On December 2, 2021, U.S. President Joe Biden unveiled his COVID-19 winter plan to make at-home testing more available than ever to the U.S. population. With this in mind, let’s look at COVID at-home test statistics to determine their accuracy.
The U.S. Food & Drug Administration (FDA) approves the use of dozens of at-home tests by giving them emergency use authorization (EUA). Understanding the statistics of what makes one test different from another can help you evaluate the proper kit for your circumstances.
So, let’s explore the statistical differences between COVID at-home kits available in the market today.
COVID self-test kits – What’s the difference between at-home testing and home collection testing?
COVID at-home tests involve collecting and processing the test yourself. You follow instructions for handling the kit (for instance, swabbing your nose or mouth). After that, the results are typically ready within a 15 to 30-minute window.
Most of the time, these tests are called antigen tests. Antigen tests measure particular proteins of the COVID-19 virus and detect that you have an active infection when there are high levels of the virus in your body.
Home collection testing involves collecting the test yourself but sending the COVID home kit to a clinical laboratory for processing. This type of testing is a polymerase chain reaction (PCR) test. PCR amplifies the genetic material of COVID-19 to detect the smallest amount of coronavirus. Because of this, PCR testing is the “gold standard” in diagnosing COVID-19, and the results are usually ready in two to three days. Recently, the FDA approved PCR testing at home.
Therefore, the most significant difference between the two testing methods is accuracy and time to get results. In this article, we will only focus on COVID at-home kit testing statistics. A later post will consider home collection tests.
How do COVID at-home testing kits get approved in the United States?
The FDA authorizes COVID at-home testing kits. At the time of writing, 100% of the home kits have emergency use authorization (EUA) in the United States. To clarify, EUA means that the FDA has authorized an unapproved medical product to diagnose, treat, or prevent a severe or life-threatening illness. So, the FDA’s EUA approval indicates there’s sufficient evidence that the test will be effective.
COVID at-home test statistics terminology
COVID at-home test statistics use key terms for measuring the accuracy of the testing.
- Sensitivity: mathematical equation for detecting a true positive test indicating COVID-19. Similarly, positive percent agreement (PPA) compares the current at-home kit to the best testing available.
- Specificity: mathematical equation for detecting a true negative test, indicating the person does not have active disease. Similarly, negative percent agreement (NPA) compares the current at-home kit to the best testing available.
COVID at-home test statistics
The following table compares COVID at-home tests approved for use by the FDA and shows the two types of at-home tests approved, antigen and PCR. The statistics go from the highest sensitivity or PPA to the lowest. Of note, most of the kits report PPA data instead of sensitivity.
How will you use the COVID home kit statistics?
Statistics are fundamental when choosing the optimal test for your needs. However, active symptoms of COVID-19 should be tested immediately, and obtaining whichever kit is readily available is also of the utmost importance.
So, watch our site for reports on updated and approved COVID-19 home kit tests available on the market.
The information contained in this blog is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions about a medical condition or health objectives.
Additional references:
- https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/12/02/remarks-by-president-biden-on-the-covid-19-winter-plan/
- Comparison of Saliva and Nasopharyngeal Swab Nucleic Acid Amplification Testing for Detection of SARS-CoV-2: A Systematic Review and Meta-analysis – PubMed (nih.gov)
- Accuracy of saliva and nasopharyngeal sampling for detection of SARS-CoV-2 in community screening: a multicentric cohort study – PubMed (nih.gov)
- Performance of Saliva, Oropharyngeal Swabs, and Nasal Swabs for SARS-CoV-2 Molecular Detection: a Systematic Review and Meta-analysis – PubMed (nih.gov)
- Coronavirus Disease 2019 Testing Basics | FDA
- Emergency Use Authorization | FDA
- In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2 | FDA
- 201207-sensitivity-specificty-factsheet.pdf (centerforhealthsecurity.org)
- BinaxNOW COVID-19 Antigen Self Test – Instructions for Use Healthcare Provider (fda.gov)
- DxTerity SARS-CoV-2 RT-PCR Test – EUA Summary (fda.gov)
- Return | Ellume COVID-19 Home Test (ellumecovidtest.com)
- download (fda.gov)
- QuickVue At-Home COVID-19 Test – Instructions for Use (fda.gov)
- iHealth COVID-19 Antigen Rapid Test – Instructions for Use for HCP (fda.gov)
- 619d515f95a3f170e221ffe4_IFU-RCPM79-E (B) IFU (ongo) 2021-11-22F.pdf (website-files.com)
- COVID-19 Antigen Self-Test | On/Go (letsongo.com)
- BD Veritor At-Home COVID-19 Test – Instructions for Use Healthcare Provider (fda.gov)
- CareStart COVID-19 Antigen Home Test – Instructions for Use Healthcare Provider (fda.gov)
- CareStart™ COVID-19 Antigen Home Test – Access Bio
- download (fda.gov)
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