Seroprevalence of anti-SARS-CoV-2 antibodies in high-risk occupational and low-risk groups in southwestern Iran

Background: Monitoring the spread of SARS-CoV-2 has been considered by the World Health Organization (WHO). We examined the prevalence of anti-SARS-CoV-2 immunoglobulin antibodies in southwestern Iran in spring 2020. The circulation of SARS-CoV-2 is high in the general population, especially among health care workers (HCWs) who are in close contact with patients. Objectives: The aim of this study was to determine the prevalence of anti-SARS-CoV-2 antigen in high-risk occupational and low-risk groups to investigate risk factors for serum positivity in Shiraz, southwestern Iran. Methods: A cross-sectional survey was performed on 366 participants (204 from high-risk and 162 from low-risk subjects). IgG and IgM antibodies were detected using Pishtaz Teb COVID-19 ELISA Kits to evaluate SARS-CoV-2-antigen in serum samples. After enzyme-linked immunosorbent assay (ELISA), serum prevalence, as well as IgG/IgM positive factors, was determined using logistic regression. Results: From July to September 2020 (a few months after reporting the first case of COVID-19 cases in Iran), out of 366 survived people, 72 (40.9%) were IgG positive, and 50 (27.5%) were IgM positive. The frequency of positive serology for IgG and IgM antibodies in individuals aged < 30 years was higher in the low-risk group than in the high-risk group. Multivariate logistic regression showed that headache (OR 0.312 [95% CI: 0.136 - 0.717]) and cough (OR 0.427 [95% CI: 0.182 - 1.004]) factors were associated with IgG or IgM positive serology. Conclusions: Between July and September 2020, the prevalence of anti-SARS-CoV-2 antigen was high in Shiraz. The prevalence of SARS-CoV-2 IgG/IgM antibodies in the high-risk group and their family as low risk was shown to increase viral infection due to close contact with COVID 19 patients than in the general population. Several factors were found to be related to the prevalence of anti-SARS-CoV-2 antigen that needs to be considered by policymakers to determine what to do about the SARS-CoV-2 pandemic.

Multivalent IgM scaffold enhances the therapeutic potential of variant-agnostic ACE2 decoys against SARS-CoV-2.

As immunological selection for escape mutants continues to give rise to future SARS-CoV-2 variants, novel universal therapeutic strategies against ACE2-dependent viruses are needed. Here we present an IgM-based decavalent ACE2 decoy that has variant-agnostic efficacy. In immuno-, pseudovirus, and live virus assays, IgM ACE2 decoy had potency comparable or superior to leading SARS-CoV-2 IgG-based mAb therapeutics evaluated in the clinic, which were variant-sensitive in their potency. We found that increased ACE2 valency translated into increased apparent affinity for spike protein and superior potency in biological assays when decavalent IgM ACE2 was compared to tetravalent, bivalent, and monovalent ACE2 decoys. Furthermore, a single intranasal dose of IgM ACE2 decoy at 1 mg/kg conferred therapeutic benefit against SARS-CoV-2 Delta variant infection in a hamster model. Taken together, this engineered IgM ACE2 decoy represents a SARS-CoV-2 variant-agnostic therapeutic that leverages avidity to drive enhanced target binding, viral neutralization, and in vivo respiratory protection against SARS-CoV-2.

Dose-Dependent Production of Anti-PEG IgM after Intramuscular PEGylated-Hydrogenated Soy Phosphatidylcholine Liposomes, but Not Lipid Nanoparticle Formulations of DNA, Correlates with the Plasma Clearance of PEGylated Liposomal Doxorubicin in Rats.

