Applications of SARS-CoV-2 serological testing: impact of test performance, sample matrices, and patient characteristics DOI

Chun Yiu Jordan Fung,

Mackenzie Scott,

Jordan Lerner‐Ellis

et al.

Critical Reviews in Clinical Laboratory Sciences, Journal Year: 2023, Volume and Issue: 61(1), P. 70 - 88

Published: Oct. 6, 2023

AbstractLaboratory testing has been a key tool in managing the SARS-CoV-2 global pandemic. While rapid antigen and PCR proven useful for diagnosing acute infections, additional methods are required to understand long-term impact of infections on immune response. Serological testing, well-documented laboratory practice, measures presence antibodies sample uncover information about host immunity. Although proposed applications serological clinical use have previously limited, current research into shown growing utility these settings. To name few, used identify patients with past active disease monitor vaccine efficacy. Test result interpretation, however, often complicated by factors that include poor test sensitivity early infection, lack response some individuals, overlying infection vaccination responses, standardization antibody titers/levels between instruments, unknown titers confer protection, large between-individual biological variation following or vaccination. Thus, three major components this review will examine (1) affect utility: performance, matrices, seroprevalence concerns viral variants, (2) patient response: timing sampling, age, sex, body mass index, immunosuppression vaccination, (3) informative testing: identifying surveillance guide health practices, examination protective should be beneficial care if it is implemented appropriately. However, as other developed tests, serology modality warrants careful consideration limitations evaluation its utility.Keywords: SARS-CoV-2COVID-19serologyimmunityantibody Disclosure statementJT receives in-kind support from Roche Diagnostics.Additional informationFundingThis open-access article supported funding Canadian Institutes Health Research (Funding Reference Number VR4-172753, VS1-175526, VS2-175572.

Language: Английский

From a recombinant key antigen to an accurate, affordable serological test: Lessons learnt from COVID-19 for future pandemics DOI Open Access
Renata G. F. Alvim, Túlio M. Lima, Danielle A. S. Rodrigues

et al.

Biochemical Engineering Journal, Journal Year: 2022, Volume and Issue: 186, P. 108537 - 108537

Published: July 16, 2022

Language: Английский

Citations

35

Recent progress on lateral flow immunoassays in foodborne pathogen detection DOI

Chunhao Wei,

Aihong Wu,

Liguang Xu

et al.

Food Bioscience, Journal Year: 2023, Volume and Issue: 52, P. 102475 - 102475

Published: Feb. 14, 2023

Language: Английский

Citations

23

Technical considerations to development of serological tests for SARS-CoV-2 DOI Open Access
Emilie Ernst, Patricia Wolfe, Corrine M. Stahura

et al.

Talanta, Journal Year: 2020, Volume and Issue: 224, P. 121883 - 121883

Published: Nov. 10, 2020

Language: Английский

Citations

35

Rapid biosensing SARS-CoV-2 antibodies in vaccinated healthy donors DOI Open Access
Sumin Bian, Min Shang, Mohamad Sawan

et al.

Biosensors and Bioelectronics, Journal Year: 2022, Volume and Issue: 204, P. 114054 - 114054

Published: Feb. 3, 2022

Language: Английский

Citations

21

A Dried Blood Spot protocol for high-throughput quantitative analysis of SARS-CoV-2 RBD serology based on the Roche Elecsys system DOI Creative Commons
Noemi Castelletti, Ivana Paunović,

Raquel Rubio‐Acero

et al.

Microbiology Spectrum, Journal Year: 2024, Volume and Issue: 12(4)

Published: March 1, 2024

ABSTRACT SARS-CoV-2 spreads pandemically since 2020; in 2021, effective vaccinations became available and vaccination campaigns commenced. Still, it is hard to track the spread of infection or assess success broader population. Measuring specific anti-SARS-CoV-2 antibodies most tool successful vaccinations. The need for venous-blood sampling however poses a significant barrier large studies. Dried-blood-spots on filter-cards (DBS) have been used serology our laboratory, but so far not follow quantitative anti-spike reactivity longitudinal cohort. We developed semi-automated protocol from self-sampled DBS, validating cohort matched DBS samples ( n = 825). investigated chromatographic effects, reproducibility, carry-over effects calculated positivity threshold as well conversion formula determine binding units with confidence intervals. Sensitivity specificity reached 96.63% 97.81%, respectively, compared same test performed paired venous samples. Between signal 0.018 250 U/mL, we correction formula. during vaccinations, demonstrated relative changes titers over time several individuals four follow-ups. has proven itself anti-nucleocapsid serosurveys laboratory. Similarly, high-throughput feasible complementary assay. Quantitative measurements are accurate enough titer dynamics populations also after campaigns. This work was supported by Bavarian State Ministry Science Arts; LMU University Hospital, Munich; Helmholtz Center Bonn; Bielefeld; German Education Research (proj. nr.: 01KI20271 others) Medical Biodefense Program Bundeswehr Service. Roche Diagnostics provided kits machines analyses at discounted rates. project funded European-wide Consortium ORCHESTRA. ORCHESTRA received funding European Union’s Horizon 2020 research innovation program under grant agreement No 101016167. views expressed this publication sole responsibility author, Commission responsible any use that may be made information contains. IMPORTANCE spreading globally pandemic 2020. To prevalence among populations, public health measuring induced vaccination. However, conducting large-scale studies involve challenging due associated feasibility cost issues. A more cost-efficient less invasive method serological testing using Dried-Blood-Spots filter cards (DBS). In paper, quantifying self-collected DBS. Our laboratory previously successfully antibody surveys. Likewise, an additional can sample preparation analysis. obtained levels even

