Vidan Diagnostics Introduces Patient Samples to Validate Beta-Hydroxbutyrate Assay

SAN ANTONIO, Texas, October 27, 2021 - Vidan Diagnostics, LLC today announced the availability of it’s beta-hydroxybutyrate validation samples for customers interested in evaluating Vidan Diagnostics’ Next Generation β-Hydroxybutyrate 21FS Reagent.

Beta-hydroxybutyrate Validation Patient Samples

CLIA (42 CFR 493.1253) and CAP (GEN 42020-42163) require that laboratories validate the performance of tests before reporting patient results. The performance characteristics that must be established include accuracy, precision, reportable range, reference interval, analytical sensitivity, and analytical specificity. Select samples with high, middle and low quantitative results should be used to validate the performance of the assay. Vidan’s validation samples can be used by customers validating β-Hydroxybutyrate 21FS Reagent. “Providing our customers with validation samples will allow our customers to quickly evaluate our beta-hydroxybutyrate assay,” said Gilbert Mejia, CEO of Vidan Diagnostics. “Our customers no longer have to wait to collect patient samples across the linear range of our assay to to complete their validation. Our validation samples include a range of high, medium, and low values,” added Mejia.

Beta-Hydroxybutyrate

Beta-hydroxybutyrate is the predominate ketone body produced during Diabetic Ketoacidosis, (DKA) It’s relative proportion in the blood, (78%) is greater than the other two ketones, acetoacetate, (20%) and acetone, (2%) and is therefore the best indicator of DKA. DKA is a serious condition that can lead to diabetic coma or even death.

Founded in 2018, Vidan Diagnostics LLC is a supplier of medical diagnostic products. It is focused on medical devices and reagents used for diagnosing and monitoring patients with conditions of diabetes, sepsis, anemia, heart disease and stroke. Vidan Diagnostics is dedicated to delivering proven and innovative products to all people in all places, in all aspects and stages of life with integrity and reliability. The company is headquartered in San Antonio, Texas.