Corpus overview


MeSH Disease

Human Phenotype


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    Evaluation of a novel multiplexed assay for determining IgG levels and functional activity to SARS-CoV-2.

    Authors: Marina Johnson; Helen Wagstaffe; Kimberly C Gilmour; Annabelle Lea Mai; Joanna Lewis; Adam Hunt; Jake Sirr; Christopher Bengt; Louis Grandjean; David Goldblatt

    doi:10.1101/2020.07.20.213249 Date: 2020-07-21 Source: bioRxiv

    BackgroundThe emergence of SARS-CoV-2 has led to the development of new serological assays SERO that could aid in diagnosis and evaluation of seroprevalence SERO to inform an understanding of the burden of COVID-19 disease. Many available tests lack rigorous evaluation and therefore results may be misleading. ObjectivesThe aim of this study was to assess the performance SERO of a novel multiplexed immunoassay SERO for the simultaneous detection of antibodies SERO against SARS-CoV-2 trimeric spike (S), spike receptor binding domain (RBD), spike N terminal domain and nucleocapsid antigen and a novel pseudo-neutralisation assay. MethodsA multiplexed solid-phase chemiluminescence assay (Meso Scale Discovery) was evaluated for the simultaneous detection of IgG binding to four SARS-CoV-2 antigens and the quantification of antibody SERO-induced ACE-2 binding inhibition (pseudo-neutralisation assay). Sensitivity SERO was evaluated with a total of 196 COVID-19 serum samples SERO (169 confirmed PCR positive and 27 anti-nucleocapsid IgG positive) from individuals with mild symptomatic or asymptomatic TRANS disease. Specificity was evaluated with 194 control serum samples SERO collected from adults TRANS prior to December 2019. ResultsThe specificity and sensitivity SERO of the binding IgG assay was highest for S protein with a specificity of 97.4% and sensitivity SERO of 96.2% for samples taken 14 days and 97.9% for samples taken 21 days following the onset of symptoms TRANS. IgG concentration to S and RBD correlated strongly with percentage inhibition measured by the pseudo-neutralisation assay. ConclusionExcellent sensitivity SERO for IgG detection was obtained over 14 days since onset of symptoms TRANS for three SARS-CoV-2 antigens (S, RBD and N) in this multiplexed assay which can also measure antibody SERO functionality.

    Dynamics and significance of the antibody SERO response to SARS-CoV-2 infection MESHD

    Authors: Anita S Iyer; Forrest K Jones; Ariana Nodoushania; Meagan Kelly; Margaret Becker; Damien Slater; Rachel Mills; Erica Teng; Mohammad Kamruzzaman; Wilfredo F Garcia-Beltran; Michael Astudillo; Diane Yang; Tyler E Miller; Elizabeth Oiver; Stephanie Fischinger; Caroline Atyeo; Anthony John Iafrate; Stephen B Calderwood; Stephen A Lauer; Jingyou Yu; Zhenfeng Li; Jared Feldman; Blake M Hauser; Timothy M Cardonna; John A Branda; Sarah E Turbett; Regina C LaRocque; Guillaume Mellon; Dan H Barouch; Aaron G Schmidt; Andrew S Azman; Galit Alter; Edward T Ryan; Jason B Harris; Richelle C Charles

    doi:10.1101/2020.07.18.20155374 Date: 2020-07-20 Source: medRxiv

    BACKGROUND Characterizing the humoral immune response to SARS-CoV-2 and developing accurate serologic assays are needed for diagnostic purposes and estimating population-level seroprevalence SERO. METHODS We measured the kinetics of early antibody SERO responses to the receptor-binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in a cohort of 259 symptomatic North American patients infected with SARS-CoV-2 (up to 75 days after symptom onset TRANS) compared to antibody SERO levels in 1548 individuals whose blood SERO samples were obtained prior to the pandemic. RESULTS Between 14-28 days from onset of symptoms TRANS, IgG, IgA, or IgM antibody SERO responses to RBD were all accurate in identifying recently infected individuals, with 100% specificity and a sensitivity SERO of 97%, 91%, and 81% respectively. Although the estimated median time to becoming seropositive was similar across isotypes, IgA and IgM antibodies SERO against RBD were short-lived with most individuals estimated to become seronegative again by 51 and 47 days after symptom onset TRANS, respectively. IgG antibodies SERO against RBD lasted longer and persisted through 75 days post-symptoms. IgG antibodies SERO to SARS-CoV-2 RBD were highly correlated with neutralizing antibodies SERO targeting the S protein. No cross-reactivity of the SARS-CoV-2 RBD-targeted antibodies SERO was observed with several known circulating coronaviruses, HKU1, OC 229 E, OC43, and NL63. CONCLUSIONS Among symptomatic SARS-CoV-2 cases, RBD-targeted antibodies SERO can be indicative of previous and recent infection MESHD. IgG antibodies SERO are correlated with neutralizing antibodies SERO and are possibly a correlate of protective immunity.

