ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This clinical study is designed to assess the analytical stability of 25-hydroxyvitamin D [25(OH)D] in human serum and plasma specimens under defined storage conditions using the ALPCO 25(OH) Vitamin D CLIA Kit, a competitive chemiluminescent immunoassay performed on the KleeYa automated platform.
The study consists of two cohorts. Cohort 1 evaluates long-term stability of 25(OH)D in human serum specimens following storage at ultra-low temperatures (-80°C). Approximately 30 donor-derived serum samples representing clinically relevant vitamin D levels (deficient, insufficient, and sufficient) will be tested at baseline and after storage for predefined time points up to six months. The objective of this cohort is to demonstrate equivalence between fresh and frozen specimens following a single freeze-thaw cycle.
Cohort 2 evaluates short-term stability of 25(OH)D in both serum and plasma specimens under multiple temperature conditions (2-8°C, 22°C, 37°C, and -80°C) over a defined period of up to 31 days. Approximately 10 donor-derived specimens will be tested at baseline and at predefined intervals to assess the impact of sample handling and storage conditions relevant to routine laboratory workflows.
Adult participants (≥22 years of age) will provide a single blood sample collected via standard venipuncture. Specimens will be processed, aliquoted, and tested according to protocol-defined procedures. The primary endpoint is the equivalence of 25(OH)D measurements between fresh and stored specimens. Data analysis will include descriptive and comparative statistical methods, including percent difference and mean bias, to evaluate stability across conditions.
This is a minimal-risk study involving no therapeutic intervention. Results are intended to support analytical performance claims, including specimen handling and storage conditions described in the assay Instructions for Use. No clinical benefit to participants is expected, and study results will not be used for medical decision-making.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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New Hampshire
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Salem, New Hampshire, Forente stater, 03079
- ALPCO
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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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.
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Equivalence of 25-hydroxyvitamin D [25(OH)D] measurements between fresh and stored specimens
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CPSP-2025-030
Plan for individuelle deltakerdata (IPD)
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