PEGylated lipid nanoparticle-based Covid-19 vaccines, including Pfizer's BNT162b2 and Moderna's mRNA-1273, have been shown to stimulate variable anti-PEG antibody production in humans. Anti-PEG antibodies have the potential to accelerate the plasma clearance of PEGylated therapeutics, such as PEGylated liposomes and proteins, and compromise their therapeutic efficacy. However, it is not yet clear whether antibody titers produced by PEGylated Covid-19 vaccines significantly affect the clearance of PEGylated therapeutics. This study examined how anti-PEG IgM levels affect the pharmacokinetics of PEGylated liposomal doxorubicin (PLD) and compared the immunogenicity of a lipid nanoparticle formulation of linear DNA (DNA-LNP) to standard PEG-HSPC liposomes. DNA-LNP was prepared using the same composition and approach as Pfizer's BNT162b2, except linear double-stranded DNA was used as the genetic material. PEGylated HSPC-based liposomes were formulated using the lipid rehydration and extrusion method. Nanoparticles were dosed IM to rats at 0.005-0.5 mg lipid/kg body weight 1 week before evaluating the plasma pharmacokinetics of clinically relevant doses of PLD (1 mg/kg, IV) or PEGylated interferon α2a (Pegasys, 5 µg/kg, SC). Plasma PEG IgM was compared between pre- and 1-week post-dose blood samples. The results showed that anti-PEG IgM production increased with increasing PEG-HSPC liposome dose and that IgM significantly correlated with the plasma half-life, clearance, volume of distribution, and area under the curve of a subsequent dose of PLD. The plasma exposure of Pegasys was also significantly reduced after initial delivery of 0.005 mg/ml PEG-HSPC liposome. However, a single 0.05 mg/kg IM dose of DNA-LNP did not significantly elevate PEG IgM and did not alter the IV pharmacokinetics of PLD. These data showed that PEGylated Covid-19 vaccines are less immunogenic compared to standard PEGylated HSPC liposomes and that there is an antibody threshold for accelerating the clearance of PEGylated therapeutics.

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG.

A small fraction of recipients who receive polyethylene-glycol (PEG)-containing COVID-19 mRNA-LNP vaccines (Comirnaty and Spikevax) develop hypersensitivity reactions (HSRs) or anaphylaxis. A causal role of anti-PEG antibodies (Abs) has been proposed, but not yet been proven in humans.We used ELISA for serial measurements of SARS-CoV-2 neutralizing Ab (anti-S) and anti-PEG IgG/IgM Ab levels before and after the first and subsequent booster vaccinations with mRNA-LNP vaccines in a total of 291 blood donors. The HSRs in 15 subjects were graded and correlated with anti-PEG IgG/IgM, just as the anti-S and anti-PEG Ab levels with each other. The impacts of gender, allergy, mastocytosis and use of cosmetics were also analyzed. Serial testing of two or more plasma samples showed substantial individual variation of anti-S Ab levels after repeated vaccinations, just as the levels of anti-PEG IgG and IgM, which were over baseline in 98-99 % of unvaccinated individuals. About 3-4 % of subjects in the strongly left-skewed distribution had 15-45-fold higher values than the median, referred to as anti-PEG Ab supercarriers. Both vaccines caused significant rises of anti-PEG IgG/IgM with >10-fold rises in about âˆ¼10 % of Comirnaty, and all Spikevax recipients. The anti-PEG IgG and/or IgM levels in the 15 vaccine reactors (3 anaphylaxis) were significantly higher compared to nonreactors. Serial testing of plasma showed significant correlation between the booster injection-induced rises of anti-S and anti-PEG IgGs, suggesting coupled anti-S and anti-PEG immunogenicity.Conclusions: The small percentage of people who have extremelevels of anti-PEG Ab in their blood may be at increased risk for HSRs/anaphylaxis to PEGylated vaccines and other PEGylated injectables. This risk might be further increased by the anti-PEG immunogenicity of these vaccines. Screening for anti-PEG Ab "supercarriers" may help predicting reactors and thus preventing these adverse phenomena.

Frequency of SARS-CoV-2 infection in hemodialysis patients

Patients with end-stage chronic kidney disease treated with hemodialysis are at risk of infection and severe course of the new coronavirus infection. This opinion was based on the data obtained as a result of PCR testing during the active phase of the disease with detailed clinical symptoms. However, this diagnostic method does not allow one to fully assess the prevalence of infection in the population. The aim - studying of the frequency of SARS-CoV-2 infection in patients receiving hemodialysis treatment and the spectrum of antiviral antibodies, depending on the nature of the course of COVID-19. Material and methods. 100 patients with chronic kidney disease (stage 5D) treated at the outpatient Dialysis Center (MCVTP) were included in the study by a simple random sample. The assessment of SARS-CoV-2 infection was carried out by analyzing the material of smears obtained from the naso-oropharynx by PCR and blood serum samples by ELISA. The study excluded 14 patients with dubious results for the determination of serological markers SARS-CoV-2 and 1 patient with active infection, who was isolated from the RNA of the virus. Results. IgM and IgG antibodies were detected in 49 (57.6%) of the 85 examined patients. 24 of them (group 1) were diagnosed with COVID-19 infection with typical clinical symptoms 3-9 months ago, and 25 (group 2) had no clinical manifestations of the acute respiratory infection at the appropriate time suggesting an asymptomatic course of the disease. IgM class antibodies were detected with equal frequency in group 1 and in group 2 (33.3 vs 24.0%, respectively, p<0.6). IgG antibodies exclusively to the nucleocapsid N-protein (IgGn) were detected only in the latent form of the disease (32%), while antibodies against the S-protein (spike protein) of the virus (IgGs and IgGn+s) were detected more often in the manifest form compared to the asymptomatic one (100 vs 60%, respectively, p<0.05). Conclusion. In a random cohort of patient receiving hemodialysis treatment, more than half were asymptomatic.Despite a wide range of prevention measures, SARS-CoV-2 infection among patients treated with hemodialysis is more than 2 times higher than in the general population.Copyright © 2021 Geotar Media Publishing Group. All rights reserved.