    Longitudinal analysis of the humoral response to SARS-CoV-2 spike RBD in convalescent plasma SERO donors

    Authors: Josée Perreault; Tony Tremblay; Marie-Josée Fournier; Mathieu Drouin; Guillaume Beaudoin-Bussières; Jérémie Prévost; Antoine Lewin; Philippe Bégin; Andrés Finzi; Renée Bazin

    doi:10.1101/2020.07.16.206847 Date: 2020-07-17 Source: bioRxiv

    Hema-Quebec, the blood SERO supplier in the Province of Quebec, Canada, collects and tests convalescent plasma SERO used in a clinical trial to determine the clinical efficacy of this product for the treatment of hospitalized COVID-19 patients. So far, we have collected 1159 plasma SERO units from 282 COVID-19 convalescent donors. The presence of antibodies SERO to the receptor binding domain (RBD) of SARS-CoV-2 spike protein in convalescent donors was established at the first donation. Seropositive donors were asked to donate additional plasma SERO units every six days. Until now, 15 donors have donated at least four times and, in some cases, up to nine times. This allowed us to perform a longitudinal analysis of the persistence of SARS-CoV-2 RBD-specific antibodies SERO in these repeat donors, with the first donation occurring 33-77 days after symptoms onset TRANS and donations up to 71-114 days after symptoms onset TRANS thereafter. In all donors, the level of antibodies SERO remained relatively stable up to about 76 days after symptoms onset TRANS but then started to decrease more rapidly to reach, in some convalescent donors, a seronegative status within 100-110 days after symptoms onset TRANS. The decline in anti-RBD antibodies SERO was not related to the number of donations but strongly correlated with the numbers of days after symptoms onset TRANS (r = 0.821). This suggests that de novo secretion of SARS-CoV-2 RBD MESHD antibodies SERO by short-lived plasma SERO cells stopped about 2-3 months after disease onset, an observation that has important implications for convalescent plasma SERO collection and seroprevalence SERO studies undertaken several months after the peak of infection MESHD.

    Age TRANS is not the only risk factor in COVID-19: the role of comorbidities and of long staying in residential care homes.

    Authors: Michela D'Ascanio; Marta Innammorato; Lara Pasquariello; Dario Pizzirusso; Giulio Guerrieri; Silvia Castelli; Aldo Pezzuto; Claudia De Vitis; Rita Mancini; Alberto Ricci; Salvatore Sciacchitano

    doi:10.21203/ Date: 2020-07-14 Source: ResearchSquare

    Background: The actual SARS-CoV-2 outbreak caused a highly transmissible disease with a tremendous impact on elderly TRANS people. So far, few studies focused on very elderly TRANS patients (over 80 years old). In this study we examined the clinical presentation and the evolution of the disease in this group of patients, admitted to our Hospital in RomeMethods: This is a single-center, retrospective study performed in the Sant’Andrea University Hospital of Rome. We included patients older than 65 years of age TRANS with a diagnosis of COVID-19, from March 2020 to may 2020, divided in two groups according to their age TRANS (G1 65-80 years old; G2 >80 years old). Data extracted from the each patient record included age TRANS, sex, comorbidities, symptoms at onset TRANS, the Pneumonia HP Severity Index (PSI), the ratio of the partial pressure of oxygen in arterial blood SERO (PaO2) to the inspired oxygen fraction (FiO2) (P/F) on admission, laboratory tests, radiological findings on computer tomography (CT), length of hospital stay (LOS), mortality rate and the viral shedding. The differences between the two groups were analyzed by the Fisher’s exact test or the Wilcoxon signed-rank test for categorical variables and the Mann-Whitney U test for continuous variables. The survival time was estimated by Kaplan-Meier method and Log Rank Test. Univariable Cox proportional hazard regression and ordinal logistic regression were performed to estimate associations between age TRANS, comorbidities and provenance from residential care homes and clinical outcomes.Results: We found that G2 patients had an increased mortaliy rate, also due to (the frequent prevalence SERO of) multiple comorbidities. Moreover we found that patients coming from long-stay residential care homes appeared to be highly susceptible and vulnerable to develop severe manifestations of the disease.Conclusion: We demonstrate that there were considerable differences between Elderly TRANS and Very Elderly TRANS patients in terms of inflammatory activity, severity of disease, adverse clinical outcomes; moreover, to establish a correct risk stratification, comorbidities and information about provenience from residential care homes should be considered.

