Pooling of Samples for SARS-CoV-2 Detection Using a Rapid Antigen Test

Salcedo, Nol; Harmon, Alexander; Herrera, Bobby Brooke

doi:10.3389/fitd.2021.707865

Cited by 7 publications

(9 citation statements)

References 18 publications

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“…Our candidate SARS-CoV-2 N rapid antigen test composed of mAb 1 conjugated to gold nanoparticles and mAb 453 absorbed to the nitrocellulose membrane performed with the lowest LoD (0.76 ng/mL) across all other mAb pairs analyzed ( Fig 2B ). We further tested the LoD of this rapid antigen test using previously quantified nasal swab specimen dilutions in which the viral loads (SARS-CoV-2 counts/ml) and concentrations of SARS-CoV-2 N had been previously characterized [ 24 ]. Using these specimens, the LoD was 9.53E5 SARS-CoV-2 counts/ml and 1.8 ng/ml (standard deviation: 0.021) of SARS-CoV-2 N protein ( Fig 2C ).…”

Section: Resultsmentioning

confidence: 99%

Monoclonal antibody pairs against SARS-CoV-2 for rapid antigen test development

Salcedo¹,

Reddy

Gómez³

et al. 2022

PLoS Negl Trop Dis

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Background The focus on laboratory-based diagnosis of coronavirus disease 2019 (COVID-19) warrants alternative public health tools such as rapid antigen tests. While there are a number of commercially available antigen tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), all cross-react with the genetically similar SARS-CoV-1 or require an instrument for results interpretation. Methodology/Principal findings We developed and validated rapid antigen tests that use pairs of murine-derived monoclonal antibodies (mAbs), along with gold nanoparticles, to detect SARS-CoV-2 with or without cross-reaction to SARS-CoV-1 and other coronaviruses. In this development, we demonstrate a robust antibody screening methodology for the selection of mAb pairs that can recognize SARS-CoV-2 spike (S) and nucleocapsid (N) proteins. Linear epitope mapping of the mAbs helped elucidate SARS-CoV-2 S and N interactions in lateral flow chromatography. A candidate rapid antigen test for SARS-CoV-2 N was validated using nasal swab specimens that were confirmed positive or negative by quantitative reverse-transcription polymerase chain reaction (RT-PCR). Test results were image-captured using a mobile phone and normalized signal pixel intensities were calculated; signal intensities were inversely correlated to RT-PCR cycle threshold (Ct) value. Conclusion/Significance Overall, our results suggest that the rapid antigen test is optimized to detect SARS-CoV-2 N during the acute phase of COVID-19. The rapid antigen tests developed in this study are alternative tools for wide scale public health surveillance of COVID-19.

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Section: Resultsmentioning

confidence: 99%

Monoclonal antibody pairs against SARS-CoV-2 for rapid antigen test development

Salcedo¹,

Reddy

Gómez³

et al. 2022

PLoS Negl Trop Dis

Self Cite

View full text Add to dashboard Cite

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“…Dilution specimens were de-identified, coded, and then aliquoted and frozen at −80 °C. Aliquots were thawed and characterized by qPCR as previously described [ 17 ]. The primary studies under which the samples were collected received ethical clearance from the PATH Institutional Review Board (IRB) (approval number 0004244).…”

Section: Methodsmentioning

confidence: 99%

“…For the dilution specimens with lower than 5000 RNA copies, known quantities of RNA (ATCC, Manassas, VA, USA) were spiked into nasal eluates negative for SARS-CoV-2. Dilution specimens were de-identified, coded, and then aliquoted and frozen at −80 • C. Aliquots were thawed and characterized by qPCR as previously described [17]. The primary studies under which the samples were collected received ethical clearance from the PATH Institutional Review Board (IRB) (approval number 0004244).…”

