Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-20 (of 20 Records) |
Query Trace: Kojima N[original query] |
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Commutability assessment of new standard reference materials (SRMs) for determining serum total 25-hydroxyvitamin D using ligand binding and liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays
Wise SA , Cavalier É , Lukas P , Peeters S , Le Goff C , Briggs LE , Williams EL , Mineva E , Pfeiffer CM , Vesper H , Popp C , Beckert C , Schultess J , Wang K , Tourneur C , Pease C , Osterritter D , Fischer R , Saida B , Dou C , Kojima S , Weiler HA , Bielecki A , Pham H , Bennett A , You S , Ghoshal AK , Wei B , Vogl C , Freeman J , Parker N , Pagliaro S , Cheek J , Li J , Tsukamoto H , Galvin K , Cashman KD , Liao HC , Hoofnagle AN , Budd JR , Kuszak AJ , Boggs ASP , Burdette CQ , Hahm G , Nalin F , Camara JE . Anal Bioanal Chem 2025 Commutability is where the measurement response for a reference material (RM) is the same as for an individual patient sample with the same concentration of analyte measured using two or more measurement systems. Assessment of commutability is essential when the RM is used in a calibration hierarchy or to ensure that clinical measurements are comparable across different measurement procedures and at different times. The commutability of three new Standard Reference Materials(®) (SRMs) for determining serum total 25-hydroxyvitamin D [25(OH)D], defined as the sum of 25-hydroxyvitamin D(2) [25(OH)D(2)] and 25-hydroxyvitamin D(3) [25(OH)D(3)], was assessed through an interlaboratory study. The following SRMs were assessed: (1) SRM 2969 Vitamin D Metabolites in Frozen Human Serum (Total 25-Hydroxyvitamin D Low Level), (2) SRM 2970 Vitamin D Metabolites in Frozen Human Serum (25-Hydroxyvitamin D(2) High Level), and (3) SRM 1949 Frozen Human Prenatal Serum. These SRMs represent three clinically relevant situations including (1) low levels of total 25(OH)D, (2) high level of 25(OH)D(2), and (3) 25(OH)D levels in nonpregnant women and women during each of the three trimesters of pregnancy with changing concentrations of vitamin D-binding protein (VDBP). Twelve laboratories using 17 different ligand binding assays and eight laboratories using nine commercial and custom liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays provided results in this study. Commutability of the SRMs with patient samples was assessed using the Clinical and Laboratory Standards Institute (CLSI) approach based on 95% prediction intervals or a pre-set commutability criterion and the recently introduced International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approach based on differences in bias for the clinical and reference material samples using a commutability criterion of 8.8%. All three SRMs were deemed as commutable with all LC-MS/MS assays using both CLSI and IFCC approaches. SRM 2969 and SRM 2970 were deemed noncommutable for three and seven different ligand binding assays, respectively, when using the IFCC approach. Except for two assays, one or more of the three pregnancy levels of SRM 1949 were deemed noncommutable or inconclusive using different ligand binding assays and the commutability criterion of 8.8%. Overall, a noncommutable assessment for ligand binding assays is determined for these SRMs primarily due to a lack of assay selectivity related to 25(OH)D(2) or an increasing VDBP in pregnancy trimester materials rather than the quality of the SRMs. With results from 17 different ligand binding and nine LC-MS/MS assays, this study provides valuable knowledge for clinical laboratories to inform SRM selection when assessing 25(OH)D status in patient populations, particularly in subpopulations with low levels of 25(OH)D, high levels of 25(OH)D(2), women only, or women who are pregnant. |
US public health preparedness and response to highly pathogenic avian influenza A(H5N1) viruses
Kojima N , Blumberg A , Radcliffe R , Flannery B , Uyeki TM . Jama 2024 ![]() ![]() US public health preparedness and response to highly pathogenic avian influenza A(H5N1) viruses are assessed in this survey study conducted by the CDC. | eng |
Clinical outcomes of US adults hospitalized for COVID-19 and influenza in the Respiratory Virus Hospitalization Surveillance Network, October 2021-September 2022
