div>\n<\/div>\n\n\n\n<!--nextpage-->\n\n\n\n<p class=\"has-text-align-center has-primary-color has-text-color\" style=\"font-size:74px;line-height:1.1\">FAQs<\/p>\n\n\n\n<div class=\"wp-block-coblocks-accordion\">\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Is this a diagnostics test? <\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>No. This device is a viral load test. If a patient undergoes viral load testing, this means they have already been diagnosed with HIV. The viral load determines the number of virions in the patient&#8217;s blood which is a crucial component to ensure anti-retroviral therapy is working. The goal is to have all patients who are living with HIV become virally suppressed.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Is this a Point-of-Care device? Why not?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>No. This device will be used in a clinic and handled by healthcare workers. This is because the blood required for the assay is more than a finger prick. Patients must go to the clinic to get their blood drawn, but may be notified of their viral load at home through a phone call, text, or letter.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Why is your team focused on patients in sub-Saharan Africa?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>In 2017, 54% of people living with HIV lived in this area. Furthermore, in 2019, 21 million people in this region are living with HIV. Remote locations in these areas also have fewer medical resources and patients have to travel long distances (60+ km\/37+ miles) to arrive at the closest healthcare clinic.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">What makes your device unique?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The cost (around $10 less than current technologies) and the fact that it functions without the need for a refrigerator for storage or a power supply.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">What was the most challenging part of the design?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Creating a device that has a workflow as intuitive as possible. Testing the effectiveness of the device, especially to provide timely results, has also been a challenge as the microfluidics paper layers are still being developed. <\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">How has COVID-19 impacted your design and the HIV epidemic? <\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The COVID-19 pandemic prevented the entire team from being in the design lab at once, and all our meetings were held over Zoom. Nonetheless, we are grateful for the support of our peers, professors, and customers. <\/p>\n\n\n\n<p>The HIV epidemic has been exacerbated by the COVID-19 pandemic. According to the WHO, the lockdowns and border closures have impacted both the production of HIV medicines and their distribution. Recent models estimate that a six-month complete disruption in HIV treatment could lead to more than 500,000 additional deaths from AIDS-related illnesses.<\/p>\n\n\n\n<p>The interplay between the COVID-19 pandemic and the HIV epidemic highlights the importance of experts from all fields from all over the world to come together as well as the need for a device that is affordable, can be purchased in bulk, and lasts for a long time.<\/p>\n\n\n\n<p>-\u201cThe cost of inaction: COVID-19-related service disruptions could cause hundreds of thousands of extra deaths from HIV,\u201d&nbsp;<em>Who.int<\/em>.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">What distinguishes this cassette from a regular box?<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Our cassette design ensures the layers are properly tight without any wiggle room, blood is only applied in one section without spilling and that the reagents are added to the correct layer in the correct orientation.<\/p>\n<\/div><\/details><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons alignfull is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--33\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">Problem statement<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--34\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">background<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--35\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/2\/\">Team members<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--36\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/3\/\">Cassette design<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--37\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/4\/\">testing &amp; Injection molding<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--38\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">next steps<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--39\"><a class=\"wp-block-button__link has-secondary-color has-background-background-color has-text-color has-background\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/5\/\">FAQ and covid-19<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--40\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">Customer Feedback &amp; AcknowledgmentS<\/a><\/div>\n<\/div>\n\n\n\n<!