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White Papers and Videos

Trends in Variant Interpretation Workflows: Expert Insights to Advance NGS Oncology Profiling

Video

Please join GenomeWeb and Qiagen for an on-demand roundtable discussion where a panel of experts reviews challenges and opportunities around genomic variant interpretation workflows in the field of oncology.

Recently, GenomeWeb and Qiagen partnered on a survey that allowed participants to assess their oncology variant interpretation workflows. This webinar presents the results of the survey and offers an interactive environment for clinical labs to assess their own variant interpretation capabilities.

The discussion covers a range of capabilities related to variant interpretation workflows, including:

  • Resources and skills
  • Workflow optimization
  • Variant interpretation content knowledge.

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White Paper

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Performance of SARS-CoV-2 Assay in Extraction-free Method Compared to that of Conventional RNA Extraction using Automated Instrument

White Paper

The standard diagnostic method for SARS-CoV-2 is real-time PCR testing with nasopharyngeal specimens. 

This poster describes a study that compared the clinical performance of a SARS-CoV-2 assay after a simple boiling step instead of a conventional RNA extraction process using an automated platform.

The Importance of Sample Pooling in COVID-19 Testing

White Paper

There is an urgent need to both increase sample throughput and decrease the costs associated with COVID-19 rRT-PCR tests.

One way to increase sample throughput is to use 384-well plates instead of the standard 96-well plates for rRT-PCR, which would allow four times as many RNA samples to be processed in a single run. Another option is to create multi-sample pools, which would reduce the amount of reagent used per sample and allow more samples to be tested at once.

This white paper outlines the benefits and challenges of pooled sample testing for COVID-19. The prevalence of COVID-19 in the population, the projected frequency of testing, and the effect of pooling on assay sensitivity must be weighed when considering whether sample pooling is beneficial and to what degree.

The Importance of Limit of Detection in COVID-19 Tests

White Paper

As the United States continues the effort to slow the spread of COVID-19, questions remain regarding the most effective testing strategies to implement. The widely accepted “gold standard” of COVID-19 testing utilizes real-time reverse transcription polymerase chain reaction (rRT-PCR), which has a very low limit of detection (LoD).

A lower limit of detection indicates greater analytic sensitivity, as the test can detect a positive result with fewer viral RNA copies per sample. However, there are trade-offs involving the limit of detection, the frequency and accessibility of testing, and the turnaround time required to generate results.

Each of these factors must be weighed to develop a testing strategy that effectively limits the spread of COVID-19 in various communities.

Automated RT-PCR Setup for COVID-19 Testing

White Paper

The novel coronavirus SARS-CoV-2 has placed unprecedented demands on laboratories testing for COVID-19, leaving scientific staff to contend with a spiraling influx of patient samples and a rapid, continuous growth in workload.

Laboratories need additional automated liquid handling instruments for viral nucleic acid extraction and RT-PCR setup – which are the most labor-intensive processes in the diagnostic testing workflow – to increase the sample throughput capacity, reduce manual intervention by laboratory analysts, and fast track the development of COVID-19 assays.

This application note describes how the ASSIST PLUS pipetting robot, together with a VOYAGER adjustable tip spacing pipette, Low Retention GripTips, and SureFlo 10 ml Reagent Reservoirs, were successfully used for RT-PCR setup in COVID-19 testing laboratories.

How To Start COVID-19 Testing In Your Lab

White Paper

This guide outlines the key aspects that a lab should consider before starting COVID-19 testing. From the most appropriate test type to choose for your lab to the certifications required, this practical guide gives answers to the common questions of lab partners and customers about COVID-19 testing.

Saliva: A Viable Alternative to Nasal and Oral Swabs for the Detection of SARS-CoV-2

White Paper

Norgen Biotek has analyzed the effectiveness of saliva-based collection methods in order to simplify mass testing. Data supports that this collection method will ensure the viral nucleic acid integrity over time. Sample sensitivity is the key component in determining the effectiveness of a sample type for the detection of SARS-CoV-2 RNA in COVID-19 patients. Research has shown that saliva offers a number of advantages over nasopharyngeal swabs when considering the safety of healthcare workers and the ease of use for patients.

In this article you will learn about:

-        Data supporting saliva sampling as an alternative to nasopharyngeal swabs.

-        The advantages of Norgen’s preservation technology.

-        The direct impact on healthcare workers and patients.

