American Laboratory Products Company
This study evaluates the stability of 25-hydroxyvitamin D \[25(OH)D\] measurements in human serum and plasma using the ALPCO 25(OH) Vitamin D CLIA Kit. The study compares results obtained from fresh specimens with those obtained after storage under various temperature and time conditions, including long-term frozen storage and short-term handling scenarios. The objective is to demonstrate that specimen storage conditions do not result in clinically meaningful differences in measured 25(OH)D concentrations, supporting the use of fresh and previously stored samples in laboratory testing.
This clinical study is designed to assess the analytical stability of 25-hydroxyvitamin D \[25(OH)D\] in human serum and plasma specimens under defined storage conditions using the ALPCO 25(OH) Vitamin D CLIA Kit, a competitive chemiluminescent immunoassay performed on the KleeYa automated platform. The study consists of two cohorts. Cohort 1 evaluates long-term stability of 25(OH)D in human serum specimens following storage at ultra-low temperatures (-80°C). Approximately 30 donor-derived serum samples representing clinically relevant vitamin D levels (deficient, insufficient, and sufficient…
Inclusion Criteria: * Male or female adults 22 years of age or older * Able and willing to provide a blood sample in accordance with the protocol * Able to understand the study requirements and provide written informed consent Exclusion Criteria: * Unable or unwilling to provide a blood sample * Current participation in another investigational study that may interfere with study results * Any condition that, in the opinion of the investigator, would preclude safe participation or compromise the integrity of the study
An in vitro diagnostic chemiluminescent immunoassay used for the quantitative measurement of 25-hydroxyvitamin D \[25(OH)D\] in human serum and plasma specimens. The device is used for analytical testing only and not for clinical decision-making.
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