The use of dried blood analysis was already described in 1913 for the estimation of blood glucose concentration.
The most prominent use of dried blood samples for clinical laboratory purposes dates back to the early sixties when Dr. Robert Guthrie developed an assay for the detection of phenylketonuria.
Guthrie’s application for collecting blood on filter paper led to the population screening of newborns for the detection of inherited metabolic diseases.
Today, collection of blood onto a solid matrix has become an important screening tool for a number of common medical conditions.
Lab Me’s core partner labs have been actively involved in the development and adaptation of traditional laboratory tests to be performed using dried capillary blood samples on a solid matrix.
The collection of capillary blood for laboratory testing has significant advantages over traditional venipuncture; it is simple to perform, requires minimal training, and does not involve the risks associated with the use and disposal of needles and syringes.
A dried blood sample also represents a low infectious hazard as many viral pathogens lose infectivity owing to disruption of their envelope upon drying.
Risks associated with shipping are also minimized as these samples cannot leak or be broken while in transit, and there is no special requirement for transportation.
This new technology, depicted in figure 1, simultaneously removes the cellular components in blood while the sample is applied to the solid matrix, allowing the use of serum portion for analysis.
Therefore, this new approach is a true alternative collection method similar to an SST tube, where red cells are separated from the serum without the need of a centrifuge.
This enables the laboratory to perform serum-based tests without red cell contamination, and the results are equivalent to those obtained using conventional methods as shown in figure 2.
Laboratories are required to perform analytic validation of clinically relevant performance specifications of each method used. All laboratories must establish accuracy, precision, analytical sensitivity, analytical specificity, interferences, and reportable range as applicable.
The validation of a new analytical method is primarily concerned with the identification of the sources of potential errors, and quantification of the potential errors in the method. Lab Me’s accredited laboratories have followed all the necessary steps to document the performance specifications of every test currently available to health awareness participants and physician clients.
These documents are routinely evaluated by the certifying agency during on-site inspections and compliance is necessary to maintain accreditation. We have also made available to clients a validation summary for each laboratory test in the form of technical bulletins for quick review by clients and other users of Lab Me’s services.