COVID-19 Antigen Tests Are Ready for Mass Utilization but Antigen Test Reporting Is Not
It will take something on the order of 200 million COVID-19 screening tests per month, as opposed to the 25 million being performed currently, to safely reopen the U.S., estimates a new report from Duke University. Because of their low costs, scalability and speed, antigen tests may play a crucial role in meeting this unprecedented level of demand, particularly in nursing home, educational and workplace settings. However, if antigen testing is to be the answer, there is one significant problem that will need to be addressed: lack of reliable and consistent test data reporting. The Promise of Antigen Testing What the country and world need right now are point-of-care tests that can deliver accurate results at cost-effective prices that can be utilized to screen asymptomatic populations. Molecular tests using reverse transcription-polymerase chain reaction (RT PCR) to detect RNA material from the SARS-CoV-2 virus performed at an offsite laboratory are accurate but too slow and expensive to satisfy the need for screening services. Blood-based serology tests that detect SARS-CoV-2 antibodies are better suited for widespread and rapid screening, but lack the specificity and sensitivity of RT PCR assays. Antigen tests that detect viruses indirectly by identifying the presence of antigens or […]
- 21 states and the District of Columbia do not report all antigen test results;
- 15 states and D.C. do not count positive results from antigen tests as COVID cases;
- Two states do not require antigen test providers to report results;
- Five states require only positive results to be reported; and
- Nearly half of states believe their antigen test results are underreported.
States that Don’t Report Antigen Test Results or Don’t Count Antigen Positives as COVID-19 Cases
California, Colorado, District of Columbia, Georgia, Illinois, Maryland, Minnesota, Missouri, Montana, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, Wyoming
Source: Kaiser Health News What Counts as a COVID-19 Case Part of the problems with antigen test reporting is that under U.S. Centers for Disease Control and Prevention (CDC) guidance, a case must be determined from a RT PCR test to be considered a “confirmed” case of COVID-19. Positive antigen tests are considered “probable” COVID-19 cases because the tests are less accurate. In early August, the CDC revised its guidelines to allow a positive antigen test to count as a probable case without assessing whether the person has COVID-19 symptoms or close contact with a person confirmed as having the virus. This asterisk placed by the CDC on antigen positives has led to a disconnect among state reporting rules, with some states requiring reporting of only “confirmed” COVID-19 cases while others require reporting of both “confirmed” and “probable” cases. Takeaway Reporting of test data will be crucial to contain the spread of COVID-19 and make scientifically sound decisions about the pace and scope of reopening. In recognition of this, the U.S. Centers for Medicare Services recently imposed draconian new testing requirements on skilled nursing facilities and stepped up the penalties for violations of existing reporting rules for hospital and other laboratories. As the use of rapid antigen testing proliferates, policy makers at both the federal and state levels will have to confront and resolve the problems that are currently preventing full, consistent, and accurate reporting of antigen test results.Subscribe to Clinical Diagnostics Insider to view
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