Kojima N , Taylor CA , Tenforde MW , Ujamaa D , O'Halloran A , Patel K , Chai SJ , Daily Kirley P , Alden NB , Kawasaki B , Meek J , Yousey-Hindes K , Anderson EJ , Openo KP , Reeg L , Tellez Nunez V , Lynfield R , Como-Sabetti K , Ropp SL , Shaw YP , Spina NL , Barney G , Bushey S , Popham K , Moran NE , Shiltz E , Sutton M , Abdullah N , Talbot HK , Schaffner W , Chatelain R , Price A , Garg S , Havers FP , Bozio CH . Open Forum Infect Dis 2024 11 (1) ofad702 Severe outcomes were common among adults hospitalized for COVID-19 or influenza, while the percentage of COVID-19 hospitalizations involving critical care decreased from October 2021 to September 2022. During the Omicron BA.5 period, intensive care unit admission frequency was similar for COVID-19 and influenza, although patients with COVID-19 had a higher frequency of in-hospital death. |
Influenza incidence, lineages, and vaccine effectiveness estimates in Lima, Peru, 2023
Acevedo-Rodriguez JG , Zamudio C , Kojima N , Krapp F , Tsukayama P , Sal YRosas Celi VG , Baldeon D , Neciosup-Vera CS , Medina C , Gonzalez-Lagos E , Castro L , Fowlkes A , Azziz-Baumgartner E , Gotuzzo E . Lancet Microbe 2024 Characterisation of influenza viruses in the southern hemisphere can guide local response and provide insights to northern hemisphere jurisdictions about their upcoming influenza season.1,2 Here, we present the information on 2023 end of influenza season in the southern hemisphere about influenza lineages, incidence of medically attended, laboratory-confirmed influenza cases, and influenza vaccine effectiveness (VE) against the antigen from surveillance clinics and a hospital in San Juan de Lurigancho and San Martin de Porres, the two most populated districts of Peru. | | From Jan 1 to Sept 30, 2023, surveillance nurses sought individuals with COVID-19-like illness (CLI) of any age seeking care at outpatient sentinel sites between Monday and Saturday. CLI was defined as presenting with at least two of the following symptoms or signs—fever, chills, rigors, myalgia, headache, or sore throat for not more than 7 days from illness onset.3 On March 7, 2023, the nurses expanded their search to CLI cases hospitalised for not more than 72 h at Cayetano Heredia National Hospital. | | Nurses obtained written consent to survey and swab CLI cases. Enrolled participants provided information on pre-existing conditions and influenza vaccination status. Individuals targeted for vaccination by Peru and vaccinated between Jan and Sept 2022, more than 14 days before enrolment, were considered vaccinated (appendix p 1). |
Laboratory-acquired infections and pathogen escapes worldwide between 2000 and 2021: a scoping review
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac JP , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Lancet Microbe 2023 Laboratory-acquired infections (LAIs) and accidental pathogen escape from laboratory settings (APELS) are major concerns for the community. A risk-based approach for pathogen research management within a standard biosafety management framework is recommended but is challenging due to reasons such as inconsistency in risk tolerance and perception. Here, we performed a scoping review using publicly available, peer-reviewed journal and media reports of LAIs and instances of APELS between 2000 and 2021. We identified LAIs in 309 individuals in 94 reports for 51 pathogens. Eight fatalities (2·6% of all LAIs) were caused by infection with Neisseria meningitidis (n=3, 37·5%), Yersinia pestis (n=2, 25%), Salmonella enterica serotype Typhimurium (S Typhimurium; n=1, 12·5%), or Ebola virus (n=1, 12·5%) or were due to bovine spongiform encephalopathy (n=1, 12·5%). The top five LAI pathogens were S Typhimurium (n=154, 49·8%), Salmonella enteritidis (n=21, 6·8%), vaccinia virus (n=13, 4·2%), Brucella spp (n=12, 3·9%), and Brucella melitensis (n=11, 3·6%). 16 APELS were reported, including those for Bacillus anthracis, SARS-CoV, and poliovirus (n=3 each, 18·8%); Brucella spp and foot and mouth disease virus (n=2 each, 12·5%); and variola virus, Burkholderia pseudomallei, and influenza virus H5N1 (n=1 each, 6·3%). Continual improvement in LAI and APELS management via their root cause analysis and thorough investigation of such incidents is essential to prevent future occurrences. The results are biased due to the reliance on publicly available information, which emphasises the need for formalised global LAIs and APELS reporting to better understand the frequency of and circumstances surrounding these incidents. |
