By InvitationNot Applicable

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

United States80 participantsStarted 2026-04-18

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Equivalence of 25-hydroxyvitamin D [25(OH)D] measurements between fresh and stored specimens

Timeframe: Up to 6 months

Trial details

NCT IDNCT07565064

SponsorAmerican Laboratory Products Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12

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