Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
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Query Trace: Villanueva J[original query] |
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Using data-to-care strategies to optimize the HIV care continuum in Connecticut: Results from a randomized controlled trial
Machavariani E , Miceli J , Altice FL , Fanfair RN , Speers S , Nichols L , Jenkins H , Villanueva M . J Acquir Immune Defic Syndr 2024 BACKGROUND: Re-engaging people with HIV (PWH) who are newly out-of-care remains challenging. Data-to-care (D2C) is a potential strategy to re-engage such individuals. METHODS: A prospective randomized controlled trial compared a D2C strategy using a disease intervention specialist (DIS) vs standard-of-care (SOC) where 23 HIV clinics in 3 counties in Connecticut could re-engage clients using existing methods. Using a data reconciliation process to confirm being newly out-of-care, 655 participants were randomized to DIS (N=333) or SOC (N=322). HIV care continuum outcomes included re-engagement at 90 days, retention in care and viral suppression (VS) by 12 months. Multivariable regression models were used to assess factors predictive of attaining HIV care continuum outcomes. RESULTS: Participants randomized to DIS were more likely to be re-engaged at 90 days (aOR=1.42, p=0.045). Independent predictors of re-engagement at 90 days were: age>40 years (aOR=1.84, p=0.012) and peri-natal HIV risk category (aOR=3.19, p=0.030). Predictors of retention at 12 months included: re-engagement at 90 days (aOR=10.31, p<0.001), drug injection HIV risk category (aOR=1.83, p=0.032), detectable HIV-1 RNA before randomization (aOR=0.40, p=0.003) and county (Hartford aOR=1.74, p=0.049; New Haven aOR=1.80, p=0.030). Predictors of VS included: re-engagement at 90 days (aOR=2.85, p<0.001), retention in HIV care (aOR=7.07, p<0.001), and detectable HIV-1 RNA pre-randomization (aOR=0.23, p<0.001). CONCLUSIONS: A D2C strategy significantly improved re-engagement at 90 days. Early re-engagement improved downstream benefits along the HIV care continuum like retention in care and VS at 12 months. Moreover, other factors predictive of care continuum outcomes can be used to improve D2C strategies. |
Rapid environmental contamination with candida auris and multidrug-resistant bacterial pathogens near colonized patients
Sansom SE , Gussin GM , Schoeny M , Singh RD , Adil H , Bell P , Benson EC , Bittencourt CE , Black S , Del Mar Villanueva Guzman M , Froilan MC , Fukuda C , Barsegyan K , Gough E , Lyman M , Makhija J , Marron S , Mikhail L , Noble-Wang J , Pacilli M , Pedroza R , Saavedra R , Sexton DJ , Shimabukuro J , Thotapalli L , Zahn M , Huang SS , Hayden MK . Clin Infect Dis 2023 BACKGROUND: Environmental contamination is suspected to play an important role in Candida auris transmission. Understanding speed and risks of contamination after room disinfection could inform environmental cleaning recommendations. METHODS: We conducted a prospective multicenter study of environmental contamination associated with C. auris colonization at six ventilator-capable skilled nursing facilities and one acute-care hospital in Illinois and California. Known C. auris carriers were sampled at five body-sites followed by sampling of nearby room surfaces before disinfection and at 0, 4, 8, and 12-hours post-disinfection. Samples were cultured for C. auris and bacterial multidrug-resistant organisms (MDROs). Odds of surface contamination after disinfection were analyzed using multilevel generalized estimating equations. RESULTS: Among 41 known C. auris carriers, colonization was detected most frequently on palms/fingertips (76%) and nares (71%). C. auris contamination was detected on 32.2% (66/205) of room surfaces pre-disinfection and 20.5% (39/190) of room surfaces by 4-hours post-disinfection. A higher number of C. auris-colonized body sites was associated with higher odds of environmental contamination at every time point following disinfection, adjusting for facility of residence. In the rooms of 38 (93%) C. auris carriers co-colonized with a bacterial MDRO, 2%-24% of surfaces were additionally contaminated with the same MDRO by 4-hours post-disinfection. CONCLUSIONS: C. auris can contaminate the healthcare environment rapidly after disinfection, highlighting the challenges associated with environmental disinfection. Future research should investigate long-acting disinfectants, antimicrobial surfaces, and more effective patient skin antisepsis to reduce the environmental reservoir of C. auris and bacterial MDROs in healthcare settings. |
Transmission of SARS-CoV-2 in standardised first few X cases and household transmission investigations: A systematic review and meta-analysis
Lewis HC , Marcato AJ , Meagher N , Valenciano M , Villanueva-Cabezas JP , Spirkoska V , Fielding JE , Karahalios A , Subissi L , Nardone A , Cheng B , Rajatonirina S , Okeibunor J , Aly EA , Barakat A , Jorgensen P , Azim T , Wijesinghe PR , Le LV , Rodriguez A , Vicari A , Van Kerkhove M , McVernon J , Pebody R , Price DJ , Bergeri I , Alemu MA , Alvi Y , Bukusi EA , Chung PS , Dambadarjaa D , Das AK , Dub T , Dulacha D , Ebrahim F , Gonzalez-Duarte MA , Guruge D , Heredia-Melo DC , Herman-Roloff A , Herring BL , Islam F , Jeewandara KC , Kant S , Lako R , Leite J , Malavige GN , Mandakh U , Mariam W , Mend T , Mize VA , Musa S , Nohynek H , Olu OO , Osorio-Merchan MB , Pereyaslov D , Ransom J , Ariqi LA , Khan W , Saxena S , Sharma P , Sreedevi A , Satheesh M , Subhashini KJ , Tippet-Barr BA , Usha A , Wamala JF , Watare SH , Yadav K , Inbanathan FY . Influenza Other Respir Viruses 2022 16 (5) 803-819 Abstract We aimed to estimate the household secondary infection attack rate (hSAR) of SARS-CoV-2 in investigations aligned with the WHO Unity Studies Household Transmission Investigations (HHTI) protocol. We conducted a systematic review and meta-analysis according to PRISMA 2020 guidelines. We searched Medline, Embase, Web of Science, Scopus and medRxiv/bioRxiv for “Unity-aligned” First Few X cases (FFX) and HHTIs published 1 December 2019 to 26 July 2021. Standardised early results were shared by WHO Unity Studies collaborators (to 1 October 2021). We used a bespoke tool to assess investigation methodological quality. Values for hSAR and 95% confidence intervals (CIs) were extracted or calculated from crude data. Heterogeneity was assessed by visually inspecting overlap of CIs on forest plots and quantified in meta-analyses. Of 9988 records retrieved, 80 articles (64 from databases; 16 provided by Unity Studies collaborators) were retained in the systematic review; 62 were included in the primary meta-analysis. hSAR point estimates ranged from 2% to 90% (95% prediction interval: 3%–71%; I2 = 99.7%); I2 values remained >99% in subgroup analyses, indicating high, unexplained heterogeneity and leading to a decision not to report pooled hSAR estimates. FFX and HHTI remain critical epidemiological tools for early and ongoing characterisation of novel infectious pathogens. The large, unexplained variance in hSAR estimates emphasises the need to further support standardisation in planning, conduct and analysis, and for clear and comprehensive reporting of FFX and HHTIs in time and place, to guide evidence-based pandemic preparedness and response efforts for SARS-CoV-2, influenza and future novel respiratory viruses. |
