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OBJECTIVE: The objective of the study was to estimate the rates of testing, prevalence, and follow-up testing for chlamydial and gonococcal infection in a nationally based population that is comparable with the US pregnant population in terms of age and race. STUDY DESIGN: We extracted laboratory results for 1,293,423 pregnant women tested over a 3-year period. RESULTS: During pregnancy, 59% (761,315 of 1,293,423) and 57% (730,796 of 1,293,423) of women were tested at least once for Chlamydia trachomatis or for Neisseria gonorrhoeae, respectively. Of those women tested, 3.5% (26,437 of 761,315) and 0.6% (4605 of 730,796) tested positive for chlamydial and gonococcal infection, respectively, at least once during pregnancy. Of those women who were initially positive for the given infection, 78% (16,039 of 20,489) and 76% (2610 of 3435) were retested, of whom 6.0% (969 of 16,039) and 3.8% (100 of 2610) were positive on their last prenatal test for C trachomatis and N gonorrhoeae, respectively. CONCLUSION: Many pregnant women are not tested for C trachomatis and N gonorrhoeae despite recommendations to test. Follow-up testing to monitor the effectiveness of treatment is also not always performed. [ABSTRACT FROM AUTHOR]

Abstract: Hemolytic disease of fetus and newborn (HDFN) is a life-threatening disease mediated by maternal alloimmunization to red blood cell (RBC) antigens. Studies of maternal alloimmunization prevalence in the United States lack national data. This study describes prevalence and trends in alloimmunization in pregnancy in the United States. RBC antibodies (abs) were identified in a large, nationwide, commercial laboratory database from 2010 through 2021. The cohort comprised pregnancies for which the year of laboratory collection and patient's state of residence were available. Data were normalized based on US Centers for Disease Control and Prevention estimates of live births and weighted by year and US Census Division. Cochrane-Armitage tests assessed temporal trends of alloimmunization. Of 9 876 196 pregnancies, 147 262 (1.5%) screened positive for RBC abs, corresponding to an estimated prevalence of 1518 of 100 000 pregnancies. Of identified RBC abs, anti-D comprised 64.1% pregnancies (586/100 000). Prevalence of other high-risk RBC abs for HDFN included anti-K (68/100 000) and anti-c (29/100 000). Incidence of all 3 high-risk abs increased from 2010 to 2021 (all P < .001). Among almost 10 million pregnancies in the United States, comprising an estimated 14.4% of all pregnancies, 1.5% screened positive for RBC abs. Almost three-quarters (679/100 000 [74.3%]) of RBC abs identified were high risk for HDFN. Although prevalence of anti-D is difficult to interpret without the ability to distinguish alloimmunization from passive immunity, it remains problematic in HDFN, ranking second only to anti-K in critical titers. Given the sequelae of HDFN, new initiatives are required to reduce the incidence of alloimmunization in patients of reproductive potential., (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

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. An analysis of progressively increasing poverty quintiles demonstrated an increasing trend in both HCV antibody positivity (from 2.6% in the lowest quintile to 6.9% in the highest, P < 0.001 for trend) and HCV RNA positivity (from 1.0% to 3.6%, P < 0.001 for trend). Increasing levels of education were associated with a decreasing trend in both HCV antibody positivity (from 8.4% in the least educated quintile to 3.0% in the most, P < 0.001 for trend) and HCV RNA positivity (from 4.7% to 1.2%, P < 0.001 for trend). Persistent differences in positivity rates by these social determinants were observed over time. HCV antibody and RNA positivity rates were nearly identical in predominantly Black non-Hispanic, Hispanic, and White non-Hispanic zip codes. However, after adjustment for all other factors in the study, residents of predominantly Black non-Hispanic and Hispanic zip codes were significantly less likely to test positive for HCV RNA (adjusted odds ratios [AOR]: 0.51, 95% confidence interval [CI]: 0.51-0.52; AOR: 0.46, 95% CI: 0.46-0.46, respectively). These findings may benefit targeted intervention initiatives by public health agencies.

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. Among pregnancies that had chlamydia or gonorrhea testing, 3.7% (149,422/4,055,016) and 0.4% (15,858/ 4,063,948) were initially positive, respectively. Initial tests occurred in the first trimester for approximately 88%. Of those initially chlamydia test positive, 71% were retested; 15.8% in <4 weeks and 37.3% >8 weeks (similarly for gonorrhea). Among patients initially test positive in early/mid pregnancy, more than one-third had no evidence of late pregnancy retesting. Individuals who were initially test negative and subsequently retested positive were approximately 50% likely to have the last available result be positive. Among all whom initially tested positive and were retested, 6.8% and 4.0%, were positive for chlamydia and gonorrhea, respectively on their last test before estimated delivery. There was no subsequent negative test before estimated delivery for 35.1% and 36.9% chlamydia or gonorrhea infected patients, respectively., Conclusions: Adherence to current recommendations is suboptimal and may not be adequate to reduce disease burden. Professional societies and practice plans should work to encourage better adherence to existing guidelines to protect the health of women and their newborns. We propose recommendations that may be helpful in reducing disease burden., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the ASCCP.)

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. Over 2.8 million results from children (<6 years old) from all 50 states and the District of Columbia were included. Compared to March-May 2019, BLL testing was lower by 53.6% in March-May 2020 and lower by 14.6% in March-May 2021. Testing rebounded more for children in predominantly White non-Hispanic communities and among children living in communities, based on ZIP codes, with the least pre-1950 housing stock and lowest poverty rates. The proportion of children with BLL at or above the United States Centers for Disease Control and Prevention reference values of 3.5 and 5.0 µg/dL fell by 19% and 24%, respectively, in 2021 versus 2019. In conclusion, pediatric BLL testing has rebounded from sharp declines during the early pandemic period but unevenly. Declines in the proportion of children with elevated BLL should be interpreted with caution, as testing rebounds were less robust among communities with the highest risk of lead poisoning, notably communities with the oldest housing stock and higher poverty rates. More public health efforts are needed to address lead toxicity throughout the United States, especially in communities that did not experience a full rebound subsequent to the early COVID-19 pandemic period.

Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Harvey W. Kaufman owns stock in Quest Diagnostics. William A. Meyer III reports receipt of consulting fees from Quest Diagnostics. No other potential conflicts of interest were disclosed.

