IVDR Class D Sample Sets
Ready-to-use compliance panels for HBV, HCV and HIV validation under EU Regulation 2017/746. Each panel is referenced to the specific Annex and table of the Common Technical Specifications (CTS 2009/108/EC) — covering diagnostic sensitivity, specificity, self-test validation and matrix equivalence studies.
HBV — Hepatitis B Virus Panels
| Panel | CTS Reference | Description | n |
|---|---|---|---|
| HBV Anti-HBs | Annex VI, table 4 | HBV naturally infected, positive specimens | 100 |
| HBV DNA | Annex VI, table 5 | HBV DNA positive | 100 |
| HBV | Annex VI, table 4 | HBV positive | 200 |
| HBV HBsAg | Annex VI, table 3 | HBsAg positive | 300 |
| HBV Anti-HBc HBsAg | Annex VI, table 2 | Anti-HBc + HBsAg positive | 400 |
| HBV-Vaccinated | Annex VI, table 4 | HBV vaccinated donors | 100 |
| HBV incl. fresh | Annex VI, table 1 | HBV positive incl. 25 same-day fresh samples | 400 |
HCV — Hepatitis C Virus Panels
| Panel | CTS Reference | Description | n |
|---|---|---|---|
| HCV | Annex V, table 5 | HCV positive | 100 |
| HCV | Annex V, table 3 | HCV positive | 300 |
| HCV | Annex V, table 2 | HCV positive | 400 |
| HCV incl. fresh | Annex V, table 1 | HCV positive incl. 25 same-day fresh samples | 400 |
HIV-1 / HIV-2 Panels
| Panel | CTS Reference | Description | n |
|---|---|---|---|
| HIV-1 | Annex III, table 5 | HIV-1 positive | 100 |
| HIV-1 | Annex III, table 3 | HIV-1 positive | 200 |
| HIV-1 | Annex III, table 1, 2 | HIV-1 positive | 400 |
| HIV-1 Ag | Annex III, table 4 | HIV-1 Antigen positive | 50 |
| HIV-2 | Annex III, table 1, 2, 5 | HIV-2 positive | 100 |
Diagnostic Specificity — Blood Donors
| Panel | CTS Reference | n |
|---|---|---|
| Blood Donors | Annex III, V, VI — unselected blood donors | 5,000 |
| Blood Donors | Annex III, V — table 2 | 1,000 |
| Blood Donors | Annex III, V, VI — table 5 | 500 |
| Blood Donors incl. Clinical | Annex VI, table 4 — 480 donors + 20 hospitalised | 500 |
| Blood Donors | Annex III, V, VI — table 4 | 200 |
| Blood Donors | Annex III, V, VI — table 5 | 100 |
| Hospitalised Donors | Annex III, V, VI — table 1, 2, 4 | 200 |
Interference & Cross-Reactivity Panels
| Panel | Description | n |
|---|---|---|
| General Interference Panel | 16 standard interferents for Class D specificity validation | 52 |
| Vaccination Panel | 5 common pathogen vaccinations | 15 |
| Inflammation Panel | 4 inflammatory markers | 12 |
| Hepatitis Panel | 4 serological markers against hepatitis viruses | 12 |
| Herpes Panel | 5 serological markers against herpes viruses | 15 |
| Microbial Pathogen Panel | 5 bacterial and eukaryotic pathogens | 15 |
| Respiratory Pathogen Panel | 4 respiratory pathogens | 12 |
| Cross-reactive incl. pregnant | Annex III, V, VI — cross-reacting specimens | 100 |
| Cross-reactive pregnant | Annex III, V, VI — pregnant donors | 200 |
Self-Test Validation (Lay Use)
Per CTS 2009/108/EC Annex III, V, VI table 6 — for self-test IVDs intended for lay use.
| Panel | CTS Reference | n |
|---|---|---|
| Self-Test Known Positive HBV | Annex VI, table 6 | 200 participants |
| Self-Test Known Positive HCV | Annex V, table 6 | 200 participants |
| Self-Test Known Positive HIV | Annex III, table 6 | 200 participants |
| Self-Test High Risk | Annex III, V, VI, table 6 | 200 participants |
| Self-Test Unknown Status | Annex III, V, VI, table 6 | 400 participants |
| Self-Test Result Interpretation | Annex III, V, VI, table 6 | 100 participants |
Matrix Equivalence Sets
| Set | CTS Reference | Composition |
|---|---|---|
| Matrix Equivalency HBV | Annex I, General Common Specification, part I | 25 positive + 25 negative |
| Matrix Equivalency HCV | Annex I | 25 positive + 25 negative |
| Matrix Equivalency HIV-1 | Annex I | 25 positive + 25 negative |
Documentation Included with Every Panel
Ethics & Consent
IRB / Ethics Board clearance certificate and donor informed consent framework documentation included as standard with every panel.
Diagnostic Confirmation
Confirmed diagnostic test results per individual sample. Standard infectious disease screening (HIV I/II Ab, HBsAg, HCV Ab) on all donors.
IVDR Package (on request)
Extended IVDR documentation package for Class D submission — including ISO 13485 quality certificate, IVDR-specific documentation and regulatory support.
Häufig gestellte Fragen
Are the panels CTS-compliant for IVDR Class D submission?
Yes. Each panel is specifically assembled to meet the requirements of the Common Technical Specifications 2009/108/EC referenced in IVDR 2017/746 for Class D IVDs — HBV, HCV, and HIV. Panels are referenced to the specific Annex and table number of the CTS so you can map them directly to your technical file.
Can you supply fresh samples (same-day collection)?
Yes — specific panels include same-day fresh samples (25 fresh per panel for HBV incl. fresh and HCV incl. fresh). Fresh sample supply requires advance coordination and scheduling — contact us to plan your timeline.
What is the typical lead time for panels?
Quote within 48 hours. Standard panels from stock: 1–3 weeks. Larger panels (>500 samples) or custom compositions: 4–8 weeks depending on availability. Advance coordination is recommended for Class D submission timelines.
Are the panels suitable for self-test (lay use) device validation?
Yes. We supply self-test validation sets per CTS Annex III, V, VI table 6 — covering known positive, high-risk, unknown-status, and result-interpretation cohorts, with the participant numbers required by the CTS for lay-use device validation.
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