Review of Clinical Performance of Serology Based Commercial Diagnostic Assays for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies

2022 ◽  
Author(s):  
Poonam S. Deshpande ◽  
Irene E. Abraham ◽  
Anjali Pitamberwale ◽  
Radhika H. Dhote
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Clinical Performance ◽  
Diagnostic Assays

scholarly journals Comparison of Five Serological Assays for the Detection of SARS-CoV-2 Antibodies

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 78
Author(s):  
Anja Dörschug ◽  
Julian Schwanbeck ◽  
Andreas Hahn ◽  
Anke Hillebrecht ◽  
Sabine Blaschke ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Blood Donor ◽  
Immunoglobulin G ◽  
The Other ◽  
Specific Antibodies ◽  
Diagnostic Assays ◽  
Immunoglobulin Class ◽  
Corona Virus ◽  
Immunoglobulin Subclass

Serological assays can contribute to the estimation of population proportions with previous immunologically relevant contact with the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) virus. In this study, we compared five commercially available diagnostic assays for the diagnostic identification of SARS-CoV-2-specific antibodies. Depending on the assessed immunoglobulin subclass, recorded sensitivity ranged from 17.0% to 81.9% with best results for immunoglobulin G. Specificity with blood donor sera ranged from 90.2% to 100%, with sera from EBV patients it ranged from 84.3% to 100%. Agreement from fair to nearly perfect was recorded depending on the immunoglobulin class between the assays, the with best results being found for immunoglobulin G. Only for this immunoglobulin class was the association between later sample acquisition times (about three weeks after first positive PCR results) and positive serological results in COVID-19 patients confirmed. In conclusion, acceptable and comparable reliability for the assessed immunoglobulin G-specific assays could be shown, while there is still room for improvement regarding the reliability of the assays targeting the other immunoglobulin classes.

scholarly journals Analytical and Clinical Comparison of Three Nucleic Acid Amplification Tests for SARS-CoV-2 Detection

2020 ◽  
Vol 58 (9) ◽  
Author(s):  
Elizabeth Smith ◽  
Wei Zhen ◽  
Ryhana Manji ◽  
Deborah Schron ◽  
Scott Duong ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Severe Acute Respiratory Syndrome ◽  
Drug Administration ◽  
Clinical Performance ◽  
Absolute Quantification ◽  
Nucleic Acid Amplification ◽  
Clinical Correlation ◽  
Molecular Assays ◽  
Percent Agreement ◽  
Rna Transcript

ABSTRACT Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first identified in December 2019 and has quickly become a worldwide pandemic. In response, many diagnostic manufacturers have developed molecular assays for SARS-CoV-2 under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) pathway. This study compared three of these assays, the Hologic Panther Fusion SARS-CoV-2 assay (Fusion), the Hologic Aptima SARS-CoV-2 assay (Aptima), and the BioFire Defense COVID-19 test (BioFire), to determine analytical and clinical performance as well as workflow. All three assays showed similar limits of detection (LODs) using inactivated virus, with 100% detection, ranging from 500 to 1,000 genome equivalents/ml, whereas use of a quantified RNA transcript standard showed the same trend but had values ranging from 62.5 to 125 copies/ml, confirming variability in absolute quantification of reference standards. The clinical correlation found that the Fusion and BioFire assays had a positive percent agreement (PPA) of 98.7%, followed by the Aptima assay at 94.7%, compared to the consensus result. All three assays exhibited 100% negative percent agreement (NPA). Analysis of discordant results revealed that all four samples missed by the Aptima assay had cycle threshold (Ct) values of >37 by the Fusion assay. In conclusion, while all three assays showed similar relative LODs, we showed differences in absolute LODs depending on which standard was employed. In addition, the Fusion and BioFire assays showed better clinical performance, while the Aptima assay showed a modest decrease in overall PPA. These findings should be kept in mind when making platform testing decisions.

scholarly journals Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2

2020 ◽  
Vol 58 (8) ◽  
Author(s):  
Wei Zhen ◽  
Elizabeth Smith ◽  
Ryhana Manji ◽  
Deborah Schron ◽  
Gregory J. Berry
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Drug Administration ◽  
Clinical Evaluation ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Molecular Diagnostic ◽  
Analytical Sensitivity ◽  
Reference Standard ◽  
Slight Improvement ◽  
Percent Agreement

ABSTRACT Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW COVID-19 [ID NOW], and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (∼17 min) compared to Xpert Xpress (∼46 min) and ePlex (∼1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms.

scholarly journals Development, Characterization, and Application of Monoclonal Antibodies against Severe Acute Respiratory Syndrome Coronavirus Nucleocapsid Protein

2010 ◽  
Vol 17 (12) ◽  
pp. 2033-2036 ◽  
Author(s):  
Dipankar Das ◽  
Sriram Kammila ◽  
Mavanur R. Suresh
Keyword(s):  
Monoclonal Antibodies ◽  
Severe Acute Respiratory Syndrome ◽  
Western Blotting ◽  
Nucleocapsid Protein ◽  
Epitope Mapping ◽  
High Specificity ◽  
Diagnostic Assays ◽  
Hybridoma Technology ◽  
Recombinant Nucleocapsid Protein

