Disease State Serum Panels
Human serum and plasma from confirmed-positive donors — for IVD assay development, cross-reactivity testing, calibrator production and quality control. Native human biomaterial with no additives, collected under IRB-cleared ethical framework with full donor documentation.
Autoimmune Diseases
For cross-reactivity testing, assay development and QC. Available as single donations (Serum OTC or Citrate Plasma) and pools.
Connective Tissue & Joint
ANA, anti-CCP, Rheumatoid Factor (IgA/IgG/IgM), dsDNA, SS-A, SS-B, Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, Cardiolipin IgA/IgG/IgM, Beta-2-Glycoprotein, U1RNP
Liver & GI
AMA-M2, Primary Biliary Cholangitis (PBC), Autoimmune Hepatitis, Celiac Disease, Crohn's Disease, Ulcerative Colitis — including faecal material
Neurological & Vasculitis
Multiple Sclerosis, Myasthenia gravis, MPO Antibodies, PR3 Antibodies, ADAMTS-13, Pernicious Anemia — Citrate Plasma, 450–850 mL
Infectious Diseases
Viral
CMV, EBV, FSME, HBV (HBsAg, Anti-HBc), HCV, HEV (IgM + PCR), HSV-1/2, HIV-1/2, Influenza A/B, Measles, VZV, Yellow Fever — Citrate Plasma
Bacterial
Bordetella pertussis, Campylobacter, Chlamydia pneumoniae & trachomatis, Helicobacter pylori, Mycoplasma pneumoniae, Syphilis (Treponema pallidum)
Parasitic & Fungal
Malaria (Ab + Ag), Toxoplasma gondii (IgA/IgG/IgM), Echinococcus, Schistosoma, Toxocara canis, Leishmania, Candida — Citrate Plasma
Thyroid Diseases
| Analyte / Condition | Matrix | Levels available |
|---|---|---|
| Anti-TPO | Serum OTC / Citrate Plasma | Positive / High positive / Negative |
| Anti-Tg | Serum OTC / Citrate Plasma | Positive / High positive / Negative |
| TRAb | Serum OTC / Citrate Plasma | Positive / High positive / Negative |
| TSH | Serum OTC | Decreased / Increased |
| fT4 / fT3 / tT4 / tT3 | Serum OTC | Decreased / Increased |
| Graves' Disease / Hashimoto's | Serum OTC | Confirmed diagnosis |
| Hyper/Hypothyroidism | Serum OTC | Confirmed diagnosis |
| Anti-TPO Pool 1L / TRAb Pool 1L | Citrate Plasma / Serum (Pool) | 1 L pool |
Allergy — Specific IgE
Total IgE and specific IgE for 30+ allergens — inhalation, food, insect venom, occupational.
Inhalation & Environmental
House dust mite (D. pteronyssinus, rDer p1, rDer p2), cat dander, dog lipocalin (rCan f1/2), silver birch (Bet v1), timothy grass, bermuda grass, ragweed, alternaria
Food Allergy
Peanut (Ara h2), hazel nut, sesame, wheat, cow's milk, shrimp, fish (cod), peach (Pru p3)
Insect Venom & Other
Bee venom, common wasp venom, Vespula, latex — plus total IgE positive/high positive/very high positive
Diabetes, Inflammation, Oncology & Drugs of Abuse
| Category | Analytes | Matrix |
|---|---|---|
| Diabetes | Type I/II (Serum + Urine), GAD65, IAA, ICA, ZnT8 Antibodies | Serum OTC / Urine |
| Inflammation | CRP (pos/high), Procalcitonin (PCT), Calprotectin, SAA | Serum / Citrate Plasma |
| Oncology | PSA, fPSA, CA 15-3, CA 125, CA 19-9, CEA, AFP, NSE — Breast, Colon, Lung, Liver Cancer | Serum OTC |
| Drugs of Abuse | CDT (pos/high/very high), EtG, PEth, Amphetamine, Benzodiazepines, Cocaine, Fentanyl, Opiates, THC, Tramadol | Serum / Urine |
Häufig gestellte Fragen
Are the materials available at specific titres?
Availability at specific titres depends on the analyte. For most autoimmune and thyroid markers, we can provide positive, high positive and negative levels. For infectious disease markers, specific viral load ranges are available for some analytes. Contact us with your titre requirement and we confirm availability within 48 hours.
Can I get consecutive donations from the same donor?
Yes — consecutive donations from the same donor are available for longitudinal studies or for applications requiring the same donor matrix across a series of samples. This is available for most disease categories. Lead time varies — contact us to plan your project.
Are the materials suitable for IVDR cross-reactivity testing?
Yes — the disease state materials are specifically used for cross-reactivity and interference testing in IVD regulatory submissions under IVDR 2017/746. They are native human biomaterial with confirmed diagnostic results, making them directly suitable for cross-reactivity panels required in performance evaluation studies.
Ähnliche Produkte
IVDR Class D Sample Sets
HBV, HCV, HIV compliance panels per CTS 2009/108/EC — for Class D IVD submissions.
Quality Controls & Standards
Native human-origin IQC and EQA controls for laboratory quality management.
What is Disease State Serum?
Definition, applications and when you need it for IVD development.
Fertility & Pregnancy Materials
hCG, AMH, FSH, LH, trimester pools — for IVD assay development.
Request Disease State Serum — Quote
Tell us the analyte, titre range, matrix and volume — we respond within 48 hours with availability and pricing.
For research use only unless stated otherwise.