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. Receptor binding domain (RBD) and SARS-CoV-2 spike protein antibody levels and T-cell responses were assessed in immunocompetent individuals with no underlying disorders ( n = 479) and immunocompromised individuals ( n = 115). All 594 individuals were vaccinated and of varying COVID-19 statuses (i.e., not known to have been infected, previously infected, or "Long-COVID"). Among immunocompromised individuals, 59% ( n = 68) had an underlying hematologic malignancy; of those, 46% ( n = 31) of individuals received cancer treatment <30 days prior to study blood collection. Ninety-eight percentage ( n = 469) of immunocompetent and 81% ( n = 93) of immunocompromised individuals had elevated RBD antibody titers (>1,000 U/mL), and of these, 60% ( n = 281) and 44% ( n = 41), respectively, also had elevated T-cell responses. Composite T-cell responses were higher in individuals previously infected with SARS-CoV-2 or those diagnosed with Long-COVID compared to uninfected individuals. T-cell responses varied between immunocompetent vs carcinoma ( n = 12) cohorts ( P < 0.01) but not in immunocompetent vs hematologic malignancy cohorts. Most SARS-CoV-2 vaccinated individuals mounted robust cellular and/or humoral responses, though higher immunogenicity was observed among the immunocompetent compared to cancer populations. The study suggests B-cell targeted therapies suppress antibody responses, but not T-cell responses, to SARS-CoV-2 vaccination. Thus, vaccination continues to be an effective way to induce humoral and cellular immune responses as a likely key preventive measure against infection and/or subsequent more severe adverse outcomes., Importance: The study was prompted by a desire to better assess the immune status of patients among our cancer host cohort, one of the largest in the New York metropolitan region. Hackensack Meridian Health is the largest healthcare system in New Jersey and cared for more than 75,000 coronavirus disease 2019 patients in its hospitals. The John Theurer Cancer Center sees more than 35,000 new cancer patients a year and performs more than 500 hematopoietic stem cell transplants. As a result, the work was undertaken to assess the effectiveness of vaccination in inducing humoral and cellular responses within this demographic., Competing Interests: Quest Diagnostics authors are employees of Quest Diagnostics and own stock in Quest Diagnostics.

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. We also assessed National Notifiable Diseases Surveillance System 2013-2020 data for trends in the number and proportion of hepatitis C cases. We applied joinpoint regression for trends testing., Results: Annual HCV antibody testing increased from 1.7 million to 4.8 million from 2013 to 2021, and the positivity proportion declined (average, 0.2% per year) from 5.5% to 3.7%. The greatest percentage-point increase in HCV antibody testing occurred in hospitals and substance use disorder treatment facilities and among addiction medicine providers. HCV RNA positivity was stable at about 60% in 2013-2015 and declined to 41.0% in 2021 (2015-2021 average, -3.2% per year). Age-specific HCV RNA positivity was highest among people aged 40-59 years during 2013-2015 and among people aged 18-39 years during 2016-2021. The number of reported hepatitis C cases (acute and chronic) declined from 179 341 in 2015 to 105 504 in 2020 (average decline, -13 177 per year). The proportion of hepatitis C cases among those aged 18-39 years increased by an average of 1.4% per year during 2013-2020; among individuals aged 40-59 years, it decreased by an average of 2.3% per year during 2013-2018., Conclusions: HCV testing increased, suggesting improved universal screening. Various data sources are valuable for monitoring elimination progress., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Harvey W. Kaufman and Justin K. Niles are employees of, and William A. Meyer III serves as a consultant to, Quest Diagnostics. Harvey W. Kaufman and William A. Meyer III own stock in Quest Diagnostics.

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. However, there are limited data on trends in hepatitis C testing during pregnancy., Objective: We estimated hepatitis C testing rates in a large cohort of patients with Medicaid and commercial insurance who gave birth during 2015-2019 and described demographic and risk-based factors associated with testing., Methods: Medicaid and commercial insurance claims for patients aged 15-44 years and who gave birth between 2015 and 2019 were included. Birth claims were identified using procedure and diagnosis codes for vaginal or cesarean delivery. Hepatitis C testing was defined as an insurance claim during the 42 weeks before delivery. Testing rates were calculated among patients who delivered and among the subset of patients who were continuously enrolled for 42 weeks before delivery. We also compared the timing of testing relative to delivery among patients with commercial or Medicaid insurance. Multivariable logistic regression was used to identify factors associated with testing., Results: Among 1,142,770 Medicaid patients and 1,207,132 commercially insured patients, 175,223 (15.3%) and 221,436 (18.3%) were tested for hepatitis C during pregnancy, respectively. Testing rates were 89,730 (21.8%) and 187,819 (21.9%) among continuously enrolled Medicaid and commercially insured patients, respectively. Rates increased from 2015 through 2019 among Medicaid (from 20,758/108,332, 19.2% to 13,971/52,330, 26.8%) and commercially insured patients (from 38,308/211,555, 18.1% to 39,152/139,972, 28%), respectively. Among Medicaid patients, non-Hispanic Black (odds ratio 0.73, 95% CI 0.71-0.74) and Hispanic (odds ratio 0.53, 95% CI 0.51-0.56) race or ethnicity were associated with lower odds of testing. Opioid use disorder, HIV infection, and high-risk pregnancy were associated with higher odds of testing in both Medicaid and commercially insured patients., Conclusions: Hepatitis C testing during pregnancy increased from 2015 through 2019 among patients with Medicaid and commercial insurance, although tremendous opportunity for improvement remains. Interventions to increase testing among pregnant persons are needed., (©Mohammed A Khan, William W Thompson, Ademola Osinubi, William A Meyer 3rd, Harvey W Kaufman, Paige A Armstrong, Monique A Foster, Noele P Nelson, Carolyn Wester. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 27.09.2023.)

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., Design: A retrospective cohort study was conducted using laboratory-based data containing SARS-CoV-2 antibody testing results, as well as medical and pharmacy claim data. SARS-CoV-2 testing was performed by two large United States-based reference clinical laboratories, Labcorp ® and Quest Diagnostics, and was linked to medical insurance claims, including vaccination receipt, through the HealthVerity Marketplace. Follow-up for outcomes began after each eligible individual's first SARS-CoV-2 semiquantitative spike-protein targeted antibody test, from 16 November 2020 to 30 December 2021., Exposures: Exposure is defined as having SARS-CoV-2 spike-protein targeted antibody testing., Main Outcomes and Measures: Study outcomes were SARS-CoV-2 infection and a serious composite outcome (hospitalization with an associated SARS-CoV-2 infection or all-cause death). Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Propensity score matching was used for confounding covariate control., Results: In total, 143,091 (73.2%) and 52,355 (26.8%) eligible individuals had detectable and non-detectable levels of SARS-CoV-2 spike-protein targeted antibodies, respectively. In the overall population, having detectable vs. non-detectable antibodies was associated with an estimated 44% relative reduction in SARS-CoV-2 subsequent infection risk (HR, 0.56; 95% CI 0.53-0.59) and an 80% relative reduction in the risk of serious composite outcomes (HR 0.20; 95% CI 0.15-0.26). Relative risk reductions were observed across subgroups, including among immunocompromised persons., Conclusion and Relevance: Individuals with detectable SARS-CoV-2 spike-protein targeted antibody levels had fewer associated subsequent SARS-CoV-2 infections and serious adverse clinical outcomes. Policymakers and clinicians may find SARS-CoV-2 spike-protein targeted serology testing to be a useful adjunct in counseling patients with non-detectable antibody levels about adverse risks and reinforcing appropriate actions to mitigate such risks., Competing Interests: The authors declare that this study received funding from Labcorp and Quest Diagnostics. The funders had the following involvement in the study: the data acquisition from HealthVerity and the independent data analysis and support for the manuscript by Aetion., (Copyright © 2023 Kaufman, Letovsky, Meyer, Gillim, Assimon, Kabelac, Kroner, Reynolds and Eisenberg.)

