Transplant patient classification and tacrolimus assays: more evidence of the need for assay standardization.

Background: A global tacrolimus proficiency study recently showed clinically significant variability between laboratories, the inability of a common calibrator to harmonize methods, and differences in patient classification depending on the test method. The authors evaluated (1) the effect of a change in methodology on patient classification based on tacrolimus blood concentration and (2) the ability of 2 methods to position the concentration in a given specimen within the correct range.

Methods: A total of 839 consecutive samples were analyzed at The Rogosin Institute and New York Presbyterian Hospital for routine tacrolimus monitoring over 30 days.

Pharmacogenomics and the future of toxicology testing.

Pharmacogenomics is a useful tool in clinical toxicology for characterizing many gene polymorphisms associated with different pharmacokinetics or pharmacodynamics of exogenously administered drugs. These genetic variants may determine ranges of variation in such fundamental aspects as drug-metabolizing enzymes, drug transporters, drug receptors, or targets of drug action. Toxicologically significant drugs for which the FDA has required the manufacturer to identify relevant pharmacogenomics markers on the label include carisoprodol, citalopram, codeine, and risperidone.

An assay to monitor bivalirudin levels on cardiopulmonary bypass.

Anticoagulation therapy for cardiopulmonary bypass in patients with recently diagnosed heparin-induced thrombocytopenia can be particularly challenging. Although heparin is the standard of care, in these situations anticoagulation is achieved with alternative agents such as direct thrombin inhibitors. Therapeutic concentrations are difficult to assess with direct thrombin inhibitors, and their use is riddled with bleeding and thrombotic complications.

Atypical serum immunofixation patterns frequently emerge in immunomodulatory therapy and are associated with a high degree of response in multiple myeloma.

The M-protein is the major reference measure for response in multiple myeloma (MM) and its correct interpretation is key to clinical management. The emergence of oligoclonal banding is recognized as a benign finding in the postautologous stem cell transplantation setting (ASCT) for MM but its significance during non-myeloablative therapy is unknown. In a study of the immunomodulatory combination BiRD, (lenalidomide and dexamethasone with clarithromycin), we frequently detected the emergence of mono- and oligo-clonal immunoglobulins unrelated to the baseline diagnostic M-protein.

Long-term transfusion of polymerized bovine hemoglobin in a Jehovah's Witness following chemotherapy for myeloid leukemia: a case report.

A 52-year-old female Jehovah's Witness presented with relapsed secondary acute myeloid leukemia. Because of chemotherapy-induced anemia, she was infused with the bovine hemoglobin (Hb)-based oxygen carrier HBOC-201 (Biopure) as the sole means of transfusion support. HBOC-201 has only been used for management of acute hemorrhage, and its utility in providing longer term transfusion support is unknown.