Prevalence of COVID-19 Antibodies Kingman AZ

March 16, 2022 updated by: John Ashurst, Kingman Regional Medical Center

Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ

The COVID-19 disease outbreak is a historic event that has challenged medical systems in the United States. Currently, most reports of confirmed cases rely on the testing of symptomatic patients. These estimates of confirmed cases miss individuals who have recovered from infection, with mild or no symptoms, and individuals with symptoms who have not been tested due to the limited availability of tests. We are conducting serology testing within the community for SARS-CoV-2-specific antibodies through a serologic test could give insight into past COVID-19 infections within our community.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adult participants aged 18 or greater will be recruited from the greater Kingman AZ area through social media, radio, newspaper, and a press release. Participants self-selected inclusion in the study by calling into a COVID-19 hotline and will be included in the sample data following self-report of absence of covid-19 symptoms. Participants will be scheduled for testing on the weeks of 09/28/2020 and 10/05/2020. Upon recruitment, participants will be asked to complete a demographic and behavioral survey, assessing socioeconomic status, interpersonal interactions, personal protective measures, and COVID-19 symptomology in the preceding two months. Two months after initial testing, all negative SARS-CoV-2-specific antibodies participants will be contacted for repeat testing and surveying.

SARS-CoV-2-specific antibodies will be tested using a lateral flow immunoassay with the VITROS Anti-SARS-CoV-2 IgG test (Ortho-Clinical Diagnostics, Inc.) under the Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The diagnostic sensitivity of the immunoassay was 87.5% and specificity was 100%. The positive and negative predictive value with a prevalence of 5% in the community was 100% and 99.3% respectively. All data will be de-identified and stored in a password protected file only visible to study investigators. All positive results were called back to participants by the lead author.

Data obtained was then used to estimate the population prevalence of SARS-CoV-2-specific antibodies in the Kingman, Arizona population. Unweighted and weighted proportions of positive tests were calculated to match the 2018 census on sex, race, education, and income. Confidence intervals for unweighted data will be estimated using exact binomial models and for weighted and adjusted estimates using bootstrap methods. All data was analyzed using SPSS.

Study Type

Observational

Enrollment (Actual)

566

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Kingman, Arizona, United States, 86409
        • Kingman Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

~30,000 individuals inhabit Kingman AZ across 7,854 households, out of which 30.1% had children under the age of 18 living with them, 54.6% were married couples living together, 10.1% had a female householder with no husband present, and 30.9% were non-families. 25.5% of all households were made up of individuals, and 11.7% had someone living alone who was 65 years of age or older.

Description

Inclusion Criteria:

  • Adults aged 18+
  • Resident of Mohave County AZ

Exclusion Criteria:

  • Children under 18yo
  • Previous positive SARS-CoV2- Antibody Test
  • Active symptoms of respiratory Illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Community Cohort 1
1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1.
Diagnostic test: VITROS Anti-SARS-CoV-2 IgG test
The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.
Community Cohort 2
1000 Participants from the community will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2.
Diagnostic test: VITROS Anti-SARS-CoV-2 IgG test
The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.
Healthcare Provider Cohort 1
500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 1.
Diagnostic test: VITROS Anti-SARS-CoV-2 IgG test
The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.
Healthcare Provider Cohort 2
500 hospital employees will be recruited to undergo serological testing for SARS-CoV2 Antibodies at time point 2.
Diagnostic test: VITROS Anti-SARS-CoV-2 IgG test
The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ
Time Frame: 2-weeks
A sample from the population of Kingman AZ will be used to determine the epidemiology of COVID-19 spread throughout Kingman AZ.
2-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ
Time Frame: 2-weeks
Participants will have a second antibody diagnostic test 2 months following initial enrollment. The concordance between positive tests will then be used to determine the longevity of SARS-CoV-2 antibodies in our community.
2-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kingman Regional Medical Center

Investigators

  • Study Director: Anthony J Santarelli, PhD, Kingman Healthcare Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2020

Primary Completion (ACTUAL)

October 9, 2020

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (ACTUAL)

August 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRMC 0205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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