19 Clinical, Medical & Diagnostic Products Identification of Known Unknowns Spectral Search Chromatogram Extracted Chromatogram


Generated Formulae


C(n1) H(n2) N(n3) O(n4)


Verify Candidate(s) Assignment Score: 85%


Predict Retention Time RT Structure d(MS) + Concentration Wavelength Sample ID Identification of Unknown Unknowns Accelerate E&L Component Characterisation


MS Structure ID Suite software helps accelerate component identifi cation for both LC/ MS and GC/MS data. The various tools in the software help elucidate each component structure effi ciently and confi dently. For known E&Ls, the semi- or fully automated workfl ow isolates compounds and searches databases to identify and list all possible candidate structures, conducting spectral comparison via mirrored plots (mass difference) and determining a hit quality index. Automated assignment then further verifi es top structure candidates by determining an assignment score and showing structural fragments and a match factor for experimental spectra.


For true unknowns, you can use the Molecular Formulae Generator to propose potential molecular formulae and then search for a target component’s accurate parent mass and predicted molecular formula to generate a ranked structure hit list. Predicted fragments are then matched to experimental spectra with automation and an additional check can be performed to predict retention time based on structural similarity to known components.


The chemical characterisation workfl ow consolidates analytical and metadata in a centralised database for easy access to information necessary for regulatory documentation and to comply with regulatory requirements, including ISO10993:18 (2020), 21 CFR Part 11 (i.e., traceability, audit trail, etc.).


Accurate Quantitation of E&Ls in Compliance


with Regulatory Guidelines Traditionally single-point calibration has been used with a single reference standard (also referred to as estimated quantitative analysis). In ISO10993-18:2020, an updated defi nition of semi-quantitative analysis has been added where the quantitation is based on the relative responses of the analyte and the surrogate reference standard, and it is now common practice for regulators to expect multiple concentration levels of standards.


Monoclonal antibodies to avian infl uenza viruses


Setup


Load Selected Data Files


Define Sample Information


Integrate Peaks


Generate Cailbration Curve


50mg/ml Amount (mg/mL)


1mg/ml 5mg/ml 10mg/ml 25mg/ml


Process xmg Amount (mg/mL) Review, Store & Report y= mx+b


Automatic Update of Database


Review Report


Verify Candidate(s) Assignment score: 82%


After identifying E&Ls at or above the AET, accurate quantitation is essential. MS Structure ID Suite offers a comprehensive LC/MS and GC/MS quantitation workfl ow. All xC/UV/MS data can be processed and quantitated effi ciently and accurately in a single interface - minimising transcription errors and ensuring consistency and standardisation in quantitative analysis. Using the workfl ow, unknowns are quantitated against the set of standards - peaks are identifi ed, and peak detection and integration parameters are applied to generate a calibration curve.


Concentration Wavelength


Sample ID


Accelerating E&L Studies with Effective


Knowledge Management Managing large volumes of data is very diffi cult without a well-organised system in place. Database curation allows users to fi nd the right data at the right time—helping to ensure data is accurate, high quality, relevant, and easily accessible.


Errors in the identifi cation of E&Ls can result in fl awed safety and biocompatibility assessments. Accurate identifi cation of E&Ls is made challenging by the lack of availability of authentic reference standards. To overcome this challenge, it is essential to create comprehensive proprietary databases. Having a comprehensive repository with the highest possible number of verifi ed identifi cations enables quick and confi dent identifi cation of both known and unknown E&Ls. Database curation minimises the duplication of work, saves time, and resources, and protects valuable data assets.


The presence of E&Ls is inevitable, emphasising the importance of assessing potential toxicological risks. E&L studies aim to test both extractables (the possible impact and materials of medical devices) and leachables (the actual impact and the products) to ensure the safety of the device. The accurate identifi cation and quantifi cation of E&Ls is challenging and there are many uncertainties in E&L analysis regarding the application of reference standards, reliability in identifi cation, and correct selection of dose-based thresholds. Some of this can be mitigated with the use of software solutions, like MS Structure ID Suite, which can help to ensure the precise identity and quantity of E&Ls found in all classes of medical devices - helping to safeguard patients.


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Advanced solutions for streamlined respiratory diagnostic testing


Thermo Fisher Scientifi c Inc has introduced new solutions aimed at simplifying and automating respiratory diagnostic testing. The newly launched Thermo Scientifi c™ KingFisher™ Apex™ Dx, an automated nucleic acid purifi cation instrument, and the Applied Biosystems™ MagMAX™ Dx Viral/Pathogen NA Isolation Kit have been designed to enhance preanalytical workfl ows in clinical laboratories.


In a bid to offer in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions, these cutting-edge products provide laboratories with increased confi dence in downstream results.


The CDC reports that the H5N1 Bird Flu has been detected in several species of wild birds as well as domestic poultry fl ocks. Sporadic infections with this virus have also been detected in mammals (fox, raccoon, skunks, mountain lions). One US case has been reported following exposure to infected birds, but no person-to-person transmission has occurred.


ViroStat’s monoclonal antibodies target the highly conserved nucleoprotein of the Infl uenza A virus. Thus these monoclonal antibody pairs detect many Flu A isolates found in human, avian, swine and equine sources. These include viruses of H1-H14 types and N1-N9 types. Immunoassays utilising these antibody pairs are useful for detecting Flu A in humans as well as for surveillance of circulation in other animal species.


More information online: ilmt.co/PL/jXK8 61045pr@reply-direct.com


Clinical laboratories conducting respiratory testing demand the highest quality results, and the high-throughput, versatile KingFisher Apex Dx system meets these needs. This automated system enables labs to recover quality nucleic acids for sensitive downstream applications, ensuring maximum consistency, reproducibility, and reliability. The system integrates into a modular sample preparation to real-time PCR analysis workfl ow, delivering precise results, accurate data management, and robust security features compliant with cybersecurity and diagnostic regulatory standards. Complementing this, the MagMAX Dx Viral/Pathogen NA Isolation Kit offers advanced formulation for reproducible results and is fully compatible with the automation features of the KingFisher Apex Dx.


Ellie Mahjubi, Vice President and General Manager of Sample Preparation at Thermo Fisher Scientifi c, emphasised: “The KingFisher Apex Dx system builds on decades of product expertise and innovation customers have come to trust in our KingFisher instrument line. The combination of the Apex Dx system and the MagMAX Dx Viral/Pathogen NA Isolation Kit further simplifi es sample preparation for clinical labs so they can have confi dence in downstream results when testing for respiratory diseases.”


The KingFisher Apex Dx system supports the extraction of up to 24 or 96 DNA, RNA, protein, or cell samples, seamlessly transitioning from clinical research to diagnostics with research use only (RUO) and IVD software modes. Integration with Laboratory Information Management Systems (LIMS) or Laboratory Information Systems (LIS) is facilitated via Diomni Enterprise Software, enhancing data management and workfl ow optimisation.


The MagMAX Dx Viral/Pathogen NA Isolation Kit, with its advanced formulation, maximises nucleic acid yield from routinely tested respiratory pathogens such as S. aureus, M. tuberculosis, infl uenza, RSV, and SARS-CoV-2. This kit also aligns with greener policies, incorporating REACH-compliant components and responsibly sourced packaging.


The MagMAX Dx Viral/Pathogen NA Isolation Kit is currently available in North America and is set to be introduced soon to other regions. More information online: ilmt.co/PL/Qmbm


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