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GEN Protocols

Analytical Testing

Analytical Testing

Protocol

Short Communication: A Descriptive Analysis of Dried Blood Spot Adherence Testing Among Ugandans with HIV Presenting with Cryptococcal Meningitis

Early antiretroviral therapy (ART) initiation after cryptococcal meningitis increases mortality, and those unmasking cryptococcosis after 2 weeks of ART have higher mortality. However, it is unknown if those presenting as ART experienced are actually adherent to their ART. Unknowingly, restarting AR... More


Protocol

Short Communication:Evidence of Novel SARS-CoV-2 Variants Circulation in Romania

New SARS-CoV-2 variants are constantly emerging and putting a strain on public health systems by spreading faster and potentially evading immune protection through vaccination. One of these strains is the B.1.1.7 variant that has initially been described in the United Kingdom and has subsequently sp... More


Protocol

Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda

Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency® assay for use in Uganda. Archived specimens (se... More


Protocol

Continuous Glucose Monitoring and Glycemic Control in Young Adults with Type 1 Diabetes: Benefit for Even the Simplest Insulin Administration Methods

The impact of continuous glucose monitoring (CGM) on glycemic control in young adults with type 1 diabetes (T1D) is controversial. Data from 888 young adults with T1D were reviewed (ages 18–30 years, 52% female, glycated hemoglobin [HbA1c] 8.1% ± 1.5%). Prescription of CGM was recorded for 54% of yo... More


Protocol

Prevalence of SARS-CoV-2 Antibodies in Children and Adults with Type 1 Diabetes

Objective: As diabetes is a risk factor for severe symptoms, hospitalization, and death with COVID-19 disease, we aimed to assess the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in children and adults with and without type 1 diabetes in Colorado during 2020.... More


Protocol

Correlates of Continuous Glucose Monitoring Use Trajectories in Children and Adolescents with Type 1 Diabetes

The goal of this study was to characterize trajectories of continuous glucose monitoring (CGM) use in youth 5–12 weeks after starting CGM and examine what factors differentiate between the trajectory groups. Parent–youth dyads completed assessments before starting CGM. Days of CGM use between weeks ... More


Protocol

Continuous Glucose Monitoring Time-in-Range and HbA1c Targets in Pregnant Women with Type 1 Diabetes

The CONCEPTT trial compared real-time Continuous Glucose Monitoring (RT-CGM) to capillary glucose monitoring in pregnant women with type 1 diabetes. We analyzed CGM and glycated hemoglobin (HbA1c) measures in first (n = 221), second (n = 197), and third (n = 172) trimesters, aiming to examine target... More


Protocol

Insulin Metrics: Need for Development of Consensus Standards for Reporting of Insulin Dosing Data

The advent of connected insulin pens will generate an avalanche of digital insulin data, especially in the context of prandial- and multiple daily injection-insulin regimens. There is a need for the diabetes community to develop standards for such data, analogous to what has been achieved using the ... More


Protocol

Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines

Current guidelines recommend 15–20 g of carbohydrate (CHO) for treatment of mild to moderate hypoglycemia. However, these guidelines do not account for reduced insulin during suspensions with predictive low-glucose suspend (PLGS). We assessed insulin suspensions, hypoglycemic events, and CHO treatme... More


Protocol

Development and Validation of an Anion Exchange High-Performance Liquid Chromatography Method for Analysis of Empty Capsids and Capsids Encapsidating Genetic Material in a Purified Preparation of Recombinant Adeno-Associated Virus Serotype 5

The development of various manufacturing platforms and analytical technologies has substantially contributed to successfully translating the recombinant adeno-associated viral vector from the laboratory to the clinic. The active deployment of these analytical technologies for process and product cha... More


Protocol

Skin Freezing Technique for Living Cell Bank

Cell banks are especially important sources of studies for which living cells are needed, as well as a repository of genetic diversity in natural populations. We propose a simple protocol for field research that can maintain viable skin cells for in vitro replication and production of fibroblast lin... More


Protocol

Protein Aggregate Identification with FMM: Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations

Don’t rely on unreliable morphology characteristics or refractive index to determine if particles in your formulation are protein or non-protein. Aura systems are the only particle analyzer that combines fluorescence membrane microscopy (FMM) with backgrounded membrane image (BMI) to give you defini... More


Protocol

High-Throughput Detection of Degraded Polysorbate in Biological Formulations with FMM

Excipients like polysorbate are used in the majority of biologic products to improve stability. However, the polysorbate itself can degrade, impairing the stability of the API and contributing an additional aggregate source that can elicit an immunogenic response. Traditionally, monitoring only poly... More


Protocol

AAV Aggregate Quantitation and Identification with the Aura System

Adeno-associated viruses (AAVs) have made the promise of gene therapy a reality by enabling safe, targeted delivery of curative genetic payloads. The formation of aggregated viral vector is an important critical quality attribute to measure because they lead to adverse immunogenic events and are an ... More