The Biosafety Research Road Map: The search for evidence to support practices in the laboratory-Crimean Congo Haemorrhagic Fever Virus and Lassa Virus
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (4) 216-229 INTRODUCTION: Crimean Congo Hemorrhagic Fever (CCHF) virus and Lassa virus (LASV) are zoonotic agents regarded as high-consequence pathogens due to their high case fatality rates. CCHF virus is a vector-borne disease and is transmitted by tick bites. Lassa virus is spread via aerosolization of dried rat urine, ingesting infected rats, and direct contact with or consuming food and water contaminated with rat excreta. METHODS: The scientific literature for biosafety practices has been reviewed for both these two agents to assess the evidence base and biosafety-related knowledge gaps. The review focused on five main areas, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. RESULTS: There is a lack of data on the safe collection and handling procedures for tick specimens and the infectious dose from an infective tick bite for CCHF investigations. In addition, there are gaps in knowledge about gastrointestinal and contact infectious doses for Lassa virus, sample handling and transport procedures outside of infectious disease areas, and the contribution of asymptomatic carriers in viral circulation. CONCLUSION: Due to the additional laboratory hazards posed by these two agents, the authors recommend developing protocols that work effectively and safely in highly specialized laboratories in non-endemic regions and a laboratory with limited resources in endemic areas. |
The Biosafety Research Road Map: The search for evidence to support practices in the laboratory-Foot and Mouth Disease Virus
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (4) 199-215 INTRODUCTION: Foot and mouth disease (FMD) is a highly contagious infection of cloven-hoofed animals. The Biosafety Research Road Map reviewed scientific literature regarding the foot and mouth disease virus (FMDV). This project aims to identify gaps in the data required to conduct evidence-based biorisk assessments, as described by Blacksell et al., and strengthen control measures appropriate for local and national laboratories. METHODS: A literature search was conducted to identify potential gaps in biosafety and focused on five main sections: the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. RESULTS: The available data regarding biosafety knowledge gaps and existing evidence have been collated. Some gaps include the need for more scientific data that identify the specific safety contribution of engineering controls, support requirements for showering out after in vitro laboratory work, and whether a 3- to 5-day quarantine period should be applied to individuals conducting in vitro versus in vivo work. Addressing these gaps will contribute to the remediation and improvement of biosafety and biosecurity systems when working with FMDV. |
Influenza antiviral shortages reported by state and territorial public health officials, 2022-2023
Kojima N , Peterson L , Hawkins R , Allen M , Flannery B , Uyeki TM . JAMA 2023 330 (18) 1793-1795 This study provides survey results from state and territorial public health preparedness directors regarding antiviral shortages during the 2022-2023 respiratory viral season. | eng |
The Biosafety Research Road Map: The search for evidence to support practices in the laboratory-zoonotic avian influenza and mycobacterium tuberculosis
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (3) 135-151 INTRODUCTION: The Biosafety Research Road Map reviewed the scientific literature on a viral respiratory pathogen, avian influenza virus, and a bacterial respiratory pathogen, Mycobacterium tuberculosis. This project aims at identifying gaps in the data required to conduct evidence-based biorisk assessments, as described in Blacksell et al. One significant gap is the need for definitive data on M. tuberculosis sample aerosolization to guide the selection of engineering controls for diagnostic procedures. METHODS: The literature search focused on five areas: routes of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination methods. RESULTS: The available data regarding biosafety knowledge gaps and existing evidence have been collated and presented in Tables 1 and 2. The guidance sources on the appropriate use of biosafety cabinets for specific procedures with M. tuberculosis require clarification. Detecting vulnerabilities in the biorisk assessment for respiratory pathogens is essential to improve and develop laboratory biosafety in local and national systems. |
