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COVID-19 Antibody Tests and Their Limitations.

ABSTRACT: COVID-19, caused by the SARS-CoV-2 virus, has developed into a global health crisis, causing over 2 million deaths and changing people's daily life the world over. Current main-stream diagnostic methods in the laboratory include nucleic acid PCR tests and direct viral antigen tests for detecting active infections, and indirect human antibody tests specific to SARS-CoV-2 to detect prior exposure. In this Perspective, we briefly describe the PCR and antigen tests and then focus mainly on existing antibody tests and their limitations including inaccuracies and possible causes of unreliability. False negatives in antibody immunoassays can arise from assay formats, selection of viral antigens and antibody types, diagnostic testing windows, individual variance, and fluctuation in antibody levels. Reasons for false positives in antibody immunoassays mainly involve antibody cross-reactivity from other viruses, as well as autoimmune disease. The spectrum bias has an effect on both the false negatives and false positives. For assay developers, not only improvement of assay formats but also selection of viral antigens and isotopes of human antibodies need to be carefully considered to improve sensitivity and specificity. For clinicians, the factors influencing the accuracy of assays must be kept in mind to test patients using currently imperfect but available tests with smart tactics and realistic interpretation of the test results.

SUBMITTER: Liu G

PROVIDER: S-EPMC7885805 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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COVID-19 Antibody Tests and Their Limitations.

Liu Guoqiang G Rusling James F JF

ACS sensors 20210205 3

COVID-19, caused by the SARS-CoV-2 virus, has developed into a global health crisis, causing over 2 million deaths and changing people's daily life the world over. Current main-stream diagnostic methods in the laboratory include nucleic acid PCR tests and direct viral antigen tests for detecting active infections, and indirect human antibody tests specific to SARS-CoV-2 to detect prior exposure. In this Perspective, we briefly describe the PCR and antigen tests and then focus mainly on existing ...[more]

PMID: 33544999

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Project description:BackgroundMore than 200 countries are experiencing the coronavirus disease (COVID-19) pandemic. COVID-19 vaccination strategies have been implemented worldwide, and repeat COVID-19 outbreaks have been seen. The purpose of this study was to investigate the impact of COVID-19 vaccination on the reduction of perceived anxiety and the association between public anxiety and antibody testing intention during the COVID-19 pandemic.MethodsChinese adults aged 18 and over were surveyed using an anonymous online questionnaire in April and May 2021. The questionnaire collected sociodemographic characteristics, vaccination characteristics, perceived anxiety due to COVID-19, and attitudes toward future antibody testing after COVID-19 vaccination. Perceived anxiety was assessed on a visual analog scale (VAS). Multivariate logistic regression analysis was used to determine the factors influencing future antibody detection.ResultsA total of 3,233 people were investigated, 3,209 valid questionnaires were collected, and the response rate was 99.3%. Of the 3,209 respondents, 2,047 were vaccinated, and 1,162 were unvaccinated. There was a significant difference in anxiety levels between vaccinated and unvaccinated respondents (24.9±25.4 vs. 50.0±33.1, respectively). With the local spread of COVID-19 in mainland China, the public anxiety VAS scores increased by 15.4±25.6 (SMD=120%) and 33.8±31.7 (SMD=49%) among vaccinated and unvaccinated respondents, respectively. Of the 2,047 respondents who were vaccinated, 1,626 (79.4%) thought they would accept antibody testing. Those who displayed more anxiety about acquiring COVID-19 disease were more likely to accept COVID-19 antibody testing. If the antibody test results showed protective antibodies, 1,190 (58.1%) were more likely to arrange travel plans in China, while 526 (25.7%) thought they would feel safer traveling abroad.ConclusionCOVID-19 vaccination strategies help reduce public anxiety. However, public anxiety may be elevated as the local transmission of COVID-19 occurs in mainland China, which is usually caused now by imported cases. Those who display more anxiety choose to have antibody testing. Improving the accessibility of COVID-19 antibody tests can help ease public anxiety and enhance the confidence of some people to participate in social activities.

