The importance of combining serological testing with RT-PCR assays for efficient detection of COVID-19 and higher diagnostic accuracy.

Misdiagnosing suspected COVID-19 individuals could largely contribute to the viruses transmission, therefore, making an accurate diagnosis of infected subjects vital in minimizing and containing the disease. Although RT-PCR is the standard method in detecting COVID-19, it is associated with some limitations, including possible false negative results. Therefore, serological testing has been suggested as a complement assay to RT-PCR to support the diagnosis of acute infections. In this study, 15 out of 639 unvaccinated healthcare workers (HCWs) were tested negative for COVID-19 by RT-PCR and were found seropositive for SARS-CoV-2 nucleocapsid protein-specific IgM and IgG antibodies. These participants underwent additional confirmatory RT-PCR and SARS-CoV-2 spike-specific ELISA tests. Of the 15 individuals, nine participants were found negative by second RT-PCR but seropositive for anti-spike IgM and IgG antibodies and neutralizing antibodies confirming their acute infection. At the time of collection, these nine individuals were in close contact with COVID-19-confirmed patients, with 77.7% reporting COVID-19-related symptoms. These results indicate that including serological tests in the current testing profile can provide better outcomes and help contain the spread of the virus by increasing diagnostic accuracy to prevent future outbreaks rapidly.

Evaluation of ten (10) SARS-CoV-2 rapid serological tests in comparison with WANTAI SARS-CoV-2 ab ELISA in Burkina Faso, West Africa.

BACKGROUND: The aim of this study was to evaluate the performance of ten (10) SARS-CoV-2 serological rapid diagnostic tests in comparison with the WANTAI SARS-CoV-2 Ab ELISA test in a laboratory setting. MATERIALS AND METHODS: Ten (10) SARS-CoV-2 serological rapid diagnostic tests (RDTs) for SARS-CoV-2 IgG/IgM were evaluated with two (2) groups of plasma tested positive for one and negative for the other with the WANTAI SARS-CoV-2 Ab ELISA. The diagnostic performance of the SARS-CoV-2 serological RDTs and their agreement with the reference test were calculated with their 95% confidence intervals. RESULTS: The sensitivity of serological RDTs ranged from 27.39 to 61.67% and the specificity from 93.33 to 100% compared to WANTAI SARS-CoV-2 Ab ELISA test. Of all the tests, two tests (STANDARD Q COVID-19 IgM/IgG Combo SD BIOSENSOR and COVID-19 IgG/IgM Rapid Test (Zhejiang Orient Gene Biotech Co., Ltd)) had a sensitivity greater than 50%. In addition, all ten tests had specificity greater than or equal to 93.33% each. The concordance between RDTs and WANTAI SARS-CoV-2 Ab ELISA test ranged from 0.25 to 0.61. CONCLUSION: The SARS-CoV-2 serological RDTs evaluated show low and variable sensitivities compared to the WANTAI SARS-CoV-2 Ab ELISA test, with however a good specificity. These finding may have implications for the interpretation and comparison of COVID-19 seroprevalence studies depending on the type of test used.

The diagnostic value of rapid anti IgM and IgG detecting tests in the identification of patients with SARS CoV-2 virus infection / [A specifikus IgM- és IgG-antitesteket detektáló gyorstesztek értéke a SARS CoV-2 vírusfertozés kimutatásában (A COVID-19-pandémia orvosszakmai kérdései)]

