Diagnosis of SARS-CoV-2 infection and COVID-19: accuracy of signs and symptoms; molecular, antigen, and antibody tests; and routine laboratory markers (original) (raw)
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BMC Infectious Diseases, 2021
Background The SARS-CoV-2 pandemic continues to be a priority health problem; According to the World Health Organization data from October 13, 2020, 37,704,153 confirmed COVID-19 cases have been reported, including 1,079,029 deaths, since the outbreak. The identification of potential symptoms has been reported to be a useful tool for clinical decision-making in emergency departments to avoid overload and improve the quality of care. The aim of this study was to evaluate the performances of symptoms as a diagnostic tool for SARS -CoV-2 infection. Methods An observational, cross-sectional, prospective and analytical study was carried out, during the period of time from April 14 to July 21, 2020. Data (demographic variables, medical history, respiratory and non-respiratory symptoms) were collected by emergency physicians. The diagnosis of COVID-19 was made using SARS-CoV-2 RT-PCR. The diagnostic accuracy of these characteristics for COVID-19 was evaluated by calculating the positive an...
Evaluation of Diagnostic Modalities for SARS-Cov-2: A Review Study
International Journal of Epidemiologic Research
Background and aims: In late December 2019, a cluster of progressive pneumonia-like respiratory syndromes broke out in Wuhan, China. As the number of cases continued to rise, the 2019 coronavirus disease (COVID-19) has been declared a global public health emergency. The causative agent, i.e., SARS-CoV-2, is a highly contagious strain, which has resulted in the rapid worldwide outbreak of COVID-19. COVID-19 is an overwhelmingly transmissible disease that requires early and accurate diagnosis for proper and timely treatment of suspected cases. Materials and Methods: In order to accessthe scientific documentation and evidence related to the subject published during 2019 to 2021, English keywords including "COVID-19", "SARS-CoV-2", "Diagnosis", "Immunoglobulin G (IgG)", "Immunoglobulin M (IgM)", and ‘Polymerase Chain Reaction (PCR)" were searched in Medline, PubMed, and Google Scholar databases and Persian versions of these keywords...
Utility of Available Methods for Diagnosing SARS-CoV-2 in Clinical Samples
Archives of Pediatric Infectious Diseases
The laboratory diagnosis of SARS-CoV-2 should be done to confirm coronavirus disease 2019 (COVID-19) in suspected patients. Although several diagnostic methods have been developed in this regard, their accuracy for clinical application is not very clear yet. To compare the diagnostic value of laboratory tests for the detection of COVID-19 infection, this study provides an upcoming review of the newly developed detection methods. Sensitivity, specificity, detection limit, and turnaround time of these methods are compared and challenges for their application in clinical settings are reviewed. PubMed and Google Scholar web sites were used for the systematic search until April 9, 2020 to identify the published studies based on the following keywords: "Detection", "Coronavirus 2019", "SARS-CoV-2", and "Sensitivity". Out of 526 results, a total of 54 articles, including 46 studies on detection methods, were considered eligible for the review. The results showed that most of the proposed tests focused on molecular methods, while immunological and point-of-care tests were investigated in 13 studies. There were also a few commercial automated methods for the qualitative detection of SARS-CoV-2 in clinical samples, most of which are not examined in the current review, as no data about their sensitivity and specificity were presented. Although the assessment of publication biases showed that 64% sensitivity and nearly 100% specificity for RT-PCR are close to reality, most of the related reports for serological methods are not valid and further studies are needed to confirm their utility in clinical settings. Moreover, the RT-PCR test alone cannot act as a gold standard because of bias in measurements. Therefore, antibody tests and other proposed methods could be used as supplementary diagnostic tests to improve RT-PCR accuracy. Although clinical findings are invaluable, in many cases, they can provide more valuable supportive data than serological tests.
