Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
Records 1-21 (of 21 Records) |
Query Trace: Shah MM[original query] |
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Long-term symptoms associated with SARS-cov-2 infection among blood donors
Shah MM , Spencer BR , James-Gist J , Haynes JM , Feldstein LR , Stramer SL , Jones JM , Saydah SH . JAMA Netw Open 2024 7 (4) e245611 IMPORTANCE: Long-term symptoms, lasting more than 4 consecutive weeks after acute COVID-19 disease, are an important consequence of SARS-CoV-2 infection. Many prior studies have lacked a non-SARS-CoV-2-infected control population to distinguish background prevalence of symptoms from the direct impact of COVID-19 disease. OBJECTIVE: To examine the prevalence of long-term physical and mental health symptoms associated with SARS-CoV-2 infection in a large population of blood donors based on self-report and serologic test results. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included American Red Cross blood donors (aged ≥18 years) who were surveyed between February 22 and April 21, 2022, about new long-term symptoms arising after March 2020 and their SARS-CoV-2 infection status. All participants underwent at least 1 serologic test for antinucleocapsid antibodies between June 15, 2020, and December 31, 2021. EXPOSURES: SARS-CoV-2 infection as defined by a self-reported, confirmed acute infection or antinucleocapsid antibody positivity. MAIN OUTCOMES AND MEASURES: New long-term symptoms since March 2020, including 5 symptom categories (neurologic, gastrointestinal, respiratory and cardiac, mental health, and other). RESULTS: Among 818 361 individuals who received the survey, 272 965 (33.4%) responded, with 238 828 meeting the inclusion criteria (138 576 [58.0%] female; median [IQR] age, 59.0 [47.0-67.0] years). Of the 83 015 individuals with a history of SARS-CoV-2 infection, 43.3% reported new long-term symptoms compared with 22.1% of those without a history of SARS-CoV-2 infection. After controlling for age, sex, race and ethnicity, and number of underlying conditions, those with a history of SARS-CoV-2 infection had an increased odds of new long-term symptoms compared with those without (adjusted odds ratio [AOR], 2.55; 95% CI, 2.51-2.61). Female sex and a history of chronic conditions were associated with new long-term symptoms. Long-term symptoms in the other category (AOR, 4.14; 95% CI, 4.03-4.25), which included changes in taste or smell, and the respiratory and cardiac symptom categories (AOR, 3.21; 95% CI, 3.12-3.31) were most associated with prior SARS-CoV-2 infection. Mental health long-term symptoms were also associated with prior SARS-CoV-2 infection (AOR, 1.05; 95%, CI, 1.02-1.08). CONCLUSIONS AND RELEVANCE: This study's findings suggest that long-term symptoms lasting more than 4 weeks are common in the adult population, but there is a significantly higher prevalence among those with SARS-CoV-2 infection. Continued efforts to define and track long-term sequelae of SARS-CoV-2 using a control group without infection and serologic information to include those who had asymptomatic or unidentified infections are needed. |
Combined protection of vaccination and nirmatrelvir-ritonavir against hospitalization in adults with COVID-19
Shah MM . Clin Infect Dis 2024 Among U.S. adults at risk for severe COVID-19 in Epic Cosmos, the lowest rate of hospitalization was among those receiving three or more mRNA vaccine doses and nirmatrelvir-ritonavir (aHR 0.22, 95%CI: 0.19-0.24). Adults who are at high-risk of severe COVID-19 disease, including vaccinated persons, should be considered for antiviral treatment. |
Use of updated COVID-19 vaccines 2023-2024 formula for persons aged ≥6 months: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2023