ABSTRACT Five monoclonal antibodies (MAbs) against recombinant nucleocapsid protein (NP) of severe acute respiratory syndrome (SARS)-causing coronavirus (CoV) were developed by hybridoma technology. Epitope mapping by Western blotting showed that these anti-SARS-CoV NP MAbs bind to distinct domains of NP. These anti-SARS-CoV NP MAbs, with their high specificity, are potentially ideal candidates for developing early and sensitive diagnostic assays for SARS-CoV.

scholarly journals Triplex Real Time RT-PCR for N1, N2 and RP probes from CDC EUA SARS-CoV-2 diagnosis kit

2020 ◽  
Author(s):  
Byron Freire-Paspuel ◽  
Patricio Vega-Mariño ◽  
Alberto Velez ◽  
Marilyn Cruz ◽  
Miguel Angel Garcia-Bereguiain
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Real Time ◽  
Reverse Transcription ◽  
Clinical Performance ◽  
Rt Pcr ◽  
Reverse Transcription Pcr ◽  
Speed Up

AbstractCDC protocol for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) include 3 targets for detection (N1, N2 and RP) labelled with FAM so 3 PCR reactions are required per sample. We developed a triplex, real-time reverse transcription PCR for SARS-CoV-2 that maintained clinical performance compared with CDC singleplex assay. This protocol could speed up detection and save reagents during current SARS-CoV-2 testing supplies shortage.

scholarly journals Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2

2020 ◽  
Vol 154 (2) ◽  
pp. 201-207 ◽  
Author(s):  
Kendall Cradic ◽  
Marie Lockhart ◽  
Patrick Ozbolt ◽  
Lisa Fatica ◽  
Lorie Landon ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Nasopharyngeal Swab ◽  
Separate Analysis ◽  
Assay Sensitivity ◽  
Limits Of Detection ◽  
Diagnostic Assays ◽  
Percent Agreement ◽  
In Vitro Diagnostic ◽  
Roche Cobas

Abstract Objectives To evaluate the clinical performance of 3 molecular assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods We used 184 nasopharyngeal swab specimens to compare Abbott ID NOW COVID-19 (Abbott ID NOW), DiaSorin Molecular Simplexa COVID-19 Direct (DiaSorin Simplexa), and Roche cobas 6800 SARS-CoV-2 (Roche cobas) assays. In a separate analysis, 3 specimens (nasopharyngeal, oropharyngeal, and nasal) were collected from 182 unique patients presenting to the emergency department with suspicion of coronavirus disease 2019 and were tested utilizing Abbott ID NOW. To further characterize each assay, relative limits of detection were evaluated utilizing positive nasopharyngeal patient samples. Results The positive percent agreement was 91% (95% confidence interval [CI], 0.76-0.97) for Abbott ID NOW and 100% (95% CI, 0.90-1.00) for DiaSorin Simplexa and Roche cobas. The negative percent agreement was 100% (95% CI, 0.98-1.00) for all 3 assays. All swab types tested with the Abbott assay produced concordant results. Polymerase chain reaction assays had approximately 10 to 100 times lower limits of detection than Abbott ID NOW. Conclusions Based on these evaluations, a multiplatform testing approach is proposed, depending on patient population and assay sensitivity, to address testing needs during a public health emergency.

scholarly journals Risk of Ruling out Severe Acute Respiratory Syndrome by Ruling in another Diagnosis: Variable Incidence of Atypical Bacteria Coinfection Based on Diagnostic Assays

2006 ◽  
Vol 13 (1) ◽  
pp. 17-22 ◽  
Author(s):  
George Zahariadis ◽  
Ted A Gooley ◽  
Phyllis Ryall ◽  
Christine Hutchinson ◽  
Mary I Latchford ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Community Hospital ◽  
Present Report ◽  
Significant Risk ◽  
Chlamydophila Pneumoniae ◽  
Clinical Suspicion ◽  
Serological Evidence ◽  
Positive Serology ◽  
Diagnostic Assays ◽  
Atypical Pathogens

BACKGROUND: Severe acute respiratory syndrome (SARS) caused the first epidemic of the 21st century and continues to threaten the global community.OBJECTIVE: To assess the incidence of coinfection in patients confirmed to have SARS-associated coronavirus (SARS-CoV) infection, and thus, to determine the risk of ruling out SARS by ruling in another diagnosis. METHODS: The present report is a retrospective study evaluating the incidence and impact of laboratory-confirmed SARS-CoV and other pulmonary pathogens in 117 patients. These patients were evaluated in a Toronto, Ontario, community hospital identified as the epicentre for the second SARS outbreak.RESULTS: Coinfection with other pulmonary pathogens occured in patients with SARS. Seventy-three per cent of the patient population evaluated had laboratory-confirmed SARS-CoV infection. Serology showing acute or recentChlamydophila pneumoniaeorMycoplasma pneumoniaeinfection revealed an incidence of 30% and 9%, respectively, in those with SARS. These rates are similar to previously published studies on coinfection in pneumonia. All nucleic acid diagnostic assays were negative forC pneumoniaeandM pneumoniaein respiratory samples from patients with SARS having serological evidence for these atypical pathogens.CONCLUSIONS: Diagnostic assays for well-recognized pulmonary pathogens have limitations, and ruling out SARS-CoV by ruling in another pulmonary pathogen carries significant risk. Despite positive serology for atypical pathogens, in a setting where clinical suspicion for SARS is high, specific tests for SARS should be performed to confirm or exclude a diagnosis.

