This paper describes different types of in vitro diagnostic (IVD) tests, identifies differences between a laboratory developed test (LDT) and an IVD test, underscores the benefits of running LDTs and IVD tests and reviews examples of LDTs and different applications for them.
This educational paper describes how a laboratory can prepare to design and implement a laboratory-developed test (LDT) and outlines the typical steps of LDT implementation and identify key questions that must be addressed at all stages of the process.
Three case studies for the multiplex detection of viral and bacterial pathogens using fragment analysis are presented highlighting the ease of assay development and the impacts assays like these can provide on patient care and scientific discoveries.
PCR is a workhorse of modern molecular biology, but it can be tedious to investigate multiple analytes in a single sample. Methods that can analyze multiple sequences from a single sample would simplify workflows and conserve precious samples. A large number of targets can be analyzed using fragment analysis by separating amplicons based on both size and fluorescent label.
This application note shows how the TrueMark MSI Assay provides data concordant with immunohistochemistry (IHC) mismatch repair (MMR) analysis TrueMark MSI Assay, the TrueMark MSI Assay demonstrates increased sensitivity and specificity relative to an alternative PCR-based assay, and the TrueMark MSI Assay can extract information from research samples that would have failed using the alternative PCR-based assay.
Multiplex ligation–dependent probe amplification (MLPA) is a widely used molecular biology technique for copy number determination of multiple DNA sequences in the study of human genetic diseases. This technique is based on the ligation and PCR amplification of up to 50 multiplexed pairs of probe oligonucleotides, which hybridize to the loci of interest.
The SeqStudio Genetic Analyzer is our newest tool to provide routine and accessible analysis of DNA using capillary electrophoresis (CE).
To provide methods for CE-based focus on strain lineages, we developed Sanger sequencing protocols for specific amplicons that can be used to confirm mutations found in some strain lineages. However, a protocol that facilitates flexible choices for confirming any mutation is needed. We therefore developed tools for selecting primer sequences for any position in the SARS-CoV-2 genome, and a protocol for using them for variant analysis via Sanger sequencing.
The Applied Biosystems 3500 Dx Series Genetic Analyzers with 3500 Dx Series Data Collection Software 3 IVD v3.2 deliver flexibility by offering dual-mode capability within the same system to help meet the needs of today and tomorrow. The secure Diagnostic Mode supports run modules that will perform both Sanger sequencing and fragment analysis.
The SeqStudio Flex Genetic Analyzer, available in both 8- and 24- capillary configurations, is the only mid-throughput genetic analyzer for Sanger sequencing and fragment analysis to deliver the high-quality data and reliable performance that scientists need, with design enhancements and advanced communications for improved flexibility, ease of use, connectivity and serviceability.