Regan JJ , Moulia DL , Link-Gelles R , Godfrey M , Mak J , Najdowski M , Rosenblum HG , Shah MM , Twentyman E , Meyer S , Peacock G , Thornburg N , Havers FP , Saydah S , Brooks O , Talbot HK , Lee GM , Bell BP , Mahon BE , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2023 72 (42) 1140-1146 COVID-19 vaccines protect against severe COVID-19-associated outcomes, including hospitalization and death. As SARS-CoV-2 has evolved, and waning vaccine effectiveness has been noted, vaccine formulations and policies have been updated to provide continued protection against severe illness and death from COVID-19. Since September 2022, bivalent mRNA COVID-19 vaccines have been recommended in the United States, but the variants these vaccines protect against are no longer circulating widely. On September 11, 2023, the Food and Drug Administration (FDA) approved the updated (2023-2024 Formula) COVID-19 mRNA vaccines by Moderna and Pfizer-BioNTech for persons aged ≥12 years and authorized these vaccines for persons aged 6 months-11 years under Emergency Use Authorization (EUA). On October 3, 2023, FDA authorized the updated COVID-19 vaccine by Novavax for use in persons aged ≥12 years under EUA. The updated COVID-19 vaccines include a monovalent XBB.1.5 component, which is meant to broaden vaccine-induced immunity and provide protection against currently circulating SARS-CoV-2 XBB-sublineage variants including against severe COVID-19-associated illness and death. On September 12, 2023, the Advisory Committee on Immunization Practices recommended vaccination with updated COVID-19 vaccines for all persons aged ≥6 months. These recommendations will be reviewed as new evidence becomes available or new vaccines are approved and might be updated. |
Performance of Repeat BinaxNOW SARS-CoV-2 Antigen Testing in a Community Setting, Wisconsin, November-December 2020 (preprint)
Shah MM , Salvatore PP , Ford L , Kamitani E , Whaley MJ , Mitchell K , Currie DW , Morgan CN , Segaloff HE , Lecher S , Somers T , Van Dyke ME , Bigouette JP , Delaney A , DaSilva J , O'Hegarty M , Boyle-Estheimer L , Abdirizak F , Karpathy SE , Meece J , Ivanic L , Goffard K , Gieryn D , Sterkel A , Bateman A , Kahrs J , Langolf K , Zochert T , Knight NW , Hsu CH , Kirking HL , Tate JE . medRxiv 2021 2021.04.05.21254834 Repeating the BinaxNOW antigen test for SARS-CoV-2 by two groups of readers within 30 minutes resulted in high concordance (98.9%) in 2,110 encounters. BinaxNOW test sensitivity was 77.2% (258/334) compared to real-time reverse transcription-polymerase chain reaction. Repeating antigen testing on the same day did not significantly improve test sensitivity while specificity remained high.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was funded by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. See e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData will be made available upon reasonable request. |
Quantitative Comparison of SARS-CoV-2 Nucleic Acid Amplification Test and Antigen Testing Algorithms: A Decision Analysis Simulation Model (preprint)
Salvatore PP , Shah MM , Ford L , Delaney A , Hsu CH , Tate JE , Kirking HL . medRxiv 2021 2021.03.15.21253608 Background Antigen tests for SARS-CoV-2 offer advantages over nucleic acid amplification tests (NAATs, such as RT-PCR), including lower cost and rapid return of results, but show reduced sensitivity. Public health organizations continue to recommend different strategies for utilizing NAATs and antigen tests in various settings. There has not yet been a quantitative comparison of the expected performance of these strategies.Methods We utilized a decision analysis approach to simulate the expected outcomes of six algorithms for implementing NAAT and antigen testing, analogous to testing strategies recommended by public health organizations. Each algorithm was simulated 50,000 times for four SARS-CoV-2 infection prevalence levels ranging from 5% to 20% in a population of 100000 persons seeking testing. Primary outcomes were number of missed cases, number of false-positive diagnoses, and total test volumes. Outcome medians and 95% uncertainty ranges (URs) were reported.Results Algorithms that use NAATs to confirm all negative antigen results minimized missed cases but required high NAAT capacity: 92,200 (95% UR: 91,200-93,200) tests (in addition to 100,000 antigen tests) at 10% prevalence. Substituting repeat antigen testing in lieu of NAAT confirmation of all initial negative antigen tests resulted in 2,280 missed cases (95% UR: 1,507-3,067) at 10% prevalence. Selective use of NAATs to confirm antigen results when discordant with symptom status (e.g., symptomatic persons with negative antigen results) resulted in the most efficient use of NAATs, with 25 NAATs (95% UR: 