Protocol

Detect Specific Protein Aggregates in Biologic Formulations with the Aura Immunoassay

Biologic co-formulations target multiple pharmacologically active sites to increase therapy efficacy. However, either biologic can be a source of protein aggregation that can negatively influence the product’s safety, efficacy, and therapy. Aura systems are the only particle analyzer that can pinpoi... More


Protocol

Evaluate Cell Therapy Product Purity with Aura CL

The CAR-T development workflow is a multi-step process that includes transfection of T cells with a viral vector to express a chimeric antigen and activation/expansion of the CAR-T using a molecule like a Dynabead conjugated to CD3/CD28. Each of these steps is a potential source of contamination tha... More


Protocol

USP Particle Count Standards with Aura and Particle Vue 3.1

All membrane microscopy methods must generate accurate and reproducible counts for bead counting standards. We present a validated methodology for accurately counting United States Pharmacopeia (USP) microsphere count standards on Aura systems by seamlessly calculating the cumulative area of all the... More


Protocol

USP Compendial Particle Measurements with the Aura System

The Aura platform provides a rapid and robust USP 788 compendial method for subvisible particle analysis, a critical quality attribute. It can handle a wide range of sample types and can analyze anywhere from 5 µL to 10 mL of sample, enabling continuity of method from developability assessment to lo... More


Protocol

Removal of rare undifferentiated induced pluripotent stem cells (iPSCs) by multi-step negative sorting

In the field of regenerative medicine involving ES or iPS cells, differentiated cells are often cultured to tissues and implanted to patients. However, there is an unneglectable problem that some remaining undifferentiated cells in the implanted tissue may cause tumors. Therefore, a complete removal... More


Protocol

Cell culture CO2 incubator decontamination process using hydrogen peroxide vapor for highly regulated and general cell culture protocols

The value of the laboratory cell culture incubator used in highly regulated research and clinical protocols is directly related to the proportion of incubator uptime vs. downtime in applications where frequent interior chamber decontamination is required or desired. The need for interior decontamina... More


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Primer

Assessing Protein Purity: Many Tests, Many Assays

Proteins provide structure to cells, catalyse enzymatic reactions, transport cargo, replicate DNA, metabolise nutrients among an array of other functions. Composed of amino acids and generally featuring a three-dimensional structure, proteins form key therapeutic and diagnostic tools as antibodies o... More


Primer

Two Critical Steps to Success in Multicolor Flow Cytometry

Flow cytometry is a powerful tool to analyze and characterize cells based on their protein expression, most often those expressed on the cell surface. Multicolor flow cytometry uses multiple fluorochromes as primary or secondary antibody conjugates to label cells. The capacity for modern flow cytome... More


Primer

Unwanted Fungi: Detecting Microbial Cell Culture Contamination

Coming into the lab and spotting an obvious fungal growth, or the tell-tale signs of cloudy media, can be a stressful experience for researchers. When carrying out cell culture in the lab, contamination from microbial agents such as bacteria and fungus can occur and have disastrous effects on ongoin... More


Primer

Benefits of Using an Electronic Laboratory Notebook

Electronic laboratory notebooks (ELNs) were developed to keep track of experiments and data so that scientists could review their work in a single place and easily reproduce experiments. Many ELNs started out as electronic versions of paper lab notebooks. Now, the most advanced ELNs offer an extensi... More


Primer

Quick Antibiotic Susceptibility Test for High-Threat Pathogens in Whole Blood Samples

By spreading so rapidly and wreaking so much havoc, COVID-19 has revealed the susceptibility of global societies to both natural pathogens and intentionally released bioterror agents. The latter include bacteria that have been engineered for enhanced antibiotic resistance.1 Once pathogenic bacteria ... More


Primer

Bio-Electrospraying and Cell Electrospinning: A Sea of Applications

Electrospraying and electrospinning have been used for a wide range of applications ranging from coatings, propulsion, and pesticide sprays to scaffolding a wide range of advanced materials for applications in filtration and tissue engineering. Although electrospun scaffolds have been explored as ti... More


Mixer

Cell Therapy Development: Tackling Analytic Challenges

Cell therapy products are an exciting new class of medicinal products that offer opportunities to treat and cure diseases that cannot be treated using conventional therapeutic options. The development and manufacturing of cell therapy products pose several challenges compared to other biologics. Yet... More


Video

GEN Protocols Expert Exchanges: COVID-19 Immunodiagnostic Test Identifies Antibody Source

Need another COVID-19 booster?A new immunodiagnostic test called PictArray helps you decide. The test tells you exactly where your antibodies to the virus are coming from - whether your antibodies are from vaccines or SARS-CoV-2 infections, or both. The test detects SARS-CoV-2 antigens--both spike p... More


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