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.

Evaluation of the Elecsys Syphilis Immunoassay for Detection of Syphilis in Populations at Risk of Disease in the US and Argentina.

Background: The Elecsys® syphilis immunoassay is an automated, qualitative immunoassay that uses a double-antigen sandwich format to detect antibodies to Treponema pallidum in human serum and plasma. We aimed to validate performance of the immunoassay in various populations at risk for syphilis infection in the US and Argentina.

Methods: Samples were obtained for a number of study cohorts, including participants from routine syphilis testing at high or low risk for syphilis, HIV-positive patients, pregnant women, and patients in various stages of syphilis infection.

Rates of vaso-vagal reactions among first time teenaged whole blood, double red cell, and plateletpheresis donors.

Given the paucity of published data regarding reaction rates in younger teenaged donors, we evaluated the reaction rates in all of our first time teenaged donors after New York Blood Center lowered the minimum permissible age for blood donations from 17 to 16 yr in 2005. The overall rates of vaso-vagal reactions in donors aged 16 to 19, and those resulting in syncope, occurring in 72,769 consecutive first time whole blood, 3,822 double red cell, and 777 platelet apheresis donations were calculated. They were correlated with age and compared to those found in donors aged 20-29.