13-57) needed to detect one additional case at 10% prevalence compared to exclusive use of antigen tests.Conclusions No single SARS-CoV-2 testing algorithm is likely to be optimal across settings with different levels of prevalence and for all programmatic priorities; each presents a trade-off between prioritized outcomes and resource constraints. This analysis provides a framework for selecting setting-specific strategies to achieve acceptable balances and trade-offs between programmatic priorities and constraints.Disclaimer The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was funded by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. See e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesCode for the algorithm simulations can be found on the CDC Epidemic Prediction Initiative GitHub site (https://github.com/cdcepi). |
Characteristics of children and antigen test performance at a SARS-CoV-2 community testing site (preprint)
Ford L , Whaley MJ , Shah MM , Salvatore PP , Segaloff HE , Delaney A , Currie DW , Boyle-Estheimer L , O'Hegarty M , Morgan CN , Meece J , Ivacic L , Thornburg NJ , Tamin A , Harcourt JL , Folster JM , Medrzycki M , Jain S , Wong P , Goffard K , Gieryn D , Kahrs J , Langolf K , Zochert T , Tate JE , Hsu CH , Kirking HL . medRxiv 2021 2021.07.06.21259792 Background Performance characteristics of SARS-CoV-2 antigen tests among children are limited despite the need for point-of-care testing in school and childcare settings. We describe children seeking SARS-CoV-2 testing at a community site and compare antigen test performance to real-time reverse transcription-polymerase chain reaction (RT-PCR) and viral culture.Methods Two anterior nasal specimens were self-collected for BinaxNOW antigen and RT-PCR testing, along with demographics, symptoms, and exposure information from individuals ≥5 years at a community testing site. Viral culture was attempted on residual antigen or RT-PCR positive specimens. Demographic and clinical characteristics, and the performance of SARS-CoV-2 antigen tests, were compared among children (<18 years) and adults.Results About one in ten included specimens were from children (225/2110); 16.4% (37/225) were RT-PCR positive. Cycle threshold values were similar among RT-PCR positive specimens from children and adults (22.5 vs 21.3, p=0.46) and among specimens from symptomatic and asymptomatic children (22.5 vs 23.2, p=0.39). Sensitivity of antigen test compared to RT-PCR was 73.0% (27/37) among specimens from children and 80.8% (240/297) among specimens from adults; among specimens from children, specificity was 100% (188/188), positive and negative predictive value were 100% (27/27) and 94.9% (188/198) respectively. Virus was isolated from 51.4% (19/37) of RT-PCR positive pediatric specimens; all 19 had positive antigen test results.Conclusions With lower sensitivity relative to RT-PCR, antigen tests may not diagnose all positive COVID-19 cases; however, antigen testing identified children with live SARS-CoV-2 virus.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was supported by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. See e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request. |
Seasonality of Common Human Coronaviruses in the United States, 2014-2021 (preprint)
Shah MM , Winn A , Dahl RM , Kniss KL , Silk BJ , Killerby ME . medRxiv 2022 22 (10) 1970-1976 The four common human coronaviruses (HCoVs), including two alpha (HCoV-NL63 and HCoV-229E) and two beta (HCoV-HKU1 and HCoV-OC43) types, generally cause mild, upper respiratory illness. HCoVs are known to have seasonal patterns and variation in predominant types each year, but defined measures of seasonality are needed. We defined seasonality of HCoVs during July 2014 to November 2021 in the United States using a retrospective method applied to National Respiratory and Enteric Virus Surveillance System (NREVSS) data. In the six HCoV seasons prior to 2020-2021, onsets ranged from October to November, peaks from January to February, and offsets from April to June; most (>93%) HCoV detections occurred within the defined seasonal onsets and offsets. The 2020-2021 HCoV season onset was delayed by 11 weeks compared to prior seasons, likely due to COVID-19 mitigation efforts. Better defining HCoV seasonality can inform clinical preparedness and the expected patterns of emerging HCoVs. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Bacterial and viral infections among adults hospitalized with COVID-19, COVID-NET, 14 states, March 2020-April 2022
