scholarly journals Serological Tests in the Detection of SARS-CoV-2 Antibodies

Diagnostics ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 678
Author(s):  
Kissy Guevara-Hoyer ◽  
Jesús Fuentes-Antrás ◽  
Eduardo De la Fuente-Muñoz ◽  
Antonia Rodríguez de la Peña ◽  
Marcos Viñuela ◽  
...  

Early detection of SARS-CoV-2 is essential for a timely update of health policies and allocation of resources. Particularly, serological testing may allow individuals with low-risk of being contagious of SARS-CoV-2 to return to daily activities. Both private and academic initiatives have sought to develop serological assays to detect anti-SARS-CoV-2 antibodies. Herein, we compared five different assays in active healthcare personnel exposed to SARS-CoV-2 in a large center in Madrid, Spain, in a retrospective study. Median time lapse between polymerase chain-reaction (PCR) and serological testing was 11 days (7–21). All tests assessed IgM/IgG titers except for Euroimmun (IgA/IgG) and The Binding-Site (IgA/IgM/IgG). The highest concordance rate was observed between Dia.Pro and Euroimmun (75.76%), while it was lowest between The Binding-Site and Euroimmun (44.55%). The Binding-Site assay showed the highest concordance (85.52%) with PCR results. Considering PCR results as reference, Dia.Pro was the most sensitive test, although The Binding-Site assay exhibited the highest area under the curve (AUC; 0.85). OrientGene and MAGLUMI tests were performed in a smaller cohort with confirmed infection and thus were not adequate to estimate sensitivity and specificity. The Binding-Site assay presented the best joint sensitivity and specificity among all the tests analyzed in our cohort. Likewise, this serological assay presents a greater repertoire of antibodies and antigen-regions tested, which is why each individual’s humoral immunity is more accurately reflected. The better the immunity test, the most adequate the health strategy to take in terms of organization of consultations, surgery, and treatments in vulnerable patients. The three antibody classes (IgG/IgM/IgA) were determined jointly, which translates to an economic impact on healthcare. While their role in the protection status remains elusive, serological tests add a valuable tool in the early management of SARS-CoV-2 after known exposition.

2020 ◽  
Author(s):  
Yong Chong ◽  
Naoki Tani ◽  
Hideyuki Ikematsu ◽  
Nobuto Terazawa ◽  
Hitoshi Nakashima ◽  
...  

Abstract Background: The Pandemic of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has critically impacted the spread of infection within nursing facilities. We evaluated the usefulness of genetic and serological tests conducted during a COVID-19 outbreak in a nursing facility in Japan.Methods: After the first identification of SARS-CoV-2 infection, a comprehensive, facility- and/or unit-wide PCR testing from nasopharyngeal swabs was repeatedly performed in a three-unit facility including 99 residents with dementia and 53 healthcare personnel. Additionally, PCR testing was conducted separately for residents and staff with fever of ≥37.5 oC. Facility-wide serological testing, including rapid kit testing and quantitative assay, was conducted twice over 1 month apart.Results: A total of 322 PCR and 257 antibody tests were performed. 37 (24.3%) of the 152 individuals (25/99 residents, 25.3%; 12/53 staff, 22.6%) were identified as PCR-positive. Seven residents died with a mortality of 7.1% (7/99). Among the 37 individuals, 10 (27.0%) were asymptomatic at the time of testing. PCR positivity was concentrated on one unit (Unit 1) (20/30 residents, 66.7%; 9/14 staff, 64.3%). The other units showed a limited spread of infection. In unit-wide and separate tests, PCR positivity detection was highly prevalent (22.9% and 44.4%, respectively) in Unit 1, compared with that in the other units. Serological testing identified two additional infected residents with a negative PCR result and showed that no staff was newly identified as infected.Conclusions: Thorough PCR testing, in combination with comprehensive and separate tests, is critical for managing COVID-19 outbreaks in nursing facilities, particularly, in units considered an epicenter. Serological testing is also beneficial for tracing contacts, confirming the number of infected individuals, and authorizing the termination of the outbreak.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yong Chong ◽  
Naoki Tani ◽  
Hideyuki Ikematsu ◽  
Nobuto Terazawa ◽  
Hitoshi Nakashima ◽  
...  

