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White Papers and Videos

ELISA Guide: A Clear and Easy Guide to ELISAs

White Paper

Your results matter. That is why choosing the right ELISA is critical for your research success.

The ELISA Guide from Bio-Techne provides a deep-dive look at the different types of ELISAs, advantages and disadvantages of each, and why you would want to use an ELISA over other techniques.

The guide also details the importance of ELISA controls and offers best practice recommendations for achieving optimum performance, precision, and reproducibility.

10 Strategic Considerations When Outsourcing Production of In Vitro Diagnostics

White Paper

This white paper highlights 10 important benefits of outsourcing and key considerations that should factor into the evaluation of an IVD  partner, from investment to development capabilities.

Life Sciences & Biotechnology Labeling Dilemmas

White Paper

Specifications for laboratory labels for biotech and diagnostics face unique demands, such as precise sizing, legibility, durability, and increasing information requirements, not to mention FDA compliance.

This white paper includes five case studies illustrating solutions for various labeling challenges for life science and biotech companies, including:

  • Chain of Custody Security & Traceability
  • Durability in Harsh Environments
  • Automatic Application Lines
  • Durability in Extreme Temperatures
  • Legibility & Sizing

Using Parallel Evaporators to Escalate COVID-19 Test Kit Preparation

White Paper

As labs globally have scaled up production of PCR test kits for COVID-19, workflow improvements continue to be important to increase the efficiency of test kit production.

SP Genevac's HT Series3i evaporator range offers a solution to improving the efficiency of test kit production, by preventing bottlenecks in high-throughput processing of oligonucleotides. It provides a fast and reliable method for drying primers and probes ready for use in PCR testing kits.

Download this white paper to learn how SP Genevac supported laboratories around the world to scale up their production of PCR test kits to aid the global fight against the COVID-19 virus.

LGC, Biosearch Technologies Accelerate Probe and Primer Production to Enable COVID-19 Testing with the SP Genevac HT Series 3i Evaporator

White Paper

During the COVID-19 pandemic, LGC, Biosearch Technologies, has been accelerating its production of oligonucleotides and other critical test kit components. However, there are problems that can slow production workflow. One particular bottleneck is in the drying process. The output from the synthesis labs and purification group can far outweigh the aliquoting, loading and drying workflow, which causes workflow to slow down upstream.

LGC, Biosearch Technologies, is using SP Genevac technology in order to facilitate the rapid production of probes and primers, and creating them to the high standards needed in this extremely challenging situation.

Download this white paper to learn how Biosearch Technologies used the SP Genevac technology to step up to the COVID-19 testing challenge.

Freeze-Drying COVID-19 Diagnostics: Formulation & Process Development and Lyophilizer Selection

White Paper

Lyophilization may be considered a relatively gentle drying process, but there are still risks and pitfalls when applying it to biomolecular reagents in diagnostic tests. Reagents typically used in ELISA- and PCR-based diagnostic kits for diseases such as COVID-19 tend to contain labile components, such as enzymes that need preserving for longevity in the supply chain or antibodies to test for a patients response to the virus, which can be challenging to stabilize for commercial use.

This technical note discusses various aspects of formulation and cycle development in the lyophilization of diagnostic reagents, including those required for COVID-19 testing.

PCR Diagnostic Kits & Freeze-Drying Considerations

White Paper

Polymerase chain reaction (PCR) is a method widely used in molecular biology to make many copies of a specific DNA segment. There are numerous processing challenges with PCR, however. The various component solutions need to be accurately combined in a plate well or tube "cocktail." The components require refrigeration and they have a relatively short shelf life and cross contamination is a concern. R&D lab bench pipetting errors can also be troublesome.

Freeze-drying has become an integral part of the PCR process and is used for both individual reagents as well as end-product test kit reagents.

This technical note discusses the considerations for freeze-dried PCR reagents and diagnostic kits.

Optimized Lateral Flow Assays Using Dyed and Fluorescent Estapor Microspheres

Video

In this technical presentation, we will discuss the use of polymeric microspheres in diagnostic assays. We will provide you with a survey of the materials used in this field, examples of readers available for this growing market, case studies, and a first preview of novel products to be released in 2020.  Material considerations to be discussed include key attributes needed to select the best spheres for qualitative and quantitative assays (such as size, functional group, and color).  We will also share best practices to troubleshoot protein binding in qualitative assay development using our raw materials. This information will be of interest to individuals involved in developing and validating qualitative and quantitative assays.

Applying AnteoBind Activated Estapor Europium Microspheres for Development of Fluorescent Lateral Flow Immunoassays

Video

In this technical presentation, we will provide you with an introduction to AnteoBind nanocoating technology and the use of AnteoBind activated Estapor europium microspheres in lateral flow immunoassays.

We will discuss the common issues encountered in antibody conjugation, the detail of the alternative protein conjugation procedure using AnteoBind activated Estapor europium microspheres, and the effects of physical characteristics (size, dispersity, surface charge) during the steps of conjugation and storage. We will also discuss the performance of conjugates in functional assay development for several popular biomarkers.

We will share best practices to troubleshoot antibody conjugation to AnteoBind activated Estapor europium microspheres in assay development and the initial scale-up procedure. This information will be of interest to individuals involved in developing and validating lateral flow immunoassays and manufacturing process development.

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.

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.

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.

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.