Introduction: At the end of March, 2020, rapid tests detecting the presence of antiviral IgM and IgG antibodies against SARS-CoV-2 virus were introduced in Hungary for the identification of SARS-CoV-2 infection (COVID-19 disease). Aim: We evaluated two rapid tests (Anhui and Clungene) in comparison with those of real-time PCR tests considered as the gold standard in the detection of infection. Method: Between 16, March and 14, April, 2020, we performed rapid IgM and IgG detecting tests without PCR; PCR without rapid tests; and PCR WITH rapid tests in 4140, 3210 and 1654 patients, respectively. (Out of these 1654 patients, Anhui and Clungene tests were used for testing in 625 and 1029 patients, respectively.) Patients were considered as positive in PCR and rapid tests when PCR positivity and IgM or IgG positivity occurred at any time, respectively. (Note: Clungene test is also marketed as 'Lungene'.) Results: The prevalence of PCR positivity in 4864 patients tested with PCR was 6.3%. The sensitivity and specificity of Anhui and Clungene tests were 33.3% and 72.85%, and 35.48% and 85.02%, respectively. At 6% PCR positivity, the positive and negative predictive values of Anhui and Clungene were 7.28%, 94.48%, 13.13%, and 95.38%, respectively. Conclusion: The low positive predictive values indicate that Anhui and Clungene rapid tests detecting the presence of anti-IgM and anti-IgG against SARS-CoV-2 virus infection are not suitable for screening SARS-CoV-2 vírus infection in the general population. These results strongly support that Anhui and Clungene rapid tests detecting IgM and IgG antibodies against SARS-CoV-2 virus should not be used in the differential diagnosis of infection. Orv Hetil. 2020; 161(20): 807-812.

Low detection rate of RT-PCR-confirmed COVID-19 using IgM/IgG rapid antibody tests in a large community sample in Lima, Peru.

BACKGROUND: Rapid IgM/IgG antibody tests were largely used in lieu of RT-PCR tests as part of COVID-19 public health response activities in Lima, Peru. To assess their utility, we explored the relationship between the time since onset of several COVID-19-related symptoms and the sensitivity of a rapid combined IgM/IgG antibody test. METHODS: We collected data from a community sample of individuals (n = 492) who received concurrent RT-PCR and rapid IgM/IgG antibody testing between May 2020 and March 2021. We estimated the sensitivity of the antibody test, against the RT-PCR test, by weeks since symptom onset via segmented regression analysis. RESULTS: The overall sensitivity of the rapid IgM/IgG antibody test was 46.7% (95% CI, 42.4-51.2%). Among 372 (75.6%) participants who reported COVID-19-related symptoms, sensitivity increased from 30.4% (95% CI, 24.7-36.6%) in week 1 after symptom onset to 83.3% (95% CI, 41.6-98.4%) in week 4. The test sensitivity increased by 31.9% (95% CI, 24.8-39.0%) per week until week 2 to 3, then decreased by - 6.0% (95% CI, - 25.7-13.7%) per week thereafter. CONCLUSION: Rapid antibody tests are a poor substitute for RT-PCR testing, regardless of presenting symptoms. This highlights the need for future pandemic planning to include timely and equitable access to gold-standard diagnostics, treatment, and vaccination.

Immunochromatographic test for differentiation detection of IgM and IgG to SARS-CoV-2.

The study presents the results of the creation and evaluation of the diagnostic characteristics of the rapid immunochromatographic test for the qualitative detection and differentiation of IgM/IgG antibodies to SARS-CoV-2 in human serum, plasma, and whole blood "ИХА-COVID-19-IgM / IgG". Have been tested some samples without antibodies to SARS-CoV-2 and a samples with two and one type of specific antibodies. The coincidence of the results of immunochromatographic analysis with the results of the immunochemiluminescent method was 87.2%. Test kit can be use as the rapid diagnostic test in the context of the COVID-19 pandemic and to assess the immune status of convalescents.

Comparison of six antibody assays and two combination assays for COVID-19.

