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

NCT07565064 | Enrolling By Invitation FDA Device

• 1 other identifier: CPSP-2025-030
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency; Healthy Volunteers

Keywords

25-hydroxyvitamin D; 25(OH)D; Vitamin D; Serum Stability; Plasma Stability; Specimen Storage; Freeze-Thaw Stability; Biomarker Stability; Chemiluminescent Immunoassay; CLIA Assay; Laboratory Diagnostics; Pre-analytical Variables; Sample Handling; Analytical Performance

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 6 months

Study Arms (2)

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.

Device: ALPCO 25(OH) Vitamin D CLIA Kit

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.

Device: ALPCO 25(OH) Vitamin D CLIA Kit

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.

Cohort 1 - Long-Term Frozen Stability; Cohort 2 - Short-Term Stability

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult volunteers from the general population, aged 22 years and older, who are able and willing to provide a blood sample. Participants are expected to represent a range of 25-hydroxyvitamin D \[25(OH)D\] levels, including deficient, insufficient, and sufficient concentrations. Subjects will be enrolled at clinical collection sites in the United States and will undergo a single blood draw for specimen collection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Laboratory Products Company: lead

Study Sites (1)

ALPCO

Salem, New Hampshire, 03079, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)