The performance of Mesa Biotech’s test may be impacted when testing SARS-CoV-2 patient samples that have a genetic variant at position 28881 (GGG to AAC). Meanwhile, the tests from Thermo Fisher and Applied DNA Sciences have shown reduced sensitivity for the virus’s S gene when certain mutations are present, including one of the mutations in the B.1.1.7 SARS-CoV-2 variant that was first identified in the U.K.
FDA notes that the overall impact of variants on these three tests does not appear to be significant—especially for the Thermo Fisher and Applied DNA Sciences tests, which detect multiple genetic targets. However, out of an abundance of caution, the agency still thought it best to alert healthcare professionals about this potential issue. Additionally, FDA wants labs that are using the Thermo Fisher and Applied DNA Sciences tests to be aware of the pattern of detection when certain mutations are present. This might help with early identification of new variants in patients, which in turn could help to further reduce the spread of infection.
FDA Aims to Increase COVID-19 Patient Access to Viscoelastic Coagulation Testing
The Food and Drug Administration (FDA) has issued new guidance in order to expand the availability and capability of viscoelastic coagulation analyzers for use in COVID-19 patients. Currently, FDA has not cleared or approved any coagulation systems for measurement of whole blood viscoelastic properties in hospital patient healthcare settings. However, as the pandemic has continued, it has become clear that these devices are needed to test for and manage coagulopathies in hospitalized COVID-19 patients, who are at an abnormally increased risk for blood clotting. With this guidance, FDA intends to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to viscoelastic coagulation systems so that they can be used in COVID-19 patients. Specifically, the agency does not intend to object to limited modifications to the indications, functionality, hardware, and/or software of viscoelastic coagulation analyzers that are within the scope of this guidance, even if the manufacturer does not submit a new 510(k) submission to FDA.
Abbott Receives FDA Authorization for Prescription Home SARS-CoV-2 Antigen Test
The Food and Drug Administration has issued a new emergency use authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card test. This SARS-CoV-2 antigen test first received an EUA in August 2020 for use in healthcare settings. With this new EUA, patients can now use the test at home with a prescription if their healthcare provider suspects that they have COVID-19. The test should be used within the first 7 days of symptom onset and is authorized for use with self-collected nasal swab samples from individuals ages 15 years or older and with adult-collected nasal swab samples from individuals 4 years or older. Abbott will offer the test in partnership with a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the relevant public health authorities in accordance with local, state, and federal requirements.
FDA OKs Siemens Test That Helps Predict COVID-19 Cytokine Storm
Siemens Healthineers has received an emergency use authorization from the Food and Drug Administration for its laboratory-based IL-6 assay that measures the presence of interleukin-6 (IL-6) in human serum or plasma. IL-6 is an indicator of potential severe inflammatory response in patients with confirmed SARS-CoV-2 infection. In conjunction with clinical findings and the results of other laboratory testing, this assay could help clinicians to identify COVID-19 patients who are at risk of cytokine storm and need intubation with mechanical ventilation. The test could also help clinicians start timely interventions with IL-6 activity blockers such as tocilizumab and sarilumab. Siemens’ IL-6 assay is currently available across the U.S. on the Advia Centaur Immunoassay systems with a time-to-result of 18 minutes. The test is also CE marked for use outside the U.S. on the Advia Centaur systems, Atellica IM analyzer, and Immulite systems.
FDA Grants EUA for Ellume’s Over-the-Counter SARS-CoV-2 Home Antigen Test
The digital diagnostics company Ellume has earned Food and Drug Administration emergency use authorization (EUA) for its rapid, direct-to-consumer SARS-CoV-2 antigen test, the Ellume COVID-19 home test. The test will be available for non-prescription home use in adults and children aged 2 years or older with or without symptoms. It works in conjunction with a smartphone application that provides step-by-step instructions for the user. All analysis is performed by the test’s electronic analyzer, which then uses Bluetooth connectivity to display the test result on the user’s smartphone in 15 minutes or less.
In a simulated home-setting clinical study of 198 subjects, the Ellume COVID-19 home test demonstrated an overall sensitivity of 95% and specificity of 97% when compared to an EUA polymerase chain reaction SARS-CoV-2 laboratory test. This same study showed that in individuals presenting with COVID-19 symptoms, Ellume’s test demonstrated 96% sensitivity and 100% specificity, while in asymptomatic individuals, the test demonstrated 91% sensitivity and 96% specificity.