INTRODUCTION: In this work, six SARS-CoV-2-specific antibody assays were evaluated, namely, two pan-immunoglobulin (pan-Ig) assays [Roche Elecsys Anti-SARS-CoV-2 (named "Elecsys" in this study) and the PerkinElmer SuperFlex™ Anti-SARS-CoV-2 Ab Assay (SuperFlex_Ab)], two IgM assays [SuperFlex™ Anti-SARS-CoV-2 IgM Assay (SuperFlex_IgM) and YHLO iFlash-SARS-CoV-2 IgM (iFlash_IgM)], and two IgG assays [SuperFlex™ Anti-SARS-CoV-2 IgG Assay (SuperFlex_IgG) and iFlash-SARS-CoV-2 IgG (iFlash_IgG)]. Combination assays of SuperFlex™ (SuperFlex_any) and iFlash (iFlash_any) were also evaluated. METHODS: A total of 438 residual serum samples from 54 COVID-19 patients in the COVID-19 group and 100 samples from individuals without evidence of SARS-CoV-2 infection in the negative control group were evaluated. RESULTS: In the early stage of COVID-19 infection, within 14 days of symptom onset, the seropositive rate was lower than that of the late stage 15 days after onset (65.4% vs 99.6%). In the total period, the pan-Ig and IgG assays had higher sensitivity (90.8-95.3%) than the IgM assays (36.5-40.7%). SuperFlex_Ab and SuperFlex_any had higher sensitivity than Elecsys and SuperFlex_IgG (p < 0.05). The specificity of all the assays was 100%, except for SuperFlex_IgM (99.0%). The concordance rate between each assay was higher (96.4-100%) in the late stage than in the early stage (77.4-98.1%). CONCLUSION: For the purpose of COVID-19 diagnosis, antibody testing should be performed 15 days after onset. For the purpose of epidemiological surveillance, highly sensitive assays should be used as much as possible, such as SuperFlex_Ab, iFlash_IgG and their combination. IgM assays were not suitable for these purposes.

Multiplex Antibody Analysis of IgM, IgA and IgG to SARS-CoV-2 in Saliva and Serum From Infected Children and Their Close Contacts.

COVID-19 affects children to a lesser extent than adults but they can still get infected and transmit SARS-CoV-2 to their contacts. Field deployable non-invasive sensitive diagnostic techniques are needed to evaluate the infectivity dynamics of SARS-CoV-2 in pediatric populations and guide public health interventions, particularly if this population is not fully vaccinated. We evaluated the utility of high-throughput Luminex assays to quantify saliva IgM, IgA and IgG antibodies against five SARS-CoV-2 spike (S) and nucleocapsid (N) antigens in a contacts and infectivity longitudinal study in 122 individuals (52 children and 70 adults). We compared saliva versus serum/plasma samples in infected children and adults diagnosed by weekly RT-PCR over 35 days (n=62), and those who consistently tested negative over the same follow up period (n=60), in the Summer of 2020 in Barcelona, Spain. Saliva antibody levels in SARS-CoV-2 RT-PCR positive individuals were significantly higher than in negative individuals and correlated with those measured in sera/plasmas. Asymptomatic infected individuals had higher levels of anti-S IgG than symptomatic individuals, suggesting a protective anti-disease role for antibodies. Higher anti-S IgG and IgM levels in serum/plasma and saliva, respectively, in infected children compared to infected adults could also be related to stronger clinical immunity in them. Among infected children, males had higher levels of saliva IgG to N and RBD than females. Despite overall correlation, individual clustering analysis suggested that responses that may not be detected in blood could be patent in saliva, and vice versa. In conclusion, measurement of SARS-CoV-2-specific saliva antibodies should be considered as a complementary non-invasive assay to serum/plasma to determine COVID-19 prevalence and transmission in pediatric populations before and after vaccination campaigns.

Differential Antibody Response to SARS-CoV-2 Antigens in Recovered and Deceased Iranian COVID-19 Patients.

The coronavirus infectious disease 2019 (COVID-19), which is initiated by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has imposed critical challenges to global health. Understanding the kinetic of SARS-CoV-2-specific IgM and IgG responses in different subsets of COVID-19 patients is crucial to get insight into the humoral immune response elicited against the virus. We investigated IgM and IgG responses against SARS-CoV-2 nucleocapsid (N) and receptor-binding domain (RBD) of spike protein in two groups of recovered and deceased COVID-19 patients. The levels of IgM and IgG specific to N and RBD proteins were detected by ELISA. N- and RBD-specific IgM was higher in deceased patients in comparison with recovered patients, while there was no significant difference in N- and RBD-specific IgG between the two groups. A significant correlation was observed between IgG and IgM titers against RBD and N, in both groups of patients. These results argue against impaired antibody response in deceased COVID-19 patients.

