New study recommends switch to volumetric DBS sampling devices to ensure accuracy of PKU monitoring
Capitainer’s qDBS card comes out top in devices evaluated for performance and ease of integration
Stockholm, September 6, 2022: Swedish medtech start-up Capitainer today announced that its qDBS card has scored highly in a major new study published in Clinica Chimica Acta on the advantages of volumetric microsampling DBS devices in monitoring of patients with phenylketonuria (PKU). The study was necessary according to the authors, because although measurement of dried blood spot phenylalanine (Phe) is central to the monitoring of PKU patients today, the volume and hematocrit (hct) of the blood applied to conventional DBS cards fluctuates and significantly affects analytical results. The study reported that performance of Capitainer’s card with qDBS technology was superior compared to the existing solutions. It also noted that its ease of use facilitates its rapid introduction into existing workflows in newborn screening/metabolic testing laboratories.
“During a laboratory evaluation the Capitainer device was demonstrated to be superior in both accuracy and precision compared to the conventional bloodspot filter paper collection device, both of which will be advantageous for monitoring patients with phenylketonuria” says Dr. Rachel Carling, Lead author, Director of Newborn Screening & Clinical Lead, Biochemical Sciences, Viapath, Guys & St Thomas’ Hospital.
Christopher Aulin, CEO added: “We are delighted with the results of this important study which we believe demonstrates conclusively the superiority of Capitainer’s solution over conventional cards and competition. The analytical quality together with the ease of implementation and readily available equipment to reduce manual steps in the lab, clearly shows the strength of the solution Capitainer has developed. The results of the trial should also have an impact in field of DBS analysis and self-sampling in general since many of the conclusions can be extrapolated into other areas.
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Link to full paper here:
https://www.sciencedirect.com/science/article/pii/S0009898122012566
For more information visit www.capitainer.se
Contacts
Christopher Aulin, CEO t: +46 708 977 577 e:aulin@capitainer.se
Media
Richard Hayhurst/Ola Bjorkman
Notes to editors
About PKU testing
Since the 1960s, the use of dried blood spot (DBS) technology for newborn screening (NBS) and monitoring of patients with inherited metabolic disorders (IMDs) has become routine in most parts of the world. NBS is typically carried out during the first hours or days of a newborn’s life using a few drops of blood collected from the heel – the so-called heel prick test – and/or a urine sample. Phenylketonuria (PKU) is a rare but potentially fatal metabolic disorder that is characterised by a deficiency or complete absence of the phenylalanine hydroxylase (PAH) enzyme. PAH is responsible for processing the amino acid phenylalanine into tyrosine, and without sufficient PAH activity, phenylalanine accumulates and becomes toxic to the brain.
PKU can be treated by a strict diet designed to keep plasma phenylalanine levels at physiologically safe levels. Restrictive diets to reduce phenylalanine must be monitored professionally given the critical role of healthy levels of phenylalanine and treatment must be initiated as early as possible after birth to avoid the onset of severe intellectual disability and other symptoms. There are roughly 16,500 people living with PKU in the United States today and the incidence is between 1 in 10,000 and 1 in 20,000 depending on the country of origin.
About Capitainer
Captainer AB is a Swedish medtech company founded in 2016. Capitainer is developing intelligent solutions for Dried Blood and Plasma Spot sampling with the market’s best volume accuracy serving several market segments, including but not limited, to Therapeutic Drug Monitoring, Biomarkers, Drug Development and Drugs of Abuse and Doping. By using a combination of paper- and polymer microfluidics the precision and accuracy of metering of capillary blood is on par with that of a standard displacement pipette. Thus, the technology enables more convenient solutions for patients’ home sampling ensuring more reliable test results for healthcare and other providers of tests based on blood or plasma.
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