Response of Clinical Laboratories to the Ongoing COVID-19 Pandemic

Kim, Young Jin; Sung, Heungsup; Ki, Chang‐Seok; Hur, Mina

doi:10.3343/alm.2021.41.6.519

Cited by 5 publications

(4 citation statements)

References 9 publications

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“…Coronavirus disease 2019 (COVID- 19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a pandemic and presents a major health concern across the globe [1,2]. Accurate antibody measurements support uncertain identification or evaluation in the case of resolved infection and can be useful for contact tracing and epidemiologic studies [3][4][5][6]. To date, many SARS-CoV-2 antibody assays have been developed with different antigen targets and assay formats.…”

Section: Introductionmentioning

confidence: 99%

Quantitative SARS-CoV-2 Spike Antibody Response in COVID-19 Patients Using Three Fully Automated Immunoassays and a Surrogate Virus Neutralization Test

Kim

Lee

et al. 2021

Diagnostics

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Quantitative SARS-CoV-2 antibody assays against the spike (S) protein are useful for monitoring immune response after infection or vaccination. We compared the results of three chemiluminescent immunoassays (CLIAs) (Abbott, Roche, Siemens) and a surrogate virus neutralization test (sVNT, GenScript) using 191 sequential samples from 32 COVID-19 patients. All assays detected >90% of samples collected 14 days after symptom onset (Abbott 97.4%, Roche 96.2%, Siemens 92.3%, and GenScript 96.2%), and overall agreement among the four assays was 91.1% to 96.3%. When we assessed time-course antibody levels, the Abbott and Siemens assays showed higher levels in patients with severe disease (p < 0.05). Antibody levels from the three CLIAs were correlated (r = 0.763–0.885). However, Passing–Bablok regression analysis showed significant proportional differences between assays and converting results to binding antibody units (BAU)/mL still showed substantial bias. CLIAs had good performance in predicting sVNT positivity (Area Under the Curve (AUC), 0.959–0.987), with Abbott having the highest AUC value (p < 0.05). SARS-CoV-2 S protein antibody levels as assessed by the CLIAs were not interchangeable, but showed reliable performance for predicting sVNT results. Further standardization and harmonization of immunoassays might be helpful in monitoring immune status after COVID-19 infection or vaccination.

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Section: Introductionmentioning

confidence: 99%

Quantitative SARS-CoV-2 Spike Antibody Response in COVID-19 Patients Using Three Fully Automated Immunoassays and a Surrogate Virus Neutralization Test

Kim

Lee

et al. 2021

Diagnostics

View full text Add to dashboard Cite

show abstract

“…Since the coronavirus disease 2019 (COVID-19) outbreak, nucleic acid-based molecular diagnostic methods have played a crucial role in the detection of the novel severe acute respiratory syndromecoronavirus-2 (SARS-CoV-2), the causative agent of COVID-19 1,2 . Real-time reverse transcription polymerase chain reaction (rRT-PCR) is the most widely used method for SARS-CoV-2 detection in clinical diagnostics [3][4][5][6][7] . rRT-PCR is a sensitive and speci c technique that enables the detection and ampli cation of viral genetic material (RNA) in patient samples.…”

Section: Introductionmentioning

confidence: 99%

Optimization of Extraction-Free Protocols for SARS-CoV-2 Detection using a Commercial rRT-PCR Assay