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. In addition to mean levels, the World Health Organization total cholesterol risk target (<5.00 mmol/L, <193 mg/dL) and proportions in guideline-based low-density lipoprotein cholesterol (LDL-C) categories were assessed. This study of 461 888 753 lipid results found wide variation by country/region, sex, and age. In most countries, total cholesterol and LDL-C peaked at 50-59 years in females and 40-49 years in males. Sex- and age-group adjusted mean total cholesterol levels ranged from 4.58 mmol/L (177.1 mg/dL) in the Republic of Korea to 5.40 mmol/L (208.8 mg/dL) in Austria. Mean total cholesterol levels exceeded the World Health Organization target in Japan, Australia, North Macedonia, Switzerland, Germany, Slovakia, and Austria. Considering LDL-C categories, North Macedonia had the highest proportions of LDL-C results >4.91 mmol/L (>190 mg/dL) for both females (9.9%) and males (8.7%). LDL-C levels <1.55 mmol/L (<60 mg/dL) were most common among females in Canada (10.7%) and males in the UK (17.3%)., Conclusion: With nearly a half billion lipid results, this study sheds light on the worldwide variability in lipid levels, which may reflect inter-country differences in genetics, lipid testing, lifestyle habits, and pharmacologic treatment. Despite variability, elevated atherogenic lipid levels are a common global problem, and these results can help inform national policies and health system approaches to mitigate lipid-mediated risk of cardiovascular disease., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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). The Viral Hepatitis National Strategic Plan for the United States calls for ≥80% of persons with hepatitis C to achieve viral clearance by 2030 (3). Characterizing the steps that follow a person's progression from testing to viral clearance and subsequent infection (clearance cascade) is critical for monitoring progress toward national elimination goals. Following CDC guidance (4), a simplified national laboratory results-based HCV five-step clearance cascade was developed using longitudinal data from a large national commercial laboratory throughout the decade since highly effective hepatitis C treatments became available. During January 1, 2013-December 31, 2021, a total of 1,719,493 persons were identified as ever having been infected with HCV. During January 1, 2013-December 31, 2022, 88% of those ever infected were classified as having received viral testing; among those who received viral testing, 69% were classified as having initial infection; among those with initial infection, 34% were classified as cured or cleared (treatment-induced or spontaneous); and among those persons, 7% were categorized as having persistent infection or reinfection. Among the 1.0 million persons with evidence of initial infection, approximately one third had evidence of viral clearance (cured or cleared). This simplified national HCV clearance cascade identifies substantial gaps in cure nearly a decade since highly effective direct-acting antiviral (DAA) agents became available and will facilitate the process of monitoring progress toward national elimination goals. It is essential that increased access to diagnosis, treatment, and prevention services for persons with hepatitis C be addressed to prevent progression of disease and ongoing transmission and achieve national hepatitis C elimination goals., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Harvey W. Kaufman is an employee of and owns stock in Quest Diagnostics. William A. Meyer III is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed.

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. Rates of reinfection among index-positive individuals were compared to rates of infection among index-negative individuals. Factors associated with reinfection were evaluated using multivariable logistic regression. For both objectives, the outcome was a subsequent positive molecular diagnostic test result. Consistent with prior findings, the risk of reinfection among index-positive individuals was 87% lower than the risk of infection among index-negative individuals. The duration of protection against reinfection was stable over the median 5 months and up to 1-year follow-up interval. Factors associated with an increased reinfection risk included older age, comorbid immunologic conditions, and living in congregate care settings; healthcare workers had a decreased reinfection risk. This large US population-based study suggests that infection induced immunity is durable for variants circulating pre-Delta predominance., Competing Interests: Shannon L. Reynolds, Carly Kabelac, and Christopher Bush are employees of and own stock in Aetion, Inc. Harvey W. Kaufman and William A. Meyer III are employees of and own stock in Quest Diagnostics. Oren Cohen and Steve Anderson are employees of and own stock in Labcorp Drug Development. Steve Anderson has received consulting fees from Luminex. Sandy Leonard is an employee of and owns stock in HealthVerity. Douglas Lowry has received royalty-related payments from NIH. Kathy Cronin, Valentina Petkov, Norman Sharpless, and Lynne Penberthy report no conflict of interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