Language: Английский

Citations

4

Dynamic Profiling and Prediction of Antibody Response to SARS-CoV-2 Booster-Inactivated Vaccines by Microsample-Driven Biosensor and Machine Learning DOI Creative Commons
Sumin Bian, Min Shang, Ying Tao

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(4), P. 352 - 352

Published: March 25, 2024

Knowledge of the antibody response to third dose inactivated SARS-CoV-2 vaccines is crucial because it subject one largest global vaccination programs. This study integrated microsampling with optical biosensors profile neutralizing antibodies (NAbs) in fifteen vaccinated healthy donors, followed by application machine learning predict at given timepoints. Over a nine-month duration, and venipuncture were conducted seven individual A refined iteration fiber optic biolayer interferometry (FO-BLI) biosensor was designed, enabling rapid multiplexed biosensing NAbs both wild-type Omicron variants minutes. Findings revealed strong correlation (Pearson r 0.919, specificity 100%) between variant NAb levels microsamples sera. Following dose, sera increased 2.9-fold after days 3.3-fold within month, subsequently waning becoming undetectable three months. Considerable but incomplete evasion latest subvariants from booster vaccine-elicited confirmed, although higher number binding (BAbs) identified another FO-BLI Significantly, highly correlated pseudovirus neutralization assay identifying capacities 0.983). Additionally, demonstrated exceptional accuracy predicting levels, an error level <5% for BAbs across multiple Microsample-driven enables individuals access their results hours self-collection, while precise models could guide personalized strategies. The technology’s innate adaptability means has potential effective translation disease prevention vaccine development.

Language: Английский

Citations

4

A dried blood spot protocol for high throughput analysis of SARS-CoV-2 serology based on the Roche Elecsys anti-N assay DOI Creative Commons

Jessica Beyerl,

Raquel Rubio‐Acero,

Noemi Castelletti

et al.

EBioMedicine, Journal Year: 2021, Volume and Issue: 70, P. 103502 - 103502

Published: July 29, 2021

Since 2020 SARS-CoV-2 spreads pandemically, infecting more than 119 million people, causing >2·6 fatalities. Symptoms of infection vary greatly, ranging from asymptomatic to fatal. Different populations react differently the disease, making it very hard track spread in a population. Measuring specific anti-SARS-CoV-2 antibodies is an important tool assess or successful vaccinations. To achieve sufficient sample numbers, alternatives venous blood sampling are needed not requiring medical personnel cold-chains. Dried-blood-spots (DBS) on filter-cards have been used for different studies, but routinely serology.

Language: Английский

Citations

27

Development and Validation of a Multiplex Microsphere Immunoassay Using Dried Blood Spots for SARS-CoV-2 Seroprevalence: Application in First Responders in Colorado, USA DOI
Jonathan Schultz, Mary K. McCarthy, Cody Rester

et al.

Journal of Clinical Microbiology, Journal Year: 2021, Volume and Issue: 59(6)

Published: April 2, 2021

Serological testing of large representative populations for antibodies to SARS-CoV-2 is needed estimate seroprevalence, transmission dynamics, and the duration antibody responses from natural infection vaccination. In this study, a high-throughput multiplex microsphere immunoassay (MMIA) was developed receptor binding domain (RBD) nucleocapsid (N) that more sensitive than enzyme-linked immunosorbent assay (ELISA) (98% versus 87%).

Language: Английский

Citations

26

SARS-CoV-2 Antibody Binding and Neutralization in Dried Blood Spot Eluates and Paired Plasma DOI Creative Commons
Hannah L. Itell,

Haidyn Weight,

Carolyn S. Fish

et al.

Microbiology Spectrum, Journal Year: 2021, Volume and Issue: 9(2)

Published: Oct. 25, 2021

Plasma and sera isolated from venous blood represent conventional sample types used for the evaluation of SARS-CoV-2 antibody responses after infection or vaccination. However, collection these samples is invasive requires trained personnel equipment immediate processing.

Language: Английский

Citations

25

Evaluation of Dried Blood Spot Testing for SARS-CoV-2 Serology Using a Quantitative Commercial Assay DOI Creative Commons
Davor Brinc, Mia J. Biondi, Daniel Li

et al.

Viruses, Journal Year: 2021, Volume and Issue: 13(6), P. 962 - 962

Published: May 22, 2021

Dried blood spots (DBS) are commonly used for serologic testing viruses and provide an alternative collection method when phlebotomy and/or conventional laboratory not readily available. DBS could be to facilitate widespread SARS-CoV-2 antibodies document past infection, vaccination, potentially immunity. We investigated the characteristics of Roche's Anti-SARS-CoV-2 (S) assay, a quantitative commercial assay against spike glycoprotein. Antibody levels were reduced relative plasma following elution from DBS. Quantitative results samples highly correlated with values (r2 = 0.98), allowing extrapolation using accurately estimate antibody levels. High concordance between fingerpick was observed in PCR-confirmed COVID-19 patients tested 90 days or more after diagnosis (45/46 matched; 1/46 mismatched vs. DBS). The assessment responses may feasible anti-S although false negatives rarely occur those very low

Language: Английский

Citations

24