Quantifying sampling method-induced imprecision in user-friendly lateral upper arm blood collection: Introducing...

Area of Science:

• Clinical diagnostics
• Biomedical engineering
• Analytical chemistry

Background:

• Growing need for alternative blood sampling methods due to phlebotomist shortages and person-centered care demands.
• Importance of scientific evidence to ensure quality of care with home-based sampling like Lateral Upper-arm Blood Collection (LUBC).
• Existing knowledge gaps in quantifying collection method-induced imprecision and its clinical impact.

Purpose of the Study:

• To introduce and validate the Six Sigma analysis for alternative sampling methods (σ³-methodology) to quantify sampling method-induced imprecision, accuracy, and precision.
• To assess the analytical performance of the LUBC TAP® II device for routine clinical analytes using the developed methodology.
• To compare the performance of LUBC TAP® II against venipuncture as the gold standard.

Main Methods:

• Development of the Six Sigma analysis for alternative Sampling methods (σ³-methodology) to quantify sampling method-induced imprecision, accuracy, and precision.
• Two-step verification of the σ³-methodology applied to the LUBC TAP® II device.
• Analysis of fourteen routine clinical analytes with venipuncture serving as the gold standard.

Main Results:

• Sampling method-induced imprecision was identified as the primary source of error for all tested analytes, with its impact on clinical usability quantified.
• The LUBC TAP® II device demonstrated acceptable analytical performance for specific analytes: ALP, bilirubin, HDL-cholesterol, CRP, and sodium.
• Unacceptable analytical performance was observed for ALT, AST, cholesterol, creatinine, GGT, HbA1c, potassium, LDH, and triglycerides, indicating significant imprecision.

Conclusions:

• Alternative blood sampling innovations offer potential for decentralized, at-home diagnostics without phlebotomist involvement.
• Quantifying sampling method-induced imprecision is critical for assessing the performance of alternative blood sampling technologies.
• Responsible development and successful societal integration of these technologies depend on rigorous performance evaluation, including method-induced imprecision.