Transmission of SARS-CoV-2 in standardised First Few X cases and household transmission investigations: a systematic review and meta-analysis (preprint)
Lewis HC , Marcato AJ , Meagher N , Valenciano M , Villanueva-Cabezas JP , Spirkoska V , Fielding JE , Karahalios A , Subissi L , Nardone A , Cheng B , Rajatonirina S , Okeibunor J , Aly EA , Barakat A , Jorgensen P , Azim T , Wijesinghe PR , Le LV , Rodriguez A , Vicari A , Van Kerkhove M , McVernon J , Pebody R , Price DJ , Bergeri I , Alemu MA , Alvi Y , Bukusi EA , Chung PS , Dambadarjaa D , Das AK , Dub T , Dulacha D , Ebrahim F , Gonzalez-Duarte MA , Guruge D , Heredia-Melo DC , Herman-Roloff A , Herring BL , Islam F , Jeewandara KC , Kant S , Lako R , Leite J , Malavige GN , Mandakh U , Mariam W , Mend T , Mize VA , Musa S , Nohynek H , Olu OO , Osorio-Merchan MB , Pereyaslov D , Ransom J , Ariqi LA , Khan W , Saxena S , Sharma P , Sreedevi A , Satheesh M , Subhashini KJ , Tippet-Barr BA , Usha A , Wamala JF , Watare SH , Yadav K , Inbanathan FY . medRxiv 2022 03 (5) 803-819 We aimed to estimate the household secondary infection attack rate (hSAR) of SARS-CoV-2 in investigations aligned with the WHO Unity Studies Household Transmission Investigations (HHTI) protocol. We conducted a systematic review and meta-analysis according to PRISMA 2020 guidelines. We searched Medline, Embase, Web of Science, Scopus and medRxiv/bioRxiv for 'Unity-aligned' First Few X cases (FFX) and HHTIs published between 1 December 2019 and 26 July 2021. Standardised early results were shared by WHO Unity Studies collaborators (to 1 October 2021). We used a bespoke tool to assess investigation methodological quality. Values for hSAR and 95% confidence intervals (CIs) were extracted or calculated from crude data. Heterogeneity was assessed by visually inspecting overlap of CIs on forest plots and quantified in meta-analyses. Of 9988 records retrieved, 80 articles (64 from databases; 16 provided by Unity Studies collaborators) were retained in the systematic review and 62 were included in the primary meta-analysis. hSAR point estimates ranged from 2%-90% (95% prediction interval: 3%-71%; I2=99.7%); I2 values remained >99% in subgroup analyses, indicating high, unexplained heterogeneity and leading to a decision not to report pooled hSAR estimates. FFX and HHTI remain critical epidemiological tools for early and ongoing characterisation of novel infectious pathogens. The large, unexplained variance in hSAR estimates emphasises the need to further support standardisation in planning, conduct and analysis, and for clear and comprehensive reporting of FFX and HHTIs in time and place, to guide evidence-based pandemic preparedness and response efforts for SARS-CoV-2, influenza and future novel respiratory viruses. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license. |
Initial public health response and interim clinical guidance for the 2019 novel coronavirus outbreak - United States, December 31, 2019-February 4, 2020.
Patel A , Jernigan DB , 2019-nCOV CDC Response Team , Abdirizak Fatuma , Abedi Glen , Aggarwal Sharad , Albina Denise , Allen Elizabeth , Andersen Lauren , Anderson Jade , Anderson Megan , Anderson Tara , Anderson Kayla , Bardossy Ana Cecilia , Barry Vaughn , Beer Karlyn , Bell Michael , Berger Sherri , Bertulfo Joseph , Biggs Holly , Bornemann Jennifer , Bornstein Josh , Bower Willie , Bresee Joseph , Brown Clive , Budd Alicia , Buigut Jennifer , Burke Stephen , Burke Rachel , Burns Erin , Butler Jay , Cantrell Russell , Cardemil Cristina , Cates Jordan , Cetron Marty , Chatham-Stephens Kevin , Chatham-Stevens Kevin , Chea Nora , Christensen Bryan , Chu Victoria , Clarke Kevin , Cleveland Angela , Cohen Nicole , Cohen Max , Cohn Amanda , Collins Jennifer , Conners Erin , Curns Aaron , Dahl Rebecca , Daley Walter , Dasari Vishal , Davlantes Elizabeth , Dawson Patrick , Delaney Lisa , Donahue Matthew , Dowell Chad , Dyal Jonathan , Edens William , Eidex Rachel , Epstein Lauren , Evans Mary , Fagan Ryan , Farris Kevin , Feldstein Leora , Fox LeAnne , Frank Mark , Freeman Brandi , Fry Alicia , Fuller James , Galang Romeo , Gerber Sue , Gokhale Runa , Goldstein Sue , Gorman Sue , Gregg William , Greim William , Grube Steven , Hall Aron , Haynes Amber , Hill Sherrasa , Hornsby-Myers Jennifer , Hunter Jennifer , Ionta Christopher , Isenhour Cheryl , Jacobs Max , Jacobs Slifka Kara , Jernigan Daniel , Jhung Michael , Jones-Wormley Jamie , Kambhampati Anita , Kamili Shifaq , Kennedy Pamela , Kent Charlotte , Killerby Marie , Kim Lindsay , Kirking Hannah , Koonin Lisa , Koppaka Ram , Kosmos Christine , Kuhar David , Kuhnert-Tallman Wendi , Kujawski Stephanie , Kumar Archana , Landon Alexander , Lee Leslie , Leung Jessica , Lindstrom Stephen , Link-Gelles Ruth , Lively Joana , Lu Xiaoyan , Lynch Brian , Malapati Lakshmi , Mandel Samantha , Manns Brian , Marano Nina , Marlow Mariel , Marston Barbara , McClung Nancy , McClure Liz , McDonald Emily , McGovern Oliva , Messonnier Nancy , Midgley Claire , Moulia Danielle , Murray Janna , Noelte Kate , Noonan-Smith Michelle , Nordlund Kristen , Norton Emily , Oliver Sara , Pallansch Mark , Parashar Umesh , Patel Anita , Patel Manisha , Pettrone Kristen , Pierce Taran , Pietz Harald , Pillai Satish , Radonovich Lewis , Reagan-Steiner Sarah , Reel Amy , Reese Heather , Rha Brian , Ricks Philip , Rolfes Melissa , Roohi Shahrokh , Roper Lauren , Rotz Lisa , Routh Janell , Sakthivel Senthil Kumar Sarmiento Luisa , Schindelar Jessica , Schneider Eileen , Schuchat Anne , Scott Sarah , Shetty Varun , Shockey Caitlin , Shugart Jill , Stenger Mark , Stuckey Matthew , Sunshine Brittany , Sykes Tamara , Trapp Jonathan , Uyeki Timothy , Vahey Grace , Valderrama Amy , Villanueva Julie , Walker Tunicia , Wallace Megan , Wang Lijuan , Watson John , Weber Angie , Weinbaum Cindy , Weldon William , Westnedge Caroline , Whitaker Brett , Whitaker Michael , Williams Alcia , Williams Holly , Willams Ian , Wong Karen , Xie Amy , Yousef Anna . Am J Transplant 2020 20 (3) 889-895 This article summarizes what is currently known about the 2019 novel coronavirus and offers interim guidance. |
Travel history among persons infected with SARS-CoV-2 variants of concern in the United States, December 2020-February 2021.
