Clinical Research Experience

Class D & high-risk IVD studies

Where the regulatory bar is highest and we run the deepest. HIV, HBV, HCV, Syphilis: the bloodborne pathogens that demand prospective sampling, broad cross-reactive panels and matrix equivalence.

• Prospective sample collection: Direct access to blood donation centres and clinical sites for fresh-day prospective samples — not just retrospective residual material.
• Cross-reactive sample panels: Broad availability of cross-reactive and interfering-substance samples to support specificity assessments.
• Residual sample pathways: Residual materials may support matrix-equivalence and sensitivity work when the protocol, site governance and applicable ethics pathway permit their use.
• Multicentric study design: Multicenter studies aligned with EU Common Specifications 2022/1107 first-line HBsAg/HIV/HCV requirements.
• Usability studies: IEC 62366 usability studies for lay-user and self-test devices when intended purpose requires it.
• Methodology coverage: RDT, ELISA, CLIA, PCR — methodology-agnostic study design that fits how your device is actually used.

Diagnostic areas we cover

Selected diagnostic categories from our anonymised project portfolio are shown below.

• Bloodborne pathogens (Class D): HIV-1/2 Ag/Ab, HBV (HBsAg, HBcAb, HBeAg), HCV, Treponema pallidum (Syphilis), HIV p24.
• Respiratory infectious disease: SARS-CoV-2, Influenza A/B, RSV, ADV, hMPV, PIV — antigen, antibody and multiplex NAAT formats.
• Women's health & STD: HPV DNA genotyping (including 28+ types and self-collection), hCG, LH, Chlamydia/Gonorrhoeae NAAT, MG, TV, UU, MH, UP.
• Cardiac & emergency markers: hs-cTnI, hs-cTnT, NT-proBNP, D-Dimer — IFCC- and CLSI-aligned method comparisons.
• POCT & self-testing: PT-INR self-test (ISO 17593), LH ovulation, blood gas, glucose, FOB — with lay-user usability per IEC 62366.
• Hematology & coagulation: CBC 3/5-part diff, ABG, PT/INR — venous vs. capillary equivalence and reference-range studies.
• GI & H. pylori: H. pylori antibody typing (CagA, VacA, type I/II), urease antibodies and concordance with UBT/PCR.
• Neurodegenerative & cytokine markers: Alzheimer biomarkers, IL-1β, IL-2R, IL-6, IL-8, IL-10, TNF-α — clinical outcome prediction and method comparison.

How we work — the standards we follow

We do not chase a single regulatory checkbox; our study and documentation work is structured around the standards notified bodies actually expect.

• IVDR 2017/746 · Annex XIII: Performance evaluation requirements for scientific validity, analytical and clinical performance.
• ISO 20916:2019: International standard for clinical performance studies using specimens from human subjects.
• EU Common Specifications 2022/1107: Class D Common Specifications for HBV, HCV, HIV, Syphilis and similar high-risk IVDs.
• IEC 62366 · ISO 14971: Usability engineering and risk management for medical devices.
• CLSI guidelines: EP05 precision, EP09 method comparison, EP35 matrix equivalence — applied to your specific device class.
• WHO TSS · FDA 510(k) · TGA: WHO Technical Specifications Series, US FDA 510(k) and Australian TGA frameworks when your market reach goes beyond the EU.

Selected project experience

Anonymised due to client confidentiality — but indicative of the IVD device categories, study designs and standards we routinely run. Each entry is one real engagement.