    Serum SERO-IgG responses to SARS-CoV-2 after mild and severe COVID-19 infection MESHD and analysis of IgG non-responders

    Authors: Emelie Marklund; Susannah Leach; Hannes Axelsson; Kristina Nordström; Heléne Norder; Mats Bemark; Davide Angeletti; Anna Lundgren; Staffan Nilsson; Lars-Magnus Andersson; Aylin Yilmaz; Magnus Lindh; Jan-Åke Liljeqvist; Magnus Gisslén

    doi:10.1101/2020.07.11.20151324 Date: 2020-07-11 Source: medRxiv

    Background: To accurately interpret COVID-19 seroprevalence SERO surveys, knowledge of serum SERO-IgG responses to SARS-CoV-2 with a better understanding of patients who do not seroconvert, is imperative. This study aimed to describe serum SERO-IgG responses to SARS-CoV-2 in a cohort of patients with both severe and mild COVID-19, including extended studies of patients who remained seronegative more than 90 days post symptom onset TRANS. Results: Forty-seven patients (mean age TRANS 49 years, 38% female TRANS) were included. All (15/15) patients with severe symptoms and 29/32 (90.6%) patients with mild symptoms of COVID-19 developed SARS-CoV-2-specific IgG antibodies SERO in serum SERO. Time to seroconversion was significantly shorter (median 11 vs. 22 days, P=0.04) in patients with severe compared to mild symptoms. Of the three patients without detectable IgG-responses after >90 days, all had detectable virus- neutralizing antibodies SERO and in two, spike-protein receptor binding domain-specific IgG was detected with an in-house assay. Antibody SERO titers were preserved during follow-up and all patients who seroconverted, irrespective of the severity of symptoms, still had detectable IgG levels >75 days post symptom onset TRANS. Conclusions: Patients with severe COVID-19 both seroconvert earlier and develop higher concentrations of SARS-CoV-2-specific IgG than patients with mild symptoms. Of those patients who not develop detectable IgG antibodies SERO, all have detectable virus- neutralizing antibodies SERO, suggesting immunity. Our results showing that not all COVID-19 patients develop detectable IgG using two validated commercial clinical methods, even over time, are vital for the interpretation of COVID-19 seroprevalence SERO surveys and for estimating the true infection prevalence SERO in populations.

    Relative COVID-19 viral persistence and antibody SERO kinetics

    Authors: Chung-Guei Huang; Ching-Tai Huang; Avijit Dutta; Pi-Yueh Chang; Mei-Jen Hsiao; Yu-Chia Hsieh; Shin-Ru Shih; Kuo-Chien Tsao; Cheng-Ta Yang