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. We evaluated treatment eligibility patterns among US patients with CHB and propose stepwise simplification of CHB treatment criteria., Methods: Using 2016-2020 Quest Diagnostics data, we evaluated treatment eligibility among patients with CHB (2 positive HBV tests [HBV surface antigen, HBV e antigen, or HBV DNA] ≥6 months apart) using American Association for the Study of Liver Disease (AASLD), European Association for Study of the Liver (EASL), Asian Pacific Association for Study of the Liver (APASL), and Asian American Treatment Algorithm (AATA) criteria., Results: Among 84 916 patients with CHB, 6.7%, 6.2%, 5.8%, and 16.4% met AASLD, EASL, APASL, and AATA criteria, respectively. Among treatment-ineligible patients with CHB, proportion with significant fibrosis (aspartate aminotransferase platelet ratio index >0.5) were 10.4%, 10.4%, 10.8%, and 7.7% based on AASLD, EASL, APASL, and AATA, respectively. In the proposed treatment simplification, the proportion of patients with CHB eligible for therapy increased from 10.3% for step 1 (HBV DNA >20 000 IU/mL, elevated alanine aminotransferase [ALT] level) to 14.1% for step 2 (HBV >2000 IU/mL, elevated ALT level), 33.5% for step 3 (HBV DNA >2000 IU/mL, any ALT level), and 87.2% for step 4 (detectable HBV DNA, any ALT level)., Conclusions: A large proportion of patients with CHB not meeting established treatment criteria have significant fibrosis. Simplifying criteria to treat all patients with detectable HBV DNA will reduce complexity and heterogeneity in assessing treatment eligibility, improving treatment rates and progress toward HBV elimination., Competing Interests: Potential conflicts of interest . R. J. W. has received funding (to his institution) from Gilead Sciences, and has served as a consultant and on the advisory board for Gilead Sciences. H. W. K., J. K. N., and H. K. are employees of and H. W. K. and H. K. own stock in Quest Diagnostics. R. G. G. reports grants received from Gilead Sciences; has served as an advisor or consultant to Abbott, AbbVie, Altimunne, Antios, Arrowhead, Dynavax, Eiger, Eisai, Enyo, Genentech, Genlantis, Gerson Lehrman Group, Gilead Sciences, Helios, HepaTX, HepQuant, Intercept, Janssen, Merck, Pfizer, Topography Health, Venatorx, Prodigy, Fibronostics, Fujifilm/Wako, Perspectum, Quest, and Sonic Incytes; has served on the data safety monitoring board for Altimmune, Arrowhead, CymaBay Therapeutics, and Durect; has served on the speaker’s bureau for AbbVie, BMS, Eisai, Genentech, Gilead Sciences, and Intercept; is a minor stock shareholder of RiboSciences and CoCrystal; and has received stock options from Eiger, Genlantis, HepQuant, and AngioCrine. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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. Decreased vaccine effectiveness among immunocompromised individuals is linked to correspondingly high rates of breakthrough infections. Negative results on SARS-CoV-2 antibody tests are associated with increased risk for subsequent infection. "Low-positive" results on semiquantitative SARS-CoV-2 spike-targeted antibody tests may help identify persons at increased risk as well. Standardized SARS-CoV-2 spike-targeted antibody tests may provide objective information on the risk of SARS-CoV-2 infection and associated adverse outcomes. This holds especially for high-risk populations that demonstrate a relatively high rate of seronegativity. The widespread availability of such tests presents an opportunity to refine risk assessment for individuals with suboptimal SARS-CoV-2 antibody levels and to promote effective interventions. Interim federal guidance would support physicians and patients while additional investigations are pursued.

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. Patients were clustered into 4 groups with varying rates of estimated glomerular filtration rate (eGFR) decline during the 2-year period prior to dialysis. Overall rates of hospitalization and death were 24.9% (582/2341) and 4.6% (108/2341), respectively. Groups with the steepest declines had the highest rates of hospitalization and death within 90 days of dialysis initiation. The rate of eGFR decline is a valuable and readily available tool to stratify short-term (90 days) risk of hospitalization and death after the initiation of renal dialysis. More intense approaches are needed that apply models that identify high risks to potentially avert or reduce short-term hospitalization and death of patients with a severe and rapidly progressive chronic kidney disease., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

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. A maximum likelihood (ML) tree was generated using IQTree. Transmission clusters with ≤3% genetic distance (GD) and ≥90% bootstrap support were identified using ClusterPicker. We conducted Bayesian analysis using BEAST to confirm transmission clusters. The proportion of nucleotides with ambiguity ≤0.5% was considered indicative of early infection. Descriptive statistics were applied to characterize clusters and group comparisons were performed using chi-square or t-test. Results: Among 2775 adults with data from 2014−2015, 2589 (93%) had subtype B HIV-1, mean age was 44 years (SD 12.7), 66.4% were male, and 25% had nucleotide ambiguity ≤0.5. There were 456 individuals in 193 clusters: 149 dyads, 32 triads, and 12 groups with ≥ four individuals per cluster. More commonly in clusters were males than females, 349 (76.5%) vs. 107 (23.5%), p < 0.0001; younger individuals, 35.3 years (SD 12.1) vs. 44.7 (SD 12.3), p < 0.0001; and those with early HIV-1 infection by nucleotide ambiguity, 202/456 (44.3%) vs. 442/2133 (20.7%), p < 0.0001. Members of 43/193 (22.3%) of clusters included individuals in different jurisdictions. Clusters ≥ four individuals were similarly found using BEAST. HIV-1 viral load (VL) ≥3.0 log10 c/mL was most common among individuals in clusters ≥ four, 18/21, (85.7%) compared to 137/208 (65.8%) in clusters sized 2−3, and 927/1169 (79.3%) who were not in a cluster (p < 0.0001). Discussion: HIV sequence data obtained for HIV clinical management provide insights into regional transmission dynamics. Our findings demonstrate the additional utility of HIV-1 VL data in combination with phylogenetic inferences as an enhanced contact tracing tool to direct HIV treatment and prevention services. Trans-jurisdictional approaches are needed to optimize efforts to end the HIV epidemic.

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), 6.7% received HDV testing, among which 2.2% were positive. HDV testing was higher in male patients, younger individuals, and patients with advanced liver disease. Among 12,002 CHB patients (Veterans Affairs), 19.7% received HDV testing, among which 3.1% were positive. HDV testing was higher in younger individuals and Asians., Discussion: Low HDV testing was observed among 2 large US cohorts of adults with CHB., (Copyright © 2022 Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.)

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., Design: Retrospective cohort study., Setting: Quest Diagnostics clinical laboratory data, 2014-2020., Patients: Chronic HBV infection was defined as any combination of 2 positive HBV surface antigen, HBV e antigen, or detectable HBV DNA tests at least 6 months apart. LTBI was defined as a positive QuantiFERON-TB or T-SPOT.TB test without evidence of active tuberculosis infection., Main Outcome Measurements: Testing patterns for chronic HBV infection and LTBI and prevalence of HBV-LTBI coinfection were evaluated from 2016 through 2020 and stratified by age, sex, and race and ethnicity., Results: Among 89 259 patients with chronic HBV infection, 9508 (10.7%) were tested for LTBI, among whom prevalence of HBV-LTBI coinfection was 19.6%, more than twice the observed prevalence of LTBI in patients with no chronic HBV infection in our cohort. Among 394 817 LTBI patients, 127 414 (32.3%) were tested for HBV, among whom prevalence of HBV-LTBI coinfection was 1.5%, approximately 3 times higher than prevalence of HBV infection in patients with no LTBI. The HBV-LTBI coinfection prevalence was highest among Asian Americans and older individuals., Limitations: The HBV-LTBI coinfection prevalence was likely underestimated because of suboptimal awareness and testing among at-risk populations., Conclusion: Among US individuals with chronic HBV infection or LTBI, prevalence of HBV-LTBI coinfection is substantial and highlights the need of testing for HBV-LTBI coinfection to mitigate risk of DILI associated with tuberculosis medications in patients with chronic HBV infection., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

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. The study included 5,048,428 pregnant persons aged 15-44 years with either Medicaid or commercial health insurance who had obstetric panel testing performed by Quest Diagnostics, January 2011-June 2021. Antibody screening for HCV infection increased before and accelerated after the updated recommendations in early 2020. Disparities in HCV testing by health insurance status were substantial over the entire study period. Despite substantial progress in the proportion of pregnant persons screened for HCV infection, current testing rates fall short of universal recommendations., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

