Rapid antigen tests to detect the presence of SARS-CoV-2
As of August 18, the FDA had issued three Emergency Use Authorizations (EUA) for rapid SARS-CoV-2 antigen tests
to Quidel Corporation, Becton, Dickinson and Company (BD), and LumiraDx UK Ltd. These assays are authorized for use in CLIA-certified laboratories which meet requirements for performing high or moderate complexity tests, or for use in patient care settings operating under a CLIA Certificate of Waiver, i.e. as Point of Care tests.
The authorized antigen tests detect the presence of SARS-CoV-2 in material collected via nasopharyngeal or nasal swab specimens. These tests can provide results in 30 minutes or less. In part because rapid antigen tests have a higher limit of detection than molecular tests, i.e. they are less able to detect smaller amounts of virus, the currently approved rapid antigen tests are best used early during infection, when viral load is highest. Additionally, rapid antigen tests might be used in scenarios with high-risk individuals or individuals living in congregate settings. These applications of rapid antigen tests maximize the potential for effective clinical and public health interventions.
As mentioned, rapid antigen tests are less sensitive than their molecular/RT-PCR counterparts, meaning that they are more likely to inappropriately classify infected individuals as uninfected. Quidel and BD rapid antigen tests demonstrated 97% and 84% sensitivity, respectively, when compared to RT-PCR. Thus, it is important for clinicians and other health professionals to understand factors that might affect assay performance, and how to appropriately manage a patient with, for example, high clinical suspicion for COVID-19 but a negative antigen test. Rapid antigen tests have, however, demonstrated 100% specificity – similar to RT-PCR – meaning that false positive results are very unlikely.
Funding available for behavioral health triage
Idaho's Division of Behavioral Health has launched a new funding opportunity to establish Emergency Department Psychiatric Triage Centers
(ED-PTCs). The ED-PTCs will provide health services during the pandemic to those suffering a behavioral health emergency, but who do not have a critical medical health need that would necessitate a hospital emergency department visit.
This funding will be used to stand up ED-PTCs in areas throughout Idaho seriously impacted by COVID-19 to meet community needs. The ED-PTCs must be able to conduct ED triage, provide the appropriate level of behavioral health interventions for patients requiring an in-patient level of care, and divert those with less acute needs to an alternative resource. This arrangement provides more availability of ED and hospital resources while still meeting the needs of behavioral health patients.
are due by September 25 with award notifications expected by October 19. Individual awards will be at least $37,000 and up to $225,000. For additional information, contact Anne Bloxham
TaqPath COVID-19 test has risk of false results
This week, the FDA alerted
labs and providers that a test kit by Thermo Fisher Scientific may produce false positive results. The FDA recommends that those using the TaqPath COVID-19 Combo Kit immediately update the software and take other steps to mitigate false results. Additional information will be released as it becomes available.