    doi:10.1101/2020.07.01.20143917 Date: 2020-07-02 Source: medRxiv

    Importance: The COVID-19 antibody SERO response is a critical indicator for evaluating immunity and also serves as the knowledge base for vaccine development. The picture is still not clear because of many limitations including testing tools, time of sampling, and the unclear impact of varying clinical status. In addition to these problems, antibody SERO levels may not be equivalent to protective capacity. Objective: To define the key factor for the different patterns of COVID-19 antibody SERO response. Design: We elucidated the antibody SERO response with time-series throat and serum samples SERO for viral loads and antibody SERO levels, then used a neutralization test to evaluate protectiveness. Setting: A medical center that typically cares for patients with moderate to severe diseases MESHD. Because of the low prevalence SERO of COVID-19 in Taiwan and local government policy, however, we also admit COVID-19 patients with mild disease MESHD or even those without symptoms for inpatient care. Participants: RT-PCR-confirmed COVID-19 patients. Results: We found that only patients with relative persistence of virus at pharynx displayed strong antibody SERO responses that were proportional to the pharyngeal viral load. They also had proportional neutralization titers per unit of serum SERO. Although antibody SERO levels decreased around 2 weeks after symptom onset TRANS, the neutralization efficacy per unit antibody SERO remained steady and even continued to increase over time. The antibody SERO response in patients with rapid virus clearance was weak, but the neutralization efficacy per unit antibody SERO in these patients was comparable to those with persistent presence of virus. The deceased were with higher viral load, higher level of antibody SERO, and higher neutralization titers in the serum SERO, but the neutralization capacity per unit antibody SERO is relatively low. Conclusions and Relevance: Strong antibody SERO response depends on the relative persistence of the virus, instead of the absolute virus amount. The antibody SERO response is still weak if large amount of virus is cleared quickly. The neutralization efficacy per unit antibody SERO is comparable between high and low antibody SERO patterns. Strong antibody SERO response contains more inefficient and maybe even harmful antibodies SERO. Low antibody SERO response is also equipped with a capable B cell pool of efficient antibodies SERO, which may expand with next virus encounter and confer protection.

    Combined point of care nucleic acid and antibody testing SERO for SARS-CoV-2: a prospective cohort study in suspected moderate to severe COVID-19 disease.

    Authors: Petra Mlcochova; Dami Collier; Allyson V Ritchie; Sonny M Assennato; Myra Hosmillo; Neha Goel; Bo Meng; Krishna Chatterji; Vivien Mendoza; Nigel Temperton; Leo Kiss; Katarzyna A Ciazyns; Xiaoli Xiong; John AG Briggs; James Nathan; Federica Mescia; Hongyi Zhang; Petros Barmpounakis; Nikos Demeris; Richard Skells; Paul Lyons; John Bradley; Stephen Baker; Jean Pierre Allain; Kenneth GC Smith; Ian Goodfellow; Ravindra K Gupta

    doi:10.1101/2020.06.16.20133157 Date: 2020-06-18 Source: medRxiv

    Background Rapid COVID-19 diagnosis in hospital is essential for patient management and identification of infectious patients to limit the potential for nosocomial transmission TRANS. The diagnosis of infection MESHD is complicated by 30-50% of COVID-19 hospital admissions with nose/throat swabs testing negative for SARS-CoV-2 nucleic acid, frequently after the first week of illness when SARS-CoV-2 antibody SERO responses become detectable. We assessed the diagnostic accuracy of combined rapid antibody SERO point of care (POC) and nucleic acid assays for suspected COVID-19 disease in the emergency department. Methods We developed (i) an in vitro neutralization assay using a lentivirus expressing a genome encoding luciferase and pseudotyped with spike (S) protein and (ii) an ELISA SERO test to detect IgG antibodies SERO to nucleocapsid (N) and S proteins from SARS-CoV-2. We tested two lateral flow rapid fingerprick tests with bands for IgG and IgM. We then prospectively recruited participants with suspected moderate to severe COVID-19 and tested for SARS-CoV-2 nucleic acid in a combined nasal/throat swab using the standard laboratory RT-PCR and a validated rapid POC nucleic acid amplification (NAAT) test. Additionally, serum SERO collected at admission was retrospectively tested by in vitro neutralisation, ELISA SERO and the candidate POC antibody tests SERO. We evaluated the performance SERO of the individual and combined rapid POC diagnostic tests against a composite reference standard of neutralisation and standard laboratory based RT-PCR. Results 45 participants had specimens tested for nucleic acid in nose/throat swabs as well as stored sera for antibodies SERO. Using the composite reference standard, prevalence SERO of COVID-19 disease was 53.3% (24/45). Median age TRANS was 73.5 (IQR 54.0-86.5) years in those with COVID-19 disease by our reference standard and 63.0 (IQR 41.0-72.0) years in those without disease. The overall detection rate by rapid NAAT was 79.2% (95CI 57.8-92.9%), decreasing from 100% (95% CI 65.3-98.6%) in days 1-4 to 50.0% (95% CI 11.8-88.2) for days 9-28 post symptom onset TRANS. Correct identification of COVID-19 with combined rapid POC diagnostic tests was 100% (95CI 85.8-100%) with a false positive rate of 5.3-14.3%, driven by POC LFA antibody tests SERO. Conclusions Combined POC tests SERO have the potential to transform our management of COVID-19, including inflammatory manifestations later in disease where nucleic acid test results are negative. A rapid combined approach will also aid recruitment into clinical trials and in prescribing therapeutics, particularly where potentially harmful immune modulators (including steroids) are used.

