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.
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.
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.
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
Kingman Regional Medical Center
Kingman, Arizona, United States
Anthony J Santarelli, PhD, Study Director
Kingman Healthcare Inc.