2021
Objective: To compare the accuracy parameters of seven commercial molecular in vitro diagnostic tests for detecting SARS-CoV-2. Methods: Studies evaluating the accuracy of seven different commercial molecular diagnostic tests for detecting SARS-CoV-2 (Cepheid Xpert Xpress SARS-CoV-2 test, Simplexa COVID-19 Direct, Abbott ID NOW COVID-19, Cobas SARS-CoV-2, Allplex 2019-nCoV Assay, Panther Fusion SARS-CoV-2, and BioFire COVID-19 Test) were included. The quality of the included studies was assessed using the QUADAS-2 checklist. A bivariate random-effects regression model was implemented.. Results: Meta-analysis of 12 included studies showed that the performances of commercial COVID-19 molecular in vitro diagnostic tests were high, with a summary sensitivity of 95.9% (95% CI 93.9-97.2%, I 2 = 60.22%) and specificity of 97.2% (95% CI 95.5-98.3%, I 2 = 56.66%). Among seven evaluated tests, the Abbott ID NOW COVID-19 and Simplexa COVID-19 Direct displayed lower sensitivity (91.6%, 95% CI 80.5-96.6% and 92%, 95% CI 86.2-95.5, respectively). Conclusion: All evaluated tests showed good accuracy. However, the slightly lower sensitivity observed in the Abbott ID Now COVID-19 and Simplexa COVID-19 Direct should be considered when deciding on a test platform. Moreover, the diagnostic accuracy of COVID-19 commercial diagnostic tests should be weighed against their ease of use and speed.
Emerging Infectious Diseases, 2021
the CDC COVID-19 Response Team 1 We evaluated the performance of self-collected anterior nasal swab (ANS) and saliva samples compared with healthcare worker-collected nasopharyngeal swab specimens used to test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We used the same PCR diagnostic panel to test all self-collected and healthcare worker-collected samples from participants at a public hospital in Atlanta, Georgia, USA. Among 1,076 participants, 51.9% were men, 57.1% were >50 years of age, 81.2% were Black (non-Hispanic), and 74.9% reported >1 chronic medical condition. In total, 8.0% tested positive for SARS-CoV-2. Compared with nasopharyngeal swab samples, ANS samples had a sensitivity of 59% and saliva samples a sensitivity of 68%. Among participants tested 3-7 days after symptom onset, ANS samples had a sensitivity of 80% and saliva samples a sensitivity of 85%. Sensitivity varied by specimen type and patient characteristics. These fi ndings can help physicians interpret PCR results for SARS-CoV-2. 1 Members are listed at the end of this article.
Journal of Infection, 2021
Objectives: We aimed to evaluate the accuracy of the Panbio TM Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard. Methods: The study was conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio TM rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group. Findings: A total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load. ✩ COVID-19 Primary Care Research Group members (alphabetical order) Layla Aoukhiyad-pharmacist,
Interpretation of Diagnostic Tests for COVID-19 (SARS-COV-2)
BioMedica, 2020
The knowledge regarding diagnostic testing for SARS COV-2 is still at hit-and-trial phases, all over the world. Evolving day by day through ongoing research and extensive trials, use for SARS-COV-2 infectionsReverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and IgM/ IgG serology by Enzyme Linked Immunosorbent Assay (ELISA) or Electro-Chemiluminescent Immunoassay remain the main stay of diagnosis. However, the time course for the PCR positivity and seroconversion seem to vary in children and adults both, which also includes a huge population of asymptomatic individuals who are potentially labelled negative hence posing a great threat to the surrounding community.
The Journal of Applied Laboratory Medicine, 2021
Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays have emerged as a response to the global pandemic, warranting studies evaluating their clinical performance. This study investigated 7 commercially available SARS-CoV-2 serological assays in samples from noninfected individuals and hospitalized patients. Methods SARS-CoV-2 qualitative serological assays by Abbott (IgG), Beckman (IgG), DiaSorin (IgG), EUROIMMUN (IgG and IgA), Roche and Bio-Rad (Total) were evaluated using specimens collected pre-December 2019 (n = 393), from nucleic acid amplification testing (NAAT) negative patients (n = 40), and from 53 patients with COVID-19 by NAAT collected 3–21 days post-onset of symptoms (POS) (N = 83). Negative agreement (NA), positive agreement (PA), and positive and negative predictive values (PPV and NPV) at prevalences of 5% and 10% were calculated. Results The overall %NA; 95% CI in the negative samples were: Roche 99.8%; 99.3–100.2, Beckman 99.8%;...