Discussion
During October 2021-May 2022, approximately 393 million self-tests were produced by the four manufacturers assessed in this study. Although not all self-tests produced by these manufacturers have been distributed, purchased, and used, the 10. See the article : Jury Rules Physician Health Care Fraud Scheme.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 strong increase of the Omicron variant (December 2021-February 2022) covered by this analysis (6,7), a lack of of ascertaining the cases (5). The lack of ascertainment can be attributed to multiple factors, including the lack of formal mechanisms that allow the reporting of self-test results to public health authorities and to persons with mild or no symptoms symptoms that do not seek tests 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. The obligation to report all self-test results to public health authorities is impractical and could negatively affect the acceptability and use of self-tests, which would be detrimental for reducing the spread of disease. Although increased self-testing (4) may result in under-ascertainment of the total number of cases, this analysis indicates that NAAT data captured through CELR, together with case data , remains strong and continues to follow trends in community transmission.††† In addition, persons with more severe disease are probably 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 care systems, heavily or disproportionately affected populations, and indicators of severity. Thus, even without formally including self-test results data in national surveillance efforts, government-wide integrated surveillance activity for the COVID-19 pandemic§§§ remains b health, incorporating data from various sources, including case surveillance, laboratory. testing, syndromic surveillance, genomics testing, hospitalizations, healthcare utilization, supply chain capabilities, school data, wastewater surveillance, vital statistics, and vaccinations.
Current limitations in self-test data limit 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 the self-tests are not administered by Clinical Laboratory Amendments (CLIA) certified providers (8). The quality of the sample, the execution of the self-test, the result produced, and the person tested are not verified in many cases; therefore, the reported interpretation of the results cannot be confirmed. In addition, in contrast to NAATs, self-test samples cannot be submitted for culture and characterization of viral isolates to identify or describe the prevalence of variants. Voluntary reporting is often anonymous and lacks the information (eg, phone number) necessary for action, including deduplication, case investigation, or contact tracing. Finally, given the similarity in trends for percentages of positive test results and demographic completeness across test types, self-test results are currently unlikely to improve the ability to understand patterns of disease transmission.
Despite these limitations, public health experts need to continue to evaluate self-test data to understand how they can be incorporated into future surveillance models. Additional analyzes could explore various factors: how communities are using and reporting 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 treatment, or confirmation of the result with laboratory-based tests; and to what degree self-testing is replacing testing in more traditional settings.
Anticipating the potential importance of self-test data to public health and the growing demand to move testing out of care and into individuals, federal agencies have been building relationships with manufacturers of the text to enable the transmission of data for public health use. 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, have worked with manufacturers to advise on data to be collected and supported data development. self-test data reporting and data transport and sharing capabilities for broad public health use. Additionally, the National Institutes of Health, through their RADx Mobile Application Reporting through Standards (MARS) program, is focusing on leveraging data standards to improve data harmonization, capture, transmission and reporting for self-tests for clinical and public health use. ¶¶¶ Additionally, certain jurisdictions are leveraging anonymous exposure notification systems that use information on voluntarily reported test results, including for self-tests, to notify close contacts of potential exposures of COVID-19.
The findings in this report are subject to at least two limitations. First, self-test data were only available from four manufacturers and from users who reported results voluntarily, representing only about 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, the completeness of the data was based on the presence of any value and not valid values, and the assessment of personally identifiable information captured data only for a short period; therefore, the estimates provided may not represent the overall quality of the data.
Established surveillance based on NAAT testing is in place that can monitor trends in the spread and effects of COVID-19 in communities. However, during the COVID-19 pandemic, self-tests have become an important public health tool to guide individual decision-making. Persons using 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 may improve their value for surveillance purposes during future public health emergencies.
Acknowledgments
Association of Public Health Laboratories; Staff members of the RADx MARS program of the National Institutes of Health; Laboratory Data Section, CDC COVID-19 Data, Analytics and Visualization Task Force. This may interest you : The Health Commissioner orders pharmacies to dispense naloxone.
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, D.C.; 6Division of Laboratory Systems, Center for Surveillance, Epidemiology, and Laboratory Services, CDC.
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.
* Self-tests primarily reflect antigen test results but may include NAAT results. Read also : SOT Caseworker – United States of America.
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 primarily reflect 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 and point-of-care test results because fields are mandated for laboratory reporting; however, these data are only made available to local and state public health agencies to support case investigations and are not included in the data sent to CDC through the Electronic Laboratory Reporting system. COVID-19. Self-test users may include personally identifiable information when submitting results to manufacturers; however, these fields are obfuscated for CDC use (ie, the field is encoded as having information but the value [eg, name] is not provided). Data for the hidden patient contact information data elements for self-test results were only available for analysis during May 25, 2022–June 3, 2022. † Self-tests primarily reflect 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.