Shah MM , Patel K , Milucky J , Taylor CA , Reingold A , Armistead I , Meek J , Anderson EJ , Weigel A , Reeg L , Como-Sabetti K , Ropp SL , Muse A , Bushey S , Shiltz E , Sutton M , Talbot HK , Chatelain R , Havers FP . Influenza Other Respir Viruses 2023 17 (3) e13107 BACKGROUND: Bacterial and viral infections can occur with SARS-CoV-2 infection, but prevalence, risk factors, and associated clinical outcomes are not fully understood. METHODS: We used the Coronavirus Disease 2019-Associated Hospitalization Surveillance Network (COVID-NET), a population-based surveillance system, to investigate the occurrence of bacterial and viral infections among hospitalized adults with laboratory-confirmed SARS-CoV-2 infection between March 2020 and April 2022. Clinician-driven testing for bacterial pathogens from sputum, deep respiratory, and sterile sites were included. The demographic and clinical features of those with and without bacterial infections were compared. We also describe the prevalence of viral pathogens including respiratory syncytial virus, rhinovirus/enterovirus, influenza, adenovirus, human metapneumovirus, parainfluenza viruses, and non-SARS-CoV-2 endemic coronaviruses. RESULTS: Among 36 490 hospitalized adults with COVID-19, 53.3% had bacterial cultures taken within 7 days of admission and 6.0% of these had a clinically relevant bacterial pathogen. After adjustment for demographic factors and co-morbidities, bacterial infections in patients with COVID-19 within 7 days of admission were associated with an adjusted relative risk of death 2.3 times that of patients with negative bacterial testing. Staphylococcus aureus and Gram-negative rods were the most frequently isolated bacterial pathogens. Among hospitalized adults with COVID-19, 2766 (7.6%) were tested for seven virus groups. A non-SARS-CoV-2 virus was identified in 0.9% of tested patients. CONCLUSIONS: Among patients with clinician-driven testing, 6.0% of adults hospitalized with COVID-19 were identified to have bacterial coinfections and 0.9% were identified to have viral coinfections; identification of a bacterial coinfection within 7 days of admission was associated with increased mortality. |
Paxlovid Associated with Decreased Hospitalization Rate Among Adults with COVID-19 - United States, April-September 2022.
Shah MM , Joyce B , Plumb ID , Sahakian S , Feldstein LR , Barkley E , Paccione M , Deckert J , Sandmann D , Gerhart JL , Hagen MB . MMWR Morb Mortal Wkly Rep 2022 71 (48) 1531-1537 Nirmatrelvir-ritonavir (Paxlovid), an oral antiviral treatment, is authorized for adults with mild-to-moderate COVID-19 who are at increased risk for progression to severe illness. However, real-world evidence on the benefit of Paxlovid, according to vaccination status, age group, and underlying health conditions, is limited. To examine the benefit of Paxlovid in adults aged ≥18 years in the United States, a large electronic health record (EHR) data set (Cosmos(†)) was analyzed to assess the association between receiving a prescription for Paxlovid and hospitalization with a COVID-19 diagnosis in the ensuing 30 days. A Cox proportional hazards model was used to estimate this association, adjusted for demographic characteristics, geographic location, vaccination, previous infection, and number of underlying health conditions. Among 699,848 adults aged ≥18 years eligible for Paxlovid during April-August 2022, 28.4% received a Paxlovid prescription within 5 days of COVID-19 diagnosis. Being prescribed Paxlovid was associated with a lower hospitalization rate among the overall study population (adjusted hazard ratio [aHR] = 0.49), among those who had received ≥3 mRNA COVID-19 vaccines (aHR = 0.50), and across age groups (18-49 years: aHR = 0.59; 50-64 years: aHR = 0.40; and ≥65 years: aHR = 0.53). Paxlovid should be prescribed to eligible adults to reduce the risk of COVID-19-associated hospitalization. |
Occupations Associated with SARS-CoV-2 Infection and Vaccination, U.S. Blood Donors, July 2021-December 2021.
