Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis
Xing et al.
The finding, in our words
Protein abundances measured by SomaScan were comparable between capillary samples collected with the TAP device and venous samples, and selected ELISA assays showed strong correlation, supporting the use of the TAP device for quantitative protein biomarker analysis in decentralised trials.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
Targeted proteomic evaluation of a novel finger-prick dried plasma device demonstrated strong quantitative correlation with conventional plasma (R = 0.99) and precision under 10% CV for 80% of quantified peptides across healthy donors. Quantified targets also remained stable during room temperature storage for up to 232 days, supporting its use for decentralised biomarker monitoring.
In 22 adults, capillary blood collection demonstrated strong correlation with venous sampling for 66 per cent of inflammatory proteins and moderate to strong correlation for 80 per cent overall, supporting its validity for proteomic measurement in decentralised trials.
TAP II capillary serum, both professionally collected and self-collected, correlated with venous serum at R > 0.9 for eight analytes including ALT, AST, cholesterol, HDL and triglycerides. Creatinine correlated acceptably but carried a consistent negative bias, and carbon dioxide, potassium and albumin did not reach acceptable agreement: the useful reading is that the panel has to be validated, not the device alone.
Patients self-collected upper-arm capillary blood with press-activated devices including TAP II; autoantibody and CRP results agreed with venous at r≥0.98, were rated less painful, and 98.6% got enough blood within two attempts.
In 480 adults, capillary specimens from fingertip lancets or the TAP Micro Select device gave clinically comparable results to venous samples for 16 of 18 routine chemistry analytes; potassium and chloride were not interchangeable, and fingertip collection showed more haemolysis, both points to weigh before decentralised microsampling of routine chemistry.