Abstract Background The Pandemic of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has critically impacted the spread of infection within nursing facilities. We evaluated the usefulness of genetic and serological tests conducted during a COVID-19 outbreak in a nursing facility in Japan. Methods After the first identification of SARS-CoV-2 infection, a comprehensive, facility- and/or unit-wide PCR testing from nasopharyngeal swabs was repeatedly performed in a three-unit facility including 99 residents with dementia and 53 healthcare personnel. Additionally, PCR testing was conducted separately for residents and staff with fever of ≥37.5 °C. Facility-wide serological testing, including rapid kit testing and quantitative assay, was conducted twice over 1 month apart. Results A total of 322 PCR and 257 antibody tests were performed. 37 (24.3%) of the 152 individuals (25/99 residents, 25.3%; 12/53 staff, 22.6%) were identified as PCR-positive. Seven residents died with a mortality of 7.1% (7/99). Among the 37 individuals, 10 (27.0%) were asymptomatic at the time of testing. PCR positivity was concentrated on one unit (Unit 1) (20/30 residents, 66.7%; 9/14 staff, 64.3%). The other units showed a limited spread of infection. In unit-wide and separate tests, PCR positivity detection was highly prevalent (22.9 and 44.4%, respectively) in Unit 1, compared with that in the other units. Serological testing identified two additional infected residents with a negative PCR result and showed that no staff was newly identified as infected. Conclusions Thorough PCR testing, in combination with comprehensive and separate tests, is critical for managing COVID-19 outbreaks in nursing facilities, particularly, in units considered an epicenter. Serological testing is also beneficial for tracing contacts, confirming the number of infected individuals, and authorizing the termination of the outbreak.


2020 ◽  
Vol 41 (S1) ◽  
pp. s431-s432
Author(s):  
Rachael Snyders ◽  
Hilary Babcock ◽  
Christopher Blank

Background: Immunization resistance is fueling a resurgence of vaccine-preventable diseases in the United States, where several large measles outbreaks and 1,282 measles cases were reported in 2019. Concern about these measles outbreaks prompted a large healthcare organization to develop a preparedness plan to limit healthcare-associated transmission. Verification of employee rubeola immunity and immunization when necessary was prioritized because of transmission risk to nonimmune employees and role of the healthcare personnel in responding to measles cases. Methods: The organization employs ∼31,000 people in diverse settings. A multidisciplinary team was formed by infection prevention, infectious diseases, occupational health, and nursing departments to develop the preparedness plan. Immunity was monitored using a centralized database. Employees without evidence of immunity were asked to provide proof of vaccination, defined by the CDC as 2 appropriately timed doses of rubeola-containing vaccine, or laboratory confirmation of immunity. Employees were given 30 days to provide documentation or to obtain a titer at the organization’s expense. Staff with negative titers were given 2 weeks to coordinate with the occupational heath department for vaccination. Requests for medical or religious accommodations were evaluated by occupational heath staff, the occupational heath medical director, and the human resources department. All employees were included, though patient-interfacing employees in departments considered higher risk were prioritized. These areas were the emergency, dermatology, infectious diseases, labor and delivery, obstetrics, and pediatrics departments. Results: At the onset of the initiative in June 2019, 4,009 employees lacked evidence of immunity. As of November 2019, evidence of immunity had been obtained for 3,709 employees (92.5%): serological evidence of immunity was obtained for 2,856 (71.2%), vaccine was administered to 584 (14.6%), and evidence of previous vaccination was provided by 269 (6.7%). Evidence of immunity has not been documented for 300 (7.5%). The organization administered 3,626 serological tests and provided 997 vaccines, costing ∼$132,000. Disposition by serological testing is summarized in Table 1. Conclusions: A measles preparedness strategy should include proactive assessment of employees’ immune status. It is possible to expediently assess a large number of employees using a multidisciplinary team with access to a centralized database. Consideration may be given to prioritization of high-risk departments and patient-interfacing roles to manage workload.Funding: NoneDisclosures: None