Shah MM , Spencer BR , Feldstein LR , Haynes JM , Benoit TJ , Saydah SH , Groenewold MR , Stramer SL , Jones JM . Clin Infect Dis 2022 76 (7) 1285-1294 BACKGROUND: There are limited data on the risk of SARS-CoV-2 infection in the U.S. by occupation. We identified occupations at higher risk for prior SARS-CoV-2 infection as defined by the presence of infection-induced antibodies among U.S. blood donors. METHODS: Using a nested case-control study design, blood donors during May-December 2021 with anti-nucleocapsid (anti-N) testing were sent an electronic survey on employment status, vaccination, and occupation. The association between previous SARS-CoV-2 infection and occupation-specific in-person work was estimated using multivariable logistic regression adjusting for sex, age, month of donation, race/ethnicity, education, vaccination, and telework. RESULTS: Among 85,986 included survey respondents, 9,504 (11.1%) were anti-N reactive. Healthcare support (20.3%), protective service (19.9%), and food preparation and serving related occupations (19.7%) had the highest proportion of prior infection. After adjustment, prior SARS-CoV-2 infection was associated with healthcare practitioners (adjusted OR [aOR] 2.10, 95% CI 1.74-2.54) and healthcare support (aOR 1.83, 95% CI 1.39-2.40) occupations compared with computer and mathematical occupations as the referent group. Lack of COVID-19 vaccination (aOR 16.13, 95% CI 15.01-17.34) and never teleworking (aOR 1.17, 95% CI 1.05-1.30) were also independently associated with prior SARS-CoV-2 infection. Protective service occupations had the highest proportion of unvaccinated workers (30.0%). CONCLUSIONS: Workers in healthcare, protective services, and food preparation had the highest prevalence of prior SARS-CoV-2 infection. Occupational risks for SARS-CoV-2 infection remained after adjusting for vaccination, telework, and demographic factors. These findings underscore the need for mitigation measures and personal protection in healthcare settings and other workplaces. |
Seasonality of Common Human Coronaviruses, United States, 2014-2021.
Shah MM , Winn A , Dahl RM , Kniss KL , Silk BJ , Killerby ME . Emerg Infect Dis 2022 28 (10) 1970-1976 The 4 common types of human coronaviruses (HCoVs)-2 alpha (HCoV-NL63 and HCoV-229E) and 2 beta (HCoV-HKU1 and HCoV-OC43)-generally cause mild upper respiratory illness. Seasonal patterns and annual variation in predominant types of HCoVs are known, but parameters of expected seasonality have not been defined. We defined seasonality of HCoVs during July 2014-November 2021 in the United States by using a retrospective method applied to National Respiratory and Enteric Virus Surveillance System data. In the 6 HCoV seasons before 2020-21, season onsets occurred October 21-November 12, peaks January 6-February 13, and offsets April 18-June 27; most (>93%) HCoV detection was within the defined seasonal onsets and offsets. The 2020-21 HCoV season onset was 11 weeks later than in prior seasons, probably associated with COVID-19 mitigation efforts. Better definitions of HCoV seasonality can be used for clinical preparedness and for determining expected patterns of emerging coronaviruses. |
Primary and Secondary Attack Rates by Vaccination Status after a SARS-CoV-2 B.1.617.2 (Delta) Variant Outbreak at a Youth Summer Camp - Texas, June 2021.
Baker JM , Shah MM , O'Hegarty M , Pomeroy M , Keiser P , Ren P , Weaver SC , Maknojia S , Machado RRG , Mitchell BM , McConnell A , Tate JE , Kirking HL . J Pediatric Infect Dis Soc 2022 11 (12) 550-556 Children are capable of initiating COVID-19 transmission into households, but many questions remain about the impact of vaccination on transmission. Data from a COVID-19 Delta variant outbreak at an overnight camp in Texas during June 23-27, 2021 were analyzed. The camp had 451 attendees, including 364 youths aged <18 years and 87 adults. Detailed interviews were conducted with 92 (20.4%) of consenting attendees and 117 household members of interviewed attendees with COVID-19. Among 450 attendees with known case status, the attack rate was 41%, including 42% among youths; attack rates were lower among vaccinated (13%) than among unvaccinated youths (48%). The secondary attack rate was 51% among 115 household contacts of 55 interviewed index patients. Secondary infections occurred in 67% of unvaccinated household members and 33% of fully or partially vaccinated household members. Analyses suggested that household member vaccination and camp attendee masking at home protected against household transmission. |
Relationship of SARS-CoV-2 Antigen and Reverse Transcription PCR Positivity for Viral Cultures.
Currie DW , Shah MM , Salvatore PP , Ford L , Whaley MJ , Meece J , Ivacic L , Thornburg NJ , Tamin A , Harcourt JL , Folster J , Medrzycki M , Jain S , Wong P , Goffard K , Gieryn D , Kahrs J , Langolf K , Zochert T , Hsu CH , Kirking HL , Tate JE . Emerg Infect Dis 2022 28 (3) 717-720 We assessed the relationship between antigen and reverse transcription PCR (RT-PCR) test positivity and successful virus isolation. We found that antigen test results were more predictive of virus recovery than RT-PCR results. However, virus was isolated from some antigen-negative and RT-PCR‒positive paired specimens, providing support for the Centers for Disease Control and Prevention antigen testing algorithm. |
Twelve-Month Follow-up of Early COVID-19 Cases in the United States: Cellular and Humoral Immune Longevity.
