Discussion
During October 2021-May 2022, approximately 393 million self-tests were produced by the four manufacturers evaluated in this study. Although not all self-tests produced by these manufacturers were distributed, purchased and used, the 10. Read also : East Baton Rouge Parish Receives $ 1 Million for New Mental Health Initiative.7 million results voluntarily reported by users and made available for public health surveillance likely reflect a small fraction of the number of self-tests used. This finding indicates that during the COVID-19 pandemic, including during the period of increase of the Omicron variant (December 2021-February 2022) covered by this analysis (6,7), there was an under-certification of cases (5) . Uncertainty could be attributed to multiple factors, including the lack of formal mechanisms to enable reporting of self-test results to public health authorities and persons with mild or no symptoms not seeking testing or health care.
Self-tests provide another option for persons seeking accessible testing and remain an important tool to guide individual decision-making and risk reduction. Mandating reporting of all self-test results to public health authorities is not practical and could negatively affect acceptability and use of self-tests, which would be detrimental to minimizing disease spread. Although the increase in self-testing (4) could result in underconfirmation of total case counts, this analysis indicates that the NAAT data captured through CELR, combined with case data, remain robust and continue to track trends in community transmission.††† In addition, people with more severe disease are more likely to receive NAAT when seeking care in outpatient or inpatient settings, and national surveillance primarily focuses on these cases. In addition, other types of surveillance data provide insight into aspects of disease burden such as demands on health systems, highly or disproportionately affected populations, and severity indicators. Therefore, even without self-test result data formally included in national surveillance efforts, the integrated, government-wide surveillance effort for the COVID-19 pandemic§§§ remains strong, incorporating data from a variety of sources, including case surveillance, laboratory. testing, syndrome surveillance, genomics testing, hospitalizations, health care utilization, supply chain capacities, school data, wastewater surveillance, vital statistics, and vaccination.
Current limitations in self-test data reduce their utility in guiding public health decision-making. Cases based solely on positive self-test results do not meet national guidance for confirmed or probable cases because self-tests are not administered by Clinical Laboratory Improvement Amendments (CLIA)-certified providers (8). The quality of the sample, performance of the self-test, result produced, and person tested are uncontrolled in most cases; therefore reported interpretation of results cannot be confirmed. In addition, unlike NAATs, self-test samples cannot be sent for culture and virus isolate characterization to identify or describe the prevalence of variants. Voluntary reporting is often anonymous and lacks information (eg, phone number) necessary for action, including deduplication, case investigation, or contact tracing. Finally, given the similarity in trends for percentage of positive test results and demographic completeness across test types, self-test results are currently unlikely to enhance the ability to understand disease transmission trends.
Despite these limitations, public health experts should continue to evaluate self-test data to understand how they can be incorporated into future surveillance models. Additional analyzes can explore several factors: how communities use and report self-tests, equitable access to self-tests, what factors drive decisions to report results, and representativeness of findings; how often positive self-test results lead to isolation, pursuit of therapy, or confirmation of a result with laboratory-based testing; and to what extent self-testing is replacing testing in more traditional settings.
Anticipating the potential importance of self-test data for public health and the growing demand to shift testing out of care and to individuals, federal agencies have built relationships with test manufacturers to enable data transmission for public health. For example, CDC, through partnerships with the US Digital Service, the National Institutes of Health, the Strategic Preparedness and Response Administration, and the Association of Public Health Laboratories, worked with manufacturers to advise on data to be collected and supported data development. . reporting and data transport capabilities and sharing of self-test data for broad public health use. In addition, the National Institutes of Health, through its RADx Mobile Application Reporting through Standards (MARS) program, is focused on leveraging data standards to improve data harmonization, capture, transmission and reporting for self-tests for clinical and public health use. ¶¶¶ In addition, certain jurisdictions utilize anonymous exposure notification systems that use voluntarily reported test result information, including for self-tests, to notify close contacts of potential COVID-19 exposures.