The biosafety research road map: The search for evidence to support practices in the laboratorympox/monkeypox virus
Blacksell SD , Dhawan S , Kusumoto M , Khanh Le K , Summermatter K , O'Keefe J , Kozlovac J , Al Muhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (3) 152-161 Introduction: The virus formerly known as monkeypox virus, now called mpoxv, belongs to the Orthopoxvirus genus and can cause mpox disease through both animal-to-human and human-to-human transmission. The unexpected spread of mpoxv among humans has prompted the World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PHEIC). Methods: We conducted a literature search to identify the gaps in biosafety, focusing on five main areas: how the infection enters the body and spreads, how much of the virus is needed to cause infection, infections acquired in the lab, accidental release of the virus, and strategies for disinfecting and decontaminating the area. Discussion: The recent PHEIC has shown that there are gaps in our knowledge of biosafety when it comes to mpoxv. We need to better understand where this virus might be found, how much of it can spread from person-to-person, what are the effective control measures, and how to safely clean up contaminated areas. By gathering more biosafety evidence, we can make better decisions to protect people from this zoonotic agent, which has recently become more common in the human population. © Stuart D. Blacksell et al. 2023; Published by Mary Ann Liebert, Inc. |
Clinical epidemiology and risk factors for critical outcomes among vaccinated and unvaccinated adults hospitalized with COVID-19-VISION Network, 10 States, June 2021-March 2023
Griggs EP , Mitchell PK , Lazariu V , Gaglani M , McEvoy C , Klein NP , Valvi NR , Irving SA , Kojima N , Stenehjem E , Crane B , Rao S , Grannis SJ , Embi PJ , Kharbanda AB , Ong TC , Natarajan K , Dascomb K , Naleway AL , Bassett E , DeSilva MB , Dickerson M , Konatham D , Fireman B , Allen KS , Barron MA , Beaton M , Arndorfer J , Vazquez-Benitez G , Garg S , Murthy K , Goddard K , Dixon BE , Han J , Grisel N , Raiyani C , Lewis N , Fadel WF , Stockwell MS , Mamawala M , Hansen J , Zerbo O , Patel P , Link-Gelles R , Adams K , Tenforde MW . Clin Infect Dis 2023 ![]() BACKGROUND: The epidemiology of COVID-19 continues to develop with emerging variants, expanding population-level immunity, and advances in clinical care. We describe changes in the clinical epidemiology of hospitalized COVID-19 and risk factors for critical outcomes over time. METHODS: We included adults aged ≥18 years from 10 states hospitalized with COVID-19 June 2021-March 2023 when multiple SARS-CoV-2 variants or sub-lineages predominated. We evaluated changes in baseline demographic and clinical characteristics and critical outcomes (intensive care unit admission and/or death) and used regression models to evaluate critical outcomes risk factors (risk ratios) stratified by COVID-19 vaccination status. RESULTS: 60,488 COVID-19-associated hospitalizations were included in the analysis. Among those hospitalized, from Delta period (June-December 2021) to the Omicron post-BA.4/BA.5 period (September 2022-March 2023), median age increased from 60 to 75 years, proportion vaccinated increased from 18.2% to 70.1%, while critical outcomes declined from 24.8% to 19.4% (all p < 0.001). Compared to all hospitalization events, those with critical outcomes had a higher proportion of four or more categories of medical conditions categories assessed (32.8% critical versus 23.0% all hospitalized). Critical outcome risk factors were similar for unvaccinated and vaccinated populations; presence of ≥4 medical condition categories was most strongly associated with risk of critical outcomes regardless of vaccine status (unvaccinated aRR 2.27 [95% CI: 2.14-2.41]; vaccinated aRR 1.73 [95% CI: 1.56-1.92]) across periods. CONCLUSION: The proportion of adults hospitalized with COVID-19 who experienced critical outcomes decreased with time and median patient age increased with time. Multimorbidity was mostly strongly associated with critical outcomes. |