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. These findings suggest heterogeneity with positivity rates of GBS-associated ganglioside antibodies during the COVID-19 pandemic. Mitigation strategies during the pandemic may have reduced the frequency of certain forms of GBS., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Recognizing that race is a social and not a biological construct, healthcare professionals and the public have called for removal of race in clinical algorithms. In response, the National Kidney Foundation and the American Society of Nephrology created the Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases to examine the issue and provide recommendations. The final report from the Task Force recommends calculating estimated glomerular filtration rate (eGFR) without a race coefficient using the recently published CKD-EPI 2021 creatinine (cr) and creatinine-cystatin C (cr-cys) equations. The Task Force recommends immediately replacing older eGFRcr equations (MDRD Study and CKD-EPI 2009) with the new CKD-EPI 2021 equation. In a 2019 survey by the College of American Pathologists, 23% of 6200 laboratories reporting eGFRcr used an incorrect equation that is not suitable for use with standardized creatinine measurements, 34% used the CKD-EPI 2009 equation and 43% used the MDRD Study 2006 equation re-expressed for standardized creatinine measurement. Rapid transition to using the CKD-EPI 2021 equation is an opportunity for laboratories to standardize to a single equation to eliminate differences in eGFRcr due to different equations used by different laboratories, and to report eGFR without use of race. We provide guidance to laboratories for implementing the CKD-EPI 2021 equations for both eGFRcr and eGFRcr-cys., (© American Association for Clinical Chemistry 2022.)

Objectives: Given the long-term consequences of untreated diabetes, patients benefit from timely diagnoses. Payer policies often recognize glucose but not hemoglobin A1c (HbA1c) for diabetes screening. This study evaluates the different information that glucose and HbA1c provide for diabetes screening., Methods: We conducted a retrospective review of national clinical laboratory testing during 2020 when glucose and HbA1c were ordered for routine diabetes screening, excluding patients with known diabetes, out-of-range glucose, or metabolic syndrome., Results: Of 15.47 million glucose and HbA1c tests ordered simultaneously, 672,467 (4.35%) met screening inclusion criteria; 116,585 (17.3%) were excluded because of diabetes-related conditions or the specimen was nonfasting, leaving 555,882 result pairs. More than 1 in 4 patients 60 years of age or older with glucose within range had an elevated HbA1c level. HbA1c claims were denied more often for Medicare beneficiaries (38,918/65,273 [59.6%]) than for other health plans combined (23,234/291,764 [8.0%])., Conclusions: Although many health plans do not cover HbA1c testing for diabetes screening, more than 1 in 4 glucose screening patients 60 years of age or older with an in-range glucose result had a concurrent elevated HbA1c result. Guideline developers and health plans should explicitly recognize that glucose and HbA1c provide complementary information and together offer improved clinical utility for diabetes screening., (© American Society for Clinical Pathology, 2021.)

Importance: No safe level of exposure to lead has been identified., Objective: To evaluate individual- and community-level factors associated with detectable and elevated blood lead levels (BLLs) in children., Design, Setting, and Participants: This cross-sectional, retrospective study analyzed deidentified results from blood lead tests performed at a large clinical laboratory from October 1, 2018, to February 29, 2020. Participants were 1 141 441 children younger than 6 years living in all 50 US states and the District of Columbia who underwent blood lead testing during the study period. Children who underwent lead testing of unknown source and those with elevated BLLs who received capillary blood lead testing without confirmatory venous testing were excluded., Exposures: Individual demographic categories included sex, age, and insurance type; community-level demographic categories included pre-1950s housing, poverty, predominant race and ethnicity, and geographical regions., Main Outcomes and Measures: Proportions of children with detectable (≥1.0 μg/dL) and elevated (≥5.0 μg/dL) BLLs, by exposure category., Results: Of the 1 141 441 children (586 703 boys [51.4%]; mean [SD] age, 2.3 [1.4] years) in the study, more than half of the children tested (576 092 [50.5%; 95% CI, 50.4%-50.6%]) had detectable BLLs, and 21 172 children (1.9% [95% CI, 1.8%-1.9%]) had BLLs of 5.0 μg/dL or more. In multivariable analyses, children with public insurance had greater odds of having detectable BLLs (adjusted odds ratio [AOR], 2.01 [95% CI, 1.99-2.04]) and elevated BLLs (AOR, 1.08 [95% CI, 1.04-1.12]). The proportion of children with detectable and elevated BLLs increased significantly for progressive pre-1950s housing and poverty quintiles (P < .001). The odds of detectable BLLs were significantly higher among children in the highest vs lowest quintile of pre-1950s housing (AOR, 1.65 [95% CI, 1.62-1.68]) and of poverty (AOR, 1.89 [95% CI, 1.86-1.93]). A similar association was found for those with elevated BLLs, with an AOR of 3.06 (95% CI, 2.86-3.27) for the highest vs lowest quintile of pre-1950 housing and 1.99 (95% CI, 1.88-2.11) for the highest quintile of poverty. Children residing in zip codes with predominantly Black non-Hispanic and non-Latinx populations had higher odds of detectable BLLs (AOR, 1.13 [95% CI, 1.11-1.15]) but lower odds for elevated BLL (AOR, 0.83 [95% CI, 0.80-0.88])., Conclusions and Relevance: This study suggests that, despite progress in reducing pediatric lead exposure, substantial individual- and community-level disparities persist.

Background: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) case surveillance relies on reported positive laboratory results. Changes in reported cases may represent changes in testing practice or infection prevalence. This study evaluated changes over time for CT and NG positivity and testing rates of pregnant persons., Methods: Prenatal testing results from persons aged 16 to 40 years tested by a national reference clinical laboratory were analyzed for CT and NG testing and positivity from 2010 to 2018 (n = 3,270,610)., Results: Testing rates increased among pregnant persons for CT (from 56.3% in 2010 to 64.1% in 2018, P < 0.001) and NG (from 55.6% to 63.2%, P < 0.001). Higher CT testing rates were found in Black non-Hispanic (adjusted odds ratio [AOR], 1.58; 95% confidence interval [CI], 1.57-1.60) and Hispanic (AOR, 1.19; 95% CI, 1.18-1.20) persons. NG and CT testing rates were virtually identical. Significant increasing trends in CT positivity were observed for each age group studied (P < 0.001 for all): 16-19 (from 11.7% to 13.0%), 20-24 (from 6.4% to 6.7%), 25-30 (from 1.9% to 2.4%), and 31-40 years (from 0.76% to 0.92%). Black non-Hispanic persons had the highest positivity for CT (AOR, 2.52; 95% CI, 2.46-2.57) and NG (AOR, 5.42; 95% CI, 5.05-5.82)., Conclusions: Testing and adjusted positivity for both CT and NG among pregnant persons increased from 2010 to 2018. Higher testing rates were observed in Black non-Hispanic and Hispanic persons (even in persons younger than 25 years), suggesting some testing decisions may have been based on perceived risk, in contrast to many guidelines recommending screening all pregnant persons younger than 25 years., Competing Interests: Conflict of Interest and Sources of Funding: Quest Diagnostics provided support in the form of salaries for J.K.N., H.W.K., and D.P.A. but had no role in study design, collection, analysis, interpretation of data, writing the report, or the decision to submit the report for publication. H.W.K. and D.P.A. own stock in Quest Diagnostics. T.A.P., G.T., and T.L.G. have no disclosures., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Jeffrey Gudin reports consulting fees from Quest Diagnostics. Harvey W. Kaufman reports stock holdings in Quest Diagnostics. No other potential conflicts of interest were disclosed.