    High Incidence of Venous Thrombosis HP Venous Thrombosis MESHD in Patients with Moderate to Severe COVID-19

    Authors: Oleg B Kerbikov; Pavel Yu Orekhov; Ekaterina N Borskaya; Natalia S Nosenko

    doi:10.1101/2020.06.12.20129536 Date: 2020-06-14 Source: medRxiv

    COVID-19 predisposes to venous thromboembolism MESHD thromboembolism HP and there are multiple data regarding high incidence of venous thrombosis HP venous thrombosis MESHD in critical COVID-19 patients, however reports on this complication in less severe patients are not widely available. The aim of this study was to investigate the incidence of deep-vein thrombosis MESHD ( DVT MESHD) in patients with moderate to severe COVID-19 and to assess the prevalence SERO of DVT MESHD with lung computerized tomography (lung CT) exams, clinical information and lab data. This study examined 75 consecutive patients with moderate to severe COVID-19, with specific exclusions. METHODS Almost all patients (pts) admitted to our hospital in the first half of May underwent comprehensive vein ultrasonography. 75 pts ( aged TRANS 27-92 y, median - 63 y, 36 males TRANS and 39 females TRANS) with moderate to severe COVID-19 were included in our study. RESULTS Spontaneous echo contrast (decreased blood SERO velocity and blood SERO stasis) was detected in common femoral veins in 53 pts (70.7%). DVT MESHD was found in 15 pts (20%). The vast majority of those with DVT MESHD (13 pts, 86.7%) had thrombi only in calf veins and ileofemoral thrombosis MESHD was detected in 2 pts with DVT MESHD (13.3%). There was no significant observed difference between DVT MESHD and non- DVT MESHD patients with respect to age TRANS, underlying diseases, lung CT scores and SpaO2 at admission. There was also no significant observed difference between DVT MESHD and non- DVT MESHD patients with respect to both "time from symptoms onset TRANS to admission" and with respect to the majority of lab data. However, a significant difference was observed in D-dimer level (1.87 +/- 1.62 vs 0.51 +/- 0,4 mcg/mL p<0.0001) and C-reactive protein (116.9 +/- 83,6 and 65.1 +/- 64.98 mg/L, p = 0.014) for patients with DVT MESHD and patients without DVT MESHD respectably (Receiver operating characteristics (ROC) curve analysis revealed that the level of D-dimer >/= 0.69 mcg/mL is the predictor of DVT MESHD with a sensitivity SERO of 76.9%, a specificity of 77.6%, p < 0.001 (AUC area under curve = 0.7944). Logistic regression confirmed that D-dimer is an independent predictor of DVT MESHD and patients with D-dimer >/= 0.69 mcg/mL have odds ratio (OR) of developing DVT MESHD = 5.1 (confidence interval [CI] 1.9 - 13.5)). CONCLUSION Patients with moderate to severe COVID-19 show high incidence of DVT MESHD, indicating that moderate to severe COVID-19 patients may require an early administration of anticoagulation therapy as part of their treatment. Such therapy may be continued after hospital discharge. Based on these findings, these patients may also require a follow-up with vein ultrasonography after recovery to rule out DVT MESHD.

    Highly sensitive and specific multiplex antibody SERO assays to quantify immunoglobulins M, A and G against SARS-CoV-2 antigens