Shah MM , Rasheed MAU , Harcourt JL , Abedi GR , Stumpf MM , Kirking HL , Tamin A , Mills L , Armstrong M , Salvatore PP , Surasi K , Scott SE , Killerby ME , Briggs-Hagen M , Saydah S , Tate JE , Fry AM , Hall AJ , Thornburg NJ , Midgley CM . Open Forum Infect Dis 2022 9 (3) ofab664 We quantify antibody and memory B-cell responses to severe acute respiratory syndrome coronavirus 2 at 6 and 12 months postinfection among 7 unvaccinated US coronavirus disease 2019 cases. All had detectable S-specific memory B cells and immunoglobulin G at both time points, with geometric mean titers of 117.2 BAU/mL and 84.0 BAU/mL at 6 and 12 months, respectively. |
Quantitative comparison of SARS-CoV-2 nucleic acid amplification test and antigen testing algorithms: a decision analysis simulation model.
Salvatore PP , Shah MM , Ford L , Delaney A , Hsu CH , Tate JE , Kirking HL . BMC Public Health 2022 22 (1) 82 BACKGROUND: Antigen tests for SARS-CoV-2 offer advantages over nucleic acid amplification tests (NAATs, such as RT-PCR), including lower cost and rapid return of results, but show reduced sensitivity. Public health organizations recommend different strategies for utilizing NAATs and antigen tests. We sought to create a framework for the quantitative comparison of these recommended strategies based on their expected performance. METHODS: We utilized a decision analysis approach to simulate the expected outcomes of six testing algorithms analogous to strategies recommended by public health organizations. Each algorithm was simulated 50,000 times in a population of 100,000 persons seeking testing. Primary outcomes were number of missed cases, number of false-positive diagnoses, and total test volumes. Outcome medians and 95% uncertainty ranges (URs) were reported. RESULTS: Algorithms that use NAATs to confirm all negative antigen results minimized missed cases but required high NAAT capacity: 92,200 (95% UR: 91,200-93,200) tests (in addition to 100,000 antigen tests) at 10% prevalence. Selective use of NAATs to confirm antigen results when discordant with symptom status (e.g., symptomatic persons with negative antigen results) resulted in the most efficient use of NAATs, with 25 NAATs (95% UR: 13-57) needed to detect one additional case compared to exclusive use of antigen tests. CONCLUSIONS: No single SARS-CoV-2 testing algorithm is likely to be optimal across settings with different levels of prevalence and for all programmatic priorities. This analysis provides a framework for selecting setting-specific strategies to achieve acceptable balances and trade-offs between programmatic priorities and resource constraints. |
Enterovirus D68-associated acute respiratory illness New Vaccine Surveillance Network, United States, July-November 2018-2020
Shah MM , Perez A , Lively JY , Avadhanula V , Boom JA , Chappell J , Englund JA , Fregoe W , Halasa NB , Harrison CJ , Hickey RW , Klein EJ , McNeal MM , Michaels MG , Moffatt ME , Otten C , Sahni LC , Schlaudecker E , Schuster JE , Selvarangan R , Staat MA , Stewart LS , Weinberg GA , Williams JV , Ng TFF , Routh JA , Gerber SI , McMorrow ML , Rha B , Midgley CM . MMWR Morb Mortal Wkly Rep 2021 70 (47) 1623-1628 Enterovirus D68 (EV-D68) is associated with a broad spectrum of illnesses, including mild to severe acute respiratory illness (ARI) and acute flaccid myelitis (AFM). Enteroviruses, including EV-D68, are typically detected in the United States during late summer through fall, with year-to-year fluctuations. Before 2014, EV-D68 was infrequently reported to CDC (1). However, numbers of EV-D68 detection have increased in recent years, with a biennial pattern observed during 2014-2018 in the United States, after the expansion of surveillance and wider availability of molecular testing. In 2014, a national outbreak of EV-D68 was detected (2). EV-D68 was also reported in 2016 via local (3) and passive national (4) surveillance. EV-D68 detections were limited in 2017, but substantial circulation was observed in 2018 (5). To assess recent levels of circulation, EV-D68 detections in respiratory specimens collected from patients aged <18 years* with ARI evaluated in emergency departments (EDs) or admitted to one of seven U.S. medical centers(†) within