Dunajcik A , Haire K , Thomas JD , Moriarty LF , Springer Y , Villanueva JM , MacNeil A , Silk B , Nemhauser JB , Byrkit R , Taylor M , Queen K , Tong S , Lee J , Batra D , Paden C , Henderson T , Kunkes A , Ojo M , Firestone M , Martin Webb L , Freeland M , Brown CM , Williams T , Allen K , Kauerauf J , Wilson E , Jain S , McDonald E , Silver E , Stous S , Wadford D , Radcliffe R , Marriott C , Owes JP , Bart SM , Sosa LE , Oakeson K , Wodniak N , Shaffner J , Brown Q , Westergaard R , Salinas A , Hallyburton S , Ogale Y , Offutt-Powell T , Bonner K , Tubach S , Van Houten C , Hughes V , Reeb V , Galeazzi C , Khuntia S , McGee S , Hicks JT , Dinesh Patel D , Krueger A , Hughes S , Jeanty F , Wang JC , Lee EH , Assanah-Deane T , Tompkins M , Dougherty K , Naqvi O , Donahue M , Frederick J , Abdalhamid B , Powers AM , Anderson M . PLOS Glob Public Health 2023 3 (3) e0001252 The first three SARS-CoV-2 phylogenetic lineages classified as variants of concern (VOCs) in the United States (U.S.) from December 15, 2020 to February 28, 2021, Alpha (B.1.1.7), Beta (B.1.351), and Gamma (P.1) lineages, were initially detected internationally. This investigation examined available travel history of coronavirus disease 2019 (COVID-19) cases reported in the U.S. in whom laboratory testing showed one of these initial VOCs. Travel history, demographics, and health outcomes for a convenience sample of persons infected with a SARS-CoV-2 VOC from December 15, 2020 through February 28, 2021 were provided by 35 state and city health departments, and proportion reporting travel was calculated. Of 1,761 confirmed VOC cases analyzed, 1,368 had available data on travel history. Of those with data on travel history, 1,168 (85%) reported no travel preceding laboratory confirmation of SARS-CoV-2 and only 105 (8%) reported international travel during the 30 days preceding a positive SARS-CoV-2 test or symptom onset. International travel was reported by 92/1,304 (7%) of persons infected with the Alpha variant, 7/55 (22%) with Beta, and 5/9 (56%) with Gamma. Of the first three SARS-CoV-2 lineages designated as VOCs in the U.S., international travel was common only among the few Gamma cases. Most persons infected with Alpha and Beta variant reported no travel history, therefore, community transmission of these VOCs was likely common in the U.S. by March 2021. These findings underscore the importance of global surveillance using whole genome sequencing to detect and inform mitigation strategies for emerging SARS-CoV-2 VOCs. |
The Cooperative Re-Engagement Controlled Trial (CoRECT): Durable viral suppression assessment
O'Shea J , Fanfair RN , Williams T , Khalil G , Brady KA , DeMaria A Jr , Villanueva M , Randall LM , Jenkins H , Altice FL , Camp N , Lucas C , Buchelli M , Samandari T , Weidle PJ . J Acquir Immune Defic Syndr 2023 93 (2) 134-142 BACKGROUND: A collaborative, data-to-care strategy to identify persons with HIV (PWH) newly out-of-care, combined with an active public health intervention, significantly increases the proportion of PWH re-engaged in HIV care. We assessed this strategy's impact on durable viral suppression (DVS). METHODS: A multi-site, prospective randomized controlled trial for out-of-care individuals using a data-to-care strategy and comparing public health field services to locate, contact, and facilitate access to care versus the standard of care (SOC). DVS was defined as the last viral load (VL), the VL at least three months prior, and any VL between the two were all <200 copies/mL during the 18 months post-randomization. Alternative definitions of DVS were also analyzed. RESULTS: Between August 1, 2016 - July 31, 2018, 1,893 participants were randomized from Connecticut (CT) (n=654), Massachusetts (MA) (n=630), and Philadelphia (PHL) (n=609). Rates of achieving DVS were similar in the intervention and SOC arms in all jurisdictions (All sites: 43.4% vs 42.4%, p=0.67; CT: 46.7% vs 45.0%, p=0.67; MA: 40.7 vs 44.4%, p=0.35; PHL: 42.4% vs 37.3%, p=0.20). There was no association between DVS and the intervention (RR:1.01, CI: 0.91-1.12; p=0.85) adjusting for site, age categories, race/ethnicity, birth sex, CD4 categories, and exposure categories. CONCLUSION: A collaborative, data-to-care strategy, and active public health intervention did not increase the proportion of PWH achieving DVS suggesting additional support to promote retention in care and antiretroviral adherence may be needed. Initial linkage and engagement services, through data-to-care or other means, are likely necessary but insufficient for achieving DVS for all PWH. |
Costs and cost-effectiveness of a collaborative data-to-care intervention for HIV treatment and care in the United States
Shrestha RK , Fanfair RN , Randall LM , Lucas C , Nichols L , Camp N , Brady KA , Jenkins H , Altice FL , DeMaria A , Villanueva M , Weidle PJ . J Int AIDS Soc 2023 26 (1) e26040 INTRODUCTION: Data-to-care programmes utilize surveillance data to identify persons who are out of HIV care, re-engage them in care and improve HIV care outcomes. We assess the costs and cost-effectiveness of re-engagement in an HIV care intervention in the United States. METHODS: The Cooperative Re-engagement Control Trial (CoRECT) employed a data-to-care collaborative model between health departments and HIV care providers, August 2016-July 2018. The health departments in Connecticut (CT), Massachusetts (MA) and Philadelphia (PHL) collaborated with HIV clinics to identify newly out-of-care patients and randomize them to receive usual linkage and engagement in care services (standard-of-care control arm) or health department-initiated active re-engagement services (intervention arm). We used a microcosting approach to identify the activities and resources involved in the CoRECT intervention, separate from the standard-of-care, and quantified the costs. The cost data were collected at the start-up and recurrent phases of the trial to incorporate potential variation in the intervention costs. The costs were estimated from the healthcare provider perspective. RESULTS: The CoRECT trial in CT, MA and PHL randomly assigned on average 327, 316 and 305 participants per year either to the intervention arm (n = 166, 159 and 155) or the standard-of-care arm (n = 161, 157 and 150), respectively. Of those randomized, the number of participants re-engaged in care within 90 days in the intervention and standard-of-care arms was 85 and 70 in CT, 84 and 70 in MA, and 98 and 67 in PHL. The additional number of participants re-engaged in care in the intervention arm compared with those in the standard-of-care arm was 15 (CT), 14 (MA) and 31 (PHL). We estimated the annual total cost of the CoRECT intervention at $490,040 in CT, $473,297 in MA and $439,237 in PHL. The average cost per participant enrolled was $2952, $2977 and $2834 and the average cost per participant re-engaged in care was $5765, $5634 and $4482. We estimated an incremental cost per participant re-engaged in care at $32,669 (CT), $33,807 (MA) and $14,169 (PHL). CONCLUSIONS: The costs of the CoRECT intervention that identified newly out-of-care patients and re-engaged them in HIV care are comparable with other similar interventions, suggesting a potential for its cost-effectiveness in the US context. |
Rapid diagnostic testing for response to the monkeypox outbreak - Laboratory Response Network, United States, May 17-June 30, 2022
Aden TA , Blevins P , York SW , Rager S , Balachandran D , Hutson CL , Lowe D , Mangal CN , Wolford T , Matheny A , Davidson W , Wilkins K , Cook R , Roulo RM , White MK , Berman L , Murray J , Laurance J , Francis D , Green NM , Berumen RA3rd , Gonzalez A , Evans S , Hudziec M , Noel D , Adjei M , Hovan G , Lee P , Tate L , Gose RB , Voermans R , Crew J , Adam PR , Haydel D , Lukula S , Matluk N , Shah S , Featherston J , Ware D , Pettit D , McCutchen E , Acheampong E , Buttery E , Gorzalski A , Perry M , Fowler R , Lee RB , Nickla R , Huard R , Moore A , Jones K , Johnson R , Swaney E , Jaramillo J , Reinoso Webb C , Guin B , Yost J , Atkinson A , Griffin-Thomas L , Chenette J , Gant J , Sterkel A , Ghuman HK , Lute J , Smole SC , Arora V , Demontigny CK , Bielby M , Geeter E , Newman KAM , Glazier M , Lutkemeier W , Nelson M , Martinez R , Chaitram J , Honein MA , Villanueva JM . MMWR Morb Mortal Wkly Rep 2022 71 (28) 904-907 As part of public health preparedness for infectious disease threats, CDC collaborates with other U.S. public health officials to ensure that the Laboratory Response Network (LRN) has diagnostic tools to detect Orthopoxviruses, the genus that includes Variola virus, the causative agent of smallpox. LRN is a network of state and local public health, federal, U.S. Department of Defense (DOD), veterinary, food, and environmental testing laboratories. CDC developed, and the Food and Drug Administration (FDA) granted 510(k) clearance* for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (non-variola Orthopoxvirus [NVO] assay), a polymerase chain reaction (PCR) diagnostic test to detect NVO. On May 17, 2022, CDC was contacted by the Massachusetts Department of Public Health (DPH) regarding a suspected case of monkeypox, a disease caused by the Orthopoxvirus Monkeypox virus. Specimens were collected and tested by the Massachusetts DPH public health laboratory with LRN testing capability using the NVO assay. Nationwide, 68 LRN laboratories had capacity to test approximately 8,000 NVO tests per week during June. During May 17-June 30, LRN laboratories tested 2,009 specimens from suspected monkeypox cases. Among those, 730 (36.3%) specimens from 395 patients were positive for NVO. NVO-positive specimens from 159 persons were confirmed by CDC to be monkeypox; final characterization is pending for 236. Prompt identification of persons with infection allowed rapid response to the outbreak, including isolation and treatment of patients, administration of vaccines, and other public health action. To further facilitate access to testing and increase convenience for providers and patients by using existing provider-laboratory relationships, CDC and LRN are supporting five large commercial laboratories with a national footprint (Aegis Science, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare) to establish NVO testing capacity of 10,000 specimens per week per laboratory. On July 6, 2022, the first commercial laboratory began accepting specimens for NVO testing based on clinician orders. |
Use of Ebola vaccine: Expansion of recommendations of the Advisory Committee on Immunization Practices to include two additional populations - United States, 2021
Malenfant JH , Joyce A , Choi MJ , Cossaboom CM , Whitesell AN , Harcourt BH , Atmar RL , Villanueva JM , Bell BP , Hahn C , Loehr J , Davey RT , Sprecher A , Kraft CS , Shoemaker T , Montgomery JM , Helfand R , Damon IK , Frey SE , Chen WH . MMWR Morb Mortal Wkly Rep 2022 71 (8) 290-292 On December 19, 2019, the Food and Drug Administration (FDA) approved rVSVΔG-ZEBOV-GP Ebola vaccine (ERVEBO, Merck) for the prevention of Ebola virus disease (EVD) caused by infection with Ebola virus, species Zaire ebolavirus, in adults aged ≥18 years. In February 2020, the Advisory Committee on Immunization Practices (ACIP) recommended preexposure vaccination with ERVEBO for adults aged ≥18 years in the United States who are at highest risk for potential occupational exposure to Ebola virus because they are responding to an outbreak of EVD, work as health care personnel at federally designated Ebola treatment centers in the United States, or work as laboratorians or other staff members at biosafety level 4 facilities in the United States (1). |
Multistate Outbreak of SARS-CoV-2 Infections, Including Vaccine Breakthrough Infections, Associated with Large Public Gatherings, United States.