Validity and reliability of immunochromatographic IgM/IgG rapid tests for COVID-19 salivary diagnosis.

OBJECTIVES: To assess the accuracy of three immunochromatographic rapid tests for salivary detection of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens and the reliability of these tests comparing saliva with plasma samples. MATERIALS AND METHODS: Plasma and saliva samples from 62 patients diagnosed with coronavirus disease 2019 (COVID-19) and 20 healthy volunteers were assayed. IgM/IgG antibody against SARS-COV-2 was detected using three immunochromatographic rapid tests and compared with real-time reverse transcription-polymerase chain reaction (qRT-PCR). RESULTS: The tests' overall accuracy for detecting anti-SARS-CoV-2 antibodies ranged from 75.6 to 79.3 for saliva and 86.6-87.8 for plasma tests. The sensitivity of saliva and plasma tests increased with the severity of COVID-19 signs and symptoms. The chance of a positive plasma test in participants with a positive qRT-PCR test was 2.27 greater than a positive saliva test. CONCLUSIONS: Although rapid immunochromatographic tests are more accurate using plasma than saliva, which was expected considering its original use, our findings support the use of saliva as a straightforward supplementary method to assess seroconversion in patients with COVID-19, with important sensitivity and sensibility, especially in severe and critical cases.

Side effects of the BNT162b2 vaccine in the personnel of the Military Central Hospital.

OBJECTIVE: The pandemic disease by SARS-CoV-2 infection does not have an effective treatment. To prevent the disease, scientists developed vaccines that the clinicians use as an emergency licensed vaccine. The objective of this study was to determine the side effects in personnel vaccinated at the Military Central Hospital of Mexico with the BNT162b2 vaccine. PATIENTS AND METHODS: This study included the subjects who had received both doses of the BNT162b2 vaccine between December 2020 and February 2021. We asked about the side effects after the first and the second vaccine doses. One group had no history of COVID-19, and the second had a history of COVID-19. ANTI-SARS-CoV-2 antibodies were measured by the immunodetection technique in the second group only. RESULTS: We included 946 participants, 62% were women, and 80% were without comorbidities; 680 were included in the first group, and only 266 were in the second group. After the first dose, 77% of the first group and 86% of the second group presented some side effects. After the second dose, 84% of the first group and 89% of the second group showed some side effects. The main side effect was mild pain. All participants (126) were IgG positive, and only 26.9% were IgM positive at 17.5 days (12.8 days, 20.3 days) after the second dose. CONCLUSIONS: There is a positive correlation between side effects after the first dose in patients with a history of previous SARS-CoV-2 infection compared to those who did not. Nevertheless, this correlation is not present after the second dose. The low percentage of IgM could be related to the time interval between vaccination and sample measure.

COVID-19 in long-term care facilities in Brazil: serological survey in a post-outbreak setting.

This cross-sectional seroepidemiological survey presents the seroprevalence of SARS-CoV-2 in a population living in 15 Long-Term Care Facilities (LTCFs), after two intra-institutional outbreaks of COVID-19 in the city of Botucatu, Sao Paulo State, Brazil. Residents were invited to participate in the serological survey performed in June and July 2020. Sociodemographic and clinical characterization of the participants as well as the LTCF profile were recorded. Blood samples were collected, processed and serum samples were tested using the rapid One Step COVID-19 immunochromatography test to detect IgM and IgG anti-SARS-CoV-2. Among 209 residents, the median of age was 81 years old, 135 (64.6%) were female and 171 (81.8%) self-referred as being white. An overall seroprevalence of 11.5% (95% CI: 7.5% - 16.6%) was found. The highest seroprevalences of 100% and 76.9% were observed in LTCFs that had experienced COVID-19 outbreaks. Most residents with positive immunochromatography tests (70.8%) referred previous contact with a confirmed COVID-19 case. Although there was a relatively low seroprevalence of COVID-19 in the total number of elderly people, this population is highly vulnerable and LTCFs are environments at higher risk for COVID-19 dissemination. A well-established test for COVID-19 policies, the adequate characterization of the level of interaction between residents and the healthcare provider team and the level of complexity of care are crucial to monitor and control the transmission of SARS-CoV-2 in these institutions.

