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Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Lab? LIMS for Automation and Data Management

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Chief Operating Officer, CloudLIMS.com
    Biography
      Shonali is the Chief Operating Officer at CloudLIMS.com. In a career spanning over twenty years, Shonali Paul has built a long and impressive track record of success in high technology bioinformatics workflow solutions, strategic collaborations, developing operational strategy, and directing new business initiatives from conception through execution. She has helped build the research and development center and is the key driver of the product and scientific teams. She has been extensively published in journals such as Biopreservation and Biobanking (BIO) and Lab Manager and has given numerous talks at ISBER, ESBB, and Labroots. She has been a member of the marketing committee and the IT working group and is now the chair of the Member Relations Committee at ISBER, the International Society for Biological and Environmental Repositories.

    Abstract

    With over 6.7 million cases and over 213 countries and territories affected worldwide, the novel coronavirus (COVID-19) has challenged the world in several ways. As the global pandemic spreads across communities, there is an urgent need to test suspected COVID-19 persons at a mass level. Proper and quick diagnostic testing of COVID-19 specimens is important for early detection, and in turn, for a check on virus spread. The need for mass testing has increased the need for establishing coronavirus (COVID-19) diagnostic testing labs across the globe.

    COVID-19 diagnostic testing laboratories perform varied tests, such as Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), serological tests for the detection of IgG/IgM antibodies, Enzyme-linked Immunosorbent Assay (ELISA), neutralization tests, and Rapid Diagnostic Tests (RDT). COVID-19 testing laboratories face several challenges on a day-to-day basis. Some of the challenges include:

    • Recruiting experienced staff and training new in handling infectious specimens
    • Standardizing and validating new test methods before testing COVID-19 specimens
    • Procuring analytical equipment and lab supplies
    • Reporting test results as per FDA and CDC guidelines
    • Following international regulatory guidelines, such as CLIA, ISO 15189:2012, and HIPAA

    Whether your diagnostic facility is expanding services to test COVID-19 specimens or you are establishing a new COVID-19 diagnostic testing laboratory, you need a Laboratory Information Management System (LIMS). A LIMS not only automates laboratory workflows but also helps securely manage sensitive patient data, plan training and mark staff competency, schedule instrument calibration, manage documents, such as SOPs, generate custom test reports, and follow regulatory guidelines, such as CLIA, ISO 15189:2012, and HIPAA.

    Learning Objectives:

    1. The talk delves into the major challenges faced by COVID-19 diagnostic testing laboratories and the urgent need for rapid testing of COVID-19 specimens

    2. The talk describes the role of a LIMS in automating workflows, right from specimen collection to disposal. Furthermore, the talk delineates the significance of a LIMS in safeguarding sensitive patient data, validating test results, tracking turnaround time, generating reports as per FDA and CDC guidelines, sharing reports with physicians in real-time, and maintaining Quality Control (QC), and following regulatory guidelines such as CLIA, ISO 15189, and HIPAA.


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