Laboratory testing for lupus anticoagulants: a review of issues affecting results.

BACKGROUND Lupus anticoagulants (LA) are a heterogeneous class of immunoglobulins. Persistent LA positivity is a risk factor for the occurrence and recurrence of venous/arterial thromboembolism and/or pregnancy morbidity and qualifies the patient for anticoagulation therapy. The laboratory diagnosis for LA that is used for crucial decision-making about the optimal duration of the therapy rests entirely on diagnostic criteria. These criteria are based on the prolongation of phospholipid-dependent tests not corrected upon mixing patient and normal plasmas, with confirmation provided by the evidence that the anticoagulant is directed against proteins bound to negatively charged phospholipids. AIMS This article reviews issues related to the diagnosis of LA, including the effect of preanalytical variables, choice of tests, results interpretation of screening, mixing and confirmation procedures, patients to be investigated, and transmission of results. Unresolved issues and future direction for research on laboratory diagnosis are also discussed. METHODS Search of PubMed with the key term "lupus anticoagulant" plus articles and unpublished data known to the author. RESULTS AND CONCLUSIONS The preanalytical variables (i.e., plasma preparation and storage before analysis) as well as the diagnostic steps to detect LA present potential problems that undermine the process of making a correct diagnosis. A truly specific test for LA detection is badly needed, but its development may require understanding of the mechanisms associated with the occurrence of clinical events. Until then, clinical laboratories should rely on the existing procedures, which must be applied with caution and awareness of the many issues that may affect their results.