Human IVD Quality Controls & Standard Materials
Native human-origin quality controls for internal laboratory quality control (IQC), external quality assurance (EQA) and proficiency testing — produced from native human biomaterial with no additives, maximising commutability with patient samples across different assay platforms.
CE-Certified Controls — In.QualiCheck
| Control | Matrix | Levels | CE-IVD |
|---|---|---|---|
| Calprotectin Control (In.QualiCheck) | Faeces | Level 1, 2, 3 | ✅ |
| Prostate Specific Antigen — PSA (In.QualiCheck) | Serum | Single level | ✅ |
Controls by Diagnostic Area
Autoimmunity
Anti-ENA, ANA, APS, autoimmune dermatosis, endocrinopathy, diabetes mellitus, celiac, hepatopathy, myasthenia gravis, paraneoplastic neuropathy, peripheral neuropathy, rheumatoid arthritis, vasculitis & glomerulonephritis
Infectiology
CMV PCR, enterovirus faeces PCR, HAV Ab, HEV Ab, HHV-6 PCR, HPV 18 PCR, measles/mumps/rubella/rabies PCR, rotavirus faeces PCR, VZV PCR
Endocrinology
Adrenal & pituitary gland, aldosterone, bone metabolism, calcium metabolism, cortisol salivary, fertility hormones, hematopoietic growth factors, thyroid autoantibodies & hormones, virilization
Gastroenterology & Special
Calprotectin & elastase faecal, H. pylori antigen faecal, haemoglobin-haptoglobin complex, occult blood faecal, CSF standard profile, urine standard profile
Immunology
Gammopathies, IgG subclasses, immunophenotyping (whole blood), interferon gamma release, CRP/PCT/SAA inflammatory markers
Allergy & Alcohol/Drugs
Inhalation, insects, nutrition allergy — CDT, EtG, PEth — antibiotics, cytostatics, cardiac glycosides, antiepileptics, immunosuppressants (EDTA plasma)
Custom Individual Quality Controls
To Your Specification
Individual quality controls produced to your detailed specification — for internal laboratory performance monitoring, proficiency testing, or as the basis for your own IVD quality control product. Specify analyte, target concentration range, matrix, volume, and stability requirements.
CE-IVD Marking Available
Production of CE-IVD certified controls to your specification is available — from the same ISO 13485 and ISO 9001 certified quality system. Contact us to discuss your project requirements and timelines.
Why native human material matters
Controls produced from native human biomaterial with no additives behave consistently across different analytical platforms — unlike reconstituted lyophilised or spiked controls, which can show matrix effects that differ between immunoassay platforms. This makes native human QC materials the preferred choice for multi-platform EQA programmes and cross-platform validation studies.
Frequently Asked Questions
Are the controls commutable across different analyser platforms?
Native human material controls have excellent commutability because they behave like real patient samples. This is a key advantage over reconstituted or spiked controls, which can show platform-specific matrix effects. For multi-platform EQA and cross-platform validation, native human controls are the recommended format.
What infectious disease screening is performed on control donors?
All control donors are screened for HIV I/II Ab, HBsAg and HCV Ab and confirmed negative/non-reactive — unless the control is specifically designed to be positive for these markers. All testing is performed using CE-certified IVD test systems.
Can controls be produced in larger volumes for multi-year programmes?
Yes — large-volume production for multi-year programmes is available. Batch reservation with free storage up to two years ensures consistency across your programme duration. Contact us to discuss volume requirements and storage arrangements.
Related Products
Request Quality Controls — Quote
CE-certified In.QualiCheck controls or custom production to your specification — 48-hour quote turnaround.
For research use only unless stated otherwise.
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