Kang,

Jeong,

Kim

et al. 2023

Preprint

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The global combat against coronavirus disease 2019 (COVID-19) has primarily focused on developing innovative nucleic acid-based molecular diagnostic techniques and streamlining associated protocols. In this study, we investigated extraction-free approaches to simplify the process and enhance efficiency. We validated the effectiveness of extraction-free protocols incorporating heat treatment and sample dilution, along with Proteinase K and RNase inhibitors, to improve nucleic acid detection. The combination of sample dilution, heat treatment, and addition of Proteinase K and RNase inhibitors showed the highest sensitivity (84.26%) with a mean increase in cycle threshold (Ct) value of + 3.8. The combination of sample dilution and heat treatment exhibited a sensitivity of 79.63%, which was a significant improvement of 38% compared to the use of heat treatment alone. The incorporation of proteinase K and RNase inhibitors in conjunction with sample dilution and heat treatment contributed to only a marginal improvement and did not yield statistically significant differences. Our study revealed that sample dilution significantly affected SARS-CoV-2 detection, and sample conditions played a crucial role in the efficiency of extraction-free methods. These findings will contribute to streamlining diagnostic testing, making it more accessible and cost-effective during the COVID-19 pandemics.

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“…The spike protein on the surface of SARS-CoV-2 virus particles is the main target for neutralizing antibodies, and the S protein expressed through the vaccine is similar to infectious particles. Because the S protein exhibits a high degree of variability between different virus strains, a comprehensive evaluation of infection-and vaccinederived antibodies against different antigenic epitopes and crossneutralization on variants is important for better understanding of immune response to COVID-19 and vaccination (2,(5)(6)(7)(8).…”

Section: Introductionmentioning

confidence: 99%

Comprehensive assessment of SARS-CoV-2 antibodies against various antigenic epitopes after naive COVID-19 infection and vaccination (BNT162b2 or ChAdOx1 nCoV-19)

Lee

Jung

et al. 2022

Front. Immunol.

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Comprehensive assessment of SARS-CoV-2 antibodies against antigenic epitopes and cross-neutralization on variants is essential to monitor after infection or vaccination. From 32 COVID-19 patients and 40 vaccinated individuals [20 Oxford–AstraZeneca (AZ) and 20 Pfizer–BioNTech (BNT)], 348 serial sera are collected until 40 days after infection and 3 months after homologous booster vaccination. Antibody levels were monitored using a multiplex-bead assay including variant spike antigens, Roche (S1/RBD total) and a surrogate virus neutralization test (GenScript). Anti-S/S1/RBD levels were higher than anti-S2/N levels from 2 weeks after infection and were higher in severe infection (P < 0.05). Vaccination showed highest antibody levels after 1-month booster and had consistently high levels in the order of anti-full S, anti-RBD, anti-S1 and anti-S2. Infection induced higher anti-S2/N levels than prime vaccination (P < 0.05). Three months after BNT/BNT vaccination, antibody levels against S1/RBD and 23 variant antigens were higher than post-infection or AZ groups (P < 0.05). Regarding intraindividual changes from post-prime to post-boost vaccination, boost induced a 1.1- to 3.9-fold increase on multiplex-bead assay, 22.8- to 24.2-fold on Roche assay and 22.8- to 24.2-fold on GenScript assay. Post-prime levels by multiplex-bead assay predicted post-boost levels, but Roche and GenScript results were not predictive in the AZ group. The kinetics of SARS-CoV-2 antibody levels vary depending on the antigenic epitopes, assay kit, disease severity or vaccine type. Assessing seroconversion using multiplex-bead assays may contribute to monitoring the disease course, adjusting vaccination strategies, and accelerating vaccination efficacy.

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Response of Clinical Laboratories to the Ongoing COVID-19 Pandemic

Cited by 5 publications

References 9 publications

Quantitative SARS-CoV-2 Spike Antibody Response in COVID-19 Patients Using Three Fully Automated Immunoassays and a Surrogate Virus Neutralization Test

Quantitative SARS-CoV-2 Spike Antibody Response in COVID-19 Patients Using Three Fully Automated Immunoassays and a Surrogate Virus Neutralization Test

Optimization of Extraction-Free Protocols for SARS-CoV-2 Detection using a Commercial rRT-PCR Assay

Comprehensive assessment of SARS-CoV-2 antibodies against various antigenic epitopes after naive COVID-19 infection and vaccination (BNT162b2 or ChAdOx1 nCoV-19)

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