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Test Kits

Coronavirus (COVID-19) Update

FDA issues authorization for first Molecular Non-Prescription, at-home test.

This test is intended for use in adults (self-swabbing) or children two years of age or older (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.

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The authorized test includes:

  • single-use Cue COVID-19 Test Cartridge
  • single-use Cue Sample Wand nasal swab
  • Cue Cartridge Reader (used by the Cue Health Monitoring System, provided separately)
  • Cue Health Mobile Application (App) that is downloaded onto compatible mobile smart devices, like a smart cell phone.

The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes.

The mobile application requires individuals to create an account, and in the future will be updated to include capability to report test results as appropriate to public health authorities to monitor disease prevalence.

Companies Inappropriately Marketing Coronavirus (COVID-19) Diagnostic or Antibody Test Kits

The U.S. Food and Drug Administration (FDA) has authorized several diagnostic COVID-19 tests for use with at-home collection of samples from the nose or saliva, that can then be sent to a lab for processing and reporting. However, there are no serology tests that are authorized for use with at-home collection of samples.

Antibody tests, also called serological tests, detect antibodies to SARS-CoV-2 (originally called 2019 Novel Coronavirus or 2019 nCoV), which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection.

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:

  • Diagnostic Tests: detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests
  • Serology or Antibody Tests: detect antibodies (IgM, IgG) to the SARS-CoV-2 virus. They cannot be used to diagnose a current infection
  • Tests for Management of COVID-19 Patients: beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions

The assays are intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic products. They are only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA) .

Emergency Use Authorization (EUA)

These EUAs are issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. An EUA is revoked, when FDA determines that it is not reasonable to believe the product may be effective in diagnosing infection or detecting antibodies against SARS-CoV-2, or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. Therefore, false test results could justify revocation to protect the public health or safety.

Manufacturers and authorized distributor(s) will collect information on the performance of the products, and report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the product of which they become aware.

Products must comply with the following labeling requirements under FDA regulations: the intended use statement, adequate, directions for use, any appropriate limitations on the use, and any available information regarding performance of the device.

  • Diagnostic or Antibody Test Kits have not been FDA cleared or approved
  • They are authorized for use by Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified laboratories
  • Tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19, unless the authorization is terminated or revoked sooner.

Current good manufacturing practice (GMP) requirements, including the quality system with respect to the design, manufacture, packaging, labeling, storage, and distribution of these products, are usually waived.