Laboratory Director EMED / Advanced Pain Management Clinic JACKSONVILLE, FL, United States
Overview:
1. Current zinc-status tests have critical limitations 2. Experts agree that there is a need for a specific, sensitive and field-friendly zinc biomarker 3. Validity Diagnostics (VDx) developed and validated the RRAPA zinc status test to meet the need 4. VDx RRAPA is a dual reagent system which can be used on automated clinical analyzer platforms with open channels 5. Approximately 300 patient urine samples were tested and the results show two distinct groups – “normal” zinc tissue levels and deficient zinc tissue levels
Introduction:
In light of COVID-19, zinc has become more well known as a vital nutrient for humans. Currently, zinc deficiency is known to be very common in the elderly and in developing countries. The United States Health and Human Services reports that plasma zinc levels are ineffective in detecting zinc deficiency due to the human body’s mechanisms to maintain homeostasis of blood plasma zinc. Scientific research on various aspects of disease caused by zinc deficiency has been hampered due to the absence of a reliable test for tissue zinc status. There is a need to find a reliable biomarker for zinc deficiency which can be used in mass screening.
Methods:
VDx Reagents: Test A R1 contains an amp buffered solution at pH 10.4 and 0.625 mmolar of zinc Test B R2 contains the Test A R1 materials except for the exclusion of zinc Test A and B R2 reagents contain a chromogen V-ZDEF Control set
Results:
The VDx assay uses two paired tests to automatically determine the Relative Activity of renal alkaline phosphatase (ALP), in contrast to the determination of the amount of ALP. An internal standard “A Test” (with optimal zinc) producing full activity of the renal ALP is compared to the “B Test” (zinc-free reagent) which gives the native activity of the renal ALP. The percent activity of the B Test native renal ALP to the optimally zinc activated A Test reflects the status of renal tissue zinc.
Conclusions:
Mass screening with a reliable and effective tissue-zinc deficiency test is needed to detect persons at high risk of complications or death due to a viral infection (e.g., COVID-19). A safe and effective treatment for zinc deficiency has been proposed with the use of eye vitamins and mineral supplements which are commonly used for the treatment of macular degeneration. However, there is no reliable test for zinc deficiency at the tissue level. The Validity Diagnostics RRAPA zinc status test was developed and validated to fill this void and can be easily automated on many clinical open-channel instruments. The chemistry of the test and the interpretation of the test results will be discussed and will be presented in the poster.