COVID-19 Immune Response In Adults Post Measles-Rubella Vaccination.

Objective: This study aimed to see how measles, mumps, and rubella vaccination affected the increase in SARS-CoV-2 immunoglobulin levels in individuals who had received the second dose of the SARS-CoV-2 vaccine. Material and Method: This research is a quasi-experimental type with a pre-post test design. The population studied were adults who had received the second dose of the SARS-CoV-2 vaccine, consisting of 30 people. Results: The results of this study were that most (60%) research subjects experienced an increase in IgM and some subjects (46.6%) experienced an increase in anti-SARS-CoV-2 IgG levels. The administration of the MR vaccination had no effect on increasing anti-SARS-CoV-2 IgG and IgM levels. This happened because the increase in IgM and IgG levels in the pre and post-tests in most research subjects was relatively low. Conclusion: The administration of the MR vaccine to adults who had received a second dose of the SARS-CoV-2 vaccine elicited a response with low levels of IgG and IgM SARS-CoV-2.

Objetivo: Este estudio tuvo como objetivo ver cómo la vacunación contra el sarampión, las paperas y la rubéola afectó el aumento de los niveles de inmunoglobulina contra el SARS-CoV-2 en personas que habían recibido la segunda dosis de la vacuna contra el SARS-CoV-2. Material y Método: Esta investigación es de tipo cuasi-experimental con un diseño pre-post test. La población estudiada fueron adultos que habían recibido la segunda dosis de la vacuna contra el SARS-CoV-2, conformada por 30 personas. Resultados: Los resultados de este estudio fueron que la mayoría de los sujetos de investigación (60%) experimentaron un aumento de IgM y algunos sujetos (46,6%) experimentaron un aumento en los niveles de IgG anti-SARS-CoV-2. Según los resultados de la prueba T pareada, el valor de p fue superior a 0,05, lo que indica que no hubo cambios significativos en los niveles de IgG e IgM antes y después de la vacunación con MR. Esto sucedió porque el aumento en los niveles de IgM e IgG en las pruebas previas y posteriores en la mayoría de los sujetos de investigación fue relativamente bajo. Conclusión: La administración de la vacuna MR a adultos que habían recibido una segunda dosis de la vacuna SARS-CoV-2 provocó una respuesta con niveles bajos de IgG e IgM SARS-CoV-2.

Seroprevalence and durability of antibody responses to AstraZeneca vaccination in Ugandans with prior mild or asymptomatic COVID-19: implications for vaccine policy.

Introduction: The duration and timing of immunity conferred by COVID-19 vaccination in sub-Saharan Africa are crucial for guiding pandemic policy interventions, but systematic data for this region is scarce. This study investigated the antibody response after AstraZeneca vaccination in COVID-19 convalescent Ugandans. Methods: We recruited 86 participants with a previous rt-PCR-confirmed mild or asymptomatic COVID-19 infection and measured the prevalence and levels of spike-directed IgG, IgM, and IgA antibodies at baseline, 14 and 28 days after the first dose (priming), 14 days after the second dose (boosting), and at six- and nine-months post-priming. We also measured the prevalence and levels of nucleoprotein-directed antibodies to assess breakthrough infections. Results: Within two weeks of priming, vaccination substantially increased the prevalence and concentrations of spike-directed antibodies (p < 0.0001, Wilcoxon signed rank test), with 97.0% and 66% of vaccinated individuals possessing S-IgG and S-IgA antibodies before administering the booster dose. S-IgM prevalence changed marginally after the initial vaccination and barely after the booster, consistent with an already primed immune system. However, we also observed a rise in nucleoprotein seroprevalence, indicative of breakthroughs six months after the initial vaccination. Discussion: Our results suggest that vaccination of COVID-19 convalescent individuals with the AstraZeneca vaccine induces a robust and differential spike-directed antibody response. The data highlights the value of vaccination as an effective method for inducing immunity in previously infected individuals and the importance of administering two doses to maintain protective immunity. Monitoring anti-spike IgG and IgA when assessing vaccine-induced antibody responses is suggested for this population; assessing S-IgM will underestimate the response. The AstraZeneca vaccine is a valuable tool in the fight against COVID-19. Further research is needed to determine the durability of vaccine-induced immunity and the potential need for booster doses.

