Blood Specimen Collection For Laboratory Assay Research
brief summary
To collect lab data from capillary and venous blood specimens for use in analytical research studies to support the development and validation of laboratory procedures.
detailed description
Introduction Overview Remote health monitoring is becoming more commonplace in traditional and non-traditional medical practices, including for the analysis of blood. As venipuncture processes may cause distress and lead to lower patient compliance, the ability to collect blood through capillary samples is becoming increasingly popular due to patient demand and the limited availability of phlebotomists. With recent advances in lab instrumentation, the ability to analyze small volumes of blood to support the diagnostic process is gradually becoming more established.
Despite the development of several novel devices to collect capillary samples, limited data is available on the stability of such samples across various environmental conditions and lengths of time. In addition, there continues to be a need to compare the correlation between lab results obtained from capillary samples, as compared to venous samples, which is the gold standard. The aim of this study is to collect capillary (fingerstick) blood samples and under various circumstances, assess their viability for broad-based consumer lab testing.
Background Traditionally, clinical lab results have been limited to data collected from select sites that have phlebotomists on-site. While valuable, these diagnostic services are only available to individuals who live close enough to a lab, thereby limiting our understanding of disease within the broader community. Lab visits are limited to very specific episodes of care, which exclude the ability to remotely monitor the progression of disease. In addition, these limited lab visits usually only study a small set of assays within each individual, biasing our understanding of any other underlying medical conditions that exist within a population. The need to develop technology to make diagnostic services more accessible is paramount to not only better treat acute and chronic diseases, but to also support behavioral change toward the prevention of disease.
At-home blood collection for lab testing has become increasingly popular to monitor disease and access treatments more rapidly. The ability to broaden access to diagnostic testing, especially in healthcare deserts, is valuable to mitigating the progression of disease. For example, clinicians will have access to a higher volume of lab data and be able to identify disease patterns more readily, which may lead to quicker intervention. On a population health level, improved access to diagnostics will provide insights into patient behavior and underlying disease states that may otherwise not be observed.
Empowering patients to collect their own samples will provide a longitudinal view of disease, and enable deeper discussions with their clinicians regarding appropriate treatment and lifestyle changes.