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Susanne F. Awad ◽  
Soha R. Dargham ◽  
Amine A. Toumi ◽  
Elsy M. Dumit ◽  
Katie G. El-Nahas ◽  
...  

AbstractWe developed a diabetes risk score using a novel analytical approach and tested its diagnostic performance to detect individuals at high risk of diabetes, by applying it to the Qatari population. A representative random sample of 5,000 Qataris selected at different time points was simulated using a diabetes mathematical model. Logistic regression was used to derive the score using age, sex, obesity, smoking, and physical inactivity as predictive variables. Performance diagnostics, validity, and potential yields of a diabetes testing program were evaluated. In 2020, the area under the curve (AUC) was 0.79 and sensitivity and specificity were 79.0% and 66.8%, respectively. Positive and negative predictive values (PPV and NPV) were 36.1% and 93.0%, with 42.0% of Qataris being at high diabetes risk. In 2030, projected AUC was 0.78 and sensitivity and specificity were 77.5% and 65.8%. PPV and NPV were 36.8% and 92.0%, with 43.0% of Qataris being at high diabetes risk. In 2050, AUC was 0.76 and sensitivity and specificity were 74.4% and 64.5%. PPV and NPV were 40.4% and 88.7%, with 45.0% of Qataris being at high diabetes risk. This model-based score demonstrated comparable performance to a data-derived score. The derived self-complete risk score provides an effective tool for initial diabetes screening, and for targeted lifestyle counselling and prevention programs.


Author(s):  
Nils F. Grauhan ◽  
Stefan M. Niehues ◽  
Robert A. Gaudin ◽  
Sarah Keller ◽  
Janis L. Vahldiek ◽  
...  

Abstract Objective Training a convolutional neural network (CNN) to detect the most common causes of shoulder pain on plain radiographs and to assess its potential value in serving as an assistive device to physicians. Materials and methods We used a CNN of the ResNet-50 architecture which was trained on 2700 shoulder radiographs from clinical practice of multiple institutions. All radiographs were reviewed and labeled for six findings: proximal humeral fractures, joint dislocation, periarticular calcification, osteoarthritis, osteosynthesis, and joint endoprosthesis. The trained model was then evaluated on a separate test dataset, which was previously annotated by three independent expert radiologists. Both the training and the test datasets included radiographs of highly variable image quality to reflect the clinical situation and to foster robustness of the CNN. Performance of the model was evaluated using receiver operating characteristic (ROC) curves, the thereof derived AUC as well as sensitivity and specificity. Results The developed CNN demonstrated a high accuracy with an area under the curve (AUC) of 0.871 for detecting fractures, 0.896 for joint dislocation, 0.945 for osteoarthritis, and 0.800 for periarticular calcifications. It also detected osteosynthesis and endoprosthesis with near perfect accuracy (AUC 0.998 and 1.0, respectively). Sensitivity and specificity were 0.75 and 0.86 for fractures, 0.95 and 0.65 for joint dislocation, 0.90 and 0.86 for osteoarthrosis, and 0.60 and 0.89 for calcification. Conclusion CNNs have the potential to serve as an assistive device by providing clinicians a means to prioritize worklists or providing additional safety in situations of increased workload.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
G Del Castillo ◽  
A Castrofino ◽  
F Grosso ◽  
A Barone ◽  
L Crottogini ◽  
...  

