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Looking for specialist controls, customised calibrators or validation materials?
🔬 ADAMTS13 ACTIVITY — LOW-LEVEL CONTROL
ADAMTS13 activity testing can be critical in the investigation of suspected TTP. For laboratories making clinically important decisions from low ADAMTS13 activity results, the choice of IQC material matters.
ISO 15189:2022 — 7.3.7.2
ISO 15189:2022 requires laboratories to select IQC material that is fit for its intended purpose and provides a clinically relevant challenge to the examination method.
Importantly, the standard states that IQC material should have concentration levels at or near clinical decision limits, where possible.
ISOCHECKS LOW-LEVEL ADAMTS13 CONTROL
Designed to support laboratories in challenging and monitoring assay performance at low ADAMTS13 activity levels relevant to clinical interpretation.
✓ Clinically relevant low-level challenge
✓ Supports ongoing IQC
✓ Precision & reproducibility monitoring
✓ Method verification & validation
✓ Lot-to-lot performance monitoring
✓ Assay & analyser evaluation
✓ UKAS-focused quality systems
ADAMTS13 IgG Antibody Control Mid-Range Control for Clinically Relevant Assay Performance
Challenge your assay. Strengthen confidence in your results.
ISOCHECKS PRODUCTS is developing a specialist mid-range ADAMTS13 IgG antibody control, targeting an antibody concentration of 30–40 U/mL, subject to product characterisation and confirmation of the assigned value.
Why a Mid-Range Control?
Negative and high-positive controls alone may not fully demonstrate assay performance across the measurement range.
A mid-range antibody control can help laboratories assess:
- Quantitative assay performance at an intermediate antibody concentration.
- Analytical precision and reproducibility across runs, operators and testing days.
- Performance across the measurement range, complementing negative and high-positive controls.
- Validation and verification evidence for specialist ADAMTS13 antibody assays.
- Ongoing quality assurance for laboratories investigating immune-mediated thrombotic thrombocytopenic purpura (iTTP).
A multi-laboratory standardised ADAMTS13 antibody calibrator for Bethesda-based and ELISA methods.
ISOCHECKS PRODUCTS ADAMTS13 Antibody Calibrator is a specialist calibration material developed to support the evaluation and standardisation of ADAMTS13 antibody testing.
Featuring both inhibitory and non-inhibitory ADAMTS13 antibodies, the material has undergone potency assessment using Bethesda-based methods and ELISA, with standardisation through multi-laboratory evaluation.
One Calibrator. Multiple Analytical Perspectives.
- Dual-method characterisation — potency assessed using Bethesda-based inhibitor methods and ELISA.
- Inhibitory and non-inhibitory antibodies — supports evaluation of distinct antibody characteristics relevant to assay performance.
- Multi-laboratory standardisation — supports improved consistency and comparability across participating laboratories.
- Assay calibration and evaluation — helps laboratories assess method performance and investigate differences between analytical approaches.
- Validation and verification support — contributes to documented analytical performance assessment and ongoing quality assurance.
Supporting consistency in ADAMTS13 antibody measurement across analytical methods.
Specialist materials. Tailored solutions. Laboratory-focused innovation.
Not every laboratory challenge can be solved with an off-the-shelf product.
ISOCHECKS develops customised haemostasis products and specialist testing materials designed around the needs of clinical laboratories, diagnostic manufacturers and research partners.
From disease-specific controls to bespoke validation materials, we help address testing challenges where standard commercial products may not provide the required concentration, clinical range or analytical characteristics.
Our bespoke solutions include:
- Specialist coagulation and platelet function controls
- ADAMTS13 activity and antibody control materials
- Disease-specific and clinically relevant sample panels
- Customised calibrators and reference materials
- Assay development, verification and validation support
- Bespoke materials for analyser evaluation and multi-site harmonisation
Your challenge. Our expertise. A solution developed around your requirements.
featured Innovative Solutions for Tomorrow's Challenges
Validation solutions
Don't have enough suitable clinical samples ?
This can be a major practical bottleneck.
A laboratory might know exactly what study it needs to perform but struggle to obtain enough representative samples covering:
- normal ranges
- pathological ranges
- low/high concentrations
- positive/negative populations
- rare conditions
- clinically relevant subgroups
Need clinical samples for your validation study?
We can support the design and execution of validation programmes using appropriately selected clinical samples.