The Biosafety Research Road Map: The search for evidence to support practices in human and veterinary laboratories
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (2) 64-71 INTRODUCTION: Lack of evidence-based information regarding potential biological risks can result in inappropriate or excessive biosafety and biosecurity risk-reduction strategies. This can cause unnecessary damage and loss to the physical facilities, physical and psychological well-being of laboratory staff, and community trust. A technical working group from the World Organization for Animal Health (WOAH, formerly OIE), World Health Organization (WHO), and Chatham House collaborated on the Biosafety Research Roadmap (BRM) project. The goal of the BRM is the sustainable implementation of evidence-based biorisk management of laboratory activities, particularly in low-resource settings, and the identification of gaps in the current biosafety and biosecurity knowledge base. METHODS: A literature search was conducted for the basis of laboratory design and practices for four selected high-priority subgroups of pathogenic agents. Potential gaps in biosafety were focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Categories representing miscellaneous, respiratory, bioterrorism/zoonotic, and viral hemorrhagic fever pathogens were created within each group were selected for review. RESULTS: Information sheets on the pathogens were developed. Critical gaps in the evidence base for safe sustainable biorisk management were identified. CONCLUSION: The gap analysis identified areas of applied biosafety research required to support the safety, and the sustainability, of global research programs. Improving the data available for biorisk management decisions for research with high-priority pathogens will contribute significantly to the improvement and development of appropriate and necessary biosafety, biocontainment and biosecurity strategies for each agent. |
The Biosafety Research Road Map: The search for evidence to support practices in the laboratory-Bacillus anthracis and Brucella melitensis
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (2) 72-86 INTRODUCTION: Brucella melitensis and Bacillus anthracis are zoonoses transmitted from animals and animal products. Scientific information is provided in this article to support biosafety precautions necessary to protect laboratory workers and individuals who are potentially exposed to these pathogens in the workplace or other settings, and gaps in information are also reported. There is a lack of information on the appropriate effective concentration for many chemical disinfectants for this agent. Controversies related to B. anthracis include infectious dose for skin and gastrointestinal infections, proper use of personal protective equipment (PPE) during the slaughter of infected animals, and handling of contaminated materials. B. melitensis is reported to have the highest number of laboratory-acquired infections (LAIs) to date in laboratory workers. METHODS: A literature search was conducted to identify potential gaps in biosafety and focused on five main sections including the route of inoculation/modes of transmission, infectious dose, LAIs, containment releases, and disinfection and decontamination strategies. RESULTS: Scientific literature currently lacks information on the effective concentration of many chemical disinfectants for this agent and in the variety of matrices where it may be found. Controversies related to B. anthracis include infectious dose for skin and gastrointestinal infections, proper use of PPE during the slaughter of infected animals, and handling contaminated materials. DISCUSSION: Clarified vulnerabilities based on specific scientific evidence will contribute to the prevention of unwanted and unpredictable infections, improving the biosafety processes and procedures for laboratory staff and other professionals such as veterinarians, individuals associated with the agricultural industry, and those working with susceptible wildlife species. |