Gharpure R , Sami S , Vostok J , Johnson H , Hall N , Foreman A , Sabo RT , Schubert PL , Shephard H , Brown VR , Brumfield B , Ricaldi JN , Conley AB , Zielinski L , Malec L , Newman AP , Chang M , Finn LE , Stainken C , Mangla AT , Eteme P , Wieck M , Green A , Edmundson A , Reichbind D , Brown VJr , Quiñones L , Longenberger A , Hess E , Gumke M , Manion A , Thomas H , Barrios CA , Koczwara A , Williams TW , Pearlowitz M , Assoumou M , Senisse Pajares AF , Dishman H , Schardin C , Wang X , Stephens K , Moss NS , Singh G , Feaster C , Webb LM , Krueger A , Dickerson K , Dewart C , Barbeau B , Salmanson A , Madoff LC , Villanueva JM , Brown CM , Laney AS . Emerg Infect Dis 2022 28 (1) 35-43 During July 2021, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.617.2 variant infections, including vaccine breakthrough infections, occurred after large public gatherings in Provincetown, Massachusetts, USA, prompting a multistate investigation. Public health departments identified primary and secondary cases by using coronavirus disease surveillance data, case investigations, and contact tracing. A primary case was defined as SARS-CoV-2 detected <14 days after travel to or residence in Provincetown during July 3-17. A secondary case was defined as SARS-CoV-2 detected <14 days after close contact with a person who had a primary case but without travel to or residence in Provincetown during July 3-August 10. We identified 1,098 primary cases and 30 secondary cases associated with 26 primary cases among fully and non-fully vaccinated persons. Large gatherings can have widespread effects on SARS-CoV-2 transmission, and fully vaccinated persons should take precautions, such as masking, to prevent SARS-CoV-2 transmission, particularly during substantial or high transmission. |
Performance characteristics of the Abbott BinaxNOW SARS-CoV-2 antigen test in comparison to real-time RT-PCR and viral culture in community testing sites during November 2020.
Almendares O , Prince-Guerra JL , Nolen LD , Gunn JKL , Dale AP , Buono SA , Deutsch-Feldman M , Suppiah S , Hao L , Zeng Y , Stevens VA , Knipe K , Pompey J , Atherstone C , Bui DP , Powell T , Tamin A , Harcourt JL , Petway M , Bohannon C , Folster JM , MacNeil A , Salerno R , Kuhnert-Tallman W , Tate JE , Thornburg N , Kirking HL , Villanueva JM , Rose DA , Neatherlin JC , Anderson M , Rota PA , Honein MA , Bower WA . J Clin Microbiol 2021 60 (1) Jcm0174221 Point-of-care antigen tests are an important tool for SARS-CoV-2 detection. Antigen tests are less sensitive than real-time reverse-transcriptase PCR (rRT-PCR). Data on the performance of the BinaxNOW antigen test compared to rRT-PCR and viral culture by symptom and known exposure status, timing during disease or exposure period and demographic variables are limited. During November 3(rd)-17(th), 2020, we collected paired upper respiratory swab specimens to test for SARS-CoV-2 by rRT-PCR and Abbott BinaxNOW (BinaxNOW) antigen test at two community testing sites in Pima County, Arizona. We administered a questionnaire to capture symptoms, known exposure status and previous SARS-CoV-2 test results. Specimens positive by either test were analyzed by viral culture. Previously we showed overall BinaxNOW sensitivity was 52.5%. Here we showed BinaxNOW sensitivity increased to 65.7% among currently symptomatic individuals reporting a known exposure. BinaxNOW sensitivity was lower among participants with a known exposure and previously symptomatic (32.4%) or never symptomatic (47.1%) within 14 days of testing. Sensitivity was 71.1% in participants within a week of symptom onset. In participants with a known exposure, sensitivity was highest 8-10 days post-exposure (75%). The positive predictive value for recovery of virus in cell culture was 56.7% for BinaxNOW-positive and 35.4% for rRT-PCR-positive specimens. Result reporting time was 2.5 hours for BinaxNOW and 26 hours for rRT-PCR. Point-of-care antigen tests have a shorter turn-around time compared to laboratory-based nucleic acid amplification tests, which allows for more rapid identification of infected individuals. Antigen test sensitivity limitations are important to consider when developing a testing program. |
Pregnancy, Birth, Infant, and Early Childhood Neurodevelopmental Outcomes among a Cohort of Women with Symptoms of Zika Virus Disease during Pregnancy in Three Surveillance Sites, Project Vigilancia de Embarazadas con Zika (VEZ), Colombia, 2016-2018
Mercado-Reyes M , Gilboa SM , Valencia D , Daza M , Tong VT , Galang RR , Winfield CM , Godfred-Cato S , Benavides M , Villanueva JM , Thomas JD , Daniels J , Zaki S , Reagan-Steiner S , Bhatnagar J , Schiffer J , Steward-Clark E , Ricaldi JN , Osorio J , Sancken CL , Pardo L , Tinker SC , Anderson KN , Rico A , Burkel VK , Hojnacki J , Delahoy MJ , González M , Osorio MB , Moore CA , Honein MA , Ospina Martinez ML . Trop Med Infect Dis 2021 6 (4) Project Vigilancia de Embarazadas con Zika (VEZ), an intensified surveillance of pregnant women with symptoms of the Zika virus disease (ZVD) in Colombia, aimed to evaluate the relationship between symptoms of ZVD during pregnancy and adverse pregnancy, birth, and infant outcomes and early childhood neurodevelopmental outcomes. During May-November 2016, pregnant women in three Colombian cities who were reported with symptoms of ZVD to the national surveillance system, or with symptoms of ZVD visiting participating clinics, were enrolled in Project VEZ. Data from maternal and pediatric (up to two years of age) medical records were abstracted. Available maternal specimens were tested for the presence of the Zika virus ribonucleic acid and/or anti-Zika virus immunoglobulin antibodies. Of 1213 enrolled pregnant women with symptoms of ZVD, 1180 had a known pregnancy outcome. Results of the Zika virus laboratory testing were available for 569 (48.2%) pregnancies with a known pregnancy outcome though testing timing varied and was often distal to the timing of symptoms; 254 (21.5% of the whole cohort; 44.6% of those with testing results) were confirmed or presumptive positive for the Zika virus infection. Of pregnancies with a known outcome, 50 (4.2%) fetuses/infants had Zika-associated brain or eye defects, which included microcephaly at birth. Early childhood adverse neurodevelopmental outcomes were more common among those with Zika-associated birth defects than among those without and more common among those with laboratory evidence of a Zika virus infection compared with the full cohort. The proportion of fetuses/infants with any Zika-associated brain or eye defect was consistent with the proportion seen in other studies. Enhancements to Colombia's existing national surveillance enabled the assessment of adverse outcomes associated with ZVD in pregnancy. |
Household Transmission of SARS-CoV-2 from Children and Adolescents.
