Evaluation of antibodies against SARS-CoV-2 and their patterns of response in health care workers and general population at a tertiary care Centre

SARS-CoV-2 (previously called 2019-nCoV), and was named in February 2020 as COVID-19 by the WHO. Estimate the seroprevalence of antibodies against SARS-CoV-2 in health care workers (HCW) and general population in the first and second wave and assess the pattern of antibody response in HCW with COVID-19 infected and non-infected over pre and post-vaccination. This was a cohort observational retrospective study done to analyse the seroprevalence in HCW from July-September 2020, in the general population in the first wave (December 2020–February 2021) and second wave (March–September 2021). SARS-CoV-2 testing by RT-PCR (QIAGEN Company). Testing for quantitative IgG and IgM (Abbott) antibodies, Total Antibodies (Roche), Anti-SARS-CoV-2 IgG RBD(Roche), and Anti-SARS-CoV-2 IgG S1/S2 (Diasorin XL), to assess the pattern of antibody responses categorized as baseline (before the first dose), 14 days after 1st dose, before 2nd dose (45 days post first dose), 14 days post-second dose. Among 1340 HCW, 1268 underwent RT-PCR testing, 540 serology testing and 431 underwent both testing. We identified 164 of 1268 positive RT-PCR and using serology testing 229 of 540 were seropositive. High seropositivity was observed in age group 26-45 years (44.9%) HCW, in males (65.9%), nurses (47.3%), and ward staff (48.6%). High seroprevalence in general population-76.07% in the 2nd wave compared to 1st wave (44.67%). SARS-CoV-2 antibodies showed gender associated seroprevalence and higher immune response was observed in COVID-19 infected than in non-infected HCW pre- and post-vaccination.

The Role of Serology Testing in the Context of Immunization Policies for COVID-19 in Latin American Countries

This review aims to explore the role and value of serology testing in the context of COVID-19 immunization policies in Latin American countries and the barriers and challenges to the adequate use and uptake of this tool. It builds on a review of the academic literature, evidence, and existing policies, and includes a multistage process of discussion and feedback by a group of five experts. Regional and country-level evidence and resources from five focus countries—Argentina, Brazil, Chile, Colombia, and Mexico—were collected and analyzed. This review contains an overview of (1) the impact of the SARS-CoV-2 pandemic, the variants of concern and current testing strategies, (2) the introduction of COVID-19 vaccination, (3) the potential use of serology testing to support immunization initiatives, (4) the current frameworks for the use of serology testing in the region, and (5) the barriers and challenges to implementing serology testing in the context of COVID-19 immunization policies, including a discussion on the potential actions required to address these barriers and facilitate the uptake of this strategy in the region. Stakeholders can use elements of this document to guide timely decision-making, raise awareness, and inspire further studies.

SARS-CoV2 serology assays: utility and limits of different antigen based tests through the evaluation and the comparison of four commercial tests

Introduction: SARS-CoV2 serology testing is multipurpose provided to choose an efficient test. We evaluated and compared 4 different commercial serology tests, three of them had the Food and Drug Administration (FDA) approval. Our goal was to provide new data to help to guide the interpretation and the choice of the serological tests. Methods: Four commercial tests were evaluated: Cobas®Roche®(total anti-N antibodies), VIDAS®Biomerieux®(IgM and IgG anti-RBD antibodies), Mindray®(IgM and IgG anti-N and anti-RBD antibodies) and Access®Beckman Coulter®(IgG anti-RBD antibodies). Were tested: a positive panel (n=72 sera) obtained from COVID-19 confirmed patients and a negative panel (n=119) of pre-pandemic sera. Were determined the analytical performances and was drawn the ROC curve to assess the manufacturer's threshold. Results: A large range of variability between the tests was found. Mindray®IgG and Cobas® tests showed the best overall sensitivity 79,2%CI95%[67,9-87,8]. Cobas® showed the best sensitivity after D14; 85,4%CI95%[72,2-93,9]. The best specificity was noted for Cobas®, VIDAS®IgG and Access® IgG(100%CI95%[96,9-100]). Access® had the lower sensitivity even after D14 (55,5% CI95%[43,4-67,3]). VIDAS®IgM and Mindray®IgM tests showed the lowest specificity and sensitivity rates. Overall, only 43 out of 72 sera gave concordant results (59,7%). Retained cut-offs for a significantly better sensitivity and accuracy, without altering significantly the specificity, were: 0,87 for Vidas®IgM(p=0,01), 0,55 for Vidas®IgG(p=0,05) and 0,14 for Access®(p<10-4). Conclusion: Although FDA approved, each laboratory should realize its own evaluation for commercial tests. Tests variability may raise some concerns that seroprevalence studies may vary significantly based on the used serology test.

