sTLR2 RAPID Assay Performance & Validation
sTLR2 RAPID Test - Assay Performance and Validation
The IMIWN sTLR2 RAPID Test has undergone rigorous analytical validation to ensure its reliability, precision, and accuracy for the measurement of human soluble Toll-like Receptor 2 (sTLR2).
Summary Analytical Performance Characteristics
Analytical Sensitivity: The limit of detection (LoD) for the sTLR2 RAPID Test is 500 pg/mL, enabling the detection of physiologically relevant concentrations of sTLR2.
Specificity: The assay demonstrates high specificity for human sTLR2, utilising our proprietary monoclonal antibodies. Further, independent studies utilising Western Blotting of a pair of proprietary monoclonal antibodies used in the sTLR2 RAPID assay, against human soluble TLR2 derived from cell culture membrane extracts of THP-1 cells, showed binding to a band approximately 100kDa in size on SDS PAGE.
Precision (Reproducibility): No significant difference was found in the classification of samples within a single assay run.
Inter-assay precision: No significant difference was found in the classification of samples between different assay runs and lots.
Interference Studies: Studies have been conducted to assess potential interference from common endogenous substances including haemolysis, bilirubin and lipaemia.
Clinical Validation of sTLR2: A study of the use of sTLR2 versus CRP in critically ill patients showed that sTLR2 has better specificity and sensitivity for sepsis than CRP, the most commonly used marker in the ICU (AUC sTLR2 0.959; CRP 0.764). Further, sTLR2 levels below 1 ng/mL had good ability to rule out sepsis, whether it was secondary to bacterial or fungal infection within the first 12 h of ICU stay, when clinical parameters and traditional markers of infection are often equivocal. The analytical performance of the sTLR2 RAPID Test is further supported by ongoing clinical validation studies that correlate sTLR2 levels with patient outcomes and immunological states in sepsis and inflammatory cohorts.
Quality Assurance: Our research & development and manufacturing facility based in North Wales, operates under a fully certified, independently audited, ISO13485:2016 medical device quality management system. The sTLR2 RAPID test is UKCA certified for clinical use in Great Britain, and registered with MHRA.
Comprehensive technical documentation, detailing the full validation report and performance specifications, is available upon request for scientific and clinical review.
Further information can be found in the current version of the IMIWN sTLR2 RAPID instructions for use.