Difference between revisions of "Team:Austin LASA/Human Practices"

Revision as of 03:57, 18 October 2018

h(g.Section, {title: 'Lindsey Dawson'},
    'Associate Director, HIV Policy',
    h('br'),
    'Kaiser Family Foundation',
    h('p', null, 'Ms. t will accompany our kit'),
    h('ul', null,
      h('li', null, 'She details on how understanding the importance of detection is important, but how it is equally important to consider the steps that should be taken to get treatment afterward (eg. antiretroviral treatment)'),
      h('li', null, 'Sent the following information (even though the CDC material is focused on US primarily)',
        h('ul', null,
          h('li', null, h('a', {href: 'https://stacks.cdc.gov/view/cdc/23447'}, 'CDC recommendations on Lab testing for HIV')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/pdf/testing/hiv-tests-laboratory-use.pdf'}, 'Lab tests')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/pdf/testing/rapid-hiv-tests-non-clinical.pdf'}, 'Rapid tests')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/pdf/testing/hiv-tests-advantages-disadvantages_1.pdf   '}, 'Advantages/Disadvantages to different HIV tests')),
          h('li', null, h('a', {href: 'https://stacks.cdc.gov/view/cdc/50872'}, 'Recommended testing algorithm')),
          h('li', null, h('a', {href: 'https://www.cdc.gov/hiv/testing/laboratorytests.html'}, 'More info here (incl. all the above links)')),
          h('li', null, h('a', {href: 'http://www.oraquick.com/What-is-OraQuick/OraQuick-In-Home-HIV-Test'}, 'OraSure’s home test')),
          h('li', null, h('a', {href: 'http://aidsinfo.unaids.org/'}, 'To see hardest hit countries, including where share of people unaware of their HIV status is highest (i.e. undiagnosed)'))
        )
      )
    )
  ),

h(g.Section, {title: 'Christopher R Singh'},
    'Biological Safety Officer, MS, Ph.D.',
    h('br'),
    'The University of Texas at Austin',
    h('br'),
    'Environmental Health and Safety',
    h('p', null, 'Dr. Singh served as our guide for various safety concerns and was able to provide us information on various regulations as follows.'),
    h('ul', null,
      h('li', null, 'Based on the procedures and information provided, are there specific clearances or hazards that we need to be aware of?'),
      h('li', null, 'What is the best way to handle blood spots or DNA samples when using a detection kit? What are things that we should keep in mind for creating the most aseptic and safe kit?'),
      h('li', null, 'What are the best disposal or packaging methods when the goal is to use kits such as these overseas in non-lab environments?',
        h('ul', null,
          h('li', null, 'For the research side of things there would need to be approvals for working with human material, blood, cells etc. and working with HIV or the potential components, depending on the research there may be several groups that will look at the work including the IBC.  Research would need to be done in a BSL-2 space hopefully equipped with a biosafety cabinet.  The hazards with the research would of course be the human material as well as the virus or viral components. In the field there would be little opportunity for working aseptically unless the plan would be for a mobile lab to be in place. The best you can do there would be best practice or universal precautions, the idea being that you would treat all samples as potentially pathogenic or infectious, but there would likely not be an opportunity to set up a BSC or any type of clean work space.  You would want proper PPE which at a minimum would be clothes that cover skin (long sleeve etc.) gloves, eye protection and a lab coat.  Depending on how samples will be obtained there may be additional requirements needed.  All the waste should be hazardous material/biowaste, this means for the research side it will need to be autoclaved or disposed of in biohazard boxes.  For field work you would need to check country regulations since they often differ, but you would still want to consider it hazardous waste. Please let me know if I missed something or if anything needs clarification or if there is anything else I can help with.')
        )
      )
    )
  )

)
  ),

h(g.Section, {title: 'OUR APPROACH'},
    p('The reason why we chose to focus so heavily on education of younger students in our human practices is because we believe that a public educated in biotechnology and genetics starts at its roots. This meant attempting to spark some inspiration in younger students, which we believe we were successful in. They were so incredibly fascinated with the results of their experiments, and we believe that this is going to be a motivator for them the persue expanding their own knowledge.'),
    p('We focused on contacting people who have experience in diagnosing HIV-1 in the field because we knew that we would not have the opportunity to experience this ourselves, but the input from these individuals was still exceptionally valuable. We wanted to know what this diagnostic process was like and what the struggles were from someone who has spent time in that environment. We also contacted a people involved with policy and safety because HIV-1 is a dangerous disease and we realized that the kit and the process of using it (hypothetically) may have complications that we may not be able to see at first glance.')
  ),

