We developed a minimum set of data elements to extract from each study reflecting typically available data fields. As described above, these data are all available at the SeroHub data repository (https://doi.org/10.17917/3pz5-5m44)18. In addition to using visualization tools available in the COVID-19 SeroHub data repository, all extracted study data can be downloaded by users of the site, without restriction, by navigating to the Seroprevalence Data Tab and clicking on the “Download Seroprevalence Data” button or obtained via API, facilitating analysis via other statistical software and webtools.

As part of our standardized protocol, the following fields are obtained from each included study and are available for download:

Data elements name

Definition.

Study and report title

Title of the manuscript or data release. If none, use study title.

Lead author

Last, First name of lead author in manuscript or data release.

Lead author email

Email address of lead author in manuscript or data release.

Lead author affiliation

Affiliation of lead author. We use a curated list of institutions for consistency.

Corresponding author

Name and email address of corresponding author if different than lead author.

National clinical trial identifier

The National Clinical Trial (NCT) identifier for the study, if available.

Study status

Status of the study. Choices are: Planning, Ongoing, and Complete.

Funding agency

The agency that provided funding for the study.

Grant or Contract #

If applicable.

Study objectives

The objective of the study in one sentence.

Primary study design

The type of study performed. Choices are: cross-sectional surveillance survey, serial surveillance survey, where repeated cross-sectional surveys of a target population are conducted, and longitudinal surveillance survey, where a single group of participants are repeatedly given serology tests over time.

Study population

What was the study population? Choices include: General Population (children, adults, blood donors), Educational Setting (college students, teachers, K-12 students, university employees), Healthcare Setting (nurses, physicians, hospital patients), Other Occupations (meat packers, private sector and government employees, first responders), Detention Centers (prison inmates and personnel), Long-Term Care Facilities (nursing homes, rehabilitation facilities, long-term chronic care facilities, inpatient behavioral health facilities), Military Setting (Air Force base residents, Navy ship residents), Pregnant People, and Not Reported.

Sampling methodology

A short description of how participants were enrolled into the study. For example:

High-risk healthcare workers employed by Regional Hospital in City, State were invited to participate in the study. Study participants completed a questionnaire and provided a blood sample.

This study included all patients who had surgery at Regional Hospital in City, State between May 10, 2020 and July 28, 2020. Residual blood samples were used for serologic testing.

Within each of the counties in a State, we selected a random census tract using cluster sampling and recruited households. Then, we randomly invited a resident from each household to complete a survey and provide a blood sample.

Collection state

State, district, or territory where the sample was collected.

Collection county

County where the sample was collected. Can also include Districts, Islands, Municipalities, Parishes, and Villages.

Collection city

City, town, or borough where the sample was collected.

Number of participants

The number of unique subjects enrolled in the study.

Collection frequency

Number of times samples were collected from participants. Choices are: Once, Twice, Biweekly, Monthly, and Multiple.

Collection period

The calendar months and year in which the study was actively collecting samples from enrolled subjects. If studies have multiple collection events, please include each collection event on a different row.

Age

The age range of participants in the study.

Gender/Sex

Female, Male, Nonbinary, Intersex, Transgender, Other, and Unknown.

Race

The race of study participants, such as American Indian or Alaska Native, Asian, Black or African American, Hawaiian or Other Pacific Islander, White, Multiracial, International, Other, or Unknown.

Ethnicity

The ethnicity of study participants, such as Hispanic or Latino, Not Hispanic or Latino, or Multiethnic.

Test manufacturer and name

The company that manufactures the test. If multiple companies or tests, please provide each separately. If a lab developed a test, (LDT), please specify.

Emergency use authorization (EUA) approval

Note if test received Food and Drug Administration (FDA) EUA approval. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.

Test type

List the type of test used. Choices are: Chemiluminescence Immunoassay (CLIA), Chemiluminescent Microparticle ImmunoAssay (CMIA), Electrochemiluminescence Immunoassay (eCLIA), Enzyme Linked Fluorescence Assay (ELFA), Enzyme Linked Immunosorbent Assay (ELISA), Fluorescence Immunoassay (FIA), Fluorescent microbead-based immunoassay (FMIA), Lateral Flow Immunoassay (LFIA), Luciferase Immunoprecipitation System (LIPS), Microsphere Immunoassay (MIA), Photonic Ring Immunoassay (PRI), Photometric Immunoassay (PIA), Unknown, and Other.

Antigen target

The antigen target of the serology test used. Choices are:

Spike, Nucleocapsid, Spike and Nucleocapsid, Spike and Spike RBD,

Spike N-terminal domain (NTD), Spike Receptor-binding Domain (RBD), Spike trimeric ectodomain (Trimer), Spike S1 subunit, Spike S2 subunit, Spike S1 and S2 subunit, Not Specified, and Other.

Antibody isotypes

The antibody isotype of the serology test used. Choices are IgG, IgM, IgA, [IgG and IgM], [IgA, IgG, or IgM] (PanIg), and Unknown.

Specimen type

Type of samples used in study. Choices are: Whole blood, Dried blood, Plasma, Serum, and Other.

Test sensitivity and 95% confidence interval

Test sensitivity for the serology test used in the study. We preferentially extract these data from the study; however, if not available, we obtain from the FDA EUA site, or if necessary, other sources.

Test sensitivity source

How was this determined? (e.g., per manufacturer or per in-house validation).

Test specificity and 95% confidence interval

Test specificity for the serology test used in the study. We preferentially extract these data from the study; however, if not available, we obtain from the FDA EUA site, or if necessary, other sources.

Test specificity

How was this determined? (e.g., per manufacturer or per in-house validation).

Testing algorithm

Describe if an algorithm was used to define seropositivity in the study. For example, how were data from multiple tests used to define seropositivity?

Analysis strategy

Are seroprevalence estimates unadjusted or adjusted by population weighting, sensitivity/specificity, antibody waning, or other factors?

Reported Seroprevalence, 95% confidence interval, and number of participants tested

The seroprevalence results reported in the study. We extract overall seroprevalence, seroprevalence by study location, seroprevalence by collection period, seroprevalence by age, seroprevalence by race and ethnicity, seroprevalence by sex, seroprevalence by serology test used, and the number of participants in each subgroup.

Data released (Y/N)

Whether the data from the study have been released publicly, for example through a publication.

Study reference

Include web link or published reference.

Report type

Can include Preprint, Peer-reviewed publication, and Other (such as press-release or image).

Publication date

For peer-reviewed publications, this is the publication date. Alternatively, it can be the data of posting on a preprint server or release of a data report, depending on the source of data.

Comments

Text describing anything else of interest related to the submission.

Study keywords

Keyword(s) are generated that summarize the study’s approach or objective.

link

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