Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories Summary of a Workshop (2012) / Chapter Skim
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6 Public Health Needs: Costs, Effectiveness, and Biosafety Requirements for Diagnostic Procedures (Breakout Sessions)
6 Public Health Needs: Costs, Effectiveness, and Biosafety Requirements for Diagnostic Procedures (Breakout Sessions)
Pages 53-64
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led a discussion. BREAKOUT SESSION PRESENTATIONS Preparedness for the Detection of Emerging and Re-emerging Pathogens in Croatia Alemka Markotić (University Hospital for Infectious Diseases, Croatia)
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When she initially tried using POC tests to detect Puumala and Dobrava hantaviruses, she experienced too many false positives; recently, however, the quality of commercial tests has improved and she has resumed using them. She also uses POC tests to look for influenza A, Dengue fever virus, and Chikungunya.
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He also reminded the audience that while TB is classified as a risk group 3 organism, different protocols for a single agent may necessitate the use of precautions from different biosafety levels.1 Dr. Shinnick explained that GLI performed a systems-based risk analysis and divided TB procedures into one of three sets depending on whether they posed a limited, moderate, or high risk of generating infectious aerosols.
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The final talks presented the range of diagnostic tests available and the associated precautions routinely employed for two diseases: severe acute respiratory syndrome (SARS) and Crimean-Congo hemorrhagic fever (CCHF)
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Polymerase chain reaction (PCR) tests for the responsible pathogen became available.
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The reference lab is particularly experienced in influenza diagnostics and offers a range of molecular diagnostics including reverse transcription polymerase chain reaction (RT-PCR) , inhouse tests for resistance-associated mutations, Sanger sequencing, and pyrosequencing.
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• ELISA assays using recombinant nucleocapsid protein as the antigen can detect SARS in 68 percent of patients 6-10 days after the start of infection and in 90 percent of patients after 10-61 days (Shi et al., 2003)
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HSADL developed an avian influenza database and a reverse transcription polymerase chain reaction (RT-PCR) test for the diagnosis of avian influenza H5N1.
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, and ELISA tests using commercial kits. He noted that the National Services of Health, Safety, and Food Quality operate an additional three molecular biology labs and that each regional lab has specialized equipment and reagents and performs specific diagnostic tests.
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dollars the price of diagnostic tests (materials and reagents only) varies from about $120 for sequencing tests to $5 for ELISA tests to $1 for hemmaglutination inhibition assays.
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In addition to elaborating on the opportunities and limitations of molecular diagnostics, including point-of-care tests, participants also discussed how transport restrictions and the availability of reference pathogen collections impact diagnostic and research work. Molecular Tests While generally enthusiastic about the potential for molecular tests, which use inactivated pathogens and can safely be performed in BSL-2 labs, multiple people stressed that molecular tests will never completely eliminate the need to isolate and characterize pathogens in high-containment labs.
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• An inability to ship samples for timely diagnostics encourages countries and localities to build their own laboratories. • Particularly burdensome transport regulations, such as the United States Select Agent rules that require individuals who ship select agents within or into the United States to obtain a United States security clearance, discourages potential, foreign collaborators.
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