Convalescent plasma anti–SARS-CoV-2 spike protein ectodomain and receptor-binding domain IgG correlate with virus neutralization

Nov 16, 2020

SciScore for 10.1101/2020.06.08.138990: (What is this?)

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

Table 1: Rigor

Institutional Review Board Statement	Consent: All donors provided written informed consent and tested negative for SARS-CoV-2 at the time of plasmapheresis. IRB: Studies were conducted with the approval of the Houston Methodist Research Institute ethics review board, and with informed patient or legally-authorized representative consent when applicable.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.
Sex as a biological variable	Generalized Liner model (GLM), using the first plasma donation data only, was performed between the same variables, as a response, and each of the following predictor factors: dyspnea (yes, no), disease severity (five classes as described above), hospitalization (yes, no) gender (male, female), and age combined into five age groups (<=30, 31-40, 41-50, 51-60 and >60).
Cell Line Authentication	not detected.

Table 2: Resources

Antibodies
Sentences	Resources
Donors were documented to be negative for anti-HLA antibodies, hepatitis B, C, HIV, HTLV I/II, Chagas disease, WNV, Zika virus, and syphilis per standard blood banking practices	anti-HLA suggested: None
The ELISA used to measure antispike IgG antibodies in donor serum specimens was performed as follows.	antispike IgG suggested: None
A similar ELISA was used to study anti-spike ECD antibody titers in serum obtained from surveilled asymptomatic individuals	anti-spike ECD suggested: None
All samples were tested with an initial screen assay and IgG antibody titers were subsequently performed on positive samples.	IgG suggested: None
Experimental Models: Cell Lines
Sentences	Resources
The virus and plasma mixture was added to Vero E6 cells grown in a 96-well microtiter plate, incubated for 3 d, after which the host cells were treated for 1 h with crystal violet-formaldehyde stain (0.013% crystal violet, 2.5% ethanol, and 10% formaldehyde in 0.01 M PBS).	Vero E6 suggested: RRID:CVCL_XD71)
Diluted plasma was mixed with the SARS-CoV-2 WA1 strain, incubated at 37° C for 1 h, then added to Vero-E6 cells at a target MOI of 0.4.	Vero-E6 suggested: None
Software and Algorithms
Sentences	Resources
Cells were fixed 24 h post-infection, and the number of infected cells was determined using SARS-CoV-S specific mAb (Sino Biological 401430-R001) and fluorescently labeled secondary antibody.	SARS-CoV-S suggested: None
Whole genome alignments of consensus virus genome sequence generated from the ARTIC nCoV-2019 bioinformatics pipeline were trimmed to the start of orf1 ab and the end of orf10 and used to generate a phylogenetic tree using RAxML (https://cme.h-its.org/exelixis/web/software/raxml/indexhtml).	RAxML suggested: (RAxML, RRID:SCR_006086)

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).

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

Limitations: Our study has several limitations. The study was retrospective, only IgG titers were analyzed, and all VN studies were conducted in vitro. Plasma from the convalescent donors was used for VN assays, whereas serum samples were used for ELISA assays. As such, the findings may not be entirely applicable to all antibody testing platforms or other sample types. Conclusions: Taken together, the data clearly show that anti-RBD and anti-ECD IgG titers serve as important surrogates for in vitro VN activity. A substantial fraction of convalescent plasma donors may have VN titers below the FDA recommended cutoff of ≥1:160. Dyspnea, hospitalization, and higher disease severity were associated with higher VN titer. Importantly, a small percentage of asymptomatic individuals have virus-neutralizing antibodies, including some with a titer of ≥1:160. In the aggregate, it is reasonable to think that our findings provide impetus for widespread implementation of anti-RBD and anti-ECD IgG antibody titer testing programs. The resulting data could be useful in several settings, including, but not limited to, identification of plasma donors for therapeutic uses (e.g., convalescent plasma transfusion and/ or source plasma for fractionation in the manufacture of hyperimmune globulin) (5, 11), assessment of recipients of candidate vaccines, assessment of recipients of passive immune therapies, assessment of previously infected individuals, and identification of asymptomatic individuals wi...

Results from TrialIdentifier: No clinical trial numbers were referenced.

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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

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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Convalescent plasma anti–SARS-CoV-2 spike protein ectodomain and receptor-binding domain IgG correlate with virus neutralization

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