Evaluation of an automated algorithm for interpretation of lupus anticoagulant testing.

Abstract

Lupus anticoagulant (LAC) testing is a multistep procedure including screening, mixing, and confirmation tests. STA Coag Expert is a software module for STA R Max and STA Compact Max analyzers which includes an on-demand LAC algorithm, based on ISTH guidelines, for automatic interpretation, calculation, and launch of assays in LAC interpretation ("Stago coag algorithm"). One hundred ninety four patient samples were analyzed in parallel and interpreted manually and automatically by LAC algorithms. LAC algorithms use identical flowcharts and cutoff values as in daily practice. Differently, it only uses index of circulating anticoagulant (ICA), whereas in routine also normalized ratios were assessed for interpretation of mixing tests. Interpretation of dRVVT and aPTT pathways and final conclusions were compared between both approaches. Compared to routine interpretation, LAC algorithm showed a sensitivity of 94% and a specificity of 100% for LAC detection, when discrepancies due to measured clotting times between both analyzers were excluded. Three false negatives were due to different interpretation of dRVVT mixing test. Discrepancies in interpretation of the aPTT mixing test (n=11) did not result in discrepant final LAC result, all having negative confirmation tests. No false positives were observed. With LAC algorithm, hands-on time reduced from 200 to 80minutes. The LAC algorithm of the STA Coag Expert shows good comparability to the manual interpretation of LAC and may be used to assist laboratories in automatic launching of additional tests and in interpretation of LAC according to ISTH guidelines. This way the STA Coag Expert LAC algorithm may improve interlaboratory and STA comparability of LAC results.