Lessons on Sample Accessioning and Processing at Clinical Labs During a Pandemic

White Paper

When the COVID-19 pandemic escalated in March 2020, many diagnostic labs pivoted to focus on detecting SARS-CoV-2, while others sprang up de novo to meet the massive and urgent demand. Each was faced with the challenge of adapting sample accessioning and processing workflows to keep pace with the unprecedented demand for testing, without sacrificing accuracy.

This e-book details the major challenges labs have faced and how they have adapted to handle the sustained demand for large-scale sample accessioning and testing. Nischay Mishra, PhD, an Assistant Professor of Epidemiology and infectious disease diagnostic developer at the Center for Infection and Immunity at the Columbia University Medical Center, provides insight and key takeaways on next steps to improve testing workflows.

Case Study: Eppendorf OEM for a Clinical Analyzer

White Paper

This case study describes an Eppendorf OEM project that provided exceptional quality customized consumables for a clinical analyzer, consisting of both tips and sample vessels. The solution required an ultra-high throughput production cleanroom environment, assuring batch-to-batch consistency, and supply continuity to the partner, a large diagnostics provider.

Positioning Your Diagnostics Lab for Success

White Paper

Clinical and molecular diagnostics labs have unique needs. A purpose-built LIMS meets those needs head on, with request management capabilities, next-gen sequencing workflows, consumables management, and statistical process control. LabVantage Diagnostics, a preconfigured lab information management system, handles these responsibilities and more as a single, centralized platform.

This white paper describes the benefits of deploying an industry-specific LIMS and how that positions your diagnostics lab for success. This includes faster turnaround times, lowering the cost of testing, consistent specimen management, clear and compliant e-signatures, compliance with CLIA, CAP and other regulations, data integrity, and more. Find out how years of LIMS customization for diagnostics labs has become an off-the-shelf solution to optimize your operations.

The Promise of Liquid Biopsy for Cancer Diagnostics and Therapeutic Monitoring: Are We There Yet?

Video

This webinar features a panel of industry stakeholders in cancer diagnostics, proficiency testing and clinical care who will discuss the promise and challenges of liquid biopsy technologies in disease diagnosis, monitoring, and patient care management.

The application of plasma samples bearing circulating tumor DNA (ctDNA) as a surrogate for solid tumor biopsy is an area of significant research and clinical interest. Genomic aberrations associated with ctDNA have been demonstrated to mirror the solid tumor mutational landscape and have the potential for early diagnosis of cancer as well as monitoring and tracking biomarkers associated with residual disease and/or recurrence.

Despite this promise, there are still open questions regarding the best way to implement liquid biopsy approaches in the clinical setting. Our panel brings together academic, clinical, and industry experts in liquid biopsy technologies who will describe the applications of this technique and discuss its benefits and shortcomings in the context of cancer disease management.

Moving from Non-Invasive Prenatal Screening to Prenatal Diagnostics: An Expert Panel Discussion

Video

Non-invasive prenatal testing (NIPT) continues to expand globally to support maternal-fetal patient care. With a growing number of available assays and more labs offering testing, it is essential to have consistency in reporting and the ability to compare results and validate current or new methods.

This on-demand webinar features a panel of experts who provide key insights into the current needs in prenatal testing, the complexities of selecting an assay format and performing quality control, as well as other challenges that labs face when setting up and validating an NIPT assay.

The panelists bring a wealth of expertise and differing viewpoints in clinical laboratory practice, diagnosis of pregnancy complications, and new molecular methods for diagnosis and treatment of pregnancy anomalies and complications. 

A Real-Time-Assay for the fast and gel-free detection of Rhesus Weak D Type 1/1.1 to Type 3

White Paper

In emergency situations, molecular typing of the Rhesus blood group can be helpful but is considered a complicated and slow procedure. This poster shares details from a study that demonstrates reliable and quick real-time PCR typing for weak D types 1, 2 and 3 for a wide range of DNA concentrations.

Fast Real-Time PCR Detection of HLA-B*27 Directly from Blood Using a Specialized Stabilizing Reagent

White Paper

Whole blood or buffy coat is the most commonly used sample material in diagnostic procedures, but often negatively effects PCR applications. In this study we show the tremendous stabilizing effect of a reagent called Blood Booster on direct real-time amplification from fresh blood samples in the FastQ B*27 kit.