RECIPE HPLC & LC-MS/MS IVD Complete Kits - Product Catalogue I

Significance of the Topic

Clinical and forensic laboratories require reliable, CE-IVD certified assays to detect a wide range of endogenous and exogenous analytes. From monitoring chronic alcohol abuse to tracking therapeutic drugs and environmental toxins, high-performance liquid chromatography (HPLC), LC-MS/MS, and photometric methods are indispensable. Complete kits with standardized reagents, calibrators, controls, and streamlined sample preparation protocols ensure consistent results, reduce operator variability, and accelerate turnaround times in high-throughput settings.

Catalogue Overview and Objectives

The 2020 / 2021 “IVD Complete Kits” catalogue presents:

• HPLC kits for Diagnostics (ClinRep®) covering alcoholism markers, biogenic amines, metabolic disease biomarkers, vitamins, hemoglobins, and oxidative stress parameters.
• HPLC kits for Therapeutic Drug Monitoring (TDM) of antiarrhythmics, antiasthmatics, antiepileptics, immunosuppressants, and psychoactive drugs.
• Photometric kits (ClinEasy®) for porphyrias and lead intoxication screening.
• LC-MS/MS kits (ClinMass®) for high-sensitivity quantification in clinical diagnostics, TDM, and human biomonitoring (HBM), including dried blood spot (DBS) analyses.

Methodology and Instrumentation

All kits follow a “complete kit” philosophy, supplying mobile phases, standards, internal standards, sample preparation reagents, and quality controls. Key workflows include:

• HPLC with manual or automated sample cleanup (protein precipitation, SPE cartridges) and UV or fluorescence detection.
• On-line SPE integration for direct injection of serum, plasma, or urine into HPLC systems.
• UHPLC methods for fast vitamin and hydrophobic analyte profiling.
• LC-MS/MS triple quadrupole methods with isotopically labeled internal standards for enhanced specificity and sensitivity.
• Photometric microplate assays for porphyrin and lead test modules.

Typical instrumentation:

• Binary/quaternary pumps, thermostated columns (C18, reversed-phase), fluorescence and UV detectors.
• Autosamplers with 1–50 µL injection loops, column switching valves, and on-line SPE modules.
• Triple quadrupole LC-MS/MS with electrospray ionization and multiple reaction monitoring.
• Photometric microplate readers with wavelength filters tailored for porphyrins and lead complexes.

Main Performance Highlights

The kits deliver:

• Wide linear ranges (ng/mL to µg/mL) and recovery rates often above 90 %.
• Intra- and inter-assay precisions typically below 5 % CV.
• Unique chromatographic separations (e.g., transferrin isoforms, carotenoid isomers) and robust matrix cleanup.
• Automated, high-throughput on-line methods (<10 min run times) for TDM and toxicology panels.

Benefits and Practical Applications

These turnkey solutions enable laboratories to:

• Implement validated CE-IVD workflows without custom reagent preparation.
• Ensure compliance with regulatory standards (ISO 15189, CAP) through standardized calibrators and controls.
• Reduce hands-on time and human error via one-step sample preparation or fully automated on-line SPE.
• Expand testing menus easily by adding “add-on” sets to a universal HPLC or LC-MS/MS platform.

Future Trends and Opportunities

Emerging directions include:

• Microflow and nanoflow LC-MS/MS to lower solvent consumption and increase sensitivity for limited sample volumes.
• Multiplexed assays combining panels of biomarkers (e.g., vitamin status, oxidative stress, drug panels) in a single run.
• Point-of-care photometric platforms with smartphone integration for rapid screening.
• Adoption of high-resolution mass spectrometry for non-targeted profiling and discovery of novel diagnostic markers.

Conclusion

The 2020 / 2021 IVD Complete Kits catalogue offers an extensive suite of ready-to-use HPLC, LC-MS/MS, and photometric kits designed to streamline laboratory workflows, maintain high quality, and adapt to evolving clinical and toxicological testing needs.

References

R-Biopharm Product Catalogue “IVD Complete Kits” 2020 / 2021