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White Papers and Videos

Lateral Flow Test Strips: Design Considerations for Optimal Performance

Video

Having been on the market for over 25 years, lateral flow test strips are widely accepted as a format for the development of diagnostic assays. Devices range from simple test strips dipped into a sample to long format tests used with quantitative readers.

Lateral flow test strips are easy to run, often requiring no more than application of a liquid sample, but reliability of performance depends on how consistently the strips are constructed. This involves the materials, the chemistries, the overall design, and the assembly processes.

This on-demand webinar discusses some of the critical features of test strip design that affect the consistency of performance. These are related back to strategies for minimizing variation where possible and managing variation where it must be accepted.

For In Vitro Diagnostic Materials: Efficacy vs. Thimerosal and Sodium Azide

White Paper

The traditional preservatives used to prevent microbe growth in in vitro diagnostic products are not ideal. Thimerosal, sodium azide, and antibiotics all present challenges.

New preservative materials can eliminate the drawbacks associated with traditional preservatives. Two isothiazolones, the active ingredient in ProCli 150, ProClin 200, ProClin 300, and ProClin 950 preservatives, have a unique mechanism of action that both inhibits bacterial, fungal, and yeast growth and causes cell death. 

This study, conducted by an independent laboratory, compares the antimicrobial efficacy of ProClin 150 preservative, ProClin 300 preservative, sodium azide, and thimerosal in phosphate buffered saline/TWEEN 20 (polysorbate 20). 

Development of a Quantitative Lateral Flow Test Using Estapor Europium Microspheres

White Paper

Lateral flow test strips faciltate user friendly, rapid, low-cost analysis for clinical diagnostics. Advancements in lateral flow tests have largely focused on increasing the sensitivity of analyte detection.

The development of quantitative tests often uses organic fluorophores to achieve increased sensitivity. Pain points associated with fluorophores include ‘photobleaching’, which can compromise sensitivity. Europium chelate microspheres are an alternative to traditional fluorophores that can bypass this limitation.

This application note is a step-by-step guide to developing a quantitative lateral flow test using Estapor Europium Microspheres. The protocols for microsphere conjugation and test strip manufacture may be applied to different antibodies for the detection of alternative antigens.

Performance of Estapor Microspheres and Hi-Flow Plus Membranes in a Lateral Flow Assay for Human Chorionic Gonadotropin (hCG)

White Paper

Lateral flow test strips are immunochromatographic assays used to test for an array of target analytes. While several types of detector particles can be used in the manufacture of lateral flow assays, latex microspheres are the most versatile of the particles currently used.

This report examines the relationship between microsphere size, membrane flow rate, and assay sensitivity, using blue Estapor carboxyl-modified dyed microspheres and Hi-Flow Plus membranes.

ProClin 300 Preservative: An In-Depth Technical Analysis

White Paper

This technical note details the properties of ProClin 300 preservative, a highly effective biocide for the control of microorganisms in reagents and products intended for in vitro diagnostic use.

Due to its broad-spectrum activity, low toxicity at recommended use levels, excellent compatibility, and stability, ProClin 300 biocide is the ideal choice as an effective preservative in diagnostic reagents. At low concentrations, it eradicates bacteria, fungi, and yeasts in reagents for prolonged periods, thereby preserving a product’s shelf life. This water-soluble preservative permits easy incorporation into reagents. Further, it does not affect the functionality of most enzyme- or antibody-linked reactions and will not interfere with assay indicators.

Contract Manufacturing Case Studies: Custom Solutions for IVD Manufacturing

White Paper

This case study series presents 10 examples of IVD developers with a range of challenges that forced them to decide whether to develop their manufacturing capabilities in-house or outsource them.

Cases range from an emerging molecular diagnostic company that had developed a probe-based assay for viral detection and was trying to determine the most efficient way to bring the kit to market, to a prominent diagnostics company that needed a partner to develop target enrichment solutions for next-generation sequencing, to a well-known IVD kit manufacturer that faced a serious issue with the production of a critical primary antibody.

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.

Demo White Paper - Test ONLY

White Paper

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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.

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.