ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study

NCT07565064 · tracked via the Priya Life Science USA tracker

Sponsor

American Laboratory Products Company

Phase

Observational

Started

2026-04-18

Last updated

2026-05-04

Condition(s) studied

Vitamin D DeficiencyVitamin D InsufficiencyHealthy Volunteers

Investigational drug(s) / intervention(s)

ALPCO 25(OH) Vitamin D CLIA Kit

ALPCO 25(OH) Vitamin D CLIA Kit: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Equivalence of 25-hydroxyvitamin D [25(OH)D] measurements between fresh and stored specimens — Up to 6 months
Assessment of agreement between 25(OH)D concentrations measured in fresh serum and plasma specimens and those measured after storage under predefined temperature and time conditions, using the ALPCO 25(OH) Vitamin D CLIA Kit. Stability will be evaluated using percent difference, mean bias, and variability across time points.

Trial sites (1)

Facility	City	Region	Status
ALPCO	Salem	New Hampshire

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07565064 on ClinicalTrials.gov ↗ ← All trials in the USA