sTLR2 RAPID Assay Performance & Validation

sTLR2 RAPID - Summary Analytical Performance Characteristics

Analytical Sensitivity: The limit of detection (LoD) for the sTLR2 RAPID Test is 500 pg/mL.

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.

Clinical Validation of sTLR2 as a biomarker of sepsis: An independent 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.

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.

Further information can be found in the current version of the IMIWN sTLR2 RAPID instructions for use.