Abstract Issue COVID-19 pandemic began in Italy on February 20th, 2020. Since the beginning of the emergency Healthcare Workers' (HCWs) involvement was prominent, mainly due to direct assistance to COVID-19 patients. Therefore, we implemented a prevention policy for HCW screening through serological and RT-PCR testing. Description of the problem HCW screening for SARS-CoV-2 infection is essential for prevention and control of the pandemic. Lombardy's Healthcare authorities settled a screening process for HCWs divided into three steps: 1) body temperature assessment at the beginning and the end of work shift, if fever > 37.5 °C was present the HCW was sent back home and a nasopharyngeal swab was performed; 2) progressive recruitment for serological testing; 3) on those positive to IgG a nasopharyngeal swab was performed and tested for viral RNA by RT-PCR. Results Among 79185 HCW tested, 9589 (12%) were positive on serological IgG testing. Of the 9589 positive a nasopharyngeal swab was performed on 6884. Of these 358 (5%) tested positive and the remaining 6526 (95%) negative to RT-PCR. We calculated a Positive Predictive Value of 5.2%. The rate of positive serological tests for each Healthcare facility varied between 0% and 78%. Five percent of all facilities, belonging to Brescia, Bergamo and Cremona area, reported a positivity rate higher than 40% in HCWs. A second cluster (18% of all facilities), involving the same geographical area, reported a rate between 20% and 40%, whereas the remaining facilities (76%) of the region a rate <20%. Lessons Serological IgG testing can be, if followed by immediate nasopharyngeal swab testing, a valid screening intervention on asymptomatic HCWs especially in a high infection prevalence setting. Key messages Serological IgG testing can be, if followed by immediate nasopharyngeal swab testing, a valid screening intervention on asymptomatic HCWs. Infection prevention in HCW may benefit from a screening campaign especially in high prevalence settings.


2021 ◽  
pp. postgradmedj-2021-140176
Author(s):  
Bahar Hassanmirzaei ◽  
Zohreh Haratian ◽  
Ali Ahmadzadeh Amiri ◽  
Amir Ahmadzadeh Amiri ◽  
Navid Moghadam

Purpose of the studyPCR 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 designParticipants 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.ResultsOf 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.ConclusionOur 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.


2016 ◽  
Vol 56 (4) ◽  
pp. 230
Author(s):  
Meta Herdiana Hanindita ◽  
Riskky Vitria Prasetyo ◽  
Ninik Asmaningsih Soemyarso ◽  
I Ketut Alit Utamayasa ◽  
Paul Tahalele

Background Acute kidney injury (AKI) is still diagnosed by measuring the estimated creatinine clearance (eCCl), despite the fact that it may not change until 50% or more of kidney function has been lost. AKI after cardiac surgery is related to prolonged intensive care, decreased quality of life, and increased long term mortality. Neutrophil gelatinase-associated lipocalin (NGAL) represents an early biomarker of AKI, which may be useful for assessing AKI in cardiac patients.Objective To determine the validity of urinary and plasma NGAL as biomarkers for AKI in children after cardiac surgery.Methods Subjects were children who underwent cardiac surgery in Dr. Soetomo Hospital, Surabaya, Indonesia from August 2013 to January 2014. Serial urine and blood samples were analyzed for NGAL before surgery, as well as at 2h, 4h, 12h, and 24h after surgery. The AKI was established based on pRIFLE criteria. Estimated creatinine clearance (eCCl) was calculated from the estimated glomerular filtration rate (eGFR), according to age by the traditional Schwartz formula. Serum creatinine was assayed by the Jaffe method before surgery, as well as at 12h, 24h, 48h, and 72h after surgery.Results Of 20 subjects, 5 developed AKI. Urinary and plasma NGAL increased markedly at 2h postoperatively, as compared to eGFR which showed a rise at 12-48 h after cardiac surgery. Analysis of 2h post-operative urinary NGAL at a cut off value of 11.270ng/mL yielded an area under the curve (AUC) of 1.00 (95%CI 2.63 to 12.13), with sensitivity and specificity of 100% each for AKI. In addition, 2h post-operative plasma NGAL at a cut off value of 8.385 ng/mL yielded an AUC of 1.00 (95%CI 3.71 to 12.15) with sensitivity and specificity of 100% each for AKI.Conclusion Urinary and plasma NGAL are valid as early biomarkers for AKI in children after cardiac surgery.