The findings in this report are subject to at least two limitations. First, self-test data were available from only four manufacturers and from users who voluntarily reported results, representing only approximately 3% of the total self-tests produced by these manufacturers and 0.4% produced by all manufacturers during the period; therefore, these data may not be representative of all self-tests used. Second, data completeness was based on presence of any value and not valid values, and personally identifiable information assessment only captured data for a short period; therefore, ratings provided may not represent overall data quality.
Established surveillance based on NAAT testing exists that can monitor trends in the spread and effects of COVID-19 within communities. However, during the COVID-19 pandemic, self-tests have become an important public health tool to guide individual decision-making. People who use self-tests should be encouraged to report results to their health care providers, who can ensure they receive additional testing, counseling, and medical care as clinically indicated. Limitations in currently available self-test data limit their value for current public health COVID-19 surveillance. Continued development of infrastructure and methods for collecting and analyzing self-test data could improve their value for surveillance purposes during future public health emergencies.
Acknowledgments
Association of Public Health Laboratories; National Institutes of Health RADx MARS program staff members; Division of Laboratory Data, CDC COVID-19 Data, Analytics, and Visualization Task Force.
1CDC COVID-19 Emergency Response Team; 2Division of Health Informatics and Surveillance, Center for Surveillance, Epidemiology, and Laboratory Services, CDC; 3Epidemic Intelligence Service, CDC; 4Deloitte Consulting LLP, Atlanta, Georgia; 5Administration for Strategic Preparedness and Response, US Department of Health and Human Services, Washington, DC; 6Division of Laboratory Systems, Center for Surveillance, Epidemiology, and Laboratory Services, CDC. On the same subject : The federal office focused on the impacts of the climate crisis on health has no permanent staff or funding.
References
FIGURE 1. Weekly number of reported results for COVID-19 self-tests,* point-of-care antigen tests, and laboratory-based and point-of-care nucleic acid amplification tests — United States, October 31, 2021–June 11, 2022
Abbreviation: NAAT = nucleic acid amplification test. On the same subject : 4 locations were upgraded to CDC ‘high’ risk for immigration.
* Self tests reflect primarily antigen test results but may include NAAT results.
FIGURE 2. Seven-day average percentage of positive test results reported for COVID-19 self-tests,* point-of-care antigen tests, and laboratory-based and point-of-care nucleic acid amplification tests — United States, October 31, 2021–June 11, 2022
Abbreviation: NAAT = nucleic acid amplification test.
* Self tests reflect primarily antigen test results but may include NAAT results.
TABLE. Completeness of reporting demographic fields for COVID-19 self-test, point-of-care antigen test, and laboratory-based and point-of-care nucleic acid amplification test results — United States, October 31, 2021–June 11, 2022*
Abbreviations: NA = not available; NAAT = nucleic acid amplification test.
* CDC does not receive information about a patient’s actual name, address, phone number, or email for laboratory-based tests, point-of-care tests, or self-tests. Patient contact information is available on nearly all laboratory-based testing and care test results because the fields are required for laboratory reporting; however, these data are only available to local and state public health agencies to support case investigations and are not included in the data submitted to CDC through the Electronic Laboratory Reporting system for COVID-19. Self-test users may include personally identifiable information when submitting results to manufacturers; however, those fields are obfuscated for CDC use (ie, the field is coded as having information but the value [eg, name] is not provided). Data for obfuscated patient contact information data elements for self-test results were only available for analysis during May 25, 2022–June 3, 2022.† Self-tests reflect primarily antigen test results but may include NAAT results.
Suggested citation for this article: Ritchey MD, Rosenblum HG, Del Guercio K, et al. COVID-19 Self-Test Data: Challenges and Opportunities — United States, October 31, 2021–June 11, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1005–1010. DOI: http://dx.doi.org/10.15585/mmwr.mm7132a1.
MMWR and Morbidity and Mortality Weekly Report are service marks of the US Department of Health and Human Services.