the New Vaccine Surveillance Network (NVSN) were summarized. This report provides a provisional description of EV-D68 detections during July-November in 2018, 2019 and 2020, and describes the demographic and clinical characteristics of these patients. In 2018, a total of 382 EV-D68 detections in respiratory specimens obtained from patients aged <18 years with ARI were reported by NVSN; the number decreased to six detections in 2019 and 30 in 2020. Among patients aged <18 years with EV-D68 in 2020, 22 (73%) were non-Hispanic Black (Black) persons. EV-D68 detections in 2020 were lower than anticipated based on the biennial circulation pattern observed since 2014. The circulation of EV-D68 in 2020 might have been limited by widespread COVID-19 mitigation measures; how these changes in behavior might influence the timing and levels of circulation in future years is unknown. Ongoing monitoring of EV-D68 detections is warranted for preparedness for EV-D68-associated ARI and AFM. |
Antigen Test Performance Among Children and Adults at a SARS-CoV-2 Community Testing Site.
Ford L , Whaley MJ , Shah MM , Salvatore PP , Segaloff HE , Delaney A , Currie DW , Boyle-Estheimer L , O'Hegarty M , Morgan CN , Meece J , Ivacic L , Thornburg NJ , Tamin A , Harcourt JL , Folster JM , Medrzycki M , Jain S , Wong P , Goffard K , Gieryn D , Kahrs J , Langolf K , Zochert T , Tate JE , Hsu CH , Kirking HL . J Pediatric Infect Dis Soc 2021 10 (12) 1052-1061 BACKGROUND: Performance characteristics of SARS-CoV-2 antigen tests among children are limited despite the need for point-of-care testing in school and childcare settings. We describe children seeking SARS-CoV-2 testing at a community site and compare antigen test performance to real-time reverse transcription-polymerase chain reaction (RT-PCR) and viral culture. METHODS: Two anterior nasal specimens were self-collected for BinaxNOW antigen and RT-PCR testing, along with demographics, symptoms, and exposure information from individuals ≥5 years at a community testing site. Viral culture was attempted on residual antigen or RT-PCR-positive specimens. Demographic and clinical characteristics, and the performance of SARS-CoV-2 antigen tests, were compared among children (<18 years) and adults. RESULTS: About 1 in 10 included specimens were from children (225/2110); 16.4% (37/225) were RT-PCR-positive. Cycle threshold values were similar among RT-PCR-positive specimens from children and adults (22.5 vs 21.3, P = .46) and among specimens from symptomatic and asymptomatic children (22.5 vs 23.2, P = .39). Sensitivity of antigen test compared to RT-PCR was 73.0% (27/37) among specimens from children and 80.8% (240/297) among specimens from adults; among specimens from children, specificity was 100% (188/188), positive and negative predictive values were 100% (27/27) and 94.9% (188/198), respectively. Virus was isolated from 51.4% (19/37) of RT-PCR-positive pediatric specimens; all 19 had positive antigen test results. CONCLUSIONS: With lower sensitivity relative to RT-PCR, antigen tests may not diagnose all positive COVID-19 cases; however, antigen testing identified children with live SARS-CoV-2 virus. |
Performance of Repeat BinaxNOW SARS-CoV-2 Antigen Testing in a Community Setting, Wisconsin, November-December 2020.
Shah MM , Salvatore PP , Ford L , Kamitani E , Whaley MJ , Kaitlin M , Currie DW , Morgan CN , Segaloff HE , Lecher S , Somers T , Van Dyke ME , Bigouette JP , Delaney A , DaSilva J , O'Hegarty M , Boyle-Estheimer L , Abdirizak F , Karpathy SE , Meece J , Ivanic L , Goffard K , Gieryn D , Sterkel A , Bateman A , Kahrs J , Langolf K , Zochert T , Knight NW , Hsu CH , Kirking HL , Tate JE . Clin Infect Dis 2021 73 S54-S57 Repeating the BinaxNOW antigen test for SARS-CoV-2 by two groups of readers within 30 minutes resulted in high concordance (98.9%) in 2,110 encounters. BinaxNOW test sensitivity was 77.2% (258/334) compared to real-time reverse transcription-polymerase chain reaction. Same day antigen testing did not significantly improve test sensitivity while specificity remained high. |
Shedding of culturable virus, seroconversion, and 6-month follow-up antibody responses in the first 14 confirmed cases of COVID-19 in the United States.