• HIV-1/2 Ag/Ab ELISA — Class D, Common Specifications first-line: Prospective fresh-day serum sensitivity assessment on a 25-sample seroconversion panel covering subtype and serotype coverage across donor and hospitalised-patient cohorts. Paired with frozen true-positive CLSI EP35 matrix-equivalence and cross-reactivity / interference panels under EU Common Specifications 2022/1107 first-line HIV requirements. Outputs: SVR, APR, CPR and PER — IVDR submission.
• HBsAg ELISA — Class D, dual-arm design: Combined retrospective matrix-equivalence (CLSI EP35, frozen true-positive serum) and prospective Common Specifications first-line clinical performance evaluation. Coverage of HBV subtypes/serotypes, hospitalised patients and donor populations, with cross-reactivity and interfering-substance panels per EU CS 2022/1107. Output: PER aligned to notified-body review expectations.
• Anti-HCV ELISA — Class D, matrix and interference: Frozen prospective true-positive matrix-equivalence study (CLSI EP35) followed by plasma cross-reactivity and interfering-substance evaluation under EU Common Specifications. Two-stage analytical performance design feeding into the APR and PER for a single Class D ELISA device.
• Cardiac biomarker panel — hs-cTnI, hs-cTnT, NT-proBNP, D-Dimer (CLIA): 99th-percentile cutoff establishment, precision (CLSI EP05) and method comparison against four independent comparator platforms in parallel — a reference CLIA immunoassay (hs-cTnT, NT-proBNP plasma), a second high-sensitivity troponin system (hs-cTnI serum), a point-of-care analyser (NT-proBNP whole blood) and an automated coagulation system (D-Dimer plasma). Four markers, four matrices, four comparators, one study. IFCC Cardiac Troponins + CLSI EP05 aligned. Public outputs: four posters at Euromedlab 2025 (Brussels) and Elas National Congress 2025.
• Cytokine panel for clinical outcome prediction (IL-1β, IL-2R, IL-6, IL-8, IL-10, TNF-α): Clinical association study linking the six-cytokine panel to clinical outcome, paired with method comparison against a multiplex cytokine immunoassay system. Public outputs: poster at Elas National Congress 2025 and a peer-reviewed publication in Natural Aging.
• SARS-CoV-2 rapid antigen — 11-product Common List study: Prospective multicentric clinical performance evaluation of 11 distinct SARS-CoV-2 antigen rapid tests benchmarked against the EU Common List of COVID-19 antigen tests. Largest multi-product evaluation in our portfolio — coordinated across sites with shared sample logistics.
• PT-INR coagulation meter self-test (IVDR self-test): Multicentric accuracy and lay-user usability study for a PT-INR self-test device. Standards applied: ISO 20916:2019 (clinical performance studies) and ISO 17593 (PT-INR self-test specific). Output: PER and usability study report for IVDR submission.
• Plasma Alzheimer biomarkers (Aβ 1-42, Aβ 1-40, pTau-181, pTau-217) — multicentric cutoff establishment: Multicentric cutoff establishment (ROC analysis with Youden index) and validation using a Dual Cut-off strategy on a cognitively symptomatic population referred for amyloid testing (CSF/PET reference). Mixed prospective and frozen retrospective samples. Standards: ISO 20916:2019, IWG 2024, NIA-AA 2024, Palmqvist 2025.

Italian clinical sites we work with

Named institutions our performance studies have run at or that we hold active research collaboration with. Site selection per study is driven by intended population, IRB landscape and sample-logistics fit.

• Policlinico di Modena: University hospital of Modena and Reggio Emilia (AOU Modena) — clinical pathology and laboratory medicine.
• Fondazione IRCCS Policlinico San Matteo (Pavia): IRCCS research hospital — clinical chemistry, microbiology and immunology.
• AOU Careggi (Florence): Tuscany regional reference hospital — clinical pathology and infectious-disease departments.
• Città della Salute e della Scienza di Torino: Major Piedmont teaching hospital — molecular pathology and central laboratory.
• Azienda Ospedale Università di Padova: Veneto regional reference hospital — clinical biochemistry and virology.
• Inpeco: Italian clinical-laboratory automation partner — instrument integration and workflow collaboration.
• Medical Bridge: Italian clinical research partner — multicentric trial coordination.
• University of Perugia: Department of Medicine and Surgery — academic cooperation including performance-evaluation studies and a funded microbiology scholarship.

Comparator methods we benchmark against

When a performance study requires method comparison, we benchmark against the established reference method for each marker — market-leading commercial analysers, named in the study report and the technical file rather than in marketing copy. Methodology-agnostic by design: we run the study to fit the device, not the other way round.

• Reference CLIA immunoassay: hs-cTnT (serum), NT-proBNP (plasma), RBC folate — cardiac and hematology comparator on a market-leading automated platform.
• High-sensitivity troponin system: hs-cTnI (serum) — cardiac troponin comparator on a second, independent immunoassay platform.
• Point-of-care cardiac analyser: NT-proBNP (whole blood) — near-patient comparator, so results are anchored in both lab and POCT settings.
• Automated coagulation system: D-Dimer (plasma) — coagulation comparator.
• Multiplex cytokine immunoassay: Cytokine panel (IL-1β, IL-2R, IL-6, IL-8, IL-10, TNF-α) — multiplex comparator.
• High-throughput hematology analyser: Hematocrit / RBC parameters — hematology comparator.
• Cartridge-based molecular system: Comparator for mycobacterial drug resistance and carbapenem-resistance gene detection.
• mRNA-based HPV assay: HPV E6/E7 mRNA comparator for cervical cancer screening.
• Multiplex NAAT panels: HPV genotyping and respiratory multiplex comparator.

Public scientific outputs

Performance studies don't only land in technical files — selected results are also presented at peer-reviewed conferences and journals.

• Euromedlab 2025 — Brussels, May 2025: Four posters on cardiac biomarker performance evaluation: hs-cTnT, hs-cTnI, NT-proBNP and D-Dimer, each CLIA result benchmarked against an established reference method.
• Elas National Congress 2025 — Italy, October 2025: Multiple posters covering the same cardiac biomarkers plus RBC folate (reference immunoassay and hematology comparators) and a six-cytokine panel (multiplex comparator).
• Publication — Natural Aging, 2025: Peer-reviewed publication on cytokine markers (IL-1β, IL-2R, IL-6, IL-8, IL-10, TNF-α) for clinical outcome prediction in the natural ageing context.

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