Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay.

Objectives: To evaluate pre-analytical challenges related to high-volume central laboratory SARS-CoV-2 antigen testing with a prototype qualitative SARS-CoV-2 antigen immunoassay run on the automated Abbott ARCHITECT instrument.

Methods: Contrived positive and negative specimens and de-identified nasal and nasopharyngeal specimens in transport media were used to evaluate specimen and reagent on-board stability, assay analytical performance and interference, and clinical performance.

Results: TCID50/mL values were similar for specimens in various transport media.

Specificity and Confirmation of SARS-CoV-2 Serological Test Methods in Emergency Department Populations across the United States.

Background: Serological testing for SARS-CoV-2 is integral for understanding prevalence of disease, tracking of infections, confirming humoral response to vaccines, and determining timing and efficacy of boosters. The study objective was to compare the specificity of serology assays in emergency department populations across the United States in 2019 (pre-pandemic) and early 2020, incorporating an automated confirmatory assay.

Methods: Patient specimens (n = 1954) were from 4 regions in the United States: New York, NY; Milwaukee, WI; Miami, FL; and Los Angeles, CA.

Specificity and Confirmation of SARS-CoV-2 Serological Test Methods in Emergency Department Populations Across the United States in 2019 and Early 2020.

Background: Serological testing for SARS-CoV-2 is integral for understanding prevalence of disease, tracking of infections, confirming humoral response to vaccines, and determining timing and efficacy of boosters. The study objective was to compare the specificity of serology assays in emergency department populations across the United States in 2019 (pre-pandemic) early 2020 incorporating an automated confirmatory assay.

Methods: Patient specimens (n = 1954) were from four regions in the United States: New York, NY; Milwaukee, WI; Miami, FL; and Los Angeles, CA.

An improved HIV antigen/antibody prototype assay for earlier detection of acute HIV infection.

Background: Early detection of acute HIV infection by HIV antigen/antibody assays depends on antigen sensitivity. Maintaining consistently high sensitivity across diverse HIV strains is critical to ensure equal detection.

Objectives: The performance of an improved HIV antigen/antibody prototype, HIV Combo Next, was evaluated for detection of genetically-diverse HIV strains and seroconversion samples.

A panel of selected serum protein biomarkers for the detection of aggressive prostate cancer.

Current PSA-based tests used to detect prostate cancer (PCa) lack sufficient specificity, leading to significant overdetection and overtreatment. Our previous studies showed that serum fucosylated PSA (Fuc-PSA) and soluble TEK receptor tyrosine kinase (Tie-2) had the ability to predict aggressive (AG) PCa. Additional biomarkers are needed to address this significant clinical problem.

Prevalence of Detectable Biotin in Five US Emergency Department Patient Cohorts.

Background: The objective of this study was to estimate the prevalence of biotin supplementation in United States emergency department patients using a multi-site, geographically distributed sampling model.

Methods: Biotin was measured using an Abbott ARCHITECT Biotin research use only assay in 7118 emergency department patient serum or plasma samples from five US medical centers. Samples with biotin ≥10 ng/mL underwent additional LC-MS/MS confirmatory testing for biotin and its primary metabolites.

Comparative evaluation of three FDA-approved HIV Ag/Ab combination tests using a genetically diverse HIV panel and diagnostic specimens.

Background: HIV Ag/Ab combination assays are recommended by CDC for routine screening and several HIV Ag/Ab combination tests are now FDA-approved. Maintaining high specificity and consistent sensitivity across diverse HIV strains is critical for these assays to accurately detect HIV infection and expedite delivery of patient results.

Objectives: To evaluate performance of three FDA-approved HIV tests: ARCHITECT HIV Combo (Abbott), ADVIA Centaur HIV Combo (Siemens) and BioPlex HIV Ag-Ab (Bio-Rad).

Association between serum adiponectin, and pathological stage and grade in men undergoing radical prostatectomy.

Purpose: Adiponectin is a polypeptide hormone produced by adipocytes that has anti-angiogenic properties. Circulating adiponectin is lower in obese men. Obesity has been associated with advanced stage and a higher risk of biochemical progression following radical prostatectomy (RP) in several series.

Serum leptin and pathological findings at the time of radical prostatectomy.

Purpose: Obesity has been associated with a higher risk of progression following radical prostatectomy (RP). Obese men have higher serum leptin, a hormone produced by adipocytes, which has also been shown to be an in vitro prostate cancer growth factor. We examined whether serum leptin correlates with advanced pathological findings at RP.

Clinical utility of proPSA and "benign" PSA when percent free PSA is less than 15%.

Objectives: To investigate the clinical utility of the subforms of free prostate-specific antigen (PSA), namely proPSA and "benign" PSA (BPSA), to improve cancer detection when the percent free PSA level is less than 15%. Percent free PSA, while maintaining sensitivity, has greatly improved the specificity of PSA for the early detection of prostate cancer. A low percent free PSA value indicates a greater risk of cancer, but only 30% to 50% of men with percent free PSA levels of less than 15% actually have cancer at biopsy.

Proenzyme psa for the early detection of prostate cancer in the 2.5-4.0 ng/ml total psa range: preliminary analysis.

Objectives: To determine the clinical utility of using proenzyme prostate-specific antigen (pPSA) for early detection of prostate cancer in the 2.5 to 4.0 ng/mL total PSA range.

Short-term stability of the molecular forms of prostate-specific antigen and effect on percent complexed prostate-specific antigen and percent free prostate-specific antigen.

Differences in stability of the free and complexed molecular forms of prostate-specific antigen (PSA) may influence the clinical utility of assays for these forms, as well as the calculated ratios to total PSA (tPSA), such as percent free PSA (fPSA) and percent complexed PSA (cPSA). The objective of this study was to directly compare the short-term stability of fPSA and cPSA under different storage conditions. Specimens (3 with prostate cancer, 3 biopsy-negative without cancer, 2 normal) from 8 men were analyzed at baseline within 2 hours of collection, and at 4 hours, 8 hours, 24 hours, 48 hours, and 1 week after storage at room temperature, 4 degrees C, or -20 degrees C.

Complexed prostate-specific antigen as a staging tool for prostate cancer: a prospective study in 420 men.

Over time, the parameters commonly used to predict pathological stage in men with localized prostate cancer have changed, and there is now little stratification in pretreatment prostate-specific antigen (PSA) concentrations, clinical stages, and biopsy Gleason scores. This prospective study evaluated the utility of complexed PSA (cPSA ) for predicting organ-confined disease in a contemporary series of subjects. The age range of the 420 men was 39 to 72 years (58.