Introduction: This study evaluates the impact of the COVID-19 pandemic on testing for common sexually transmitted infections. Specifically, changes are measured in chlamydia and gonorrhea testing and case detection among patients aged 14-49 years during the COVID-19 pandemic., Methods: U.S. chlamydia and gonorrhea testing and positivity were analyzed on the basis of >18.6 million tests (13.6 million tests for female patients and 4.7 million tests for male patients) performed by a national reference clinical laboratory from January 2019 through June 2020., Results: Chlamydia and gonorrhea testing reached a nadir in early April 2020, with decreases (relative to the baseline level) of 59% for female patients and 63% for male patients. Declines in testing were strongly associated with increases in weekly positivity rates for chlamydia (R 2 =0.96) and gonorrhea (R 2 =0.85). From March 2020 through June 2020, an expected 27,659 (26.4%) chlamydia and 5,577 (16.5%) gonorrhea cases were potentially missed., Conclusions: The COVID-19 pandemic impacted routine sexually transmitted infection services, suggesting an increase in syndromic sexually transmitted infection testing and missed asymptomatic cases. Follow-up analyses will be needed to assess the long-term implications of missed screening opportunities. These findings should serve as a warning for the potential sexual and reproductive health implications that can be expected from the overall decline in testing and potential missed cases., (Copyright © 2021 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This study examined changes in prostate disease screening (prostatic-specific antigen [PSA] testing), prostate biopsy testing, and prostate cancer diagnoses during the COVID-19 pandemic through December 2020., Materials and Methods: This analysis included test results from men ≥ 40 years, without prior International Classification of Diseases-10 record of prostate cancer since January 2016, who received PSA or prostate biopsy testing at Quest Diagnostics during January 2018-December 2020. Monthly trends were evaluated for three periods: prepandemic (January 2018-February 2020), early-pandemic (March-May 2020), and late-pandemic (June-December 2020)., Results: Meeting inclusion criteria were 16,365,833 PSA and 48,819 prostate biopsy results. The average monthly number of PSA tests declined from 465,187 prepandemic to 295,786 early-pandemic (36.4% decrease; P = .01) before rebounding to 483,374 (3.9% increase; P = .23) late-pandemic. The monthly average number of PSA results ≥ 50 ng/mL (23,356; 0.14% of all PSA results) dipped from 659 prepandemic to 506 early-pandemic (23.2% decrease; P = .02) and rebounded to 674 late-pandemic (2.3% increase; P = .65). The average monthly number of prostate biopsy results decreased from 1,453 prepandemic to 903 early-pandemic (37.9% decrease; P = .01) before rebounding to 1,190 late-pandemic (18.1% decrease; P = .01). The average monthly number for Gleason score ≥ 8 (6,241; 12.8% of all prostate biopsies) declined from 182 prepandemic to 130 early-pandemic (28.6% decrease; P = .02) and decreased to 161 late-pandemic (11.5% decrease; P = .02)., Conclusion: The findings suggest that a substantial number of prostate screening opportunities and cancer diagnoses have been missed. Efforts are needed to bring such patients back for screening and diagnostic testing and to restore appropriate care for non-COVID-19-related medical conditions., Competing Interests: Harvey W. KaufmanStock and Other Ownership Interests: Quest Diagnostics Zhen ChenEmployment: Quest DiagnosticsStock and Other Ownership Interests: Quest Diagnostics Justin K. NilesEmployment: Quest Diagnostics Jeff RadcliffEmployment: Quest DiagnosticsStock and Other Ownership Interests: Quest Diagnostics Yuri FeskoEmployment: Quest DiagnosticsLeadership: Quest DiagnosticsStock and Other Ownership Interests: Quest DiagnosticsNo other potential conflicts of interest were reported.

Introduction: The COVID-19 pandemic has disrupted healthcare services, reducing opportunities to conduct routine hepatitis C virus antibody screening, clinical care, and treatment. Therefore, people living with undiagnosed hepatitis C virus during the pandemic may later become identified at more advanced stages of the disease, leading to higher morbidity and mortality rates. Further, unidentified hepatitis C virus-infected individuals may continue to unknowingly transmit the virus to others., Methods: To assess the impact of the COVID-19 pandemic, data were evaluated from a large national reference clinical laboratory and from national estimates of dispensed prescriptions for hepatitis C virus treatment. Investigators estimated the average number of hepatitis C virus antibody tests, hepatitis C virus antibody-positive test results, and hepatitis C virus RNA-positive test results by month in January-July for 2018 and 2019, compared with the same months in 2020. To assess the impact of hepatitis C virus treatment, dispensed hepatitis C virus direct-acting antiretroviral medications were examined for the same time periods. Statistical analyses of trends were performed using negative binomial models., Results: Compared with the 2018 and 2019 months, hepatitis C virus antibody testing volume decreased 59% during April 2020 and rebounded to a 6% reduction in July 2020. The number of hepatitis C virus RNA-positive results fell by 62% in March 2020 and remained 39% below the baseline by July 2020. For hepatitis C virus treatment, prescriptions decreased 43% in May, 37% in June, and 38% in July relative to the corresponding months in 2018 and 2019., Conclusions: During the COVID-19 pandemic, continued public health messaging, interventions and outreach programs to restore hepatitis C virus testing and treatment to prepandemic levels, and maintenance of public health efforts to eliminate hepatitis C infections remain important., (Copyright © 2021 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Importance: Understanding the effect of serum antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on susceptibility to infection is important for identifying at-risk populations and could have implications for vaccine deployment., Objective: The study purpose was to evaluate evidence of SARS-CoV-2 infection based on diagnostic nucleic acid amplification test (NAAT) among patients with positive vs negative test results for antibodies in an observational descriptive cohort study of clinical laboratory and linked claims data., Design, Setting, and Participants: The study created cohorts from a deidentified data set composed of commercial laboratory tests, medical and pharmacy claims, electronic health records, and hospital chargemaster data. Patients were categorized as antibody-positive or antibody-negative according to their first SARS-CoV-2 antibody test in the database., Main Outcomes and Measures: Primary end points were post-index diagnostic NAAT results, with infection defined as a positive diagnostic test post-index, measured in 30-day intervals (0-30, 31-60, 61-90, >90 days). Additional measures included demographic, geographic, and clinical characteristics at the time of the index antibody test, including recorded signs and symptoms or prior evidence of coronavirus 2019 (COVID) diagnoses or positive NAAT results and recorded comorbidities., Results: The cohort included 3 257 478 unique patients with an index antibody test; 56% were female with a median (SD) age of 48 (20) years. Of these, 2 876 773 (88.3%) had a negative index antibody result, and 378 606 (11.6%) had a positive index antibody result. Patients with a negative antibody test result were older than those with a positive result (mean age 48 vs 44 years). Of index-positive patients, 18.4% converted to seronegative over the follow-up period. During the follow-up periods, the ratio (95% CI) of positive NAAT results among individuals who had a positive antibody test at index vs those with a negative antibody test at index was 2.85 (95% CI, 2.73-2.97) at 0 to 30 days, 0.67 (95% CI, 0.6-0.74) at 31 to 60 days, 0.29 (95% CI, 0.24-0.35) at 61 to 90 days, and 0.10 (95% CI, 0.05-0.19) at more than 90 days., Conclusions and Relevance: In this cohort study, patients with positive antibody test results were initially more likely to have positive NAAT results, consistent with prolonged RNA shedding, but became markedly less likely to have positive NAAT results over time, suggesting that seropositivity is associated with protection from infection. The duration of protection is unknown, and protection may wane over time.