Estimated seroprevalence of SARS-CoV-2 antibodies among adults in Orange County, California.

Clinic-based estimates of SARS-CoV-2 may considerably underestimate the total number of infections. Access to testing in the US has been heterogeneous and symptoms vary widely in infected persons. Public health surveillance efforts and metrics are therefore hampered by underreporting. We set out to provide a minimally biased estimate of SARS-CoV-2 seroprevalence among adults for a large and diverse county (Orange County, CA, population 3.2 million). We implemented a surveillance study that minimizes response bias by recruiting adults to answer a survey without knowledge of later being offered SARS-CoV-2 test. Several methodologies were used to retrieve a population-representative sample. Participants (n = 2979) visited one of 11 drive-thru test sites from July 10th to August 16th, 2020 (or received an in-home visit) to provide a finger pin-prick sample. We applied a robust SARS-CoV-2 Antigen Microarray technology, which has superior measurement validity relative to FDA-approved tests. Participants include a broad age, gender, racial/ethnic, and income representation. Adjusted seroprevalence of SARS-CoV-2 infection was 11.5% (95% CI: 10.5-12.4%). Formal bias analyses produced similar results. Prevalence was elevated among Hispanics (vs. other non-Hispanic: prevalence ratio [PR] = 1.47, 95% CI 1.22-1.78) and household income < $50,000 (vs. > $100,000: PR = 1.42, 95% CI: 1.14 to 1.79). Results from a diverse population using a highly specific and sensitive microarray indicate a SARS-CoV-2 seroprevalence of ~ 12 percent. This population-based seroprevalence is seven-fold greater than that using official County statistics. In this region, SARS-CoV-2 also disproportionately affects Hispanic and low-income adults.

SARS-CoV-2 Antibodies in Breast Milk After Vaccination.

BACKGROUND AND OBJECTIVES: Passive and active immunity transfer through human milk (HM) constitutes a key element in the infant's developing immunity. Certain infectious diseases and vaccines have been described to induce changes in the immune components of HM. METHODS: We conducted a prospective cohort single-institution study from February 2 to April 4, 2021. Women who reported to be breastfeeding at the time of their coronavirus disease 2019 (COVID-19) vaccination were invited to participate. Blood and milk samples were collected on day 14 after their second dose of the vaccine. Immunoglobulin G (IgG) antibodies against nucleocapsid protein as well as IgG, immunoglobulin M and immunoglobulin A (IgA) antibodies against the spike 1 protein receptor-binding domain against severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2 RBD-S1) were analyzed in both serum and HM samples. RESULTS: Most of the participants (ie, 94%) received the BNT162b2 messenger RNA COVID-19 vaccine. The mean serum concentration of anti-SARS-CoV-2 RBD-S-IgG antibodies in vaccinated individuals was 3379.6 ± 1639.5 binding antibody units per mL. All vaccinated study participants had anti-SARS-CoV-2 RBD-S1-IgG, and 89% of them had anti-SARS-CoV-2 RBD-S-IgA in their milk. The antibody concentrations in the milk of mothers who were breastfeeding 24 months were significantly higher than in mothers with breastfeeding periods <24 months (P < .001). CONCLUSIONS: We found a clear association between COVID-19 vaccination and specific immunoglobulin concentrations in HM. This effect was more pronounced when lactation periods exceeded 23 months. The influence of the lactation period on immunoglobulins was specific and independent of other variables.

Detection of SARS-CoV-2 antibodies in pediatric patients: An Iranian referral hospital-based study.

