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Published on: September 14, 2011
Comparability of venous and capillary blood measurements for a host-protein test differentiating bacterial from viral
Mary Hainrichson1, Nitzan Shamir1, Naftalie Senderovich1
1MeMed, 7 Nahum Het St, Tirat Carmel 3508506, Israel.
Background:
MeMed BV is a host-protein test for discriminating bacterial and viral infections. It was analytically and clinically validated in serum and venous whole blood samples. Here we investigated the comparability of venous versus capillary blood measurements of the MeMed BV score and of tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), and C-reactive protein (CRP) biomarkers.
Methods:
Adult patients with suspected acute infection were enrolled prospectively at three medical centers. Eligibility criteria were based on MeMed BV instructions for use. Paired venous and capillary samples (50 µL) were collected and measured. Three predetermined acceptance criteria for comparability for MeMed BV score were: (1) Slope 0.9-1.1 and intercept -5 to 5 in Passing-Bablok regression; (2) 95 % confidence intervals (CI) for bias at score bin cutoffs fall within -12.5 to 12.5; and (3) <5 % of paired scores fall in non-adjacent clinical interpretation bins.
Results:
Among 58 patients (median age 58.5 years), TRAIL, IP-10, and CRP measurements in venous and capillary blood were highly correlated (r = 0.98-0.99). For the MeMed BV score, slope was 1.00 (95 % CI: 0.99, 1.01), intercept 0.00 (-1.04, 0.08), 95 % CI for bias at each cutoff was within limits and no paired scores fell in non-adjacent bins. All three criteria were met and findings were consistent in a single replicates analysis.
Conclusion:
Venous and capillary blood yield comparable MeMed BV scores and biomarker values. The findings can serve as the basis for expanding MeMed BV's use to include capillary blood specimens, potentially widening its clinical utility.