Rapid cassette test results in anti-SARS-CoV-2 antibody screening verification by electrochemiluminescence immunoassay method

Objective: Since the resumption of face-to-face education in October 2020, which was suspended due to the COVID-19 pandemic, coincides with the period when SARS-CoV-2 infection rates in young adults are on the rise. This study focuses on the 2019 corona virus outbreak in young adults, the largest link in the chain of transmission, which can be defined as silent contagious agents. It is aimed to provide epidemiological data by detecting virus disease (COVID-19) seropositivity with two different serological methods, and to evaluate the symptom-test performance relationship of asymptomatic/mild symptom/symptomatic cases. Methods: A cross-sectional study was conducted with students studying at Cappadocia University health programs between December 2020 and February 2021 and who will attend practice courses face-to-face. Participants were surveyed about their COVID-19 symptoms and disease histories based on SARS-CoV-2 exposure. For SARS-CoV-2 antibody detection, blood samples were taken from the participants and investigated with a single lateral flow immunoAssay (LFIA, Novatech, Turkey) cassette test. The samples with positive test result were then SARS-CoV-2 Anti-N IgM+IgG;SARS-CoV-2 Anti-S IgM+IgG;SARS-CoV-2 Anti-RBD IgG;It was re-evaluated using the electrochemiluminescence immunoassay (ECLIA) method with the anti-SARS-CoV-2 kit (Roche, Germany). Results: Of the 239 samples participating in the study, 50 (20.9%) samples that were positive for SARS-CoV2 IgM/ IgG according to the LFIA method were then studied again with the ECLIA method. According to the ECLIA result, 72% (36/50) of individuals against both nucleocapsid (N) and spike (S) antigens, and 70% (35) against RBD antigen were seropositive. Based on the ECLIA test results, 239 samples were studied and 50 samples were found to be IgM/IgG positive, with a sensitivity of 64% and a specificity of 93%. Contingence history was reported in 46% (n=23) of patients who were seropositive by both methods, while 30% (n=15) showed a COVID-19 clinic. Fifty four percent (n=27) of the participants reported that they did not have a PCR (polymerase chain reaction) test, but antibody response was observed in all of them. Only 28% (n=14) of seropositive patients reported positive PCR results, and 4% of them stated that they had a chronic disease. It will be important to continue to observe the serological status of young people, particularly in the context of new COVID-19 variants and in the low interest in mass vaccination campaigns targeting young people. Conclusion: It is thought that the performance of ECLIA with rapid casette test does not have a good degree of agreement and confirmation with different immunoassay tests would be more useful for epidemiological surveillance. Especially the new COVID-19 in the context of the variants and targeting youth due to the lack of interest in vaccination champaigns continue to monitor the serological status of young people it will be important.

Comparison of diagnostic performance of RT-qPCR, RT-LAMP and IgM/IgG rapid tests for detection of SARS-CoV-2 among healthcare workers in Brazil.

BACKGROUND: COVID-19 has become a major public health problem after the outbreak caused by SARS-CoV-2 virus. Great efforts to contain COVID-19 transmission have been applied worldwide. In this context, accurate and fast diagnosis is essential. METHODS: In this prospective study, we evaluated the clinical performance of three different RNA-based molecular tests - RT-qPCR (Charité protocol), RT-qPCR (CDC (USA) protocol) and RT-LAMP - and one rapid test for detecting anti-SARS-CoV-2 IgM and IgG antibodies. RESULTS: Our results demonstrate that RT-qPCR using the CDC (USA) protocol is the most accurate diagnostic test among those evaluated, while oro-nasopharyngeal swabs are the most appropriate biological sample. RT-LAMP was the RNA-based molecular test with lowest sensitivity while the serological test presented the lowest sensitivity among all evaluated tests, indicating that the latter test is not a good predictor of disease in the first days after symptoms onset. Additionally, we observed higher viral load in individuals who reported more than 3 symptoms at the baseline. Nevertheless, viral load had not impacted the probability of testing positive for SARS-CoV-2. CONCLUSION: Our data indicates that RT-qPCR using the CDC (USA) protocol in oro-nasopharyngeal swabs samples should be the method of choice to diagnosis COVID-19.