h(g.Section, {title: 'INTEGRATION'},
    p('When conducting any research, it is important to understand the extent of its repercussions on various groups in society. In the planning stages of the project, we had a plan for the type of protocols we wanted to test, but we were looking for the correct purpose to use it for. With the tools in hand, we had discussed various diseases that we could target, but agreed upon focusing on HIV-1 detection in infants specifically. The reason was simple. HIV is a global health problem that affects millions all over the world. Its impact is especially prevalent over disadvantaged groups in low and middle-income countries. Thereby, we decided to improve the already existing tests available in these locations, by creating one better suited to the needs of the patients.'),
    p('The current antibody tests are not suited to testing newborn infants for HIV. In order to create a more accurate test, we used a different method of detection. Our proposed kit relies on HIV viral DNA and utilizes protocols that can be replicated in low resource environments as well. In order to better understand the currents testing protocols in rural locations, we discussed with Dr. Leautaud (who works with Rice Global Health) and a research fellow, Jessie Anderson on the current conditions. After reviewing the issues faced by patients in these locations, we were better able to focus our project to handle the problems. We learned that the hospitals were regularly understaffed, and the hospitals in the area (district hospitals) did not have adequate resources in the lab either. According to Dr. Leautaud’s experience, “In Malawi, there is no lab. They had a separate room with a fridge, centrifuge, agar plates, did not have pipettes or a vortexer; Eppendorf tubes and gloves were scarce.” In order to corroborate her statements, we discussed with Jessie who stated, “The neonatal wards for both QECH and KCH seemed understaffed, even for this season which is not the busiest of the year. There were two short (10-30 seconds long) power outages within 20 minutes in the KCH ward. KCH had more equipment available to them than QECH (much more incubators, radiant warmers, blue-lights, etc; I think also a higher proportion of the room heaters was working), but the flow and size of space available seemed better at QECH. Still not ideal at either location.” Throughout our conversations, it became increasingly clear that local hospitals did not have any substantial equipment.'),
    p('Additionally, when discussing with Dr. Leautaud, she mentioned that “One major problem in Africa or Malawi is that there is no communication and follow up with patients and the hospital, so even if a child is diagnosed the parent will not know. The hospitals don’t have the manpower to do that.” The mother’s that came to the hospitals often left soon after delivery, hence any testing results may not reach the mother, nor any future precautionary measures.  On top of short-staffed hospitals, many of the nurses or lab technicians that ran the test were not trained adequately. During discussions with Dr. Leautaud, she mentioned, “The nurse or lab technician, who is not as highly trained as they are in America. Instead, they have technical degrees. You need to teach them to not contaminate the test.” Upon learning of these various problems, we began integrating it into our project.'),
    p('Taking this into consideration, challenged ourselves to design a detection protocol that would utilize the least parts and would be able to withhold the most severe conditions. This would accommodate for the lack of resources that was discussed earlier with Dr. Leautaud. In order to integrate her advice into our lab work, we designed protocols utilizing lyophilized cellular reagents and decided to use LAMP for amplification purposes. The lyophilized reagents are stable as they do not need to be frozen, and LAMP amplification would only need a constant water bath, not a thermocycler like with PCR. Not only would this take the hospital’s capabilities into consideration, but it would offer our kit a competitive edge in the market as advised by Ms. Dawson. She recommended that in creating our kit to take into consideration the comfort level of the patient, but also to ensure that the kit is unique. The reason being, it would increase the chances for the kit to be sponsored by organizations, allowing the kit to be used by a larger clientele.'),
    p('Previously, Dr. Leautaud stated that “The test needs to be under 3 or 4 hours for the mother to stay in the hospital. In order to integrate this into our project, we designed a protocol that would fit this limit. The final protocol we decided upon would take about 3 hours to complete, allowing the mother to receive the results before her exit from the hospital. This would allow the hospital to provide additional information and would aid in the treatment of the infant.'),
    p('In terms of sterility, we created an educational training protocol to include with the kit which would help equalize any differences in training. In order to do so successfully, we reached out to a safety officer for advice (Dr. Singh) and consulted with an NGO official (Ms. Dawson) who offered information regarding HIV kits. Dr. Singh recommended that “ The best you can do there would be best practice or universal precautions, the idea being that you would treat all samples as potentially pathogenic or infectious, but there would likely not be an opportunity to set up a BSC or any type of clean workspace.  You would want proper PPE which at a minimum would be clothes that cover skin (long sleeve etc.) gloves, eye protection, and a lab coat. All the waste should be hazardous material/biowaste, this means for the research side it will need to be autoclaved or disposed of in biohazard boxes.”  This information proved valuable when creating our sample training protocol. Ms. Dawson provided us comparisons of HIV tests in order to differentiate ours and sent us example home tests that were on the market. After reviewing these existing solutions, we were able to clearly define the differences and advantages in our kit. With the information procured from the human practices part of the project, we were able to adapt our research to best suit the needs of the target group.')
  ),

h(g.Section, {title: 'Human Practices in Our Kit'},
    h('p', null, 'We integrated human practices into our project throughout the iGEM season. Below we’ve summarized how our integrated human practices fits the requirements for the Gold Medal Integrated Human Practices criterion and the Best Integrated Human Practices Award.'),
    h('p', null, 'For a much more detailed reference on the development of our kit and how our human practices played a role in that, please see our Kit Considerations page. For a much more detailed reference on how our human practices impact our wet lab work, please see our Design, Development, and Results page.')
  )
);