BACKGROUND: As the extent of the pandemic and its seroprevalence pattern has been less clarified in pediatrics to date, we aimed to conduct this study to investigate the clinical and laboratory characteristics of COVID-19 in Iranian children, with a focus on evaluating the antibody prevalence and its relation with the laboratory tests. METHODS: All children with highly suspected COVID-19 were included. Anti-nucleoprotein SARS-CoV-2 were measured using SARS-CoV-2 immunoglobulin M (IgM) and SARS-CoV-2 IgG ELISA kits. Hypothesis testing was carried out through SPSS to unravel any association between the measurement tools and important clinical and laboratory characteristics. RESULTS: In this study, 254 patients were evaluated and 117 cases (46%) were male. The nucleic acid detection results for patient 55 were negative, but the IgM and IgG results were positive. Totally, 190 patients were tested for IgM in which only 14 (7.3%) had positive tests. Positive IgG was detected in 51 (20%) out of 254 patients; among them, 30 patients had negative SARS-CoV-2 RT-PCR (59%). Lower level of platelets in IgG positive group in comparison with the IgG negative group was observed (P value: 0.015). Moreover, higher alanine aminotransferase (ALT) was observed in the in IgG positive group (P value: 0.02). In patients with positive IgM, relative hypocalcemia (median of 8.25; IQR: 8.02-8.62) was found which appeared to be significant (P value: 0.02). CONCLUSION: This is the first largest study describing the SARS-CoV-2 seropositivity among children in Iran and provides important insight about the COVID-19 infection in children.

Comparison of SARS-CoV-2 Antibody Responses and Seroconversion in COVID-19 Patients Using Twelve Commercial Immunoassays.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody assays have high clinical utility in managing the pandemic. We compared antibody responses and seroconversion of coronavirus disease 2019 (COVID-19) patients using different immunoassays. METHODS: We evaluated 12 commercial immunoassays, including three automated chemiluminescent immunoassays (Abbott, Roche, and Siemens), three enzyme immunoassays (Bio-Rad, Euroimmun, and Vircell), five lateral flow immunoassays (Boditech Med, SD biosensor, PCL, Sugentech, and Rapigen), and one surrogate neutralizing antibody assay (GenScript) in sequential samples from 49 COVID-19 patients and 10 seroconversion panels. RESULTS: The positive percent agreement (PPA) of assays for a COVID-19 diagnosis ranged from 84.0% to 98.5% for all samples (>14 days after symptom onset), with IgM or IgA assays showing higher PPAs. Seroconversion responses varied across the assay type and disease severity. Assays targeting the spike or receptor-binding domain protein showed a tendency for early seroconversion detection and higher index values in patients with severe disease. Index values from SARS-CoV-2 binding antibody assays (three automated assays, one LFIA, and three EIAs) showed moderate to strong correlations with the neutralizing antibody percentage (r=0.517-0.874), and stronger correlations in patients with severe disease and in assays targeting spike protein. Agreement among the 12 assays was good (74.3%-96.4%) for detecting IgG or total antibodies. CONCLUSIONS: Positivity rates and seroconversion of SARS-CoV-2 antibodies vary depending on the assay kits, disease severity, and antigen target. This study contributes to a better understanding of antibody response in symptomatic COVID-19 patients using currently available assays.

Serological profiles of pan-coronavirus-specific responses in COVID-19 patients using a multiplexed electro-chemiluminescence-based testing platform.

