On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
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FDA’s final rule on LDTs: what does it mean for clinical laboratories?
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
Questions and answers to help improve your mycotoxin analysis
During a recent webinar I shared method details for mycotoxin analysis on the SCIEX 7500 system. In this blog i will share the Q&A for the submitted questions that we did not have chance to answer during the live webinar.
Library database file types imported into LibraryView™
As is stated in official guidance, many different types of compound and library databases can be imported into LibraryView™ software, such as Excel file (*.xls) and Third Party Library Package (*.tplp). Can somebody tell me what's the format like "tplp", which is so...
New features in OneOmics suite
I just wanted to thank the readers here, both the OneOmics suite users who’ve shared their time and watched OneOmics grow, and for all the talented developers and scientists who’ve made OneOmics suite what it is today.
Current proteomics software compatibility for ZenoTOF 7600 system
Below is a summary of various other software packages that are useful for processing proteomics data from the ZenoTOF 7600 system. Note this list is not comprehensive and only covers the tools we have lightly tested to date. Acquisition Type Software Files needed...
Processing ZenoTOF 7600 system data with DIA-NN software
DIA-NN software is a powerful software tool for processing data independent acquisition (DIA) proteomics datasets. It uses neural networks and other algorithms to identify and quantify peptides and proteins from DIA data and is specifically optimized for fast...
Excel macro for calculating averages or percent CVs from replicates in a 384 -well plate
This excel workbook is designed to be used with data copied from a SCIEX OS software Analytics module results file
Excel macro for plate building for transformation of 96-well to 384-well plates with generation of batch lists for SCIEX OS software
This macro-enabled workbook is designed to help with creating a formatted analysis list for the Echo® MS system, using 96-well plate maps or lists
How to optimize sample plating to run Echo MS system in ‘Fast acquisition mode’
The Echo MS system can acquire data extremely rapidly, at 1 second per sample. To achieve this speed, it should be ensured that there is adequate time between ejections for the analyte signal to return to baseline between ejections. Plating your samples such that you...
How do I check the quality of the Auto Retention Time Calibration used in my Extractor processing?
When using the Auto-Calibration option in Extractor, a set of retention time calibration peptides will be determined automatically from the library and used for RT calibration. To determine how the fit looks for the calibration on each datafile, follow these steps....
Uploading data for use in OneOmics suite
There are two options for data storage when working with the OneOmics suite. You can store your data either within the SCIEX Cloud platform in the Data Store, or you can store data in BaseSpace (Illumina) and link your BaseSpace account with the SCIEX Cloud platform....
Getting access to demo data and other files for learning the OneOmics suite
In order to help you get proficient in using the OneOmics suite workflows, we have provided some demo datasets along with numerous other valuable files and supporting information to help you get started. Once you get access to your SCIEX Cloud account and can view...
How to download and use SVG files from OneOmics suite
Results workspaces in the OneOmics suite contain a variety of figures, all available for download as SVG (scalable vector graphic) files. To download your figures, select the orange arrow icon located in the upper right-hand corner of each plot. Download will...
How to share your results with collaborators
As multi-omics research is often highly collaborative, tools for rapidly sharing important results files are needed to drive scientific progress. The SCIEX Data Store in the OneOmics suite enables you to not only organize your uploaded multi-omics data files into...
sMRM Concurrency Calculator
This excel sheet allows you to quickly estimate the MRM concurrency and approximate dwell time for your Scheduled MRM Algorithm acquisition method. Paste your MRM method with retention times into the input tab then calculate the Excel workbook. Plots will update to...
Uploading and using transcriptomics data in the OneOmics suite
RNA experiments can be created in the OneOmics suite for multi-omics analyses, enabling integration of transcriptomics data and proteomics data for biological insight. To build RNA experiments, either CloudConnect for PeakView software 2.2 or BaseSpace (Illumina) can...
Merging two FASTA files
There is an easy way to merge two FASTA files together. Open notepad and type this string: type %*>"newfile.fasta" Enter any name for the FASTA file between the quotes. Save the file as: Merge FASTA files.bat Copy the two files you want to merge into the same...
What is the difference between MRM3 vs MS/MS/MS (MS3)?
The MRM3 workflow and the MS3 scan are functionally the same QTRAP system scan, but used with different goals in mind. The main difference is how these scans are used in the whole MS workflow. With MS3 scans, you can use these in a data dependent mode for discovery...
Downloading results from SCIEX Data Store or BaseSpace
Once your data processing sessions have completed, the results files are saved back to either SCIEX Data Store or BaseSpace. These can be downloaded from the cloud to your desktop for additional analysis. Please see these community posts to learn more: Explaining the...
Understanding MS1 Peak Intensity in ProteinPilot software
The “Intensity (Peptide)” values come from LCMSReconstruct, in ProteinPilot software 5.0. It maps the RT, m/z, intensity MS1 surface to find the peak information for the peptide. The Intensity (Peptide) is a weighted sum of the heights of the isotope series at the...
What is the difference between a rapid and a thorough search in ProteinPilot software?
When setting up your search in ProteinPilot software, you select either a Rapid Search or a Thorough Search in the Search Effort section. This setting determines which parts of the algorithm will be invoked and effectively how deep into your sample you will search to...
What are my normalization options in MarkerView software and when should I use them?
In an LC-MS experiment there are multiple sources of variance that can confound the quality of your results. This variation can be biological e.g. differences between treated and control groups, but can also be non-biological, usually from small variations in...
Breaking down the SCIEX Triple Quad™ 7500 LC-MS/MS System – QTRAP® Ready
Sensitivity and robustness carry different meanings in the world of mass spectrometry. Generally, sensitivity refers to an instrument’s ability to achieve lower limits of detection (LOD). Robustness, on the other hand, refers to an instrument’s ability to consistently...
A rising star in food allergen research: proteomics of shellfish allergen
It’s important to know what you’re eating, especially if you suffer from a food allergy.
About 220 million people worldwide live with a food allergy.1 These numbers, along with the complexity and severity of conditions, continue to rise. In America, there are about 32 million food allergy sufferers—5.6 million of those are children under the age of 18.2.2 That’s 1 out of every 13 children, or about 2 in every classroom. From a financial perspective, the cost of food allergy childcare for US families is up to $25 billion