Evaluation of a Prototype of a Novel Galactomannan Sandwich Assay Using the VIDAS Technology for the Diagnosis of Invasive Aspergillosis.

Objectives: To evaluate the analytical and clinical performance of a prototype of a VIDAS Galactomannan (GM) unitary test (bioMérieux, Marcy l'Etoile, France) and compare to that of the Platelia™ Ag assay (Bio-Rad, CA, USA).

Methods: Repeatability, reproducibility, and freeze-thaw stability of VIDASGM were evaluated. Sera from patients at risk of IA were concurrently tested with both the VIDASGM and Platelia™ Ag assays.

Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays.

The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemic, notably through epidemiological surveillance. Well-validated and highly specific SARS-CoV-2 serological assays are urgently needed.

The kinetic profile and clinical implication of SCC-Ag in squamous cervical cancer patients undergoing radical hysterectomy using the Simoa assay: a prospective observational study.

Background: To study the kinetic profile and clinicopathological implications of squamous cell carcinoma antigen (SCC-Ag) in cervical cancer patients who underwent surgery by a self-developed SCC-Ag single molecule assay (Simoa) prototype immunoassay.

Methods: Participants were prospectively enrolled between 04/2016 and 06/2017. Consecutive serum samples were collected at five points: day 0 (the day before surgery), postoperative day 4, weeks 2-4, months 2-4 and months 5-7.

Assessment of an ultra-sensitive IFNγ immunoassay prototype for latent tuberculosis diagnosis.

Worldwide there are about 1.7 billion individuals with latent tuberculosis infection (LTBI) and only 5% to 15% will develop active tuberculosis (TB). It is recommended to treat only those most at risk of developing active TB to avoid problems of drug resistance.

Comparative evaluation of the VIDAS HIV DUO Ultra assay for combined detection of HIV-1 antigen and antibodies to HIV.

The aim of the study was to evaluate the performance of the combined antigen and antibody HIV screening assay VIDAS HIV DUO Ultra (BioMérieux, Marcy l'Etoile, France) in comparison with two other combined tests: the former version of the same test (VIDAS HIV DUO, BioMérieux) and the AxSYM HIV Ag/Ab Combo assay (Abbott Laboratories, Rungis, France). A prospective study was performed on serum specimens received on a routine basis for HIV testing: 1443 blood samples were tested with the three assays. Sensitivity was 100% for the three tests.