Risk stratification of HIV infection for patients needing molecular confirmation with the Abbott 4th generation Architect System.

BACKGROUND: Some patients need their 4th generation HIV testing results confirmed with molecular testing after primary confirmatory testing which may not be immediately available. Further risk stratification of these patients pending the results of molecular testing may be of value not only for patient counseling but also for treatment of women in labor. OBJECTIVES: To determine the risk of a positive test result on molecular testing for these patients. STUDY DESIGN: The risk of a positive molecular test result for patients with a result needing molecular confirmation on a 4th generation HIV testing algorithm (Abbott Architect, Multispot/Geenius confirmatory test) was stratified based on the patient's white blood cell (WBC) count and the magnitude of Architect result Signal Cut Off ratio (S/CO). RESULTS: A total of 61,666 patients were tested with 658 (1.1%) positive results and 76 (0.12%) patients needing molecular confirmation. Patients with an S/CO of <5 or an S/CO of 5-100 with a WBC > 6.5 × 10 9 cells/l had a significantly lower risk of a positive molecular HIV test (0/48, 0%) than patients with an S/CO 5-100 with a WBC < 6.0 s × 10 9 cells/l (5/9, 56%, p < .001) or an S/CO > 100 (2/2, 100%, p < .001). Pregnant women had a significantly lower rate of positive test results (24/6924, 0.4%) than non-pregnant patients (634/54742, 1.1%, p < 0.001). All 12 cases needing molecular confirmation in pregnant women had negative NAT test results. CONCLUSIONS: Patients who need their HIV results confirmed with molecular testing using a 4th generation algorithm that includes the Abbott Architect System can be further stratified into low, intermediate, and high risk groups based on additional laboratory information pending the results of molecular testing. This risk stratification may be of value for patient counseling and treatment of women in labor.

Screening and Diagnosis of Monoclonal Gammopathies: An International Survey of Laboratory Practice.

CONTEXT: - Serum tests used for the screening and diagnosis of monoclonal gammopathies include serum protein electrophoresis (SPE; agarose gel or capillary zone), immunofixation (IFE) and immunosubtraction capillary electrophoresis, serum free light chains, quantitative immunoglobulins, and heavy/light-chain combinations. Urine protein electrophoresis and urine IFE may also be used to identify Bence-Jones proteinuria. OBJECTIVE: - To assess current laboratory practice for monoclonal gammopathy testing. DESIGN: - In April 2016, a voluntary questionnaire was distributed to 923 laboratories participating in a protein electrophoresis proficiency testing survey. RESULTS: - Seven hundred seventy-four laboratories from 38 countries and regions completed the questionnaire (83.9% response rate; 774 of 923). The majority of participants (68.6%; 520 of 758) used agarose gel electrophoresis as their SPE method, whereas 31.4% (238 of 758) used capillary zone electrophoresis. The most common test approaches used in screening were SPE with reflex to IFE/immunosubtraction capillary electrophoresis (39.3%; 299 of 760); SPE only (19.1%; 145 of 760); SPE and IFE or immunosubtraction capillary electrophoresis (13.9%; 106 of 760); and SPE with IFE, serum free light chain, and quantitative immunoglobulins (11.8%; 90 of 760). Only 39.8% (305 of 767) of laboratories offered panel testing for ordering convenience. Although SPE was used by most laboratories in diagnosing new cases of myeloma, when laboratories reported the primary test used to follow patients with monoclonal gammopathy, only 55.7% (403 of 724) chose SPE, with the next most common selections being IFE (18.9%; 137 of 724), serum free light chain (11.7%; 85 of 724), and immunosubtraction capillary electrophoresis (2.1%; 15 of 724). CONCLUSIONS: - Ordering and testing practices for the screening and diagnosis of monoclonal gammopathy vary widely across laboratories. Improving utilization management and report content, as well as recognition and development of laboratory-directed testing guidelines, may serve to enhance the clinical value of testing.

Applying principles of formulary management to blood banking.

The pharmacy and therapeutics (P&T) committee or its equivalent has been a long-standing committee of the medical staff in almost every institution. The P&T committee is typically defined as the body that recommends policy to the medical staff and the administration of the organization on matters related to the safe and therapeutic use of medications as well as other matters relating to medication use. The Food and Drug Administration definition of a drug includes blood and blood components, and the American Society of Health-System Pharmacists guidelines suggest including blood derivatives in their definition of a drug. Clinicians and other health care providers have needed to become more familiar with blood and blood component therapy as more prescription blood products have become available. As such, the P&T committee could work collaboratively with blood bank personnel, who are experts in this area, to help ensure that blood derivative products undergo the same evidence-based formulary review process as other medications.