The biosafety research road map: The search for evidence to support practices in the laboratory-Shigella spp
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Davis BJ , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Bennett AM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (2) 96-101 INTRODUCTION: Shigella bacteria cause shigellosis, a gastrointestinal infection most often acquired from contaminated food or water. METHODS: In this review, the general characteristics of Shigella bacteria are described, cases of laboratory-acquired infections (LAIs) are discussed, and evidence gaps in current biosafety practices are identified. RESULTS: LAIs are undoubtedly under-reported. Owing to the low infectious dose, rigorous biosafety level 2 practices are required to prevent LAIs resulting from sample manipulation or contact with infected surfaces. CONCLUSIONS: It is recommended that, before laboratory work with Shigella, an evidence-based risk assessment be conducted. Particular emphasis should be placed on personal protective equipment, handwashing, and containment practices for procedures that generate aerosols or droplets. |
The biosafety research road map: The search for evidence to support practices in the laboratory-SARS-CoV-2
Blacksell SD , Dhawan S , Kusumoto M , Le KK , Summermatter K , O'Keefe J , Kozlovac J , Almuhairi SS , Sendow I , Scheel CM , Ahumibe A , Masuku ZM , Kojima K , Harper DR , Hamilton K . Appl Biosaf 2023 28 (2) 87-95 ![]() INTRODUCTION: The SARS-CoV-2 virus emerged as a novel virus and is the causative agent of the COVID-19 pandemic. It spreads readily human-to-human through droplets and aerosols. The Biosafety Research Roadmap aims to support the application of laboratory biological risk management by providing an evidence base for biosafety measures. This involves assessing the current biorisk management evidence base, identifying research and capability gaps, and providing recommendations on how an evidence-based approach can support biosafety and biosecurity, including in low-resource settings. METHODS: A literature search was conducted to identify potential gaps in biosafety and focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. RESULTS: There are many knowledge gaps related to biosafety and biosecurity due to the SARS-CoV-2 virus's novelty, including infectious dose between variants, personal protective equipment for personnel handling samples while performing rapid diagnostic tests, and laboratory-acquired infections. Detecting vulnerabilities in the biorisk assessment for each agent is essential to contribute to the improvement and development of laboratory biosafety in local and national systems. |
Changing severity and epidemiology of adults hospitalized with coronavirus disease 2019 (COVID-19) in the United States after introduction of COVID-19 vaccines, March 2021-August 2022
Kojima N , Adams K , Self WH , Gaglani M , McNeal T , Ghamande S , Steingrub JS , Shapiro NI , Duggal A , Busse LW , Prekker ME , Peltan ID , Brown SM , Hager DN , Ali H , Gong MN , Mohamed A , Exline MC , Khan A , Wilson JG , Qadir N , Chang SY , Ginde AA , Withers CA , Mohr NM , Mallow C , Martin ET , Lauring AS , Johnson NJ , Casey JD , Stubblefield WB , Gibbs KW , Kwon JH , Baughman A , Chappell JD , Hart KW , Jones ID , Rhoads JP , Swan SA , Womack KN , Zhu Y , Surie D , McMorrow ML , Patel MM , Tenforde MW . Clin Infect Dis 2023 77 (4) 547-557 ![]() INTRODUCTION: Understanding the changing epidemiology of adults hospitalized with coronavirus disease 2019 (COVID-19) informs research priorities and public health policies. METHODS: Among adults (≥18 years) hospitalized with laboratory-confirmed, acute COVID-19 between 11 March 2021, and 31 August 2022 at 21 hospitals in 18 states, those hospitalized during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron-predominant period (BA.1, BA.2, BA.4/BA.5) were compared to those from earlier Alpha- and Delta-predominant periods. Demographic characteristics, biomarkers within 24 hours of admission, and outcomes, including oxygen support and death, were assessed. RESULTS: Among 9825 patients, median (interquartile range [IQR]) age was 60 years (47-72), 47% were women, and 21% non-Hispanic Black. From the Alpha-predominant period (Mar-Jul 2021; N = 1312) to the Omicron BA.4/BA.5 sublineage-predominant period (Jun-Aug 