Quantitative serology for SARS-CoV-2 using self-collected saliva and finger-stick blood

Convenient and widespread serology testing may alter the trajectory of the COVID-19 pandemic. This study seeks to leverage high-throughput, multiplexed serologic assays, which have been adopted as benchmarks for vaccine efficacy, to support large-scale surveys of SARS-CoV-2 immunity using finger-stick blood and/or saliva. Specifically, we optimized MSD’s serology assays, which were analytically validated for serum, to test self-collected finger-stick blood and saliva samples. We show that these assays can be used with FDA-registered specimen collection devices to obtain quantitative measurements for self-collected samples. Antibody levels were measured using an electrochemiluminescent (ECL) multiplex immunoassay, which has been used to measure humoral responses to several COVID-19 vaccines, including those funded by the U.S. Government’s Operation Warp Speed. First, we show that salivary antibodies are stable without refrigeration or preservatives for at least five days. Using matched samples, we show that testing of saliva and finger-stick blood equivalently identified individuals with humoral responses to CoV-2 antigens. Moreover, we piloted a simple saliva collection kit that can be used to safely send samples through the mail. This work demonstrates that robust methods for self-collection of finger-stick blood and saliva, in combination with quantitative, automated immunoassays, provide the technical capabilities needed to support large-scale serology testing.

Using mobile phone data to estimate dynamic population changes and improve the understanding of a pandemic: A case study in Andorra

Compartmental models are often used to understand and predict the progression of an infectious disease such as COVID-19. The most basic of these models consider the total population of a region to be closed. Many incorporate human mobility into their transmission dynamics, usually based on static and aggregated data. However, mobility can change dramatically during a global pandemic as seen with COVID-19, making static data unsuitable. Recently, large mobility datasets derived from mobile devices have been used, along with COVID-19 infections data, to better understand the relationship between mobility and COVID-19. However, studies to date have relied on data that represent only a fraction of their target populations, and the data from mobile devices have been used for measuring mobility within the study region, without considering changes to the population as people enter and leave the region. This work presents a unique case study in Andorra, with comprehensive datasets that include telecoms data covering 100% of mobile subscribers in the country, and results from a serology testing program that more than 90% of the population voluntarily participated in. We use the telecoms data to both measure mobility within the country and to provide a real-time census of people entering, leaving and remaining in the country. We develop multiple SEIR (compartmental) models parameterized on these metrics and show how dynamic population metrics can improve the models. We find that total daily trips did not have predictive value in the SEIR models while country entrances did. As a secondary contribution of this work, we show how Andorra's serology testing program was likely impacted by people leaving the country. Overall, this case study suggests how using mobile phone data to measure dynamic population changes could improve studies that rely on more commonly used mobility metrics and the overall understanding of a pandemic.

Clinical Application of Metagenomic Next-Generation Sequencing in Patients with Hematologic Malignancies Suffering from Sepsis

Background: Sepsis remains a common but fatal complication among patients with immune suppression. We aimed to investigate the performance of metagenomic next-generation sequencing (mNGS) compared with standard microbiological diagnostics in patients with hematologic malignancies. Methods: We performed a prospective study from June 2019 to December 2019. Adult patients with hematologic malignancies and a clinical diagnosis of sepsis were enrolled. Conventional diagnostic methods included blood cultures, serum galactomannan for Aspergillus, cryptococcal antigen and cytomegalovirus (CMV) viral loads. Blood samples for mNGS were collected within 24 h after hypotension developed. Results: Of 24 patients enrolled, mNGS and conventional diagnostic methods (blood cultures, serology testing and virus RT-PCR) reached comparable positive results in 9 cases. Of ten patients, mNGS was able to identify additional pathogens compared with conventional methods; most of the pathogens were virus. Conclusion: Our results show that mNGS may serve as adjunctive diagnostic tool for the identification of pathogens of hematologic patients with clinically sepsis.

Point-of-Need Disposable ELISA System for COVID-19 Serology Testing

A disposable enzyme-linked immunosorbent assay (dELISA) device for ate-home or doctor’s office use was developed to detect SARS-CoV-2 antibodies. Serology testing for SARS-CoV-2 antibodies is currently run using well-plate ELISAs in centralized laboratories. However, the scale of serology testing needed for epidemiological and clinical screening studies will overwhelm existing clinical laboratory resources. Instead, a point-of-need device that can be used at home or in doctor’s offices for COVID-19 serology testing must be developed and is one of four target products prioritized by the World Health Organization. Lateral flow assays are common and easy to use, but lack the sensitivity needed to reliably detect SARS-CoV-2 antibodies in clinical samples. This work describes a disposable ELISA device that is as simple to use as a lateral flow assay, but as sensitive as a well-plate ELISA. The device utilizes capillary-driven flow channels made of transparency films and double-sided adhesive combined with paper pumps to drive flow. The geometry of the channels and storage pads enables automated sequential washing and reagent addition steps with two simple end-user steps. An enzyme label is used to produce a colorimetric signal instead of a nanoparticle label in order to amplify signal and increase sensitivity, while the integrated washing steps decrease false positives and increase reproducibility. Naked-eye detection can be used for qualitative results or a smartphone camera for quantitative analysis. The device can detect antibodies at 2.8 ng/mL from whole blood, which was very close the concentration of detectable target in a well-plate ELISA (1.2 ng/mL). In this study the dELISA system was used to detect SARS-CoV-2 antibodies, but we believe that the device represents a fundamental step forward in point-of-care technology that will enable sensitive detection of many other analytes outside of a centralized laboratory.