--nextpage-->\n\n\n\n<p class=\"has-text-align-center has-primary-color has-text-color\" style=\"font-size:74px;line-height:1.1\">Next Steps<\/p>\n\n\n\n<div class=\"wp-block-coblocks-accordion\">\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Regulatory: Testing, Development, &amp; Post-Marketing<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p style=\"font-size:25px\">Testing and Development Phase<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li><strong>Non-clinical testing:<\/strong> requires documentation of procedures<\/li><li><strong>Clinical Investigations:<\/strong> must comply with ClinicalTrials.gov requirements<\/li><\/ul>\n\n\n\n<p style=\"font-size:25px\">Post-Marketing Phase Regulations<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li><strong>Advertisement:<\/strong> must be marketed in&nbsp;compliance with regulations<\/li><\/ul>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li><strong>Post-market surveillance:<\/strong> implement device-specific QR code (analysis, recall)<\/li><\/ul>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li><strong>Export:<\/strong> market globally \u2192 must comply with&nbsp;foreign government regulations<\/li><\/ul>\n\n\n\n<p style=\"font-size:25px\">Feedback from Design Control Process \u2192 revise prevent adverse events, maximize safety<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Environment &amp; Sustainability: Medical Waste Treatment &amp; Alternatives<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<ul class=\"is-style-checkbox wp-block-list\"><li>Cassette material: Utilized waxed coated cardboard or a biodegradable plastic instead of polypropylene in the future to mitigate waste production<\/li><li>Limit packaging: Package cassettes in 50-100 in quantity <\/li><li>Sterilization techniques: Explore sterilization techniques such as autoclaving or microwaving the device rather than incineration<\/li><li>Implement proper medical waste management&nbsp;following World Health Organization guidelines<\/li><\/ul>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"369\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Blog-Header-ExBiohazWaste-USA.jpg\" alt=\"\" class=\"wp-image-1164\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Blog-Header-ExBiohazWaste-USA.jpg 1000w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Blog-Header-ExBiohazWaste-USA-300x111.jpg 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/Blog-Header-ExBiohazWaste-USA-768x283.jpg 768w\" sizes=\"auto, (max-width: 1000px) 100vw, 1000px\" \/><\/figure><\/div>\n\n\n\n<p>\u201cExamples of biohazardous waste,\u201d <em>Danielshealth.com<\/em>, 2020<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Global &amp; Economics: Cost-Effectiveness <\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>HIV, an epidemic that has affected the entire world, the global and economic aspects are intrinsic to viral load tests which is the gold standard for quantifying the levels of HIV in the blood and can notify a patient of their status. This can also determine the success of antiretroviral therapy (ART). Therefore, it is crucial that the HIV viral load assay is affordable, fast, and accessible so patients can be continuously monitored and become virally suppressed.<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li>Current technologies cost $25-44<\/li><li>MSF\/UNITAID support reduces HIV testing cost to $17-29<\/li><li>Our device<ul><li>Each cassette is approximately $3<\/li><li>Cassette &amp; reagents are less than $10 total<\/li><\/ul><\/li><li>Who will pay?<ul><li>MSF, UNITAID, UNAIDS<\/li><li>The Global Fund<\/li><li>Governments<\/li><\/ul><\/li><\/ul>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Social &amp; Ethics Concerns<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>The <strong>stigma surrounding HIV<\/strong> has aggravated the need to increase testing and provide effective treatment while keeping the patients&#8217; trust, confidentiality, and autonom<strong>y<\/strong>. -&#8220;HIV\/AIDS,&#8221; World Health Organization<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li>Making up <strong>6.2%<\/strong> of global population, Sub-Saharan Africa has <strong>54%<\/strong> of people living with HIV<\/li><li>Out of the rest of the population, <strong>young women &amp; children<\/strong> are at high risk<\/li><\/ul>\n\n\n\n<p>&#8220;HIV and AIDS in East and Southern Africa regional overview,&#8221; <em>Avert<\/em><\/p>\n\n\n\n<p>HIV is aggravated by a lack of awareness of affordable testing options. Low literacy rates impact this as well. A vast majority of people who would be needing access to this HIV load assay are in significant poverty. Proper introduction and instruction on the viral load assay\u2019s usage and benefits to clinics in areas with fewer means is key to its success. -&#8220;HIV\/AIDS,&#8221; World Health Organization<\/p>\n\n\n\n<p><strong>Medical Ethics<\/strong><\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li><strong>Confidentiality<\/strong> is essential to prevent discrimination<\/li><li>HIV status should ideally have no effect in any shape or form on rights to employment, medical care, or other fundamental liberties<\/li><li>\u2018Partner notification&#8217; is encouraged by the National AIDS Control Guidelines for HIV to prevent transmission of HIV which is the right of every sexual partner<\/li><\/ul>\n\n\n\n<p>Z. Singh and A. Banerjee, \u201cHIV \/ AIDS : Social and Ethical Issues,\u201d <em>Medical journal, Armed Forces India<\/em>, 2011<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Manufacturing<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<p>Since the cassettes might be manufactured on a large scale in the future, the team has considered the possibility of making changes to our design and material for better outcomes. The potential adjustments include the following:<\/p>\n\n\n\n<ul class=\"is-style-checkbox wp-block-list\"><li>Different material selection for injection molding<\/li><li>Thicker hinge connecting lids to the bottom of the cassette<\/li><li>Multiple sizes of replaceable phone trays to accommodate all makes of phones for the LTOE<\/li><\/ul>\n\n\n\n<p>The team acknowledges that alterations to the design are necessary before it can be put into use. All changes will be made following the principle that the cassette will be efficient and cost-effective.