Killerby ME , Ata Ur Rasheed M , Tamin A , Harcourt JL , Abedi GR , Lu X , Kujawski S , Shah MM , Kirking HL , Gold JAW , Salvatore PP , Coughlin MM , Whitaker B , Tate JE , Watson JT , Lindstrom S , Hall AJ , Fry AM , Gerber SI , Midgley CM , Thornburg NJ . J Infect Dis 2021 224 (5) 771-776 We aimed to characterize presence of culturable virus in clinical specimens during acute illness, and antibody kinetics up to six months post-onset, among 14 early US COVID-19 patients. We isolated viable SARS-CoV-2 from rRT-PCR-positive respiratory specimens collected during days 0-8 post-onset, but not after. All 13 patients with two or more serum specimens developed anti-spike antibodies; 12 developed detectable neutralizing antibodies. We did not isolate virus after detection of neutralizing antibodies. Eight participants provided serum at six months post-onset; all retained detectable anti-spike IgG, and half had detectable neutralizing antibodies. Two participants reported not feeling fully recovered at six months. |
Associations between presence of handwashing stations and soap in the home and diarrhoea and respiratory illness, in children less than five years old in rural western Kenya
Kamm KB , Feikin DR , Bigogo GM , Aol G , Audi A , Cohen AL , Shah MM , Yu J , Breiman RF , Ram PK . Trop Med Int Health 2014 19 (4) 398-406 OBJECTIVE: We tested whether soap presence in the home or a designated handwashing station was associated with diarrhoea and respiratory illness in Kenya. METHODS: In April 2009, we observed presence of a handwashing station and soap in households participating in a longitudinal health surveillance system in rural Kenya. Diarrhoea and acute respiratory illness (ARI) in children < 5 years old were identified using parent-reported syndromic surveillance collected January-April 2009. We used multivariate generalised linear regression to estimate differences in prevalence of illness between households with and without the presence of soap in the home and a handwashing station. RESULTS: Among 2547 children, prevalence of diarrhoea and ARI was 2.3 and 11.4 days per 100 child-days, respectively. Soap was observed in 97% of households. Children in households with soap had 1.3 fewer days of diarrhoea/100 child-days (95% CI -2.6, -0.1) than children in households without soap. ARI prevalence was not associated with presence of soap. A handwashing station was identified in 1.4% of households and was not associated with a difference in diarrhoea or ARI prevalence. CONCLUSIONS: Soap presence in the home was significantly associated with reduced diarrhoea, but not ARI, in children in rural western Kenya. Whereas most households had soap in the home, almost none had a designated handwashing station, which may prevent handwashing at key times of hand contamination. |
The Centers for Disease Control and Prevention's maternal health response to 2009 H1N1 influenza
Mosby LG , Ellington SR , Forhan SE , Yeung LF , Perez M , Shah MM , MacFarlane K , Laird SK , House LD , Jamieson DJ . Am J Obstet Gynecol 2011 204 S7-12 We describe the efforts of the Maternal Health Team, which was formed to address the needs of pregnant and breastfeeding women during the Centers for Disease Control and Prevention's (CDC's) 2009 pandemic influenza A (2009 H1N1) emergency response. We examined the team's activities, constructed a timeline of key pandemic events, and analyzed the Maternal Health 2009 H1N1 inquiry database. During the pandemic response, 9 guidance documents that addressed the needs of pregnant and breastfeeding women and their providers were developed by the Maternal Health Team. The Team received 4661 maternal health-related inquiries that came primarily from the public (75.5%) and were vaccine related (69.3%). Peak inquiry volume coincided with peak hospitalizations (October-November 2009). The Maternal Health 2009 H1N1 inquiry database proved useful to identify information needs of the public and health care providers during the pandemic. |
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