Numerous reports indicate that African Americans and Latinos are being affected disproportionately by coronavirus disease 2019 (COVID-19). Positivity rates have not been analyzed on scale because only 4 states report race/ethnicity as part of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. Previous studies also have had little ability to control for many known risk factors to better identify the effects of COVID-19 on racial and ethnic communities. Using test results from a large national reference laboratory database that included patients from all 50 states and the District of Columbia, this study compared positivity rates for SARS-CoV-2 nucleic acid amplification tests (NAAT) among various race/ethnicity groups by linking zip code-based race/ethnicity proportions from US Census data. Analysis of 2,331,175 unique patients tested March-May 2020 demonstrated an increasing trend in SARS-CoV-2 NAAT positivity across Black non-Hispanic community progressive quintiles (from 7.8% to 17.2%, P  < 0.0001) and Hispanic community progressive quintiles (from 8.4% to 15.5%, P  < 0.0001) and a decreasing trend across White non-Hispanic community progressive quintiles (from 17.4% to 7.1%, P  < 0.0001). These trends in viral ribonucleic acid positivity remained in stratified analyses and in multivariable models that controlled for known risk factors including sex, population density, and the states initially hardest hit by COVID-19. These findings indicate that communities with the highest proportions of Black non-Hispanic and Hispanic populations have the highest SARS-CoV-2 NAAT positivity rates, even after controlling for other risk factors. More efforts are needed to mitigate the increased impact of COVID-19 on both the African American and Hispanic communities.

The convergence of the opioid epidemic and the coronavirus disease 2019 (COVID-19) pandemic has created new health care challenges. The authors analyzed changes in clinical drug testing patterns and results at a national clinical laboratory, comparing data obtained before and during the pandemic. Testing for prescription and illicit drugs declined rapidly during the pandemic, with weekly test volumes falling by approximately 70% from the baseline period to the trough (the week beginning March 29) before rising in subsequent weeks. Among individuals tested, positivity increased by 35% for non-prescribed fentanyl and 44% for heroin during the pandemic. Positivity for non-prescribed fentanyl increased significantly among patients positive for other drugs: by 89% for specimens positive for amphetamines; 48% for benzodiazepines; 34% for cocaine; and 39% for opiates ( P  < 0.01 for all comparisons). These findings suggest significant increases in dangerous drug combinations. Positivity for non-prescribed use of many other drugs remained consistent or declined for some drugs, relative to pre-pandemic patterns. Models adjusting for potential confounding variables, including medication-assisted treatment and treatment at a substance use disorder facility indicated that the risk for non-prescribed fentanyl positivity rose by more than 50% during the pandemic. In summary, these findings demonstrate decreased drug testing overall, with increased positivity for high-risk drugs and dangerous drug combinations. The convergence of the drug abuse epidemic and COVID-19 pandemic has led to an increased need for health care and public health resources dedicated to supporting vulnerable patients and addressing the underlying causes of these disturbing trends.

Serologic tests for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) provide information on past infection and immune response. To better understand the persistence of immune response and the proportion of the population who can develop one, the authors assessed patterns of immunoglobulin G (IgG) positivity over time in individuals tested for SARS-CoV-2 RNA or IgG at a large national reference laboratory. More than 2.4 million SARS-CoV-2 IgG serology (initiated April 21, 2020) and 6.6 million nucleic acid amplification testing (NAAT) (initiated March 9, 2020) results on persons from across the United States as of July 10, 2020 were analyzed. Additional IgG serology results through August 11, 2020 were used for one household analysis. SARS-CoV-2 IgG positivity was observed in 91% (19,434/21,452) of individuals tested after a positive NAAT result and in 10% (7,831/80,968) after a negative NAAT result. Factors associated with seropositivity include age, region of patient residence, and interval between NAAT and IgG serology. The probability of persistent IgG seropositivity declined from 98.6% after 1 week to 74.3% after 2 months, less so in individuals ages ≥55 years than in younger groups. Specimens within 2 days from pairs of same-household members showed 92% IgG antibody concordance. Household adults were more frequently IgG positive prior to household children testing positive (36% versus 8%). IgG serology testing can identify an immune response to SARS-CoV-2 that varies based on age, sex, and duration since exposure. Loss of detectable IgG seropositivity occurs, in some patients, over weeks or months. Adults may be infecting household children.

