ELISA detection of SARS-CoV-2 antibodies in saliva

MacMullan, Melanie A.; Ibrayeva, Albina; Trettner, Kylie; Deming, Laura; Das, Sudipta Sekhar; Tran, Frances; Moreno, Jose Ricardo; Casian, Joseph G.; Chellamuthu, Prithivi; Kraft, Jeffrey; Kozak, Kenneth; Turner, Fred; Slepnev, Vladimir I.; Page, Lydia M. Le

doi:10.1101/2020.08.17.20176594

Cited by 17 publications

(21 citation statements)

References 13 publications

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“…While SIgA is produced as dimeric IgA by plasma cells in salivary gland stroma, IgG in saliva largely originates from blood circulation by leakage mainly via gingival crevicular epithelium. 33 The strong correlation between vaccine induced saliva and capillary blood-derived IgG adds to previous data [34][35][36] suggesting this passive conduit may be a means to reliably monitor anti-SARS-CoV-2 IgG status and could be a viable alternative to venous and finger stick sample collection which may not be ideal for broad surveillance, including sampling from children. 34 Digital immunoassay technology provides the analytical capability to precisely quantify salivary IgG directly in whole saliva with high throughput.…”

Section: Discussionmentioning

confidence: 67%

Quantifying post-vaccination protective anti-SARS-CoV-2 IgG antibodies in blood and saliva with a fully automated, high throughput digital immunoassay

Johnson

Fernandes

Wuelfing

et al. 2022

Preprint

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Background: Antibodies induced by COVID-19 vaccination have been shown to wane over time. Current tests for assessing virus-neutralizing antibodies are complex and time-intensive. There is a need for a simple diagnostic test that measures levels of protective antibodies to help monitor immunity status. Method: Using a commercially available FDA-authorized semi-quantitative SARS-CoV-2 IgG test, we monitored the duration of the immune response in dried blood microsamples (DBS) and saliva to vaccination by 3 different vaccines across prospective cohorts of 8 COVID-19 naive and 29 COVID-19 recovered individuals over a six-month period. We correlated the results to a binding blockade assay validated to a live virus neutralization assay to validate the test for measurement of protective antibodies. Results: The immune response characteristics between the two mRNA vaccines were similar over the 6-month period in both the COVID-19 naive and recovered cohorts. IgG titers in DBS were generally 3-4 orders of magnitude higher than in saliva, and longitudinal profiles were highly correlated between the two matrices (Rm = 0.80). Median IgG concentrations post-vaccination declined to <10% neutralization capacity with all vaccines by six months. Conclusions: The potential of a simple, fully automated high throughput anti-SARS-CoV-2 IgG test to quantitatively measure protective antibodies in samples collected remotely or at the point of care was demonstrated. The IgG immune response and protective immunity was shown to decline significantly by six months.

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Section: Discussionmentioning

confidence: 67%

Quantifying post-vaccination protective anti-SARS-CoV-2 IgG antibodies in blood and saliva with a fully automated, high throughput digital immunoassay

Johnson

Fernandes

Wuelfing

et al. 2022

Preprint

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“…While the agreement between the two matrices for classi cation was strong, their correlation in levels was only moderate (R=0.25; p=0.005), which is consistent with another study. 17 In 97.5% of donors with matched saliva and nger-stick blood, saliva and nger-stick blood measurements were concordant for classi cation of SARS-CoV-2 spike IgG and SARS-CoV-2 S1 RBD IgG levels as high or low relative to their matrix-speci c thresholds (Cohen's κ= 0.83; p=8.4e-18). 112 donors had low levels of SARS-CoV-2 Spike IgG for both saliva and nger-stick blood, and 8 donors had high levels of SARS-CoV-2 Spike IgG in both saliva and nger-stick blood.…”

Section: Reactivity To Cov-2 Antigens In Salivamentioning

confidence: 88%

“…This study advances methods for serosurvillance by directly comparing self-collected nger-stick blood against saliva self-collected with a simple kit designed to maximize scalability and minimize downstream sample processing and handling. In prior studies 17,37 , saliva was collected under supervision in research settings using devices that are not FDA approved and/or require secondary containers to be compliant with UN3373 category B shipping requirements. This study collected samples using FDA registered devices that can be sent through the mail.…”