Chu VT , Yousaf AR , Chang K , Schwartz NG , McDaniel CJ , Lee SH , Szablewski CM , Brown M , Drenzek CL , Dirlikov E , Rose DA , Villanueva J , Fry AM , Hall AJ , Kirking HL , Tate JE , Lanzieri TM , Stewart RJ . N Engl J Med 2021 385 (10) 954-956 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children is often asymptomatic or results in only mild disease.1 Data on the extent of transmission of SARS-CoV-2 from children and adolescents in the household setting, including transmission to older persons who are at increased risk for severe disease, are limited.2 After an outbreak of coronavirus disease 2019 (Covid-19) at an overnight camp,3 we conducted a retrospective cohort study involving camp attendees and their household contacts to assess secondary transmission and factors associated with household transmission (additional details are provided in the Methods section in the Supplementary Appendix, available with the full text of this letter at NEJM.org). |
SARS-CoV-2 Transmission Dynamics in a Sleep-Away Camp.
Szablewski CM , Chang KT , McDaniel CJ , Chu VT , Yousaf AR , Schwartz NG , Brown M , Winglee K , Paul P , Cui Z , Slayton RB , Tong S , Li Y , Uehara A , Zhang J , Sharkey SM , Kirking HL , Tate JE , Dirlikov E , Fry AM , Hall AJ , Rose DA , Villanueva J , Drenzek C , Stewart RJ , Lanzieri TM . Pediatrics 2021 147 (4) OBJECTIVES: In late June 2020, a large outbreak of coronavirus disease 2019 (COVID-19) occurred at a sleep-away youth camp in Georgia, affecting primarily persons </=21 years. We conducted a retrospective cohort study among campers and staff (attendees) to determine the extent of the outbreak and assess factors contributing to transmission. METHODS: Attendees were interviewed to ascertain demographic characteristics, known exposures to COVID-19 and community exposures, and mitigation measures before, during, and after attending camp. COVID-19 case status was determined for all camp attendees on the basis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test results and reported symptoms. We calculated attack rates and instantaneous reproduction numbers and sequenced SARS-CoV-2 viral genomes from the outbreak. RESULTS: Among 627 attendees, the median age was 15 years (interquartile range: 12-16 years); 56% (351 of 627) of attendees were female. The attack rate was 56% (351 of 627) among all attendees. On the basis of date of illness onset or first positive test result on a specimen collected, 12 case patients were infected before arriving at camp and 339 case patients were camp associated. Among 288 case patients with available symptom information, 45 (16%) were asymptomatic. Despite cohorting, 50% of attendees reported direct contact with people outside their cabin cohort. On the first day of camp session, the instantaneous reproduction number was 10. Viral genomic diversity was low. CONCLUSIONS: Few introductions of SARS-CoV-2 into a youth congregate setting resulted in a large outbreak. Testing strategies should be combined with prearrival quarantine, routine symptom monitoring with appropriate isolation and quarantine, cohorting, social distancing, mask wearing, and enhanced disinfection and hand hygiene. Promotion of mitigation measures among younger populations is needed. |
Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites - Pima County, Arizona, November 3-17, 2020.
Prince-Guerra JL , Almendares O , Nolen LD , Gunn JKL , Dale AP , Buono SA , Deutsch-Feldman M , Suppiah S , Hao L , Zeng Y , Stevens VA , Knipe K , Pompey J , Atherstone C , Bui DP , Powell T , Tamin A , Harcourt JL , Shewmaker PL , Medrzycki M , Wong P , Jain S , Tejada-Strop A , Rogers S , Emery B , Wang H , Petway M , Bohannon C , Folster JM , MacNeil A , Salerno R , Kuhnert-Tallman W , Tate JE , Thornburg NJ , Kirking HL , Sheiban K , Kudrna J , Cullen T , Komatsu KK , Villanueva JM , Rose DA , Neatherlin JC , Anderson M , Rota PA , Honein MA , Bower WA . MMWR Morb Mortal Wkly Rep 2021 70 (3) 100-105 Rapid antigen tests, such as the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW), offer results more rapidly (approximately 15-30 minutes) and at a lower cost than do highly sensitive nucleic acid amplification tests (NAATs) (1). Rapid antigen tests have received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in symptomatic persons (2), but data are lacking on test performance in asymptomatic persons to inform expanded screening testing to rapidly identify and isolate infected persons (3). To evaluate the performance of the BinaxNOW rapid antigen test, it was used along with real-time reverse transcription-polymerase chain reaction (RT-PCR) testing to analyze 3,419 paired specimens collected from persons aged ≥10 years at two community testing sites in Pima County, Arizona, during November 3-17, 2020. Viral culture was performed on 274 of 303 residual real-time RT-PCR specimens with positive results by either test (29 were not available for culture). Compared with real-time RT-PCR testing, the BinaxNOW antigen test had a sensitivity of 64.2% for specimens from symptomatic persons and 35.8% for specimens from asymptomatic persons, with near 100% specificity in specimens from both groups. Virus was cultured from 96 of 274 (35.0%) specimens, including 85 (57.8%) of 147 with concordant antigen and real-time RT-PCR positive results, 11 (8.9%) of 124 with false-negative antigen test results, and none of three with false-positive antigen test results. Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. When the pretest probability for receiving positive test results for SARS-CoV-2 is elevated (e.g., in symptomatic persons or in persons with a known COVID-19 exposure), a negative antigen test result should be confirmed by NAAT (1). Despite a lower sensitivity to detect infection, rapid antigen tests can be an important tool for screening because of their quick turnaround time, lower costs and resource needs, high specificity, and high positive predictive value (PPV) in settings of high pretest probability. The faster turnaround time of the antigen test can help limit transmission by more rapidly identifying infectious persons for isolation, particularly when used as a component of serial testing strategies. |
Association Between Social Vulnerability and a County's Risk for Becoming a COVID-19 Hotspot - United States, June 1-July 25, 2020.
Dasgupta S , Bowen VB , Leidner A , Fletcher K , Musial T , Rose C , Cha A , Kang G , Dirlikov E , Pevzner E , Rose D , Ritchey MD , Villanueva J , Philip C , Liburd L , Oster AM . MMWR Morb Mortal Wkly Rep 2020 69 (42) 1535-1541 Poverty, crowded housing, and other community attributes associated with social vulnerability increase a community's risk for adverse health outcomes during and following a public health event (1). CDC uses standard criteria to identify U.S. counties with rapidly increasing coronavirus disease 2019 (COVID-19) incidence (hotspot counties) to support health departments in coordinating public health responses (2). County-level data on COVID-19 cases during June 1-July 25, 2020 and from the 2018 CDC social vulnerability index (SVI) were analyzed to examine associations between social vulnerability and hotspot detection and to describe incidence after hotspot detection. Areas with greater social vulnerabilities, particularly those related to higher representation of racial and ethnic minority residents (risk ratio [RR] = 5.3; 95% confidence interval [CI] = 4.4-6.4), density of housing units per structure (RR = 3.1; 95% CI = 2.7-3.6), and crowded housing units (i.e., more persons than rooms) (RR = 2.0; 95% CI = 1.8-2.3), were more likely to become hotspots, especially in less urban areas. Among hotspot counties, those with greater social vulnerability had higher COVID-19 incidence during the 14 days after detection (212-234 cases per 100,000 persons for highest SVI quartile versus 35-131 cases per 100,000 persons for other quartiles). Focused public health action at the federal, state, and local levels is needed not only to prevent communities with greater social vulnerability from becoming hotspots but also to decrease persistently high incidence among hotspot counties that are socially vulnerable. |
Mitigating a COVID-19 Outbreak Among Major League Baseball Players - United States, 2020.
