- 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
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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. -
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
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Full Genome Coverage now available AccuPlex™ SARS-CoV-2 Verification Panel, from SeraCare, is optimised for assay verification at installation by documenting test performance along the assay’s range enabling laboratories to establish lower limits of detection, perform assay comparisons, and evaluate staff proficiency. The product contains positive materials including the full SARS-CoV-2 viral genome, and negative 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 designed to challenge the entire molecular test procedure ensuring clinical laboratories can have confidence in their SARS-CoV-2 assay results.
- 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
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Measure day-to-day performance AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit, from SeraCare, is designed to measure day-to-day performance of the assay, providing both a positive and a negative reference solution. Designed for use with multiplexed molecular assays that can detect SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV). AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit, coupled with the AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel, is a complete Quality Solution designed to challenge the entire molecular test procedure ensuring clinical laboratories can have confidence in their multiplex assay results.
- 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
- 2 year stability at 2 - 8°C
- Optimised for assay verification and day-to-day performance monitoring
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Have confidence in your multiplex assay results for SARS-CoV-2 & Flu A/B AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel, from SeraCare, is optimised for assay verification at installation by documenting test performance along the assay’s range, enabling laboratories to establish lower limits of detection, perform assay comparisons, and evaluate staff proficiency. Designed for use with multiplexed molecular assays that can detect SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV). AccuPlex™ SARS-CoV-2, Flu A/B and RSV Verification Panel, coupled with the AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit, is a complete Quality Solution designed to challenge the entire molecular test procedure ensuring clinical laboratories can have confidence in their multiplex assay results.
- 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
- 2 year stability at 2 - 8°C
- Optimised for assay verification and day-to-day performance monitoring
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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.
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Whole-cell or whole-organism external controls Empower your results and challenge your methods with SeraCare’s ACCURUN® molecular controls and reference materials. ACCURUN molecular controls and reference materials are whole-cell or whole-organism external controls that help you monitor all aspects of your molecular testing methods and provide additional confidence in your laboratory test results. A well-designed QC program can help you avoid costly false-negative or false-positive results. ACCURUN molecular controls effectively detect low-positives closer to assay-specific cutoffs, enabling better detection of assay variability. Powerful ACCURUN controls and reference materials help to ensure complete control over assay performance monitoring. Monitors the Entire Testing Process. In order to execute the highest level of quality control, QC methods should be able to monitor the entire testing process, not just a portion. ACCURUN molecular controls are whole-cell or whole-organism controls that can appropriately challenge your assay from extraction through detection. -
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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Available for use with serological and molecular assays, SeraCare’s portfolio of AccuSet performance panels contains highly characterized, raw, undiluted plasma specimens collected from unique individuals positive for your analytes of interest. Each panel contains a comprehensive comparative data sheet with test results from a wide variety of leading commercially available assays and platforms. AccuSet performance panels can be used to evaluate assay specificity, sensitivity, repeatability, and reproducibility to assist you in validating new test methods and equipment, run head-to-head assay comparisons, demonstrate lab proficiency, and train laboratory personnel.
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Ensure antibody testing accuracy and performance AccuSet™ SARS-CoV-2 Performance Panel from SeraCare - This eleven-member validation panel consists of undiluted, naturally occurring human-plasma members. Ten panel members represent collections from multiple individuals positive for antibodies to SARS-CoV-2; a single negative member is also included. Test results from commercially available SARS-CoV-2 antibody assays are included for comparative analysis. 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 characterized human specimens whether generating validation data for a regulatory submission or performing assay verification in a clinical laboratory setting. ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is designed to support assay installation and monitoring of day-to-day assay performance, providing a complete quality solution for SARS-CoV-2 antibody testing.
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Validate and Monitor your assays AccuSpan linearity panels from SeraCare are designed to span the dynamic range of quantitative infectious disease assays and evaluate instrumentation analytical sensitivity. Linearity panels effectively challenge assay performance at defined intervals to ensure consistency throughout the entire reportable range. In addition to linearity studies, these panels are useful in validation procedures for new assay implementation, operator training, and troubleshooting signs of assay deterioration. -
Ensure reagents are operating effectively from lot-to-lot AccuTrak qualification panels from SeraCare are designed as a cost-effective solution to deliver the consistent results you need to gain confidence in your assay’s performance and ensure reagents are operating effectively from lot-to-lot. SeraCare's AccuTrak qualification panels are utilised by clinical laboratories worldwide to help strengthen quality control protocols and procedures for infectious disease diagnostic assays. With products for HIV, hepatitis, CMV, syphilis, HPV, and HTLV, SeraCare offers a comprehensive portfolio to help effectively monitor assay performance. Reliable, Consistent, Cost-Effective Solutions for Your Assay QC Program