Coronavirus Disease 2019 (COVID-19) Real World Data Infrastructure: A Big-Data Resource for Study of the Impact of COVID-19 in Patient Populations With Immunocompromising Conditions.

Background: We developed a United States-based real-world data resource to better understand the continued impact of the coronavirus disease 2019 (COVID-19) pandemic on immunocompromised patients, who are typically underrepresented in prospective studies and clinical trials.

Methods: The COVID-19 Real World Data infrastructure (CRWDi) was created by linking and harmonizing de-identified HealthVerity medical and pharmacy claims data from 1 December 2018 to 31 December 2023, with severe acute respiratory syndrome coronavirus 2 virologic and serologic laboratory data from major commercial laboratories and Northwell Health; COVID-19 vaccination data; and, for patients with cancer, 2010 to 2021 National Cancer Institute Surveillance, Epidemiology, and End Results registry data.

Results: The CRWDi contains 4 cohorts: patients with cancer; patients with rheumatic diseases receiving pharmacotherapy; noncancer solid organ and hematopoietic stem cell transplant recipients; and people from the general population including adults and pediatric patients.

Social Determinants of Hepatitis C Virus Infection in the United States, 2016-2021.

This cross-sectional study assessed hepatitis C virus (HCV) antibody and RNA test results performed from 2016 to 2021 at a large US clinical reference laboratory. When individual patient factors (ie, income, education, and race/ethnicity) were not available, estimates from the US Census were linked to the residential zip code. The final analytic cohort comprised 19,543,908 individuals with 23,233,827 HCV antibody and RNA test results.

Chlamydia and Gonorrhea Testing in Pregnancy: Time to Improve Adherence and Update Recommendations.

Objective: The aim of the study is to evaluate adherence to national recommendations for Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) testing during pregnancy including tests for cure/clearance and for persistence/potential reinfection at time of delivery.

Materials And Method: We evaluated results of chlamydia and gonorrhea nucleic acid amplification tests (NAAT) performed by major national reference laboratory from January 2010 through July 2022.

Results: Of 3,519,781 uniquely identified pregnant individuals, we identified 4,077,212 pregnancies.

Impact of the COVID-19 Pandemic on Blood Lead Testing in Children in the United States.

The study objective was to evaluate the impact of the coronavirus disease (COVID-19) pandemic on pediatric blood lead testing in the United States. Clinical laboratory pediatric (ages <6 years) blood lead level (BLL) tests performed by Quest Diagnostics, January 2019-March 2022, were analyzed. Patients were categorized by age, by sex, and, through matching by ZIP code with US Census data, for race, ethnicity, pre-1950 housing, and poverty estimates.

Humoral and cellular immune responses against SARS-CoV-2 post-vaccination in immunocompetent and immunocompromised cancer populations.

Unlabelled: Cancer patients are at risk for severe coronavirus disease 2019 (COVID-19) outcomes due to impaired immune responses. However, the immunogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is inadequately characterized in this population. We hypothesized that cancer vs non-cancer individuals would mount less robust humoral and/or cellular vaccine-induced immune SARS-CoV-2 responses.

Hepatitis C Virus Testing, Infection, and Cases Reported Through Public Health Surveillance During Expanded Screening Recommendations, United States, 2013-2021.

Objectives: Hepatitis C virus (HCV) infection is the most common bloodborne infection in the United States. We assessed trends in HCV testing, infection, and surveillance cases among US adults.

Methods: We used Quest Diagnostics data from 2013-2021 to assess trends in the numbers tested for HCV antibody and proportion of positivity for HCV antibody and HCV RNA.

Testing for Hepatitis C During Pregnancy Among Persons With Medicaid and Commercial Insurance: Cohort Study.

Background: The reported incidence of acute hepatitis C virus (HCV) infection is increasing among persons of childbearing age in the United States. Infants born to pregnant persons with HCV infection are at risk for perinatal HCV acquisition. In 2020, the United States Preventive Services Task Force and Centers for Disease Control and Prevention recommended that all pregnant persons be screened during each pregnancy for hepatitis C.

SARS-CoV-2 spike-protein targeted serology test results and their association with subsequent COVID-19-related outcomes.

Importance: In the absence of evidence of clinical utility, the United States' Centers for Disease Control and Prevention does not currently recommend the assessment of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike-protein antibody levels. Clinicians and their patients, especially immunocompromised patients, may benefit from an adjunctive objective clinical laboratory measure of risk, using SARS-CoV-2 serology.

Objective: The aim of this study is to estimate the association between SARS-CoV-2 spike-protein targeted antibody levels and clinically relevant outcomes overall and among clinically relevant subgroups, such as vaccine and immunocompetency statuses.

Lipid distributions in the Global Diagnostics Network across five continents.

Aims: Lipids are central in the development of cardiovascular disease, and the present study aimed to characterize variation in lipid profiles across different countries to improve understanding of cardiovascular risk and opportunities for risk-reducing interventions.

