SARS-CoV-2 Reference Materials for Assay Validation and QC
LGC SeraCare develops and manufactures a comprehensive portfolio of SARS-CoV-2 catalog and custom-developed diagnostic controls, standards and reference materials for IVD assay developers, clinical labs and CROs. This presentation will focus on the products and technologies being used today to help validate and QC SARS-CoV-2 RNA testing and SARS-CoV-2 serological testing.
Joel A Lefferts:
Making Qualitative SARS-CoV-2 RNA Tests Quantitative
The current SARS-CoV-2 pandemic has had a dramatic impact on healthcare and more specifically, laboratory medicine. Clinical laboratories across the country are meeting the new challenges that continue to emerge from month to month such as uncertain reagent supply issues, need for new technologists, increased needs for instrument servicing, and adding staff to work additional shifts. Many laboratories are even facing supply chain issues with even the most basic items such as PPE or pipette tips. As laboratories continue to perform high volumes of SARS-CoV-2 testing a common trend in clinical, development, and research testing is the growing need for tests that can produce quantitative results. Quantitative SARS-CoV-2 test results are valuable for test validation, quality improvement, and a better understanding of the biology of the virus and its effects on those who become infected.
1. Understand the challenges facing clinical laboratories performing or planning to perform diagnostic SARS-CoV-2 RNA testing
2. List reasons why quantitative SARS-CoV-2 results may be valuable to clinical and research laboratories
New Immunogenicity Strategies to Meet the Needs of a Developing Pandemic
Shortly after the COVID-19 pandemic began, the subject of serological testing for anti-viral antibodies became common in the global news media as a key indicator of previous infection by the virus, and a potential indicator of future immunity to the disease. The analysis of unwanted immunogenicity is commonplace in bioanalytical workstreams, but what differs when you have evolving frontiers, mass testing requirements, emerging biology and a regulatory minefield? Our goal was to create an assay that could be used for both serum samples and with dried blood microsamples that enable remote sampling. In addition to validating the assay performance for both matrices, we set about verifying the assays according to recommendations and guidance from UK Government agencies and the Royal College of Pathologists. This included sensitivity and specificity assessments of the serum assay using cohorts of COVID-19 patient samples, where infection by SARS-CoV-2 was confirmed by a PCR test 21 days prior to the sample being taken, along with prepandemic era samples that included patients exposed to other coronaviruses and respiratory diseases. Additionally sample comparisons were performed with collaborating laboratories using government approved commercial assays from major IVD manufacturers. The utility of microsampling was confirmed by performing analysis on surrogate blood samples, along with paired capillary Mitra and venous samples taken simultaneously from volunteers. This presentation will further touch on the conundrums that arose on our journey when we decided to apply our standard approaches for measuring unwanted immunogenicity to the measurement of anti-SARS-CoV-2 antibodies.
1. Understanding the integral value of collaboration for advancement in scientific research; how to establish and grow clinical lab, academic, Pharma, and industry connections
2. Learn about the high-tech science technologies and techniques being used to defeat the global COVID-19 epidemic