Murray MT , Riggs MA , Engelthaler DM , Johnson C , Watkins S , Longenberger A , Brett-Major DM , Lowe J , Broadhurst MJ , Ladva CN , Villanueva JM , MacNeil A , Qari S , Kirking HL , Cherry M , Khan AS . MMWR Morb Mortal Wkly Rep 2020 69 (42) 1542-1546 Mass gatherings have been implicated in higher rates of transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), and many sporting events have been restricted or canceled to limit disease spread (1). Based on current CDC COVID-19 mitigation recommendations related to events and gatherings (2), Major League Baseball (MLB) developed new health and safety protocols before the July 24 start of the 2020 season. In addition, MLB made the decision that games would be played without spectators. Before a three-game series between teams A and B, the Philadelphia Department of Public Health was notified of a team A player with laboratory-confirmed COVID-19; the player was isolated as recommended (2). During the series and the week after, laboratory-confirmed COVID-19 was diagnosed among 19 additional team A players and staff members and one team B staff member. Throughout their potentially infectious periods, some asymptomatic team A players and coaches, who subsequently received positive SARS-CoV-2 test results, engaged in on-field play with teams B and C. No on-field team B or team C players or staff members subsequently received a clinical diagnosis of COVID-19. Certain MLB health and safety protocols, which include frequent diagnostic testing for rapid case identification, isolation of persons with positive test results, quarantine for close contacts, mask wearing, and social distancing, might have limited COVID-19 transmission between teams. |
CDC Deployments to State, Tribal, Local, and Territorial Health Departments for COVID-19 Emergency Public Health Response - United States, January 21-July 25, 2020.
Dirlikov E , Fechter-Leggett E , Thorne SL , Worrell CM , Smith-Grant JC , Chang J , Oster AM , Bjork A , Young S , Perez AU , Aden T , Anderson M , Farrall S , Jones-Wormley J , Walters KH , LeBlanc TT , Kone RG , Hunter D , Cooley LA , Krishnasamy V , Fuld J , Luna-Pinto C , Williams T , O'Connor A , Nett RJ , Villanueva J , Oussayef NL , Walke HT , Shugart JM , Honein MA , Rose DA . MMWR Morb Mortal Wkly Rep 2020 69 (39) 1398-1403 Coronavirus disease 2019 (COVID-19) is a viral respiratory illness caused by SARS-CoV-2. During January 21-July 25, 2020, in response to official requests for assistance with COVID-19 emergency public health response activities, CDC deployed 208 teams to assist 55 state, tribal, local, and territorial health departments. CDC deployment data were analyzed to summarize activities by deployed CDC teams in assisting state, tribal, local, and territorial health departments to identify and implement measures to contain SARS-CoV-2 transmission (1). Deployed teams assisted with the investigation of transmission in high-risk congregate settings, such as long-term care facilities (53 deployments; 26% of total), food processing facilities (24; 12%), correctional facilities (12; 6%), and settings that provide services to persons experiencing homelessness (10; 5%). Among the 208 deployed teams, 178 (85%) provided assistance to state health departments, 12 (6%) to tribal health departments, 10 (5%) to local health departments, and eight (4%) to territorial health departments. CDC collaborations with health departments have strengthened local capacity and provided outbreak response support. Collaborations focused attention on health equity issues among disproportionately affected populations (e.g., racial and ethnic minority populations, essential frontline workers, and persons experiencing homelessness) and through a place-based focus (e.g., persons living in rural or frontier areas). These collaborations also facilitated enhanced characterization of COVID-19 epidemiology, directly contributing to CDC data-informed guidance, including guidance for serial testing as a containment strategy in high-risk congregate settings, targeted interventions and prevention efforts among workers at food processing facilities, and social distancing. |
Disparities in Incidence of COVID-19 Among Underrepresented Racial/Ethnic Groups in Counties Identified as Hotspots During June 5-18, 2020 - 22 States, February-June 2020.
Moore JT , Ricaldi JN , Rose CE , Fuld J , Parise M , Kang GJ , Driscoll AK , Norris T , Wilson N , Rainisch G , Valverde E , Beresovsky V , Agnew Brune C , Oussayef NL , Rose DA , Adams LE , Awel S , Villanueva J , Meaney-Delman D , Honein MA . MMWR Morb Mortal Wkly Rep 2020 69 (33) 1122-1126 During January 1, 2020-August 10, 2020, an estimated 5 million cases of coronavirus disease 2019 (COVID-19) were reported in the United States.* Published state and national data indicate that persons of color might be more likely to become infected with SARS-CoV-2, the virus that causes COVID-19, experience more severe COVID-19-associated illness, including that requiring hospitalization, and have higher risk for death from COVID-19 (1-5). CDC examined county-level disparities in COVID-19 cases among underrepresented racial/ethnic groups in counties identified as hotspots, which are defined using algorithmic thresholds related to the number of new cases and the changes in incidence.(†) Disparities were defined as difference of ≥5% between the proportion of cases and the proportion of the population or a ratio ≥1.5 for the proportion of cases to the proportion of the population for underrepresented racial/ethnic groups in each county. During June 5-18, 205 counties in 33 states were identified as hotspots; among these counties, race was reported for ≥50% of cumulative cases in 79 (38.5%) counties in 22 states; 96.2% of these counties had disparities in COVID-19 cases in one or more underrepresented racial/ethnic groups. Hispanic/Latino (Hispanic) persons were the largest group by population size (3.5 million persons) living in hotspot counties where a disproportionate number of cases among that group was identified, followed by black/African American (black) persons (2 million), American Indian/Alaska Native (AI/AN) persons (61,000), Asian persons (36,000), and Native Hawaiian/other Pacific Islander (NHPI) persons (31,000). Examining county-level data disaggregated by race/ethnicity can help identify health disparities in COVID-19 cases and inform strategies for preventing and slowing SARS-CoV-2 transmission. More complete race/ethnicity data are needed to fully inform public health decision-making. Addressing the pandemic's disproportionate incidence of COVID-19 in communities of color can reduce the community-wide impact of COVID-19 and improve health outcomes. |
Trends in Number and Distribution of COVID-19 Hotspot Counties - United States, March 8-July 15, 2020.