BJGP Open ◽  
2022 ◽  
pp. BJGPO.2021.0141
Author(s):  
Anna Ruiz-Comellas ◽  
Pere Roura Poch ◽  
Glòria Sauch Valmaña ◽  
Víctor Guadalupe-Fernández ◽  
Jacobo Mendioroz Peña ◽  
...  

Backgroundamong the manifestations of COVID-19 are Taste and Smell Disorders (TSDs).AimThe aim of the study is to evaluate the sensitivity and specificity of TSDs and other associated symptoms to estimate predictive values for determining SARS-CoV-2 infection.Design and settingRetrospective observational study.Methodsa study of the sensitivity and specificity of TSDs has been carried out using the Polymerase Chain Reaction (PCR) test for the diagnosis of SARS-CoV-2 as the Gold Standard value. Logistic regressions adjusted for age and sex were performed to identify additional symptoms that might be associated with COVID-19.Resultsthe results are based on 226 healthcare workers with clinical symptoms suggestive of COVID-19, 116 with positive PCR and 111 with negative PCR. TSDs had an OR of 12.43 (CI 0.95 6.33–26.19), sensitivity 60.34% and specificity 89.09%. In the logistic regression model, the association of TSD, fever or low-grade fever, shivering, dyspnoea, arthralgia and myalgia obtained an area under the curve of 85.7% (CI 0.95: 80.7 % - 90.7 %), sensitivity 82.8 %, specificity 80% and positive predictive values 81.4% and negative 81.5%.ConclusionsTSDs are a strong predictor of COVID-19. The association of TSD, fever, low-grade fever or shivering, dyspnoea, arthralgia and myalgia correctly predicts 85.7% of the results of the COVID-19 test.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4914-4914
Author(s):  
Ikhwan Rinaldi ◽  
Arif Mansjoer

Background There are many factors associated with early mortality after CABG, including postoperative thrombocytopenia (Kertai, 2016). Many factors during CABG surgery, such as administration of heparin or cardio pulmonary bypass during surgery are related to thrombocyte count reduction (Hamid, Akhtar, Naqvi, & Ahsan, 2017; Arepally, 2017). However, it is possible for a post-CABG patient to suffer a significant thrombocyte reduction without reaching the thrombocytopenic state (thrombocyte count <150000/µL). Up to this time, there is still lack of study about association between thrombocyte reduction after surgery and 30-day mortality in patients undergo CABG. This study aim to determine cut off point for postoperative thrombocyte reduction as a predictor of 30-day mortality after CABG surgery. Method This is a retrospective cohort study using medical record of 263 adult patients who underwent CABG surgery in dr. Ciptomangunkusumo National Hospital on 2012-2015. Thrombocyte reduction was determined by substracting preoperative thrombocyte count from postoperative thrombocyte count. Receiver operating curve (ROC) analysis between percentage of thrombocyte reduction and 30-day mortality after surgery was done to obtain the sensitivity and specificity value of a particular degree of thrombocyte reduction. Cut off point was obtained from intersection between sensitivity and specificity value. Result Thirty-day mortality rate after CABG surgery in this study was 11.9%. Cut off point obtained from ROC analysis was 30% with area under the curve (AUC) 0.671. The sensitivity of this cut off point to predict early mortality after CABG surgery was 64.5%, while the specificity was 64.7% Conclusion Thrombocyte reduction more than or equal to 30% can be used as a predictor of 30-day mortality after CABG surgery. Figure Disclosures No relevant conflicts of interest to declare.


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