FORMATION OF ANTI-INFECTIOUS AND POST-VACCINATION ANTI-SARS-CoV-2 HUMORAL IMMUNITY IN MEDICAL WORKERS OF THE PERINATAL CENTER

In the context of the global spread of the new coronavirus infection, studies aimed at investigating formation of anti-infectious and post-vaccination immunity are of special importance, which is necessary to prevent and reduce morbidity and mortality due to SARS-CoV-2 infection. Purpose: to assess anti-infectious immunity against SARS-CoV-2 in various forms of the disease and development of post-vaccination humoral reactions in medical workers of the perinatal center. Materials and methods. A study of blood serum was carried out to assess SARS-CoV-2-specific IgM and IgG antibodies in 119 medical workers recovered after COVID-19, divided into groups based on the disease severity (mild, moderate and asymptomatic), as well as in 62 vaccinated employees, divided into groups according to age. Semi-quantitative measurement of virus-specific antibodies was carried out by ELISA with test systems "SARS-CoV-2-IgG-ELISA-BEST" and "SARS-CoV-2-IgM-ELISA-BEST". Statistical processing of the research results was carried out using Microsoft Excel 2010 and Statistica 6. Quantitative characteristics were presented as median (ME), lower and upper quartiles (LQ1-UQ3);qualitative parameters - as absolute value and relative number (%). Difference between groups was analyzed by using the chi(2) test (qualitative) and the Mann-Whitney U-test (quantitative). Results. The results of the study showed that the majority of employees with a moderate-severe form of SARS-CoV-2 had a high level of IgG (PR - a positivity rate of more than 9.0 arbitrary units) 9 months after the disease compared to those who suffered from mild or asymptomatic (83.3% versus 25.8% and 13.3%, p < 0.017) infection. The duration of IgG circulation after former illness had no relation to its severity and patient age. The effectiveness of the primary vaccination "Sputnik V" and revaccination with "Sputnik Light" and "KoviVak" was 100% after inoculating the vaccine second component. The lowest level of antibodies after the first vaccination is recorded in persons over 60 years old (1.48 (1.12-3.25 versus PR = 8.48 (5.78-10.11) and 9.27 (5.84-10.31) arbitrary units, p < 0.017)), in comparison with young and middle-age subjects. The speed SARS-CoV-2 elimination of IgG at 6, 9 or more months after vaccination depends on relevant initial peak antibody concentration. Subjects who were initially vaccinated with the KoviVac vaccine, IgG was not detected 2 months after vaccination. The protective effect of "Sputnik V", "Sputnik Light", "KoviVac" after re-infection with SARS-CoV-2 averages 71.2%. Conclusion. Thus, the results obtained on assessing anti-infectious and post-vaccination immunity against SARS-CoV-2 emphasize the need for further studies on a larger patient cohort, especially in those with asymptomatic infection as well as the elderly subjects.

IGG and IGM response in a group of Iraqi health care worker following SARS- CoV-2 mRNA vaccine

The global pandemic of coronavirus disease 2019 (COVID-19) is caused by infection with the SARS-CoV-2 virus. Positive detection of IgM and IgG antibodies specific to SARS-CoV-2 has been recognized as an evidence for confirmed SARS-CoV-2 infection or vaccination. Method: One hundred healthy health care workers from both genders over eighteen years old were participated to test their humeral response (IgG, IgM) after vaccinated with Pfizer vaccine in the vaccination center Baghdad Teaching Hospital after one week of the second shot, and one hundred healthy health care workers with matched age and gender had test of their humeral response (IgG, IgM) before they get vaccinated (control), both groups deny recent COVID-19 infection.Result: Our finding shows that increase antibody responses of both (IgG, IgM) following vaccination with lesser extent increase of IgM titer than the obvious increase IgG titer in our entire participant compared with control. Conclusion our result support that the vaccine successful in production of humoral immunity and protection against COVID-19 infection.

Performance of VIDAS® Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies: A Multicentre, International Study.

Dengue is a serious mosquito-transmitted disease caused by the dengue virus (DENV). Rapid and reliable diagnosis of DENV infection is urgently needed in dengue-endemic regions. We describe here the performance evaluation of the CE-marked VIDAS® dengue immunoassays developed for the automated detection of DENV NS1 antigen and anti-DENV IgM and IgG antibodies. A multicenter concordance study was conducted in 1296 patients from dengue-endemic regions in Asia, Latin America, and Africa. VIDAS® dengue results were compared to those of competitor enzyme-linked immunosorbent assays (ELISA). The VIDAS® dengue assays showed high precision (CV ≤ 10.7%) and limited cross-reactivity (≤15.4%) with other infections. VIDAS® DENGUE NS1 Ag showed high positive and negative percent agreement (92.8% PPA and 91.7% NPA) in acute patients within 0-5 days of symptom onset. VIDAS® Anti-DENGUE IgM and IgG showed a moderate-to-high concordance with ELISA (74.8% to 90.6%) in post-acute and recovery patients. PPA was further improved in combined VIDAS® NS1/IgM (96.4% in 0-5 days acute patients) and IgM/IgG (91.9% in post-acute patients) tests. Altogether, the VIDAS® dengue NS1, IgM, and IgG assays performed well, either alone or in combination, and should be suitable for the accurate diagnosis of DENV infection in dengue-endemic regions.

