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Testing with Compliance and Confidence
Products and consultancy to meet clinical and ISO 15189 regulatory needs for rare disorders and in-house procedures.
Focus on IQC
IQC Standards 7.3.7.2
The structure and content of ISO 15189:2022 have been revised.
For IQC Standards 7.3.7.2 focus is on specifications based on the intended clinical application of the examination.
Key Change
The IQC section has been expanded from three subclauses to seven (a-g) where ‘a’ is defined as:
- a1) The intended clinical application of the examination should be considered, as the performance specifications for the same measurand can differ in different clinical settings.
IQC Design requirements
When designing an appropriate QC strategy several risk factors need to be taken into consideration:
- high-risk tests with a large impact on the wrong result
- tests used to support the clinician’s decision in isolation
- tests acted upon immediately
Remember, IQC is not just about compliance; it is about managing quality effectively. Implementing IQC in a medical laboratory is essential to ensure accurate and reliable test results.
How to select IQC materials? To be fit for purpose!
- Stability concerning properties of interest.
- Matrix as close as possible to the examination method & as close as possible to the patient sample.
- Concentration levels at/near the clinical decision limits and, when possible, covering the measurement range.
Third-party quality control materials
Manufactured outside the quality system specifications based on the intended clinical application of the examination.to monitor.
They are designed to deliver an unbiased and independent assessment of performance with any instrument or method, enabling laboratories to gain accreditation and ensure optimum performance and accuracy in clinical laboratory.
Become Compliant
Embed Third party controls in clinical testing to cover critical decision points to avoid testing accreditation noncompliance
Innovative Solutions for Tomorrow's Challenges
ISO15189 Accreditation solutions
We provides from consultancy through to tailored solutions to ensure your laboratory meets the necessary standards and regulations to fulfil the requirements of ISO 15198,2022.
Enlist a specialist to take the hassle of the ISO 15189 accreditation process of any equipment or processes you require!
Training and Development
- Introductory Haemostasis Training for Scientists and Junior Doctors.
- Quality assurances.
- Assay development & Advance haemostasias
- Blood Morphology
- Assay limitations, Diagnosis pathways and much more tailored for the individual or the organization.
3rd Party Controls
Provide assurances with our confirmatory ISO-Checks
control specific for diagnosis and monitoring for rare disorders.
- Lupus anticoagulant controls specific for the Taipen Venom test.
- Clinically Coagulation Factor deficiencies controls- levels below 15%.
- Diagnostic controls for TTP diagnosis, method specific (FRET, ELISA or CLIA ).
- Controls levels for caplacizumab cessation decision points (levels of ADAMTS13 antigen and activity levels of 25 -30%).
- ADAMTS13 IgG antibodies controls to monitor Rituximab efficacy.
- Vaccine (like) induced Thrombocytopenia (VITT) controls. Specific to detect pathological anti-PF4 antibodies.
Validation solutions
Premade validations sample packs delivered to conduct location evaluations of your procedure /instrument
- Normal Serum or plasma for normal ranges establishment
- Pathological samples for method comparison studies
- Spiked samples to evaluate treatment efficacy of methods
- Samples with inference substances to evaluate assay limitations
ADAMTS13 assays implementation
Set up testing for ADAMTS13 activity, antigen, open/close, IgG antibody and functional antibody assays for both clinical and research use.
Assays will be set up for direct user applications, accurately monitor patients on any Standard Of Care (SOC) or research therapeutics.
Antiplatelet drug responses & platelet activation evaluation
The inability to prevent ischemic stroke or major vascular events despite optimal use of anti-platelet medications is multi-factorial hence we evaluate using a multiple marker model for a tailor made assessment for the individual.