Clinical evaluation of the automated Abbott RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex assays.

Background: Detection of SARS-CoV-2 infections relies on the use of sensitive, accurate and high throughput RT-PCR assays.

Objectives: We assessed the analytical performance of the Abbott RealTime SARS-CoV-2 (RT-SARS), Alinity m SARS-CoV-2 (AlinSARS) assays and compared the clinical performance of the RT-SARS, AlinSARS, and Alinity m Resp-4-Plex (Alin4Plex) assays to the Seegene Allplex assay (Allplex) and an inhouse test (Inhouse).

Results: We found 100 % positive percent agreement (PPA) and 100 % negative percent agreement (NPA) comparing RT-SARS and Allplex.

Multicenter clinical evaluation of alinity m HCV assay performance.

Background: Nucleic acid testing is essential for the detection and quantification of HCV RNA in the diagnosis of HCV infection and treatment monitoring. The Alinity m HCV assay was recently developed by Abbott Molecular for rapid detection and quantification of HCV RNA on the fully automated, continuous, random-access Alinity m analyzer.

Objectives: Our study assessed the performance of the new Alinity m HCV assay for detection and quantification of HCV RNA in a large series of patient samples of various genotypes.

Multicenter clinical comparative evaluation of Alinity m HIV-1 assay performance.

Background: Accurate, rapid detection of HIV-1 RNA is critical for early diagnosis, treatment decision making, and long-term management of HIV-1 infection.

Objective: We evaluated the diagnostic performance of the Alinity m HIV-1 assay, which uses a dual target/dual probe design against highly conserved target regions of the HIV-1 genome and is run on the fully automated Alinity m platform.

Study Design: This was an international, multisite study that compared the diagnostic performance of the Alinity m HIV-1 assay to four commercially available HIV-1 assays routinely used in nine independent clinical laboratories.

Multicenter clinical evaluation of alinity m HBV assay performance.

Background: Accurate molecular methods to detect and quantify hepatitis B virus (HBV) DNA are essential to diagnose chronic infections, guide treatment decisions, assess response to treatment, and determine risk of HBV-related complications. New generations of real-time HBV DNA assay platforms provide results in less than 2-3 h, with continuous loading of specimens and true random-access capability.

Objectives: We examined the clinical performance of the new Alinity m HBV assay, run on the fully automated, continuous, random-access Alinity m platform, to accurately detect and quantify HBV DNA in a large series of patient samples infected with different HBV genotypes frequently encountered in clinical practice.

Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany.

Background: Despite strong recommendations for colorectal cancer (CRC) screening, participation rates are low. Understanding factors that affect screening choices is essential to developing future screening strategies. Therefore, this study assessed patient willingness to use non-invasive stool or blood based screening tests after refusing colonoscopy.

The Range of Uncertainty: a Tool for Efficiently Addressing Result Variability Around Clinical Decision Points for Hepatitis C Response-guided Therapy.

Despite efforts to standardize molecular diagnostic tests, performance differences are not rare. Laboratories are challenged in situations where treatment rules have been established using a reference assay that is different from the assays being used in daily practice. Assessing the viral load status of patients with chronic hepatitis C under modern triple therapy is a recognized example.

Diagnostic performance of the ARCHITECT C-Peptide immunoassay.

Background: Measurement of C-peptide under standardized conditions provides a sensitive and well-established assessment of beta-cell function. We describe the analytical and clinical validation of an automated, microparticle-based chemiluminescent immunoassay method. The assay is designed to measure C-peptide in human serum, plasma and urine.

Performance characteristics of the new ARCHITECT Toxo IgG and Toxo IgG Avidity assays.

The ARCHITECT Toxo IgG and IgG Avidity assays have been developed as a fully automated panel for immune status determination and acute infection exclusion. Resolved relative specificity and sensitivity of the ARCHITECT Toxo IgG assay were 99.6% (1359/1365) and 99.