scholarly journals SARS-CoV-2 supply shortages and TB diagnostics: Current issues requiring immediate solutions

2021 ◽  
Author(s):  
Derek T. Armstrong ◽  
Erin A. Tacheny ◽  
Gene Olinger ◽  
Ryan Howard ◽  
M. Megan Lemmon ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Laboratory Testing ◽  
The United States ◽  
Current Testing ◽  
Testing Algorithms ◽  
Tb Diagnostics

The SARS-CoV-2 pandemic has strained manufacturing capacity worldwide resulting in significant shortages of laboratory supplies both directly and indirectly. Such shortages include probe-based kits for detection of the M. tuberculosis complex from positive liquid broth cultures. These shortages and possible loss of this particular assay have consequences for laboratory testing algorithms and public health in the United States. As there are no FDA approved, commercially available options that currently exist which could immediately fill this gap, laboratories must identify alternatives and plan for modifying current testing algorithms to accommodate this change.

National Inventory of Clinical Laboratory Testing Services (NICLTS)

2000 ◽  
Vol 124 (8) ◽  
pp. 1201-1208 ◽  
Author(s):  
Steven J. Steindel ◽  
William J. Rauch ◽  
Marianne K. Simon ◽  
James Handsfield
Keyword(s):  
Public Health ◽  
United States ◽  
Health Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
High Complexity ◽  
Specimen Type ◽  
The Us ◽  
Clinical Laboratory Testing

Abstract Context.—A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective.—To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design.—Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main Outcome Measure.—Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results.—An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 ± 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.—A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

Characterization of Microorganism Identification in the United States in 1996

2001 ◽  
Vol 125 (7) ◽  
pp. 913-920
Author(s):  
Steven J. Steindel ◽  
Marianne K. Simon
Keyword(s):  
Public Health ◽  
United States ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Direct Methods ◽  
The United States ◽  
Test Method ◽  
Confidence Limits ◽  
Public Health Importance ◽  
Microorganism Identification

Abstract Context.—The National Inventory of Clinical Laboratory Testing Services (NICLTS) was designed to give an unbiased estimate of all patient testing performed by laboratories registered under the Clinical Laboratory Improvement Amendments in 1996. Objective.—Survey data were used to develop a profile of laboratory testing primarily intended to identify microorganisms or antibodies to these microorganisms. Design.—Estimates of the extent of microorganism identification were derived from the NICLTS database by identifying associated tests and methods. The volumes for tests performed at locations that primarily prepared blood components for distribution were excluded. Organisms of public health importance were identified from the National Notifiable Disease list maintained by the Centers for Disease Control and Prevention. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing in 1996. Outcome Measure.—Estimated volumes and associated confidence limits by test, method, specimen type, public health importance, and testing location. Results.—Excluding testing of the blood supply, 315 million tests (95% confidence limits, 280–354 million tests) were performed in the United States for microorganism identification. Those tests for which public health consensus requires national reporting represented 38% of this total. Although hospitals performed 46% of all microorganism identification, they only performed 33% of the testing for microorganisms of public health importance. Independent and specialty laboratories performed 38% of all testing but 65% of the testing for microorganisms of public health importance. Direct methods (methods not involving culture) were used in 77% of the tests for microorganisms of public health importance and in 42% of all identification tests. Conclusions.—The distribution of microorganism identification testing found using NICLTS data is consistent with plans to modernize the public health surveillance system in the United States.

Can increases in Twitter posts predict increases in cumulative incidence of COVID-19 in the United States? Evidence that social media can inform epidemic surveillance. (Preprint)

2020 ◽  
Author(s):  
Ruoyan Sun ◽  
Henna Budhwani
Keyword(s):  
Public Health ◽  
United States ◽  
Cumulative Incidence ◽  
Hot Spots ◽  
Adult Population ◽  
State Level ◽  
The United States ◽  
Education Attainment ◽  
Public Health Systems ◽  
Per Capita