2022; N = 1307): the percentage of patients who had ≥4 categories of underlying medical conditions increased from 11% to 21%; those vaccinated with at least a primary COVID-19 vaccine series increased from 7% to 67%; those ≥75 years old increased from 11% to 33%; those who did not receive any supplemental oxygen increased from 18% to 42%. Median (IQR) highest C-reactive protein and D-dimer concentration decreased from 42.0 mg/L (9.9-122.0) to 11.5 mg/L (2.7-42.8) and 3.1 mcg/mL (0.8-640.0) to 1.0 mcg/mL (0.5-2.2), respectively. In-hospital death peaked at 12% in the Delta-predominant period and declined to 4% during the BA.4/BA.5-predominant period. CONCLUSIONS: Compared to adults hospitalized during early COVID-19 variant periods, those hospitalized during Omicron-variant COVID-19 were older, had multiple co-morbidities, were more likely to be vaccinated, and less likely to experience severe respiratory disease, systemic inflammation, coagulopathy, and death. |
Vaccine effectiveness against influenza-associated urgent care, emergency department, and hospital encounters during the 2021-2022 season, VISION Network
Tenforde MW , Weber ZA , DeSilva MB , Stenehjem E , Yang DH , Fireman B , Gaglani M , Kojima N , Irving SA , Rao S , Grannis SJ , Naleway AL , Kirshner L , Kharbanda AB , Dascomb K , Lewis N , Dalton AF , Ball SW , Natarajan K , Ong TC , Hartmann E , Embi PJ , McEvoy CE , Grisel N , Zerbo O , Dunne MM , Arndorfer J , Goddard K , Dickerson M , Patel P , Timbol J , Griggs EP , Hansen J , Thompson MG , Flannery B , Klein NP . J Infect Dis 2023 228 (2) 185-195 BACKGROUND: Following historically low influenza activity during the 2020-2021 season, the United States saw an increase in influenza circulating during the 2021-2022 season. Most viruses belonged to the influenza A(H3N2) 3C.2a1b 2a.2 subclade. METHODS: We conducted a test-negative case-control analysis among adults ≥18 years of age at three sites within the VISION Network. Encounters included emergency department/urgent care (ED/UC) visits or hospitalizations with ≥1 acute respiratory illness (ARI) discharge diagnosis codes and molecular testing for influenza. Vaccine effectiveness (VE) was calculated by comparing the odds of influenza vaccination ≥14 days before the encounter date between influenza-positive cases (type A) and influenza-negative and SARS-CoV-2-negative controls, applying inverse probability-to-be-vaccinated weights, and adjusting for confounders. RESULTS: 86,732 ED/UC ARI-associated encounters (7,696 [9%] cases) and 16,805 hospitalized ARI-associated encounters (649 [4%] cases) were included. VE against influenza-associated ED/UC encounters was 25% (95% confidence interval (CI): 20-29%) and 25% (95%CI: 11-37%) against influenza-associated hospitalizations. VE against ED/UC encounters was lower in adults ≥65 years of age (7%; CI: -5-17%) or with immunocompromising conditions (4%, CI:-45-36%). CONCLUSIONS: During an influenza A(H3N2)-predominant influenza season, modest VE was observed. These findings highlight the need for improved vaccines, particularly for A(H3N2) viruses that are historically associated with lower VE. |
Early and increased influenza activity among children - Tennessee, 2022-23 influenza season
Thomas CM , White EB , Kojima N , Fill MA , Hanna S , Jones TF , Newhouse CN , Orejuela K , Roth E , Winders S , Chandler DR , Grijalva CG , Schaffner W , Schmitz JE , DaSilva J , Kirby MK , Mellis AM , Rolfes MA , Sumner KM , Flannery B , Talbot HK , Dunn JR . MMWR Morb Mortal Wkly Rep 2023 72 (3) 49-54 Influenza seasons typically begin in October and peak between December and February (1); however, the 2022-23 influenza season in Tennessee began in late September and was characterized by high pediatric hospitalization rates during November. This report describes a field investigation conducted in Tennessee during November 2022, following reports of increasing influenza hospitalizations. Data from surveillance networks, patient surveys, and whole genome sequencing of influenza virus specimens were analyzed to assess influenza activity and secondary illness risk. Influenza activity increased earlier than usual among all age groups, and rates of influenza-associated hospitalization among children were high in November, reaching 12.6 per 100,000 in children aged <5 years, comparable to