Analytical and Clinical Performance Evaluation of the Elecsys HIV combi PT Assay on the cobas e 602 Analyzer for the Diagnosis of Human Immunodeficiency Virus.

OBJECTIVES: We evaluated the performance of the Elecsys HIV combi PT assay on the cobas e 602 analyzer for diagnosing human immunodeficiency virus (HIV; part of the US Food and Drug Administration [FDA] submission). METHODS: The HIV combi PT and reference (ARCHITECT HIV Ag/Ab Combo) assays were assessed at four independent clinical laboratories/one reference laboratory (United States; July 2014 to November 2015). Clinical performance was evaluated using four reagent lots. Analytical performance was evaluated per Clinical and Laboratory Standards Institute EP05-A3 guidelines. Serum/plasma samples from 18 clinical sites/vendors (United States and outside the United States) were tested. RESULTS: Sensitivity (95% confidence interval [CI]) in HIV-1 antibody-positive individuals (United States and outside the United States; n = 1,460) was 100.00% (99.75%-100.00%). Specificity was 99.94% (95% CI, 99.85%-99.98%) in low-risk individuals (United States; n = 6,843), 98.19% (95% CI, 96.93%-99.04%) in high-risk individuals (United States and outside the United States; n = 758), and 97.43% (95% CI, 95.32%-98.76%) in pregnant women (United States and outside the United States; n = 440). Analytical performance was acceptable. CONCLUSIONS: We demonstrate the robustness of the FDA-approved Elecsys HIV combi PT assay on the cobas e 602 analyzer for HIV testing in the United States.

Investigating the impact of blood culture bundles on the incidence of blood culture contamination rates.

Blood cultures are integral diagnostic procedures for identifying serious infections and selecting antimicrobials. Positive blood cultures are the initial step in attaining a conclusive diagnosis of sepsis. Relative risk is blood culture contamination, false-positive blood culture results, diagnostic error delays, treatment errors, excessive lab testing, and increased length of stay. A complicating issue is the increased use of central venous access devices (CVADs). The purpose of this descriptive, comparative study is to evaluate the effectiveness of blood culture bundles on blood cultures drawn through a CVAD and contamination rates. The study revealed a decrease in blood culture contamination rates by 61%.