Project description:Background & aimsRecent data on the coronavirus disease 2019 (COVID-19) outbreak caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has begun to shine light on the impact of the disease on the liver. But no studies to date have systematically described liver test abnormalities in patients with COVID-19. We evaluated the clinical characteristics of COVID-19 in patients with abnormal liver test results.MethodsClinical records and laboratory results were obtained from 417 patients with laboratory-confirmed COVID-19 who were admitted to the only referral hospital in Shenzhen, China from January 11 to February 21, 2020 and followed up to March 7, 2020. Information on clinical features of patients with abnormal liver tests were collected for analysis.ResultsOf 417 patients with COVID-19, 318 (76.3%) had abnormal liver test results and 90 (21.5%) had liver injury during hospitalization. The presence of abnormal liver tests became more pronounced during hospitalization within 2 weeks, with 49 (23.4%), 31 (14.8%), 24 (11.5%) and 51 (24.4%) patients having alanine aminotransferase, aspartate aminotransferase, total bilirubin and gamma-glutamyl transferase levels elevated to more than 3× the upper limit of normal, respectively. Patients with abnormal liver tests of hepatocellular type or mixed type at admission had higher odds of progressing to severe disease (odds ratios [ORs] 2.73; 95% CI 1.19-6.3, and 4.44, 95% CI 1.93-10.23, respectively). The use of lopinavir/ritonavir was also found to lead to increased odds of liver injury (OR from 4.44 to 5.03, both p <0.01).ConclusionPatients with abnormal liver tests were at higher risk of progressing to severe disease. The detrimental effects on liver injury mainly related to certain medications used during hospitalization, which should be monitored and evaluated frequently.Lay summaryData on liver tests in patients with COVID-19 are scarce. We observed a high prevalence of liver test abnormalities and liver injury in 417 patients with COVID-19 admitted to our referral center, and the prevalence increased substantially during hospitalization. The presence of abnormal liver tests and liver injury were associated with the progression to severe pneumonia. The detrimental effects on liver injury were related to certain medications used during hospitalization, which warrants frequent monitoring and evaluation for these patients.

Project description:BackgroundTwo years since the onset of the COVID-19 pandemic no predictive algorithm has been generally adopted for clinical management and in most algorithms the contribution of laboratory variables is limited.ObjectivesTo measure the predictive performance of currently used clinical laboratory tests alone or combined with clinical variables and explore the predictive power of immunological tests adequate for clinical laboratories. Methods: Data from 2,600 COVID-19 patients of the first wave of the pandemic in the Barcelona area (exploratory cohort of 1,579, validation cohorts of 598 and 423 patients) including clinical parameters and laboratory tests were retrospectively collected. 28-day survival and maximal severity were the main outcomes considered in the multiparametric classical and machine learning statistical analysis. A pilot study was conducted in two subgroups (n=74 and n=41) measuring 17 cytokines and 27 lymphocyte phenotypes respectively.Findings1) Despite a strong association of clinical and laboratory variables with the outcomes in classical pairwise analysis, the contribution of laboratory tests to the combined prediction power was limited by redundancy. Laboratory variables reflected only two types of processes: inflammation and organ damage but none reflected the immune response, one major determinant of prognosis. 2) Eight of the thirty variables: age, comorbidity index, oxygen saturation to fraction of inspired oxygen ratio, neutrophil-lymphocyte ratio, C-reactive protein, aspartate aminotransferase/alanine aminotransferase ratio, fibrinogen, and glomerular filtration rate captured most of the combined statistical predictive power. 3) The interpretation of clinical and laboratory variables was moderately improved by grouping them in two categories i.e., inflammation related biomarkers and organ damage related biomarkers; Age and organ damage-related biomarker tests were the best predictors of survival, and inflammatory-related ones were the best predictors of severity. 4) The pilot study identified immunological tests (CXCL10, IL-6, IL-1RA and CCL2), that performed better than most currently used laboratory tests.ConclusionsLaboratory tests for clinical management of COVID 19 patients are valuable but limited predictors due to redundancy; this limitation could be overcome by adding immunological tests with independent predictive power. Understanding the limitations of tests in use would improve their interpretation and simplify clinical management but a systematic search for better immunological biomarkers is urgent and feasible.

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COVID-19 Antibody Tests and Their Limitations.

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COVID-19 Antibody Tests and Their Limitations.

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