ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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New Hampshire
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Salem, New Hampshire, Estados Unidos, 03079
- ALPCO
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Equivalence of 25-hydroxyvitamin D [25(OH)D] measurements between fresh and stored specimens
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CPSP-2025-030
Plano para dados de participantes individuais (IPD)
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