Section: Clinical Samplesmentioning

confidence: 99%

“…Additionally, surveillance testing can be conducted with antigen tests using de-identified and/or pooled nasal swab specimens. A proof-of-concept study demonstrated that an antigen test can detect SARS-CoV-2 positive nasal swab specimens up to Ct value 30.1 (viral load 4.8E4 viruses/mL), even when the positive specimen is pooled into negative nasal swab specimens [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

“…Antigen-based tests, which utilize combinations of monoclonal antibodies and nanoparticles to detect viral proteins, do not require instruments or skilled operators; as of December 2021, 10 antigen tests for SARS-CoV-2 were approved for at-home use in the United States [ 27 ]. Although antigen tests have lower analytical sensitivity and specificity compared to qPCR assays, they have increased ability to detect SARS-CoV-2 during the acute phase of COVID-19 when an infected individual is most likely to transmit the virus [ 17 , 19 , 28 , 29 ].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparative Evaluation of Rapid Isothermal Amplification and Antigen Assays for Screening Testing of SARS-CoV-2

Salcedo¹,

Sena²,

Qu³

et al. 2022

Viruses

Self Cite

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Human transmission of SARS-CoV-2 and emergent variants of concern continue to occur globally, despite mass vaccination campaigns. Public health strategies to reduce virus spread should therefore rely, in part, on frequent screening with rapid, inexpensive, and sensitive tests. We evaluated two digitally integrated rapid tests and assessed their performance using stored nasal swab specimens collected from individuals with or without COVID-19. An isothermal amplification assay combined with a lateral flow test had a limit of detection of 10 RNA copies per reaction, and a positive percent agreement (PPA)/negative percent agreement (NPA) during the asymptomatic and symptomatic phases of 100%/100% and 95.83/100%, respectively. Comparatively, an antigen-based lateral flow test had a limit of detection of 30,000 copies and a PPA/NPA during the asymptomatic and symptomatic phases of 82.86%/98.68% and 91.67/100%, respectively. Both the isothermal amplification and antigen-based lateral flow tests had optimized detection of SARS-CoV-2 during the peak period of transmission; however, the antigen-based test had reduced sensitivity in clinical samples with qPCR Ct values greater than 29.8. Low-cost, high-throughput screening enabled by isothermal amplification or antigen-based techniques have value for outbreak control.

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Optimal targeted mass screening in non‐uniform populations with multiple tests and schemes

Lin

Aprahamian

Golovko

2023

Naval Research Logistics

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We study the problem of designing optimal targeted mass screening of non‐uniform populations. Mass screening is an essential tool that is widely utilized in a variety of settings, for example, preventing infertility through screening programs for sexually transmitted diseases, ensuring a safe blood supply for transfusion, and mitigating the transmission of infectious diseases. The objective of mass screening is to maximize the overall classification accuracy under limited budget. In this paper, we address this problem by proposing a proactive optimization‐based framework that factors in population heterogeneity, limited budget, different testing schemes, the availability of multiple assays, and imperfect assays. By analyzing the resulting optimization problem, we take advantage of the structure of the problem as a multi‐dimensional fractional knapsack problem and identify an efficient globally convergent threshold‐style solution scheme that fully characterizes an optimal solution across the entire budget spectrum. Using real‐world data, we conduct a geographic‐based nationwide case study on targeted COVID‐19 screening in the United States. Our results reveal that the identified screening strategies substantially outperform conventional practices by significantly lowering misclassifications while utilizing the same amount of budget. Moreover, our results provide valuable managerial insights with regard to the distribution of testing schemes, assays, and budget across different geographic regions.

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Pooling of Samples for SARS-CoV-2 Detection Using a Rapid Antigen Test

Cited by 7 publications

References 18 publications

Monoclonal antibody pairs against SARS-CoV-2 for rapid antigen test development

Monoclonal antibody pairs against SARS-CoV-2 for rapid antigen test development

Comparative Evaluation of Rapid Isothermal Amplification and Antigen Assays for Screening Testing of SARS-CoV-2

Optimal targeted mass screening in non‐uniform populations with multiple tests and schemes

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