BACKGROUND Though public health systems are responding rapidly to the COVID-19 pandemic, outcomes from publicly available, crowd-sourced big data may assist in helping to identify hot spots, prioritize equipment allocation and staffing, while also informing health policy related to “shelter in place” and social distancing recommendations. OBJECTIVE To assess if the rising state-level prevalence of COVID-19 related posts on Twitter (tweets) is predictive of state-level cumulative COVID-19 incidence after controlling for socio-economic characteristics. METHODS We identified extracted COVID-19 related tweets from January 21st to March 7th (2020) across all 50 states (N = 7,427,057). Tweets were combined with state-level characteristics and confirmed COVID-19 cases to determine the association between public commentary and cumulative incidence. RESULTS The cumulative incidence of COVID-19 cases varied significantly across states. Ratio of tweet increase (p=0.03), number of physicians per 1,000 population (p=0.01), education attainment (p=0.006), income per capita (p = 0.002), and percentage of adult population (p=0.003) were positively associated with cumulative incidence. Ratio of tweet increase was significantly associated with the logarithmic of cumulative incidence (p=0.06) with a coefficient of 0.26. CONCLUSIONS An increase in the prevalence of state-level tweets was predictive of an increase in COVID-19 diagnoses, providing evidence that Twitter can be a valuable surveillance tool for public health.

Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA

2021 ◽  
pp. 174113432110235
Author(s):  
Chandan Saini ◽  
Ashish Miglani ◽  
Pankaj Musyuni ◽  
Geeta Aggarwal
Keyword(s):  
Public Health ◽  
United States ◽  
Regulatory Authority ◽  
The United States ◽  
Federal Law ◽  
Pharmaceutical Manufacturers ◽  
The World ◽  
Considerable Impact ◽  
A Company ◽  
Responsible Person

Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.

scholarly journals Challenges in evaluating the use of viral sequence data to identify HIV transmission networks for public health

2020 ◽  
Vol 12 (s1) ◽  
Author(s):  
Rami Kantor ◽  
John P. Fulton ◽  
Jon Steingrimsson ◽  
Vladimir Novitsky ◽  
Mark Howison ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Hiv Transmission ◽  
Sequence Data ◽  
The United States ◽  
Viral Sequence ◽  
Transmission Networks ◽  
New Methods ◽  
Hiv Epidemic ◽  
The World

AbstractGreat efforts are devoted to end the HIV epidemic as it continues to have profound public health consequences in the United States and throughout the world, and new interventions and strategies are continuously needed. The use of HIV sequence data to infer transmission networks holds much promise to direct public heath interventions where they are most needed. As these new methods are being implemented, evaluating their benefits is essential. In this paper, we recognize challenges associated with such evaluation, and make the case that overcoming these challenges is key to the use of HIV sequence data in routine public health actions to disrupt HIV transmission networks.

scholarly journals Dual MD–MPH Degree Students in the United States: Moving the Medical Workforce Toward Population Health

2021 ◽  
pp. 003335492097842
Author(s):  
Jo Marie Reilly ◽  
Christine M. Plepys ◽  
Michael R. Cousineau
Keyword(s):  
Public Health ◽  
United States ◽  
Population Health ◽  
Health Care Policy ◽  
The United States ◽  
Extensive Literature ◽  
Master Of Public Health ◽  
Telephone Interviews ◽  
Public Health Training ◽  
The Impact

Objective A growing need exists to train physicians in population health to meet the increasing need and demand for physicians with leadership, health data management/metrics, and epidemiology skills to better serve the health of the community. This study examines current trends in students pursuing a dual doctor of medicine (MD)–master of public health (MPH) degree (MD–MPH) in the United States. Methods We conducted an extensive literature review of existing MD–MPH databases to determine characteristics (eg, sex, race/ethnicity, MPH area of study) of this student cohort in 2019. We examined a trend in the MD community to pursue an MPH career, adding additional public health and health care policy training to the MD workforce. We conducted targeted telephone interviews with 20 admissions personnel and faculty at schools offering MD–MPH degrees in the United States with the highest number of matriculants and graduates. Interviews focused on curricula trends in medical schools that offer an MD–MPH degree. Results No literature describes the US MD–MPH cohort, and available MD–MPH databases are limited and incomplete. We found a 434% increase in the number of students pursuing an MD–MPH degree from 2010 to 2018. The rate of growth was greater than the increase in either the number of medical students (16%) or the number of MPH students (65%) alone. Moreover, MD–MPH students as a percentage of total MPH students more than tripled, from 1.1% in 2010 to 3.6% in 2018. Conclusions As more MD students pursue public health training, the impact of an MPH degree on medical school curricula, MD–MPH graduates, and MD–MPH career pursuits should be studied using accurate and comprehensive databases.

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