To build on the internal validation performed by VMRD, our Serum Amyloid A (SAA) test was independently evaluated by at the University of California-Davis. Blood samples were collected from horses with acute inflammation, and results were compared between sample types (blood and EDTA plasma) and to results from a reference assay. Assay linearity, repeatability, and reproducibility were also assessed. Full data will be included in a research manuscript that has been submitted for publication in a peer-reviewed journal, which will represent the first published validation of a point-of-care SAA test using whole blood. Findings of this study support the product performance claims of consistent clinical accuracy across the SAA concentration range of <20 to 3000 mg/mL with both blood and plasma, using recommended dilutions.
Evaluation of test precision revealed appropriate coefficients of variation ranging between 7.8-13.3% for repeatability (multiple tests performed on one day) and 5.7-12.0% for reproducibility (multiple tests performed on consecutive days), showing the consistency of results obtained with this test.
The SAA kit comes with the appropriate components and instructions for performing tests with either fresh or anticoagulated blood. Serum or plasma can also be used but require a different sample dilution. If interested in using plasma or serum, please contact VMRD for an appropriate protocol.
Additional studies are ongoing to further expand the capabilities of this assay – stay tuned for further updates!