Convalescent human IgG, but not IgM, from COVID-19 survivors confers dose-dependent protection against SARS-CoV-2 replication and disease in hamsters.

Introduction: Antibody therapeutic strategies have served an important role during the COVID-19 pandemic, even as their effectiveness has waned with the emergence of escape variants. Here we sought to determine the concentration of convalescent immunoglobulin required to protect against disease from SARS-CoV-2 in a Syrian golden hamster model. Methods: Total IgG and IgM were isolated from plasma of SARS-CoV-2 convalescent donors. Dose titrations of IgG and IgM were infused into hamsters 1 day prior to challenge with SARS-CoV-2 Wuhan-1. Results: The IgM preparation was found to have ~25-fold greater neutralization potency than IgG. IgG infusion protected hamsters from disease in a dose-dependent manner, with detectable serum neutralizing titers correlating with protection. Despite a higher in vitro neutralizing potency, IgM failed to protect against disease when transferred into hamsters. Discussion: This study adds to the growing body of literature that demonstrates neutralizing IgG antibodies are important for protection from SARS-CoV-2 disease, and confirms that polyclonal IgG in sera can be an effective preventative strategy if the neutralizing titers are sufficiently high. In the context of new variants, against which existing vaccines or monoclonal antibodies have reduced efficacy, sera from individuals who have recovered from infection with the emerging variant may potentially remain an efficacious tool.

Correlation of serum SARS-CoV-2 IgM and IgG serology and clinical outcomes in COVID-19 patients: Experience from a tertiary care centre.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has become a pandemic for the last 2 years. Inflammatory response to the virus leads to organ dysfunction and death. Predicting the severity of inflammatory response helps in managing critical patients using serology tests IgG and IgM. AIM: To investigate the correlation of the serology (IgM and IgG) with reverse transcriptase polymerase chain reaction (RT-PCR) status, disease severity [mild to critical], intensive care unit (ICU) admission, septic shock, acute kidney injury, and in-hospital mortality. METHODS: We conducted a longitudinal study to correlate serum SARS-CoV-2 immunoglobulin M (IgM) and immunoglobulin G (IgG) serology with clinical outcomes in coronavirus disease 2019 (COVID-19) patients. We analyzed patient data from March to December 2020 for those who were admitted at All India Institute of Medical Sciences Rishikesh. Clinical and laboratory data of these patients were collected from the e-hospital portal and analyzed. A correlation was seen with clinical outcomes and was assessed using MS Excel 2010 and SPSS software. RESULTS: Out of 494 patients, the mean age of patients was 48.95 ± 16.40 years and there were more male patients in the study (66.0%). The patients were classified as mild-moderate 328 (67.1%), severe 131 (26.8%), and critical 30 (6.1%). The mean duration from symptom onset to serology testing was 19.87 ± 30.53 d. In-hospital mortality was observed in 25.1% of patients. The seropositivity rate (i.e., either IgG or IgM > 10 AU) was 50%. IgM levels (AU/mL) (W = 33428.000, P ≤ 0.001) and IgG levels (AU/mL) (W = 39256.500, P ≤ 0.001), with the median IgM/ IgG levels (AU/mL), were highest in the RT-PCR-Positive group compared to RT-PCR-Negative clinical COVID-19. There was no significant difference between the two groups in terms of all other clinical outcomes (disease severity, septic shock, ICU admission, mechanical ventilation, and mortality). CONCLUSION: The study showed that serology levels are high in RT-PCR positive group compared to clinical COVID-19. However, serology cannot be useful for the prediction of disease outcomes. The study also highlights the importance of doing serology at a particular time as antibody titers vary with the duration of the disease. In week intervals there was a significant correlation between clinical outcomes and serology on week 3.

An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies.

