States’ failure to report SARS-CoV-2 antigen results disrupts effectiveness of monitoring testing data and may lead clinical laboratories to fail to report results correctly, which could trigger federal penalties
As the COVID-19 pandemic continues, the need for more testing has become increasingly recognized. One solution is SARS-CoV-2 antigen testing. Even though these antigen tests are slightly less accurate than laboratory-based PCR tests, antigen test benefits of speed, cost, and availability seem to outweigh the potential disadvantages.
Such rapid antigen testing has only started to be used on a large scale within the last few weeks with the initial fulfillment of state and federal government agreements that enable both increased production and rapid rollout of these tests to nursing homes nationwide.
However, one problem with SARS-CoV-2 antigen tests has come to light following a national survey conducted in the US by Kaiser Health News (KHN). The survey ran from Sept. 3-10, 2020, and with it, KHN sought information for each state about how their SARS-CoV-2 antigen testing is reported.
Since test reporting has become increasingly standardized, inconsistencies would typically be unexciting. However, in this case, the KHN survey reveals that many (respondents in nearly half of the states) believe that antigen-based COVID-19 test results are underreported in their states.
The KHN antigen test survey reveals four significant findings:
- Some 21 states and the District of Columbia responded that they do not report all antigen test results.
- Fifteen states responded that they do not count positive results from individuals’ SARS-CoV-2 antigen tests as being a COVID-19 case. (All the available SARS-CoV-2 antigen tests with emergency use authorizations (EUAs) are authorized as diagnostic tests by the US Food and Drug Administration (FDA), and the fact that some states are not counting positive results as infections is particularly surprising.)
- Two states do not require entities performing antigen tests to report test results.
- Five states only require reporting of positive results.
Reminder of Clinical Laboratories’ COVID-19 Test Reporting Requirements
The results of this survey are indeed surprising and highlight the barriers that exist in COVID-19 results reporting and inadequacies in the data. “The absence of information is a very dangerous thing,” Janet Hamilton, MPH, Executive Director of the Council for State and Territorial Epidemiologists, told KHN. “We will be blind to the pandemic. It will be happening around us and we will have no data.”
One of the effects of states not reporting antigen test results consistently is confusion. With some states not requiring the reporting of any COVID-19 data acquired from antigen-based tests, and others only requiring the reporting of positive results, some clinical laboratories may misunderstand their own reporting obligations as a result.
Under the Centers for Disease Control and Prevention’s (CDC’s) interim guidance for SARS-CoV-2 antigen testing, the CDC cites federal law that requires reporting of test results from “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19.” As the EUAs for existing antigen tests all require the testing entity to hold CLIA certification, every entity that performs a COVID-19 antigen test falls under this requirement.
Entities that do not report COVID-19 tests appropriately may face fines that accumulate daily. Even if the states in which an antigen test is performed are not requiring reporting (or only requiring partial reporting), clinical laboratory directors should be aware that federal regulations do require that all test results be reported—even for antigen tests.
Furthermore, the CDC also states: “Antigen test results that are reported to public health departments must be clearly distinguished from other COVID-19 tests, such as RT-PCR tests and antibody tests.” Clinical laboratories that use antigen testing or assist entities that perform POC antigen testing need to be aware of reporting requirements. They should also pay attention to differences between what their state requires and the federal guidelines. Only by adhering to federal guidelines will laboratories avoid the potential legal liabilities and pitfalls that can result from improper reporting.
—By Caleb Williams, Editor, COVID-19 STAT
Related Resources:
CDC: Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
KHN: Lack of Antigen Test Reporting Leaves Country ‘Blind to Pandemic’
