What this study is
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.
What's being tested
- ALPCO 25(OH) Vitamin D CLIA Kit
Intervention · 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
- Sponsor
- American Laboratory Products Company
- Conditions
- Vitamin D Deficiency · Vitamin D Insufficiency · Healthy Volunteers
- Enrolling
- 80 people
- Starts
- 2026-04-18
- Est. completion
- 2026-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openALPCO
Salem, New Hampshire, United States
Study team
Sponsor
American Laboratory Products Company
Study ID CPSP-2025-030
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.