@@ Line 223: / Line 223: @@
      p('The current antibody tests are not suited to testing newborn infants for HIV. In order to create a more accurate test, we used a different method of detection. Our proposed kit relies on HIV viral DNA and utilizes protocols that can be replicated in low resource environments as well. In order to better understand the currents testing protocols in rural locations, we discussed with Dr. Leautaud (who works with Rice Global Health) and a research fellow, Jessie Anderson on the current conditions. After reviewing the issues faced by patients in these locations, we were better able to focus our project to handle the problems. We learned that the hospitals were regularly understaffed, and the hospitals in the area (district hospitals) did not have adequate resources in the lab either. According to Dr. Leautaud’s experience, “In Malawi, there is no lab. They had a separate room with a fridge, centrifuge, agar plates, did not have pipettes or a vortexer; Eppendorf tubes and gloves were scarce.” In order to corroborate her statements, we discussed with Jessie who stated, “The neonatal wards for both QECH and KCH seemed understaffed, even for this season which is not the busiest of the year. There were two short (10-30 seconds long) power outages within 20 minutes in the KCH ward. KCH had more equipment available to them than QECH (much more incubators, radiant warmers, blue-lights, etc; I think also a higher proportion of the room heaters was working), but the flow and size of space available seemed better at QECH. Still not ideal at either location.” Throughout our conversations, it became increasingly clear that local hospitals did not have any substantial equipment.'),
      p('Additionally, when discussing with Dr. Leautaud, she mentioned that “One major problem in Africa or Malawi is that there is no communication and follow up with patients and the hospital, so even if a child is diagnosed the parent will not know. The hospitals don’t have the manpower to do that.” The mother’s that came to the hospitals often left soon after delivery, hence any testing results may not reach the mother, nor any future precautionary measures.  On top of short-staffed hospitals, many of the nurses or lab technicians that ran the test were not trained adequately. During discussions with Dr. Leautaud, she mentioned, “The nurse or lab technician, who is not as highly trained as they are in America. Instead, they have technical degrees. You need to teach them to not contaminate the test.” Upon learning of these various problems, we began integrating it into our project.'),
-     p('Taking this into consideration, challenged ourselves to design a detection protocol that would utilize the least parts and would be able to withhold the most severe conditions. This would accommodate for the lack of resources that was discussed earlier with Dr. Leautaud. In order to integrate her advice into our lab work, we designed protocols utilizing lyophilized cellular reagents and decided to use LAMP for amplification purposes. The lyophilized reagents are stable as they do not need to be frozen, and LAMP amplification would only need a constant water bath, not a thermocycler like with PCR. Not only would this take the hospital’s capabilities into consideration, but it would offer our kit a competitive edge in the market as advised by Ms. Dawson. She recommended that in creating our kit to take into consideration the comfort level of the patient, but also to ensure that the kit is unique. The reason being, it would increase the chances for the kit to be sponsored by organizations, allowing the kit to be used by a larger clientele.')
+     p('Taking this into consideration, challenged ourselves to design a detection protocol that would utilize the least parts and would be able to withhold the most severe conditions. This would accommodate for the lack of resources that was discussed earlier with Dr. Leautaud. In order to integrate her advice into our lab work, we designed protocols utilizing lyophilized cellular reagents and decided to use LAMP for amplification purposes. The lyophilized reagents are stable as they do not need to be frozen, and LAMP amplification would only need a constant water bath, not a thermocycler like with PCR. Not only would this take the hospital’s capabilities into consideration, but it would offer our kit a competitive edge in the market as advised by Ms. Dawson. She recommended that in creating our kit to take into consideration the comfort level of the patient, but also to ensure that the kit is unique. The reason being, it would increase the chances for the kit to be sponsored by organizations, allowing the kit to be used by a larger clientele.'),
+    p('Previously, Dr. Leautaud stated that “The test needs to be under 3 or 4 hours for the mother to stay in the hospital. In order to integrate this into our project, we designed a protocol that would fit this limit. The final protocol we decided upon would take about 3 hours to complete, allowing the mother to receive the results before her exit from the hospital. This would allow the hospital to provide additional information and would aid in the treatment of the infant.'),
+    p('In terms of sterility, we created an educational training protocol to include with the kit which would help equalize any differences in training. In order to do so successfully, we reached out to a safety officer for advice (Dr. Singh) and consulted with an NGO official (Ms. Dawson) who offered information regarding HIV kits. Dr. Singh recommended that “ The best you can do there would be best practice or universal precautions, the idea being that you would treat all samples as potentially pathogenic or infectious, but there would likely not be an opportunity to set up a BSC or any type of clean workspace.  You would want proper PPE which at a minimum would be clothes that cover skin (long sleeve etc.) gloves, eye protection, and a lab coat. All the waste should be hazardous material/biowaste, this means for the research side it will need to be autoclaved or disposed of in biohazard boxes.”  This information proved valuable when creating our sample training protocol. Ms. Dawson provided us comparisons of HIV tests in order to differentiate ours and sent us example home tests that were on the market. After reviewing these existing solutions, we were able to clearly define the differences and advantages in our kit. With the information procured from the human practices part of the project, we were able to adapt our research to best suit the needs of the target group.')
    ),