Methods And Results: This first collaborative report of the Global Diagnostics Network (GDN) evaluated lipid distributions from nine laboratory organizations providing clinical laboratory testing in 17 countries on five continents. This cross-sectional study assessed aggregated lipid results from patients aged 20-89 years, tested at GDN laboratories, from 2018 through 2020.

Hepatitis C Virus Clearance Cascade - United States, 2013-2022.

Approximately 2.4 million adults were estimated to have hepatitis C virus (HCV) infection in the United States during 2013-2016 (1). Untreated, hepatitis C can lead to advanced liver disease, liver cancer, and death (2).

Risk of and duration of protection from SARS-CoV-2 reinfection assessed with real-world data.

This retrospective observational study aimed to gain a better understanding of the protective duration of prior SARS-CoV-2 infection against reinfection. The objectives were two-fold: to assess the durability of immunity to SARS-CoV-2 reinfection among initially unvaccinated individuals with previous SARS-CoV-2 infection, and to evaluate the crude SARS-CoV-2 reinfection rate and associated risk factors. During the pandemic era time period from February 29, 2020, through April 30, 2021, 144,678,382 individuals with SARS-CoV-2 molecular diagnostic or antibody test results were studied.

Assessing Vulnerability to COVID-19 in High-Risk Populations: The Role of SARS-CoV-2 Spike-Targeted Serology.

Individuals at increased risk for severe coronavirus disease-2019 (COVID-19) outcomes, due to compromised immunity or other risk factors, would benefit from objective measures of vulnerability to infection based on vaccination or prior infection. The authors reviewed published data to identify a specific role and interpretation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike-targeted serology testing. Specific recommendations are provided for an evidence-based and clinically-useful interpretation of SARS-CoV-2 spike-targeted serology to identify vulnerability to infection and potential subsequent adverse outcomes.

Machine Learning Case Study: Patterns of Kidney Function Decline and Their Association With Clinical Outcomes Within 90 Days After the Initiation of Renal Dialysis.

A case study explores patterns of kidney function decline using unsupervised learning methods first and then associating patterns with clinical outcomes using supervised learning methods. Predicting short-term risk of hospitalization and death prior to renal dialysis initiation may help target high-risk patients for more aggressive management. This study combined clinical data from patients presenting for renal dialysis at Fresenius Medical Care with laboratory data from Quest Diagnostics to identify disease trajectory patterns associated with the 90-day risk of hospitalization and death after beginning renal dialysis.

Insights into HIV-1 Transmission Dynamics Using Routinely Collected Data in the Mid-Atlantic United States.

Background: Molecular epidemiological approaches provide opportunities to characterize HIV transmission dynamics. We analyzed HIV sequences and virus load (VL) results obtained during routine clinical care, and individual’s zip-code location to determine utility of this approach. Methods: HIV-1 pol sequences aligned using ClustalW were subtyped using REGA.

Low Performance of Hepatitis Delta Virus Testing Among 2 National Cohorts of Chronic Hepatitis B Patients in the United States.

Introduction: The purpose of this study was to evaluate hepatitis delta virus (HDV) testing patterns among US adults with chronic hepatitis B (CHB).

Methods: HDV testing was evaluated among CHB patients using Quest Diagnostics (2016-2020) and Veterans Affairs (2010-2020) data.

Results: Among 157,333 CHB patients (Quest), 6.

Prevalence of Hepatitis B Virus and Latent Tuberculosis Coinfection in the United States.

Context: Underlying chronic hepatitis B virus (HBV) infection increases the risk of drug-induced liver injury (DILI) when receiving tuberculosis therapies. Prevalence of HBV and latent tuberculosis infection (LTBI) coinfection is not well reported and no studies have evaluated testing patterns for and prevalence of HBV-LTBI coinfection in the United States.

Objective: To evaluate patterns of HBV and LTBI testing and prevalence of HBV-LTBI coinfection in the United States.

Hepatitis C Virus Testing During Pregnancy After Universal Screening Recommendations.

The study evaluates the effect of the 2020 Centers for Disease Control and Prevention and U.S. Preventive Services Task Force recommendations on hepatitis C virus (HCV) screening among pregnant persons nationally and by health insurance type.

Simplifying Treatment Criteria in Chronic Hepatitis B: Reducing Barriers to Elimination.

Background: Early, sustained hepatitis B virus (HBV) DNA suppression reduces long-term risks of hepatocellular carcinoma. Chronic hepatitis B (CHB) treatment criteria are complex. Simplifying criteria will improve timely linkage to therapy.

Changes in ganglioside antibody positivity rates during the COVID-19 pandemic.

Reports suggested an association between SARS-CoV-2 infection and GBS, but subsequent studies produced conflicting results regarding the incidence of GBS during the pandemic. This study assessed positivity rates for GQ1b, GM-1, GD1a, and GD1b for tests performed January 2016, through March 2021, at a national laboratory. Relative to pre-pandemic levels, positivity rates during the pandemic declined by 61% for GQ1b and 24% for GM-1, while unchanged for GD1a and GD1b.