scholarly journals Accurate SARS-CoV-2 seroprevalence surveys require robust multi-antigen assays

2020 ◽  
Author(s):  
Christos Fotis ◽  
Nikolaos Meimetis ◽  
Nikos Tsolakos ◽  
Marianna Politou ◽  
Karolina Akinosoglou ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Blood Donors ◽  
Clinical Performance ◽  
Antibody Responses ◽  
Receptor Binding Domain ◽  
Accurate Identification ◽  
Serological Tests ◽  
Partial Agreement ◽  
Multiplex Immunoassay ◽  
Single Antigen

AbstractThere is a plethora of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) serological tests based either on nucleocapsid phosphoprotein (N), S1-subunit of spike glycoprotein (S1) or receptor binding domain (RBD). Although these single-antigen based tests demonstrate high clinical performance, there is growing evidence regarding their limitations in epidemiological serosurveys. To address this, we developed a Luminex-based multiplex immunoassay that detects total antibodies (IgG/IgM/IgA) against the N, S1 and RBD antigens and used it to compare antibody responses in 1,225 blood donors across Greece. Seroprevalence based on single-antigen readouts was strongly influenced by both the antigen type and cut-off value and ranged widely [0.8% (95% CI, 0.4-1.5%)-7.5% (95% CI, 6.0-8.9%)]. A multi-antigen approach requiring partial agreement between RBD and N or S1 readouts (RBD&N|S1 rule) was less affected by cut-off selection, resulting in robust seroprevalence estimation [0.6% (95% CI, 0.3-1.1%)-1.2% (95% CI, 0.7-2.0%)] and accurate identification of seroconverted individuals.

scholarly journals A Highly Sensitive and Specific SARS-CoV-2 Spike- and Nucleoprotein-Based Fluorescent Multiplex Immunoassay (FMIA) to Measure IgG, IgA, and IgM Class Antibodies

2021 ◽  
Author(s):  
Anna Solastie ◽  
Camilla Virta ◽  
Anu Haveri ◽  
Nina Ekström ◽  
Anu Kantele ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Clinical Performance ◽  
Neutralizing Antibody ◽  
Serological Assay ◽  
Multiplex Immunoassay ◽  
Reliable Estimation ◽  
Highly Sensitive ◽  
Antibody Titers

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays with excellent clinical performance are essential for reliable estimation of the persistence of immunity after infection or vaccination. In this paper we present a thoroughly validated SARS-CoV-2 serological assay with excellent clinical performance and good comparability to neutralizing antibody titers.

scholarly journals Profiles of Antibody Responses against Severe Acute Respiratory Syndrome Coronavirus Recombinant Proteins and Their Potential Use as Diagnostic Markers

2004 ◽  
Vol 11 (2) ◽  
pp. 362-371 ◽  
Author(s):  
Yee-Joo Tan ◽  
Phuay-Yee Goh ◽  
Burtram C. Fielding ◽  
Shuo Shen ◽  
Chih-Fong Chou ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Mammalian Cells ◽  
Viral Proteins ◽  
Bacterial Cells ◽  
Diagnostic Assays ◽  
Healthy Donors ◽  
The Difference ◽  
Acute Nature ◽  
Potential Use

ABSTRACT A new coronavirus (severe acute respiratory syndrome coronavirus [SARS-CoV]) has been identified to be the etiological agent of severe acute respiratory syndrome. Given the highly contagious and acute nature of the disease, there is an urgent need for the development of diagnostic assays that can detect SARS-CoV infection. For determination of which of the viral proteins encoded by the SARS-CoV genome may be exploited as diagnostic antigens for serological assays, the viral proteins were expressed individually in mammalian and/or bacterial cells and tested for reactivity with sera from SARS-CoV-infected patients by Western blot analysis. A total of 81 sera, including 67 from convalescent patients and seven pairs from two time points of infection, were analyzed, and all showed immunoreactivity towards the nucleocapsid protein (N). Sera from some of the patients also showed immunoreactivity to U274 (59 of 81 [73%]), a protein that is unique to SARS-CoV. In addition, all of the convalescent-phase sera showed immunoreactivity to the spike (S) protein when analyzed by an immunofluorescence method utilizing mammalian cells stably expressing S. However, samples from the acute phase (2 to 9 days after the onset of illness) did not react with S, suggesting that antibodies to N may appear earlier than antibodies to S. Alternatively, this could be due to the difference in the sensitivities of the two methods. The immunoreactivities to these recombinant viral proteins are highly specific, as sera from 100 healthy donors did not react with any of them. These results suggest that recombinant N, S, and U274 proteins may be used as antigens for the development of serological assays for SARS-CoV.

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