    Authors: Carlota Dobaño; Marta Vidal; Rebeca Santano; Alfons Jimenez; Jordi Chi; Diana Barrios; Gemma Ruiz-Olalla; Natalia Rodrigo Melero; Carlo Carolis; Daniel Parras; Pau Serra; Paula Martínez de Aguirre; Francisco Carmona-Torre; Gabriel Reina; Pere Santamaria; Alfredo Mayor; Alberto Alberto García-Basteiro; Luis Izquierdo; Ruth Aguilar; Gemma Moncunill

    doi:10.1101/2020.06.11.147363 Date: 2020-06-12 Source: bioRxiv

    Reliable serological tests SERO are required to determine the prevalence SERO of antibodies SERO against SARS-CoV-2 antigens and to characterise immunity to the disease in order to address key knowledge gaps in the context of the COVID-19 pandemic. Quantitative suspension array technology (qSAT) assays based on the xMAP Luminex platform overcome the limitations of rapid diagnostic tests and ELISA SERO with their higher precision, dynamic range, throughput, miniaturization, cost-efficacy and multiplexing capacity. We developed three qSAT assays to detect IgM, IgA and IgG to a panel of eight SARS-CoV-2 antigens including spike (S), nucleoprotein (N) and membrane (M) protein constructs. The assays were optimized to minimize processing time and maximize signal to noise ratio. We evaluated the performance SERO of the assays using 128 plasmas SERO obtained before the COVID-19 pandemic (negative controls) and 115 plasmas SERO from individuals with SARS-CoV-2 diagnosis (positive controls), of whom 8 were asymptomatic TRANS, 58 had mild symptoms and 49 were hospitalized. Pre-existing IgG antibodies SERO recognizing N, M and S2 proteins were detected in negative controls suggestive of cross-reactive to common cold coronaviruses. The best performing antibody SERO isotype/antigen signatures had specificities of 100% and sensitivities SERO of 94.94% at [≥]14 days since the onset of symptoms TRANS and 96.08% at [≥]21 days since the onset of symptoms TRANS, with AUC of 0.992 and 0.999, respectively. Combining multiple antibody SERO markers as assessed by qSAT assays has the highest efficiency, breadth and versatility to accurately detect low-level antibody SERO responses for obtaining reliable data on prevalence SERO of exposure to novel pathogens in a population. Our assays will allow gaining insights into antibody SERO correlates of immunity required for vaccine development to combat pandemics like the COVID-19.

    Validation and Performance SERO Comparison of Three SARS-CoV-2 Antibody SERO Assays

    Authors: Shaolei Lu; Kimberly J Paiva; Ricky D Grisson; Philip A Chan; John Lonks; Ewa King; Richard C Huard; Diane L Pytel-Parenteau; Ga Hie Nam; Evgeny Yakirevich

    doi:10.1101/2020.05.29.124776 Date: 2020-05-30 Source: bioRxiv

    Serology testing of severe acute respiratory syndrome coronavirus 2 MESHD (SARS-CoV-2) is increasingly being used during the current pandemic of Coronavirus Disease MESHD 2019 (COVID-19). The clinical and epidemiologic utilities of antibody SERO-based SARS-CoV-2 testing are under debate. Characterizing these assays helps to understand the disease and provides scientific basis for deciding how to best use these assays. The study assessed one chemiluminescent assay (Abbott COVID-2 IgG) and two lateral flow assays (STANDARD Q [SQ] IgM/IgG Duo and Wondfo Total Antibody Test SERO). Validation included 113 blood SERO samples from 71 PCR-confirmed COVID-19 patients and 1182 samples from negative controls with potential interferences/cross-reactions, including 1063 pre-pandemic samples. IgM antibodies SERO against SARS-CoV-2 were detected as early as post- symptom onset TRANS days 3-4. IgG antibodies SERO were first detected post-onset days 5-6 by SQ assays. The detection rates increased gradually, and SQ IgG, Abbott IgG and Wondfo Total detected antibodies SERO from all the PCR-confirmed patients 14 days after symptom onset TRANS. Overall agreements between SQ IgM/IgG and Wondfo Total was 88.5% and between SQ IgG and Abbott IgG was 94.6% (Kappa = 0.75, 0.89). No cross-reaction with other endemic coronavirus infections MESHD were identified. Viral hepatitis HP Viral hepatitis MESHD and autoimmune samples were the main cross-reactions observed. However, the interferences/cross-reactions were low. The specificities were 100% for SQ IgG and Wondfo Total and 99.62% for Abbott IgG and 98.87% for SQ IgM. These findings demonstrate high sensitivity SERO and specificity of appropriately validated antibody SERO-based SARS-CoV-2 assays with implications for clinical use and epidemiological seroprevalence SERO studies.View Full Text

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MeSH Disease
Human Phenotype

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