Abstract
To best understand the use of dried blood spots (DBS) in clinical chemistry, we must first differentiate laboratory screening from diagnostics. Newborn screening (NBS) utilizes DBS to detect and quantify biomarkers indicative of more than 50 congenital diseases primarily of metabolic origin [1]. Many different methods are used, including modern analytical technologies such as tandem mass spectrometry (MS/MS) [2, 3] and molecular analyses [4, 5]. Each method is designed specifically to analyze DBS specimens with laboratory protocols and systems that begin with a paper hole puncher rather than a pipette. Unfortunately, NBS is often differentiated from clinical chemistry because it is “screening” tool rather than a “diagnostic” application. This is a common misconception because no method is diagnostic, but rather leads to a physician diagnosis that is based, in part, on laboratory results. Like any clinical test, NBS results take into consideration additional data such as age of newborn, birth weight, gestational age, and nutritional status [6–8]. Additionally, NBS is regulated by a comprehensive quality assurance/quality control (QA/QC) network that is shared worldwide [9]. There are a small number of traditional clinical laboratories that use DBS in a diagnostic setting, primarily in specialized metabolic applications, further supporting that DBS utilization is not restricted to “screening” laboratories, nor does it involve relaxed laboratory standards. The question is: why are DBS not used to a greater extent in traditional clinical laboratories? It is likely due to the analytical challenges and common misperceptions of the DBS. Specifically, the challenges of DBS implementation such as cross-validation of a DBS assay from a liquid sample analysis, logistical systems limitations for handling DBS versus liquid samples, and clinical laboratory bias towards single metabolite analysis versus metabolic profiles.
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