peak levels typically seen in high-severity seasons. Circulating influenza viruses were genetically similar to vaccine components. Among persons who received testing for influenza at outpatient clinics, children were twice as likely to receive a positive influenza test result as were adults. Among household contacts exposed to someone with influenza, children were more than twice as likely to become ill compared with adults. As the influenza season continues, it is important for all persons, especially those at higher risk for severe disease, to protect themselves from influenza. To prevent influenza and severe influenza complications, all persons aged ≥6 months should get vaccinated, avoid contact with ill persons, and take influenza antivirals if recommended and prescribed. |
Risk-based reboot for global lab biosafety
Kojima K , Booth CM , Summermatter K , Bennett A , Heisz M , Blacksell SD , McKinney M . Science 2018 360 (6386) 260-262 Laboratory biosafety is fundamental to controlling exposure to pathogens, protecting the laboratory workforce and the wider community against inadvertent exposures or releases. Since 1983, the World Health Organization (WHO) Laboratory Biosafety Manual (LBM) has encouraged countries to implement basic concepts in biological safety and to develop national codes of practice for the safe handling of pathogenic microorganisms in laboratories. But as technologies continue to evolve, and with them potential threats and benefits to laboratory safety, so too must approaches to biosafety. With revision toward the fourth edition of the LBM under way, we propose a shift in focus to a risk-based, technology-neutral, and cost-effective approach to biosafety, making sure that laboratory facilities, safety equipment, and work practices are locally relevant, proportionate, and sustainable. This will allow more flexibility in laboratory design, reduce focus on pathogen risk groups and biosafety levels as the de facto starting point of laboratory considerations, and place more emphasis on human factors and worker training. Improved sustainability of laboratory operations through lower construction and operating costs, particularly in resource-limited settings, may pave the way for equitable access to clinical and public health laboratory tests and biomedical research opportunities, without compromising safety. |
Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing: state of the science and planning the way forward
Stokes W , McFarland R , Kulpa-Eddy J , Gatewood D , Levis R , Halder M , Pulle G , Kojima H , Casey W , Gaydamaka A , Miller T , Brown K , Lewis C , Chapsal JM , Bruckner L , Gairola S , Kamphuis E , Rupprecht CE , Wunderli P , McElhinney L , De Mattia F , Gamoh K , Hill R , Reed D , Doelling V , Johnson N , Allen D , Rinckel L , Jones B . Biologicals 2012 40 (5) 369-81 Potency testing of most human and veterinary rabies vaccines requires vaccination of mice followed by a challenge test using an intracerebral injection of live rabies virus. NICEATM, ICCVAM, and their international partners organized a workshop to review the availability and validation status of alternative methods that might reduce, refine, or replace the use of animals for rabies vaccine potency testing, and to identify research and development efforts to further advance alternative methods. Workshop participants agreed that general anesthesia should be used for intracerebral virus injections and that humane endpoints should be used routinely as the basis for euthanizing animals when conducting the mouse rabies challenge test. Workshop participants recommended as a near-term priority replacement of the mouse challenge with a test validated to ensure potency, such as the mouse antibody serum neutralization test for adjuvanted veterinary rabies vaccines for which an international collaborative study was recently completed. The workshop recommended that an in vitro antigen quantification test should be a high priority for product-specific validation of human and non-adjuvanted veterinary rabies vaccines. Finally, workshop participants recommended greater international cooperation to expedite development, validation, regulatory acceptance, and implementation of alternative test methods for rabies vaccine potency testing. |
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