Oster AM , Kang GJ , Cha AE , Beresovsky V , Rose CE , Rainisch G , Porter L , Valverde EE , Peterson EB , Driscoll AK , Norris T , Wilson N , Ritchey M , Walke HT , Rose DA , Oussayef NL , Parise ME , Moore ZS , Fleischauer AT , Honein MA , Dirlikov E , Villanueva J . MMWR Morb Mortal Wkly Rep 2020 69 (33) 1127-1132 The geographic areas in the United States most affected by the coronavirus disease 2019 (COVID-19) pandemic have changed over time. On May 7, 2020, CDC, with other federal agencies, began identifying counties with increasing COVID-19 incidence (hotspots) to better understand transmission dynamics and offer targeted support to health departments in affected communities. Data for January 22-July 15, 2020, were analyzed retrospectively (January 22-May 6) and prospectively (May 7-July 15) to detect hotspot counties. No counties met hotspot criteria during January 22-March 7, 2020. During March 8-July 15, 2020, 818 counties met hotspot criteria for ≥1 day; these counties included 80% of the U.S. population. The daily number of counties meeting hotspot criteria peaked in early April, decreased and stabilized during mid-April-early June, then increased again during late June-early July. The percentage of counties in the South and West Census regions* meeting hotspot criteria increased from 10% and 13%, respectively, during March-April to 28% and 22%, respectively, during June-July. Identification of community transmission as a contributing factor increased over time, whereas identification of outbreaks in long-term care facilities, food processing facilities, correctional facilities, or other workplaces as contributing factors decreased. Identification of hotspot counties and understanding how they change over time can help prioritize and target implementation of U.S. public health response activities. |
Zika virus disease and pregnancy outcomes in Colombia
Ospina ML , Tong VT , Gonzalez M , Valencia D , Mercado M , Gilboa SM , Rodriguez AJ , Tinker SC , Rico A , Winfield CM , Pardo L , Thomas JD , Avila G , Villanueva JM , Gomez S , Jamieson DJ , Prieto F , Meaney-Delman D , Pacheco O , Honein MA . N Engl J Med 2020 383 (6) 537-545 BACKGROUND: In 2015 and 2016, Colombia had a widespread outbreak of Zika virus. Data from two national population-based surveillance systems for symptomatic Zika virus disease (ZVD) and birth defects provided complementary information on the effect of the Zika virus outbreak on pregnancies and infant outcomes. METHODS: We collected national surveillance data regarding cases of pregnant women with ZVD that were reported during the period from June 2015 through July 2016. The presence of Zika virus RNA was identified in a subgroup of these women on real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Brain or eye defects in infants and fetuses and other adverse pregnancy outcomes were identified among the women who had laboratory-confirmed ZVD and for whom data were available regarding pregnancy outcomes. We compared the nationwide prevalence of brain and eye defects during the outbreak with the prevalence both before and after the outbreak period. RESULTS: Of 18,117 pregnant women with ZVD, the presence of Zika virus was confirmed in 5926 (33%) on rRT-PCR. Of the 5673 pregnancies with laboratory-confirmed ZVD for which outcomes had been reported, 93 infants or fetuses (2%) had brain or eye defects. The incidence of brain or eye defects was higher among pregnancies in which the mother had an onset of ZVD symptoms in the first trimester than in those with an onset during the second or third trimester (3% vs. 1%). A total of 172 of 5673 pregnancies (3%) resulted in pregnancy loss; after the exclusion of pregnancies affected by birth defects, 409 of 5426 (8%) resulted in preterm birth and 333 of 5426 (6%) in low birth weight. The prevalence of brain or eye defects during the outbreak was 13 per 10,000 live births, as compared with a prevalence of 8 per 10,000 live births before the outbreak and 11 per 10,000 live births after the outbreak. CONCLUSIONS: In pregnant women with laboratory-confirmed ZVD, brain or eye defects in infants or fetuses were more common during the Zika virus outbreak than during the periods immediately before and after the outbreak. The frequency of such defects was increased among women with a symptom onset early in pregnancy. (Funded by the Colombian Instituto Nacional de Salud and the Centers for Disease Control and Prevention.). |
US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2.
Lu X , Wang L , Sakthivel SK , Whitaker B , Murray J , Kamili S , Lynch B , Malapati L , Burke SA , Harcourt J , Tamin A , Thornburg NJ , Villanueva JM , Lindstrom S . Emerg Infect Dis 2020 26 (8) 1654-65 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the etiologic agent associated with coronavirus disease, which emerged in late 2019. In response, we developed a diagnostic panel consisting of 3 real-time reverse transcription PCR assays targeting the nucleocapsid gene and evaluated use of these assays for detecting SARS-CoV-2 infection. All assays demonstrated a linear dynamic range of 8 orders of magnitude and an analytical limit of detection of 5 copies/reaction of quantified RNA transcripts and 1 x 10(-1.5) 50% tissue culture infectious dose/mL of cell-cultured SARS-CoV-2. All assays performed comparably with nasopharyngeal and oropharyngeal secretions, serum, and fecal specimens spiked with cultured virus. We obtained no false-positive amplifications with other human coronaviruses or common respiratory pathogens. Results from all 3 assays were highly correlated during clinical specimen testing. On February 4, 2020, the Food and Drug Administration issued an Emergency Use Authorization to enable emergency use of this panel. |
Impact of deltamethrin selection on kdr mutations and insecticide detoxifying enzymes in Aedes aegypti from Mexico.
Contreras-Perera Y , Ponce-Garcia G , Villanueva-Segura K , Lopez-Monroy B , Rodriguez-Sanchez IP , Lenhart A , Manrique-Saide P , Flores AE . Parasit Vectors 2020 13 (1) 224 BACKGROUND: Insecticide resistance is a serious problem for vector control programmes worldwide. Resistance is commonly attributed to mutations at the insecticide's target site or increased activity of detoxification enzymes. METHODS: We determined the knockdown concentration (KC50) and lethal concentration (LC50) of deltamethrin in six natural populations of adult Aedes aegypti from southeastern Mexico. These populations were then selected over five generations using the LC50 from the preceding generation that underwent selection, and the heritability of deltamethrin resistance was quantified. For each generation, we also determined the frequency of the kdr alleles L410, I1016 and C1534, and the levels of activity of three enzyme families (alpha- and beta-esterases, mixed-function oxidases and glutathione S-transferases (GST)) associated with insecticide detoxification. RESULTS: There was an increase in KC50 and LC50 values in the subsequent generations of selection with deltamethrin (FS5vs FS0). According to the resistance ratios (RRs), we detected increases in LC50 ranging from 1.5 to 5.6 times the values of the parental generation and in KC50 ranging from 1.3-3.8 times the values of the parental generation. Triple homozygous mutant individuals (tri-locus, LL/II/CC) were present in the parental generations and increased in frequency after selection. The frequency of L410 increased from 1.18-fold to 2.63-fold after selection with deltamethrin (FS5vs FS0) in the populations analyzed; for I1016 an increase between 1.19-fold to 2.79-fold was observed, and C1534 was fixed in all populations after deltamethrin selection. Enzymatic activity varied significantly over the generations of selection. However, only alpha- esterase activity remained elevated in multiple populations after five generations of deltamethrin selection. We observed an increase in the mean activity levels of GSTs in two of the six populations analyzed. CONCLUSIONS: The high levels of resistance and their association with high frequencies of kdr mutations (V410L, V1016I and F1534C) obtained through artificial selection, suggest an important role of these mutations in conferring resistance to deltamethrin. We highlight the need to implement strategies that involve the monitoring of kdr frequencies in insecticide resistance monitoring and management programmes. |
Rapid nanopore whole-genome sequencing for anthrax emergency preparedness
McLaughlin HP , Bugrysheva JV , Conley AB , Gulvik CA , Cherney B , Kolton CB , Marston CK , Saile E , Swaney E , Lonsway D , Gargis AS , Kongphet-Tran T , Lascols C , Michel P , Villanueva J , Hoffmaster AR , Gee JE , Sue D . Emerg Infect Dis 2020 26 (2) 358-361 Human anthrax cases necessitate rapid response. We completed Bacillus anthracis nanopore whole-genome sequencing in our high-containment laboratory from a human anthrax isolate hours after receipt. The de novo assembled genome showed no evidence of known antimicrobial resistance genes or introduced plasmid(s). Same-day genomic characterization enhances public health emergency response. |
Zika virus detection in amniotic fluid and Zika-associated birth defects