Over the last three years, after the outbreak of the COVID-19 pandemic, an unprecedented number of novel diagnostic tests have been developed. Assays to evaluate the immune response to SARS-CoV-2 have been widely considered as part of the control strategy. The lateral flow immunoassay (LFIA), to detect both IgM and IgG against SARS-CoV-2, has been widely studied as a point-of-care (POC) test. Compared to laboratory tests, LFIAs are faster, cheaper and user-friendly, thus available also in areas with low economic resources. Soon after the onset of the pandemic, numerous kits for rapid antibody detection were put on the market with an emergency use authorization. However, since then, scientists have tried to better define the accuracy of these tests and their usefulness in different contexts. In fact, while during the first phase of the pandemic LFIAs for antibody detection were auxiliary to molecular tests for the diagnosis of COVID-19, successively these tests became a tool of seroprevalence surveillance to address infection control policies. When in 2021 a massive vaccination campaign was implemented worldwide, the interest in LFIA reemerged due to the need to establish the extent and the longevity of immunization in the vaccinated population and to establish priorities to guide health policies in low-income countries with limited access to vaccines. Here, we summarize the accuracy, the advantages and limits of LFIAs as POC tests for antibody detection, highlighting the efforts that have been made to improve this technology over the last few years.

Qualitative and quantitative detection of SARS-CoV-2 antibodies from dried blood spots.

INTRODUCTION: Dried blood spot (DBS) sampling is a minimally invasive method for specimen collection with potential multifaceted uses, particularly for serosurveillance of previous SARS-CoV-2 infection. In this study, we assessed DBS as a potential specimen type for assessing IgG and total (including IgG and IgM) antibodies to SARS-CoV-2 in vaccinated and naturally infected patients. METHODS: Six candidate buffers were assessed for eluting blood from DBS cards. The study utilized one hundred and five paired plasma specimens and DBS specimens from prospectively collected SARS-CoV-2 vaccinated individuals, remnants from those with PCR confirmed SARS-CoV-2 infections, or remnants from those without history of infection or vaccination. All specimens were tested with the Siemens SARS-CoV-2 total assay (COV2T) or IgG assay (sCOVG). RESULTS: The lowest backgrounds were observed with water and PBS, and water was used for elution. Relative to plasma samples, DBS samples had a positive percent agreement (PPA) of 94.4% (95% CI: 94.9-100%) for COV2T and 79.2 (68.4-87.0) for sCOVG using the manufacturer's cutoff. The NPA was 100 % (87.1-100.0 and 85.13-100) for both assays. Dilution studies revealed 100% (95% CI: 90.8-100%) qualitative agreement between specimen types on the COV2T assay and 98.0% (88.0-99.9%) with the sCOVG using study defined cutoffs. CONCLUSION: DBS specimens demonstrated high PPA and NPA relative to plasma for SARS-CoV-2 serological testing. Our data support feasibility of DBS sampling for SARS-CoV-2 serological testing.

Antiphospholipid antibody (aPL) presence in COVID-19 patients

Objective: In our study, we aimed to show whether there is a relationship between antiphospholipid antibody (aPL) positivity and complications of COVID-19. Material and Methods: Eighty-three patients who were diagnosed with COVID-19 infection and hospitalized in the intensive care unit (ICU) of Bakirkoy Dr. Sadi Konuk Research and Training Hospital were included in our study as the case group and 79 healthy volunteers as the control group. Only patients with a positive Polymerase Chain Reaction (PCR) test were included in the case group. Serum antiphospholipid antibodies (aPL IgM/G), C-Reactive Protein (CRP), ferritin, procalcitonin (PCT), plasma D-Dimer levels, prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) were analyzed by routine laboratory methods. Results: Both groups were found statistically similar in terms of gender (X2 test, p=0.236). The mean age of the case group and control group was 60.54..16.86 and 51.47..14.64 years, respectively. When aPL positivity was evaluated between the case and control groups, a statistically remarkable difference was found between the groups (p=0.046). The case group showed an aPL positivity of 7.5% and the control group 1%. The correlation between D-Dimer, PT, INR, aPTT levels, and aPL IgM/G positivity in the case group was significant. Conclusion: Our results revealed that aPL positivity in patients with COVID-19 infection relate to the severity of the disease, independent from age and gender. To confirm the result of this study further studies with participation of larger patient groups from national and international hospitals are required.

Transmission of SARS-CoV-2 associated with wastewater treatment: a seroprevalence study

The detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during wastewater treatment leads to concerns about whether this process may represent a focal point for the transmission of COVID-19. An epidemiological analysis, based on a COVID-19 IgG/IgM Rapid Test Cassette, performed on 134 wastewater workers from 59 wastewater treatment plants from the province of Granada (Spain) showed a seroprevalence of 8.95% in IgG for SARS-CoV-2, which is similar to the incidence rate found for the general population of the province (9.6%;95%CI = 7.2-12.8). These findings suggest that current safety measures are sufficient for the protection of workers against SARS-CoV-2.

