A New Saliva-Based Lateral-Flow SARS-CoV-2 IgG Antibody Test for mRNA Vaccination

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1. 

   ScreenIT

   Jun 18, 2021

   SciScore for 10.1101/2021.06.11.21258769: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	IRB: Biological samples and chemicals: The study was performed in accordance with standard ethical principles and approved by the LifeBridge Health local institutional review board under Protocol # 1707882 and clinical trials # 04910971. Consent: All patients provided written consent.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   nLF assay for SARS-CoV-2 IgG antibody detection: To test a saliva sample, 200 μl of saliva was mixed with 10 μl Au-S1 and 50 μl Tris buffer in a 1.5 ml microcentrifuge tube.	SARS-CoV-2 IgG suggested: None
   Software and Algorithms
   Sentences	Resources
   The test …

   SciScore for 10.1101/2021.06.11.21258769: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	IRB: Biological samples and chemicals: The study was performed in accordance with standard ethical principles and approved by the LifeBridge Health local institutional review board under Protocol # 1707882 and clinical trials # 04910971. Consent: All patients provided written consent.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   nLF assay for SARS-CoV-2 IgG antibody detection: To test a saliva sample, 200 μl of saliva was mixed with 10 μl Au-S1 and 50 μl Tris buffer in a 1.5 ml microcentrifuge tube.	SARS-CoV-2 IgG suggested: None
   Software and Algorithms
   Sentences	Resources
   The test line image intensity and background intensity were read and analyzed by ImageJ.	ImageJ suggested: (ImageJ, RRID:SCR_003070)

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   Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   A limitation of our work is that rigorous immunity assessments require serological neutralizing antibody quantification, raising the question of relevance of anti-SARS-CoV-2 spike protein levels in saliva and blood. However, neutralization assays are time-consuming and employ live viruses, which are unsuitable for mass vaccination studies. Several simplified neutralization assays have been developed without using live viruses20,40-42. Importantly, there have been mounting evidence that neutralizing antibody levels in COVID-19 patients are well correlated with antibodies against spike protein on the surface of SARS-CoV-214,16,20-22. Further, our results here showed that salivary anti-S1 IgG was well correlated with that in the blood for the mRNA vaccinated cohort as a whole (Figure 4) and at the individual level (Figure 5, Figure S4, and Figure S5). Such correlation has been seen recently for COVID-19 patients23,24,27 and in various other infectious diseases in the past few decades30,31. All of these results present a compelling case for monitoring salivary IgG against spike protein in vaccinated population as a non-invasive approach to assessing antibody levels and immunity. We clearly observed similar evolution trends and patterns for anti-S1 IgG in saliva and in blood. Since these antibodies are resulted entirely from vaccination, and when immunity wanes, salivary antibodies could also diminish. Continual monitoring of antibody persistence is crucial as COVID-19 vaccines ci...

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   Results from rtransparent:

   • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
   • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
   • No protocol registration statement was detected.

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   Results from scite Reference Check: We found no unreliable references.

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2. 

   Version published to 10.1101/2021.06.11.21258769v1 on medRxiv

   Jun 16, 2021