Reyes MM , Ailes EC , Daza M , Tong VT , Osorio J , Valencia D , Turca AR , Galang RR , Gonzalez Duarte M , Ricaldi JN , Anderson KN , Kamal N , Thomas JD , Villanueva J , Burkel VK , Meaney-Delman D , Gilboa SM , Honein MA , Jamieson DJ , Martinez MO . Am J Obstet Gynecol 2020 222 (6) 610 e1-610 e13 BACKGROUND: Zika virus (ZIKV) infection during pregnancy can cause serious birth defects, including brain and eye abnormalities. The clinical importance of detection of ZIKV ribonucleic acid (RNA) in amniotic fluid is unknown. OBJECTIVES: To describe patterns of ZIKV RNA testing of amniotic fluid relative to other clinical specimens and to examine the association between ZIKV detection in amniotic fluid and Zika-associated birth defects. Our null hypothesis was that ZIKV detection in amniotic fluid was not associated with Zika-associated birth defects. STUDY DESIGN: We conducted a retrospective cohort analysis of women with amniotic fluid specimens submitted to Colombia's National Institute of Health as part of national ZIKV surveillance from January 2016 to January 2017. Specimens (maternal serum, amniotic fluid, cord blood, umbilical cord tissue, and placental tissue) were tested for the presence of ZIKV RNA using a singleplex or multiplex real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) assay. Birth defect information was abstracted from maternal prenatal and infant birth records and reviewed by expert clinicians. Chi-square and Fisher's exact tests were used to compare the frequency of Zika-associated birth defects (defined as brain abnormalities [with or without microcephaly, but excluding neural tube defects and their associated findings] or eye abnormalities) by frequency of detection of ZIKV RNA in amniotic fluid. RESULTS: Our analysis included 128 women with amniotic fluid specimens. Seventy-five women (58%) had prenatally-collected amniotic fluid, 42 (33%) at delivery, and 11 (9%) had missing collection dates. Ninety-one women had both amniotic fluid and other clinical specimens submitted for testing, allowing for comparison across specimen types. Of those 91 women, 68 had evidence of ZIKV infection based on detection of ZIKV RNA (ZIKV+) in >1 specimen. Testing of amniotic fluid collected prenatally or at delivery identified 39 (57%) of these ZIKV infections (15 [22%] identified only in amniotic fluid), and 29 (43%) infections were identified in other specimen types and not amniotic fluid. Among women included in the analysis, 89 had pregnancy outcome information available, allowing for assessment of the presence of Zika-associated birth defects. Zika-associated birth defects were significantly (p<0.05) more common among pregnancies with ZIKV+ amniotic fluid specimens collected prenatally (19/32, 59%) than for those with no laboratory evidence of ZIKV infection in any specimen (6/23, 26%), but the proportion was similar in pregnancies with only ZIKV+ specimens other than amniotic fluid (10/23, 43%). Though Zika-associated birth defects were more common among women with any ZIKV+ amniotic fluid specimen (i.e., collected prenatally or at delivery; 21/43, 49%) than those with no laboratory evidence of ZIKV infection (6/23, 26%), this comparison did not reach statistical significance (p=0.07). CONCLUSIONS: Testing of amniotic fluid provided additional evidence for maternal diagnosis of ZIKV infection. Zika-associated birth defects were more common among women with ZIKV RNA detected in prenatal amniotic fluid specimens than women with no laboratory evidence of ZIKV infection, but similar to women with ZIKV RNA detected in other, non-amniotic fluid specimen types. |
Detecting emerging infectious diseases: An overview of the Laboratory Response Network for Biological Threats
Villanueva J , Schweitzer B , Odle M , Aden T . Public Health Rep 2019 134 16s-21s The Laboratory Response Network (LRN) was established in 1999 to ensure an effective laboratory response to high-priority public health threats. The LRN for biological threats (LRN-B) provides a laboratory infrastructure to respond to emerging infectious diseases. Since 2012, the LRN-B has been involved in 3 emerging infectious disease outbreak responses. We evaluated the LRN-B role in these responses and identified areas for improvement. LRN-B laboratories tested 1097 specimens during the 2014 Middle East Respiratory Syndrome Coronavirus outbreak, 180 specimens during the 2014-2015 Ebola outbreak, and 92 686 specimens during the 2016-2017 Zika virus outbreak. During the 2014-2015 Ebola outbreak, the LRN-B uncovered important gaps in biosafety and biosecurity practices. During the 2016-2017 Zika outbreak, the LRN-B identified the data entry bottleneck as a hindrance to timely reporting of results. Addressing areas for improvement may help LRN-B reference laboratories improve the response to future public health emergencies. |
Implementing data to care - what are the costs for the health department
Neblett Fanfair R , Shrestha RK , Randall L , Lucas C , Nichols L , Camp NM , Brady K , Jenkins H , Altice F , Villanueva M , DeMaria A . J Acquir Immune Defic Syndr 2019 82 Suppl 1 S57-s61 BACKGROUND: The Cooperative Re-Engagement Controlled Trial (CoRECT) is a randomized controlled trial that uses a combined health department-provider data to care (D2C) model to identify out-of-care HIV-infected persons. We present cost data for programmatic aspects of the trial during the start-up period (first 30 days of the study). METHODS: We used microcosting methods to estimate health department start-up costs. We collected start-up cost data between September 2016 and December 2016; 3 health departments completed a form to capture expenses for the initial 30 days of study implementation; the start date varied by health department. All costs are expressed in 2016 US dollars. RESULTS: Among the 3 health departments, the total start-up costs ranged from $14,145 to $26,058. Total start-up labor hours ranged from 224 to 640 hours. CONCLUSIONS: As D2C expands nationally with cooperative agreement, PS 18-1802 health departments may be able to use a similar analysis to consider the labor, time, and resources needed to implement D2C within their jurisdiction. |
Safety, immunogenicity and protection of A(H3N2) live attenuated influenza vaccines containing wild-type nucleoprotein in a ferret model.
Korenkov DA , Laurie KL , Reading PC , Carolan LA , Chan KF , Isakova Sivak II , Smolonogina TA , Subbarao K , Barr IG , Villanueva J , Shcherbik S , Bousse T , Rudenko LG . Infect Genet Evol 2018 64 95-104 Live attenuated influenza vaccines (LAIVs) are promising tools for the induction of broad protection from influenza due to their ability to stimulate cross-reactive T cells against influenza pathogens. One of the major targets for cytotoxic T-cell immunity is viral nucleoprotein (NP), which is relatively conserved among antigenically distant influenza viruses. Nevertheless, a diversity of epitope composition has been found in the NP protein of different lineages of influenza A viruses. The H2N2 master donor virus which is currently used as a backbone for the LAIV and donor of the six genomic segments encoding the internal proteins, A/Leningrad/134/17/57 (MDV Len/17), was isolated 60years ago. As such, NP-specific T-cell immunity induced upon vaccination with classical LAIVs with a 6:2 genome composition containing this older NP might be suboptimal against currently circulating influenza viruses. In this study, a panel of H3N2 LAIV candidates with wild-type NP genes derived from circulating viruses were generated by reverse genetics (5:3 genome composition). These viruses displayed the cold adaptation and temperature sensitivity phenotypes of MDV Len/17 in vitro. LAIVs with both 6:2 and 5:3 genome compositions were attenuated and replicated to a similar extent in the upper respiratory tract of ferrets. LAIVs were immunogenic as high neutralizing and hemagglutination inhibition serum antibody titers were detected 21days after infection. All vaccinated animals were protected against infection with heterologous H3N2 influenza A viruses. Thus, LAIV with a 5:3 genome composition is safe, immunogenic and can induce cross-protective immunity. |
Performance of the Trioplex real-time RT-PCR assay for detection of Zika, dengue, and chikungunya viruses.
Santiago GA , Vazquez J , Courtney S , Matias KY , Andersen LE , Colon C , Butler AE , Roulo R , Bowzard J , Villanueva JM , Munoz-Jordan JL . Nat Commun 2018 9 (1) 1391 The emergence and spread of Zika virus (ZIKV) presented a challenge to the diagnosis of ZIKV infections in areas with transmission of dengue (DENV) and chikungunya (CHIKV) viruses. To facilitate detection of ZIKV infections, and differentiate these infections from DENV and CHIKV, we developed the Trioplex real-time RT-PCR assay (Trioplex assay). Here, we describe the optimization of multiplex and singleplex formats of the assay for a variety of chemistries and instruments to facilitate global standardization and implementation. We evaluated the analytical performance of all Trioplex modalities for detection of these three pathogens in serum and whole blood, and for ZIKV in urine. The limit of detection for the three viruses and in different RNA-extraction modalities is near 10(3) genome copy equivalents per milliliter (GCE/mL). Simultaneous testing of more than one specimen type from each patient provides a 6.4% additional diagnostic sensitivity. Overall, the high sensitivity of the Trioplex assay demonstrates the utility of this assay ascertaining Zika cases. |
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