Introduction: This study aims to determine if and how the age distribution of Chlamydia trachomatis and Neisseria gonorrhoeae infections in women evolved from 2010 to 2017, given changes in sexual practices over this time., Methods: All Chlamydia trachomatis/Neisseria gonorrhoeae co-testing laboratory results from females aged 12-30 years tested at Quest Diagnostics during 2010-2017 (n=17,794,680) were evaluated to assess trends in Chlamydia trachomatis and Neisseria gonorrhoeae positivity over time. Data were collected and analyzed in November 2018., Results: Age-based positivity shifted toward older ages from 2010 to 2017 for both Chlamydia trachomatis and Neisseria gonorrhoeae. There was a declining trend in Chlamydia trachomatis positivity from 2010 to 2017 for the youngest age group (12-17 years; 17% decline, 8.9% to 7.4%, p<0.0001) but increasing trends for both those aged 18-24 years (21% increase, 6.1% to 7.4%, p<0.0001) and 25-30 years (50% increase, 2.2% to 3.3%, p<0.0001). The Chlamydia trachomatis positivity rate for 27-year-olds in 2017 (3.5%) and 24-year-olds in 2010 (3.5%) was the same. Similarly, there was a declining trend in Neisseria gonorrhoeae positivity from 2010 to 2017 for the youngest age group (12-17 years; 14% decline, 1.33% vs 1.17%, p<0.0001) but increasing trends for both those aged 18-24 years (27% increase, 0.79% vs 1.00%, p<0.0001) and 25-30 years (117% increase, 0.29% vs 0.63%, p<0.0001). For Neisseria gonorrhoeae, 30-year-old women tested in 2017 had an identical positivity rate to 23-year-old women tested in 2010, at 0.5%., Conclusions: Healthcare providers may want to consider this positivity rate age shift in Chlamydia trachomatis and Neisseria gonorrhoeae to inform prevention and control strategies, including considering the potential for increased risk in women aged 25-30 years., (Copyright © 2020 American Journal of Preventive Medicine. All rights reserved.)

Background: Nucleic acid amplification testing is a critical tool for addressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Specimen pooling can increase throughput and conserve testing resources but requires validation to ensure that reduced sensitivity does not increase the false-negative rate. We evaluated the performance of a real-time reverse transcription polymerase chain reaction (RT-PCR) test authorized by the US Food and Drug Administration (FDA) for emergency use for pooled testing of upper respiratory specimens., Methods: Positive specimens were selected from 3 prevalence groups, 1%-3%, >3%-6%, and >6%-10%. Positive percent agreement (PPA) was assessed by pooling single-positive specimens with 3 negative specimens; performance was assessed using Passing-Bablok regression. Additionally, we assessed the distributions of RT-PCR cycle threshold (Ct) values for 3091 positive specimens., Results: PPA was 100% for the 101 pooled specimens. There was a linear relationship between Ct values for pooled and single-tested specimens ( r = 0.96-0.99; slope ≈ 1). The mean pooled Ct shifts at 40 cycles were 2.38 and 1.90, respectively, for the N1 and N3 targets. The median Cts for 3091 positive specimens were 25.9 (N1) and 24.7 (N3). The percentage of positive specimens with Cts between 40 and the shifted Ct was 1.42% (N1) and 0.0% (N3)., Conclusions: Pooled and individual testing of specimens positive for SARS-CoV-2 demonstrated 100% agreement, which demonstrates the viability of pooled specimens for SARS-COV-2 testing using a dual-target RT-PCR system. Pooled specimen testing can help increase testing capacity for SARS-CoV-2 with a low risk of false-negative results., (© The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Until treatment and vaccine for coronavirus disease-2019 (COVID-19) becomes widely available, other methods of reducing infection rates should be explored. This study used a retrospective, observational analysis of deidentified tests performed at a national clinical laboratory to determine if circulating 25-hydroxyvitamin D (25(OH)D) levels are associated with severe acute respiratory disease coronavirus 2 (SARS-CoV-2) positivity rates. Over 190,000 patients from all 50 states with SARS-CoV-2 results performed mid-March through mid-June, 2020 and matching 25(OH)D results from the preceding 12 months were included. Residential zip code data was required to match with US Census data and perform analyses of race/ethnicity proportions and latitude. A total of 191,779 patients were included (median age, 54 years [interquartile range 40.4-64.7]; 68% female. The SARS-CoV-2 positivity rate was 9.3% (95% C.I. 9.2-9.5%) and the mean seasonally adjusted 25(OH)D was 31.7 (SD 11.7). The SARS-CoV-2 positivity rate was higher in the 39,190 patients with "deficient" 25(OH)D values (<20 ng/mL) (12.5%, 95% C.I. 12.2-12.8%) than in the 27,870 patients with "adequate" values (30-34 ng/mL) (8.1%, 95% C.I. 7.8-8.4%) and the 12,321 patients with values ≥55 ng/mL (5.9%, 95% C.I. 5.5-6.4%). The association between 25(OH)D levels and SARS-CoV-2 positivity was best fitted by the weighted second-order polynomial regression, which indicated strong correlation in the total population (R2 = 0.96) and in analyses stratified by all studied demographic factors. The association between lower SARS-CoV-2 positivity rates and higher circulating 25(OH)D levels remained significant in a multivariable logistic model adjusting for all included demographic factors (adjusted odds ratio 0.984 per ng/mL increment, 95% C.I. 0.983-0.986; p<0.001). SARS-CoV-2 positivity is strongly and inversely associated with circulating 25(OH)D levels, a relationship that persists across latitudes, races/ethnicities, both sexes, and age ranges. Our findings provide impetus to explore the role of vitamin D supplementation in reducing the risk for SARS-CoV-2 infection and COVID-19 disease., Competing Interests: HWK, JKN, MHK, and CB are employees of Quest Diagnostics. HWK, MHK and CB own stock in Quest Diagnostics. MFH is a consultant to Quest Diagnostics and was on the speakers’ bureau for Abbott Inc. and Hyatt Pharmaceutical Industries Company PLC.

Objectives: Given the recent debate challenging the contribution of cytology in cervical screening, we evaluated results of liquid-based cytology (LBC) and human papillomavirus (HPV) testing in cotesting preceding cervical cancer (CxCa) and precancer diagnoses in a national, heterogeneous population., Methods: We assessed the results of cotesting, performed by Quest Diagnostics, in 13,633,071 women 30 years and older, tested 2010 to 2018. Cotest results preceding CxCa or precancer diagnoses were analyzed and stratified by histopathology., Results: Among all screening results, 1,615 cotests preceded 1,259 CxCa diagnoses, and 11,164 cotests preceded 8,048 cervical precancer diagnoses. More women who were subsequently diagnosed with CxCa within 1 year were identified by the LBC result than by the HPV result (85.1%, 1,015/1,193 vs 77.5%, 925/1,193). Among all women with CxCa, the overall rate of nondetection was 13.1% (212/1,615) for cotesting results (LBC negative/HPV negative) and this rate increased substantially when testing exceeded 12 months compared to within 1 year prediagnosis of either CxCa or precancer., Conclusions: Analysis of 9-year cotest results from a national reference laboratory confirms the value of LBC element in cotesting. This supports that LBC/HPV cotesting enhances screening for the identification of CxCa in women 30 years and older, more so than LBC or HPV alone within cotesting., (© American Society for Clinical Pathology, 2020.)