Serological assessment of SARS-CoV-2 specific responses are an essential tool for determining the prevalence of past SARS-CoV-2 infections in the population especially when testing occurs after symptoms have developed and limited contact tracing is in place. The goal of our study was to test a new 10-plex electro-chemiluminescence-based assay to measure IgM and IgG responses to the spike proteins from multiple human coronaviruses including SARS-CoV-2, assess the epitope specificity of the SARS-CoV-2 antibody response against full-length spike protein, receptor-binding domain and N-terminal domain of the spike protein, and the nucleocapsid protein. We carried out the assay on samples collected from three sample groups: subjects diagnosed with COVID-19 from the U.S. Army hospital at Camp Humphreys in Pyeongtaek, South Korea; healthcare administrators from the same hospital but with no reported diagnosis of COVID-19; and pre-pandemic samples. We found that the new CoV-specific multiplex assay was highly sensitive allowing plasma samples to be diluted 1:30,000 with a robust signal. The reactivity of IgG responses to SARS-CoV-2 nucleocapsid protein and IgM responses to SARS-CoV-2 spike protein could distinguish COVID-19 samples from non-COVID-19 and pre-pandemic samples. The data from the three sample groups also revealed a unique pattern of cross-reactivity between SARS-CoV-2 and SARS-CoV-1, MERS-CoV, and seasonal coronaviruses HKU1 and OC43. Our findings show that the CoV-2 IgM response is highly specific while the CoV-2 IgG response is more cross-reactive across a range of human CoVs and also showed that IgM and IgG responses show distinct patterns of epitope specificity. In summary, this multiplex assay was able to distinguish samples by COVID-19 status and characterize distinct trends in terms of cross-reactivity and fine-specificity in antibody responses, underscoring its potential value in diagnostic or serosurveillance efforts.

SARS-CoV-2 serological assay and viral testing: a report of professional football setting.

PURPOSE OF THE STUDY: PCR is the current standard test for the diagnosis of SARS-CoV-2 infection. However, due to its limitations, serological testing is considered an alternative method for detecting SARS-CoV-2 exposure. In this study, we measured the level of SARS-CoV-2 IgM and IgG antibodies of male professional football players and compared the results with the standard PCR test to investigate the association between the two tests. STUDY DESIGN: Participants were male professional football players and team officials. Nasopharyngeal swabs and peripheral blood samples were collected for the PCR and serological tests, respectively. Also, previous records of COVID-19 testing and symptoms were gathered. Those with previous positive PCR tests who tested negative for the second time were considered to be recovered patients. RESULTS: Of the 1243 subjects, 222 (17.9%) were seropositive, while 29 (2.3%) tested positive for the SARS-CoV-2 PCR test. Sixty percent of symptomatic cases with a negative PCR were found to be seropositive. The mean level of IgM was significantly higher in PCR-positive and symptomatic subjects, whereas the recovered cases showed significantly higher levels of IgG. CONCLUSION: Our study revealed an inconsistency of results between the two tests; therefore, although application of serological assays alone seems insufficient in diagnosing COVID-19 disease, the findings are beneficial in the comprehension and the management of the disease.

COVID-19 Infection: Viral Clearance and Antibody Response in Dialysis Patients and Renal Transplant Recipients.

BACKGROUND/AIMS: The coronavirus disease 2019 (CO-VID-19) pandemic is the major current health emergency worldwide, adding a significant burden also to the community of nephrologists for the management of their patients. Here, we analyzed the impact of COVID-19 infection in renal patients to assess the time to viral clearance, together with the production and persistence of IgG and IgM antibody response, in consideration of the altered immune capacity of this fragile population. METHODS: Viral clearance and antibody kinetics were investigated in 49 renal patients recovered from COVID-19 infection: 7 of them with chronic decompensated renal failure, 31 under dialysis treatment, and 11 kidney transplant recipients. RESULTS: The time span between the diagnosis of infection and recovery based on laboratory testing (2 negative nasopharyngeal swabs in consecutive days) was 31.7 ± 13.3 days. Three new positive cases were detected from 8 to 13 days following recovery. At the first serological determination after swab negativization, all the patients developed IgG and IgM antibodies. The semiquantitative analysis showed a progressive increase in IgG and a slow reduction in IgM. DISCUSSION/CONCLUSION: In subjects with decompensated chronic kidney disease, under dialysis and in transplant recipients, viral clearance is lengthened compared to the general population. However, in spite of their common status of immunodepression, all of them were able to produce specific antibodies. These data might provide useful insights for monitoring and planning health-care activities in the weak category of patients with compromised renal function recovered from COVID-19.