Specific antibodies of 95 health care workers vaccinated with inactivated 2019-nCoV vaccines

OBJECTIVE: To investigate the immune antibodies in blood specimens of 95 health care workers vaccinated with inactivated 2019-nCoV vaccines and explore the rules and characteristics of production of antibodies after vaccination. METHODS: From Oct 2020 to Jul 2021, the venous blood specimens were collected from 95 health care workers of the 305 Hospital of PLA after the injection of 2 doses of 2019-nCoV vaccines fo30 days, 65 days, 91 days, 6 months and 9 months. SARS-CoV-2 immunoglobin(Ig) M, IgG and titers of neutralizing antibodies and total antibodies were detected by chemiluminescence immunoassay, the results of antibody tests were dynamically analyzed, the immune durability of the antibody, influencing factors and correlation were determined. RESULTS: Almost all of the subjects produced IgG, neutralizing antibody and total antibody, some subjects retained high level of IgM titer. Smoking could affect the production of total antibody. The subjects of the low body weight group produced higher level of IgG, and there was no significant difference when the weight was over 60 kg. The titers of the four types of antibodies decreased significantly at the following time points, and the positive rates of all the antibodies were less than 50% except for IgG after the vaccination for 9 months. CONCLUSION: Specific IgM and IgG, neutralizing antibody and total antibody can be produced after the 2-doses vaccination of inactivated 2019-nCoV vaccines. But the titers and positive rates of the antibodies decrease with time, which means the protective effects on the body decrease. Therefore, in order to improve the autoimmunity against novel coronavirus, one booster vaccination of an inactivated 2019-nCoV vaccine will be necessary after the 2 doses of vaccination for 6 months.

Dynamic characteristics of specific antibodies IgM, IgG and viral RNA in patients with COVID-19

Objective: To study the changed trend of IgM and IgG specific antibody with chemiluminescent immunoassay (CLIA) and RT-PCR in SARS-CoV-2 infection patients during hospitalization. Methods: A total of 100 hospitalized patients with SARS-CoV-2 infection who admitted to the First People's Hospital of Zhaoqing were divided into vaccinated group and unvaccinated group according to whether they were vaccinated COVID-19 vaccine or not. The unvaccinated group was further divided into severe, normal, mild and asymptomatic groups. The nucleic acid test results, the positive rate of IgM and IgG antibodies measured by CLIA, and the dynamic trend of S/CO values of all SARS-CoV-2 infected patients since admission 0-<8 days, 8-<15 days, 15-<22 days, 22-<29 days, 29-<36 days and36 days were monitored, and the statistical differences between different groups were compared. Results: The positive rate of IgM antibody in the unvaccinated group 55.6% (15/27) and 0 (0/27) were all significantly higher than that in the vaccinated group 68.5% (50/73) and 49.0% (36/73) at 8-<15 days and 36 days of hospitalization (X2=11.048, 20.805, P < 0.05). The positive rate of IgG antibody in the vaccinated group 96.3% (26/27) and 100% (27/27) were all significantly higher than that in the unvaccinated group 45.2% (31/73) and 78.1% (57/73) at 0-< 8 days and 8-<15 days of hospitalization (X2=21.268, 7.576, P < 0.05). The positive rate of RNA in the unvaccinated were all significantly higher than that in the vaccinated group at 8-<15 days 76.7% (56/73) and 29.6% (8/27), 15-<22 days 65.8% (48/73) and 14.8% (4/27), 22-<29 days 42.5%(31/73) and 7.4% (2/27), 29~<36 days 26.0% (19/73) and 7.4% (2/27) of hospitalization (X2=18.694,20.490, 10.957, 4.119, all P < 0.05). The S/CO value of IgG antibody in the vaccinated group were all significantly higher than that in the unvaccinated group at differentperiods of hospitalization (t=2.841, 7.135, all P < 0.05), but there was no significant difference in the S/CO value of IgM antibodyat different periods of hospitalization in pairwise comparison (P > 0.05). The IgM and IgG antibody levels of severe patients in the unvaccinated group were significantly higher than those in the normal, mild, and asymptomatic groups at 22-<29 days and 29-<36 days of hospitalization (F=17.694,15.116, 4.037, 4.115, all P < 0.05). Conclusion: IgM and IgG antibody levels in severe patients are more activated by immune defense during recovery. In the case of vaccination, IgM antibody can well reflect the whole course of SARS-CoV-2 infection.