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Prevalence of COVID-19 Antibodies Kingman AZ

Seroprevalence of SARS CoV2 Antibodies Among Adults in Kingman AZ

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04533360
Enrollment
566
Registered
2020-08-31
Start date
2020-09-28
Completion date
2021-05-01
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTVITROS 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.

Sponsors

Kingman Regional Medical Center
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Seroprevelence of SARS-CoV-2 Antibodies among Adults in Kingman AZ2-weeksA sample from the population of Kingman AZ will be used to determine the epidemiology of COVID-19 spread throughout Kingman AZ.

Secondary

MeasureTime frameDescription
Retention of SARS-CoV-2 Antibodies among Adults in Kingman AZ2-weeksParticipants 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026