Section: Discussionmentioning

confidence: 99%

“…While saliva has been previously described as a useful self-collected sample for serology, and is the sample used in an FDA-cleared serology test for HIV 11,12 , saliva-based serology tests for SARS-CoV-2 are not yet commercially available. The potential of saliva as a sample for SARS-CoV-2 serosurveillance is supported by the strong correlation that has been observed in the antibody response in serum and saliva during acute infection and recovery [13][14][15][16][17] .…”

Section: Introductionmentioning

confidence: 99%

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Quantitative serology for SARS-CoV-2 using self-collected saliva and finger-stick blood

Campbell

Padmanabhan

Romero

et al. 2021

Preprint

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Convenient and widespread serology testing may alter the trajectory of the COVID-19 pandemic. This study seeks to leverage high-throughput, multiplexed serologic assays, which have been adopted as benchmarks for vaccine efficacy, to support large-scale surveys of SARS-CoV-2 immunity using finger-stick blood and/or saliva. Specifically, we optimized MSD’s serology assays, which were analytically validated for serum, to test self-collected finger-stick blood and saliva samples. We show that these assays can be used with FDA-registered specimen collection devices to obtain quantitative measurements for self-collected samples. Antibody levels were measured using an electrochemiluminescent (ECL) multiplex immunoassay, which has been used to measure humoral responses to several COVID-19 vaccines, including those funded by the U.S. Government’s Operation Warp Speed. First, we show that salivary antibodies are stable without refrigeration or preservatives for at least five days. Using matched samples, we show that testing of saliva and finger-stick blood equivalently identified individuals with humoral responses to CoV-2 antigens. Moreover, we piloted a simple saliva collection kit that can be used to safely send samples through the mail. This work demonstrates that robust methods for self-collection of finger-stick blood and saliva, in combination with quantitative, automated immunoassays, provide the technical capabilities needed to support large-scale serology testing.

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“…The bulk of salivary IgG is thought to originate from blood due to transudation or bleeding from the gingival tissue [22][23][24] . The potential of saliva as a sample for SARS-CoV-2 serosurveillance is supported by the strong correlation that has been observed in the antibody response in serum and saliva during acute infection and recovery [25][26][27][28][29] . Although the FDA has cleared serology tests for HIV 30,31 , saliva-based serology tests for SARS-CoV-2 are not yet commercially available.…”

Section: Introductionmentioning

confidence: 99%

Saliva-based SARS-CoV-2 serology using at-home collection kits returned via mail

Campbell

Roblin

Padmanabhan

et al. 2022

Preprint

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Serology provides tools for epidemiologic studies, and may have a role in vaccine prioritization and selection. Automated serologic testing of saliva, especially specimens that are self-collected at home and sent to a laboratory via the mail without refrigeration, could be a highly-scalable strategy for population-wide testing. In this prospective study, patients were recruited after PCR testing to self-collect saliva and return their specimens via mail. Longitudinal specimens were analyzed in order to monitor seroconversion in the weeks after a diagnostic PCR test for SARS-CoV-2. Diverse users self-collected saliva and returned specimens via mail in compliance with shipping regulations. At our pre-established threshold (0.963 AU/mL), salivary IgG reactivity to full-length spike protein achieved 95.8% sensitivity and 92.4% specificity at 2-4 weeks after diagnostic testing, which is comparable to the typical sensitivity and specificity achieved for serum testing. Reactivity to N antigen also was detected with 92.6% sensitivity and 90.7% specificity at 4-8 weeks after diagnostic testing. Moreover, serologic testing for endemic coronaviruses performed in multiplex with SARS-CoV-2 antigens has the potential to identify samples that may require retesting due to effects of pre-analytical factors. The easy-to-use saliva collection kit, coupled with thresholds for positivity and methods of flagging samples for retest, provides a framework for large-scale serosurveillance of SARS-CoV-2.

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ELISA detection of SARS-CoV-2 antibodies in saliva

Cited by 17 publications

References 13 publications

Quantifying post-vaccination protective anti-SARS-CoV-2 IgG antibodies in blood and saliva with a fully automated, high throughput digital immunoassay

Quantifying post-vaccination protective anti-SARS-CoV-2 IgG antibodies in blood and saliva with a fully automated, high throughput digital immunoassay

Quantitative serology for SARS-CoV-2 using self-collected saliva and finger-stick blood

Saliva-based SARS-CoV-2 serology using at-home collection kits returned via mail

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