Serology & Molecular QC

  • SeraCare’s SARS-CoV-2 Quality Solution AccuPlex™ SARS-CoV-2 Reference Material, from SeraCare, is designed to measure day-to-day performance of the assay, providing both a positive and a negative reference solution. The product is available in versions that offer different SARS-CoV-2 sequence coverage: Version 1 covers the CDC and WHO consensus sequences, Version 2 has been enhanced to also include the S gene region, and Version 3 is expanded to include the full SARS‐CoV‐2 viral genome (Table 1). All products also include negative reference materials targeting the human RNase P gene. AccuPlex™ SARS-CoV-2 Verification Panel, coupled with the AccuPlex™ SARS-CoV-2 Reference Material, is a complete Quality Solution. Both products are available in three versions with different SARS-CoV-2 sequence coverage: Version 1 covers the CDC and WHO consensus sequences, Version 2 has been enhanced to also include the S gene region, and Version 3 is expanded to include the full SARS-CoV-2 viral genome (Table 1).  All products also include negative reference materials targeting the human RNase P gene.
    • Non-infectious and replication deficient, enables safe handling of positive material
    • Fully-extractable with a real viral protein coat; serves as a full-process reference material
    • Compatible with assays targeting CDC and WHO consensus sequences
    • Includes negative reference material for targeting sequences for the human RNAse P gene
    • 2 year stability at 2 - 8°C
    • Customisable to sequences of interest to meet unique assay design requirements
  • Performance Panels from SeraCare
    Clinical Diagnostic Quality Solutions for SARS-CoV-2 Variant Analysis AccuPlex SARS-CoV-2 Variant Panel 1 contains the full SARS-CoV-2 genomic RNA with a focus on S-gene mutations (Table 1) in three prominent variants of concern (VOC): UK variant B.1.1.7, South Africa variant B.1.351, and Brazil variant P.1. The kit has one vial for each variant as well as a fourth wild type (reference sequence NC_045512) control vial. An RNase P negative control vial is also included.
    • Performance confirmation of existing SARS-CoV-2 molecular assays with different variants
    • Reference materials for SARS-CoV-2 variant genotyping assays
    • Reference materials for SARS-CoV-2 NGS assays
    • Non-infectious and replication deficient, enables safe handling of positive material
    • Fully extractable with a real viral protein coat; superior to “naked” transcribed RNA
    • 2 year stability at 2 - 8°C
  • Performance Panels from SeraCare
    Ensure antibody testing accuracy and performance To support the many SARS-CoV-2 serology assay formats available, the kit is currently offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Series 1000 is released using the Abbott ARCHITECT SARS-CoV-2 IgG assay, and Series 2000 is released using the Roche cobas® Elecsys® Anti-SARS-CoV-2 assay. Reference materials are specifically formulated to exhibit low positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries. AccuSet™ SARS-CoV-2 Performance Panel is intended to provide an out-of-the-box solution to evaluate SARS-CoV-2 antibody detection assays with highly characterised human specimens whether generating validation data for a regulatory submission or performing assay verification in a clinical laboratory setting.
  • SeraCare ACCURUN Controls
    Empower your results and challenge your methods with SeraCare’s ACCURUN® serology controls and reference materials. SeraCare's ACCURUN controls and reference materials are designed to be weakly reactive to help monitor your serology assays and provide additional confidence in your laboratory test results. Monitoring your assay performance can help you avoid costly repeats and, more importantly, avoid false-negative and false-positive results. With ACCURUN controls, you can troubleshoot your test methods and isolate system errors in your laboratory. Powerful ACCURUN controls and reference materials help to ensure complete control over assay performance monitoring. Challenges Your Assay More Effectively A low-positive control challenges your assay more than a medium-to-high control since it is closer to the assay cut-off; therefore, any variability in the assay will be easier to detect. Assay monitoring with ACCURUN single and multi-analyte controls improves confidence in your serology test results.
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