<\/p>\n<\/div><\/details><\/div>\n\n\n\n<div class=\"wp-block-coblocks-accordion-item\"><details><summary class=\"wp-block-coblocks-accordion-item__title\">Future Directions<\/summary><div class=\"wp-block-coblocks-accordion-item__content\">\n<ul class=\"is-style-checkbox wp-block-list\"><li>Develop a pictogram pamphlet that will depict the workflow of the HIV viral load assay and the L-TOE<\/li><li>Update the cassette design to include a picture to indicate where the blood sample is applied<\/li><li>Optimize L-TOE to be used for multiple smartphone devices<\/li><li>Develop an app to image and determine the viral load for each patient<\/li><li>Apply barcodes or QR codes to each device during manufacturing to ensure each device will be patient-specific<\/li><li>Potentially include a phlebotomy kit for each package of devices<\/li><li>Preclinical &amp; Clinical Testing<\/li><li>Field Testing<\/li><\/ul>\n<\/div><\/details><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Customer Feedback<\/h2>\n\n\n\n<p>Our customers, Dr. Benjamin Miller and Jeffrey Beard have been excited to work with us thus far. They are extremely pleased with our progress as we have been able to successfully engineer a cassette while taking into consideration the difficulties of developing a class III medical device for a low-resource setting. The team appreciates the guidance and feedback from our customers to further understand the various aspects of the device.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Acknowledgments <\/h2>\n\n\n\n<p><strong>Customers<\/strong><\/p>\n\n\n\n<ul class=\"is-style-default wp-block-list\"><li>Benjamin Miller, Ph.D., Biomedical Engineering, University of Rochester<\/li><li>Jeffrey Beard, Ph.D. Candidate, Biomedical Engineering, University of Rochester<\/li><\/ul>\n\n\n\n<p><strong>Supervisors <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Regine Choe, Ph.D., Biomedical Engineering, University of Rochester<\/li><li>Mitchell Hoestermann, CMTI Student, University of Rochester<\/li><\/ul>\n\n\n\n<p>Viriotech Biomedical Engineering would like to thank our customers, Dr. Benjamin Miller and Jeffrey Beard, who provided us useful information and materials that helped us develop the prototype. We are also grateful to our supervisor, Dr. Choe, and project management liaison, Mitchell Hoestermann, who had frequent meetings with the team and provided valuable feedback. Finally, we would also like to express our gratitude for all their support and guidance from Dr. Amy Lerner, Dr. Scott Seidman, Dr. Daphne Pariser, Dr. Peter R. Mariuz, Dr. Steven Mark Fine, and fellow students in BME 296. <\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"900\" height=\"500\" src=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/university-of-rochester-medical-center-urmc-logo-vector.png\" alt=\"\" class=\"wp-image-1475\" srcset=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/university-of-rochester-medical-center-urmc-logo-vector.png 900w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/university-of-rochester-medical-center-urmc-logo-vector-300x167.png 300w, https:\/\/www.hajim.rochester.edu\/senior-design-day\/wp-content\/uploads\/2021\/05\/university-of-rochester-medical-center-urmc-logo-vector-768x427.png 768w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><\/figure><\/div>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-circular\"><a class=\"wp-block-button__link has-secondary-background-color has-background\" href=\"https:\/\/www.urmc.rochester.edu\/labs\/benjamin-miller.aspx\" target=\"_blank\" rel=\"noreferrer noopener\">Dr. Benjamin Miller Lab<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons alignfull is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--41\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">Problem statement<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--42\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/\">background<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--43\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/2\/\">Team members<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--44\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/3\/\">Cassette design<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--45\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/4\/\">testing &amp; Injection molding<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--46\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">next steps<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--47\"><a class=\"wp-block-button__link has-secondary-color has-background-background-color has-text-color has-background\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/5\/\">FAQ and covid-19<\/a><\/div>\n\n\n\n<div class=\"wp-block-button is-style-outline is-style-outline--48\"><a class=\"wp-block-button__link has-secondary-color has-text-color\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/virion-biomedical-technologies\/6\/\">Customer Feedback &amp; AcknowledgmentS<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>To design a cassette for a cost effective and fast HIV viral load assay to increase testing accessibility in areas such as sub-Saharan Africa where HIV rates are highly prevalent.<\/p>\n","protected":false},"author":6242,"featured_media":1030,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"templates\/template-full-width.php","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[56,3016,2946],"tags":[],"coauthors":[8612],"class_list":["post-40342","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bme-archive","category-global-health-archive","category-medical-archive"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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