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

Part of paid clinical trials in Salem, New Hampshire.

Sponsor
American Laboratory Products Company
Study ID
NCT07565064
Status
Enrolling By Invitation

Conditions

  • Healthy Volunteers
  • Vitamin D Deficiency
  • Vitamin D Insufficiency

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ALPCO 25(OH) Vitamin D CLIA Kit — DEVICE
    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 Details

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.

Key Dates

Start date
Apr 18, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Cohort 1 - Long-Term Frozen Stability
    Serum specimens derived from adult donors will be evaluated for long-term stability of 25(OH) vitamin D following storage at -80°C. Samples will be tested at baseline and after predefined storage intervals up to 6 months.
  • Arm: Cohort 2 - Short-Term Stability
    Serum and plasma specimens derived from adult donors will be evaluated for short-term stability of 25(OH) vitamin D under multiple storage conditions (2-8°C, 22°C, 37°C, and -80°C) over a defined study period.

Primary Outcome Measure

Equivalence of 25-hydroxyvitamin D [25(OH)D] measurements between fresh and stored specimens [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
ALPCOSalemNew Hampshire03079-

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By research site
ALPCO· Salem, NH

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