Evaluating Cobas ^® b101 for lipid profile and SCORE2 risk assessment from capillary blood in population screening

Abstract Objectives Cardiovascular disease (CVD) is a leading cause of mortality worldwide. Emerging lung cancer screening in smokers may offer an opportunity for simultaneous cardiovascular risk evaluation. We developed a mobile CT screening unit and assessed the feasibility of integrating dyslipidemia screening and non-HDL cholesterol-based SCORE2 estimation using the Cobas ® b101 point-of-care testing (POCT) analyzer on capillary blood samples. Methods Following a preliminary evaluation of two POCT analyzers, the Cobas ® b101 was selected for capillary lipid profiling. Lipid results obtained from capillary samples analyzed in the mobile unit were compared with venous samples analyzed in the central laboratory in 84 screened participants. Results For total cholesterol and HDL-C, the Passing–Bablok regression were strong, with clinically acceptable differences of −0.81 % and +5.23 %, respectively. Triglycerides showed a clinically unacceptable difference of +29.4 %, but strong agreement with clinical categories was observed (kappa 95 % CI [0.55; 0.82]); this may reflect both matrix effects and the non-fasting status of almost all participants (∼91 % were non-fasting). Calculated LDL-C misclassification rates were 47 %, 37 %, and 32 % using the Friedewald, Sampson, and Martin–Hopkins equations, respectively. Non-HDL-C showed a clinically acceptable bias of −2.83 %, supporting its use for prevention goals and familial hypercholesterolemia screening. Concordance analysis of SCORE2 based on non-HDL-C categories revealed high reliability (95 % CI [0.72; 0.92]). Conclusions These findings support the use of Cobas ® b101 with capillary sampling for population-level screening and preliminary CVD risk assessment using SCORE2, despite reduced analytical performance for TG. Abnormal results should be confirmed by a fasting lipid profile.