COVID rapid diagnostic options expand with at-home LAMP test

Regulatory NewsRegulatory News | 18 November 2020 |  By 

US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the first COVID-19 diagnostic test that can be used to provide rapid results at-home.  
The newly authorized Lucira COVID-19 All-in-One test kit is a molecular test that uses real-time loop-mediated amplification (LAMP) technology to detect the presence of SARS-CoV-2, the virus that causes COVID-19. The test enters the market as the pandemic surges worldwide and governments are re-thinking how testing strategies can play into containment of the novel coronavirus, while the world waits for authorization, and then widespread delivery, of vaccines against COVID-19.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” said FDA Commissioner Stephen Hahn, MD, in a 17 November press release announcing the EUA. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home.”
The test is authorized for home use via prescription for individuals who are at least 14 years old and are “suspected of COVID-19 by their health care provider,” according to FDA. Patients collect a nasal swab and then place it in a vial in the Lucira test unit. Results, which are available within 30 minutes, are indicated by a light-up display.
The test also can be administered by health care professionals or self-administered at point of care (POC); it cannot be self-administered for those under 14 years of age.
“A test that can be fully administered entirely outside of a lab or health care setting has always been a major priority for the FDA to address the pandemic,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”
Lucira reports that each single-use test kit will cost about $50.
Other home-use and rapid options in the US
Other at-home COVID-19 test collection options are currently in use; for example, the state of Minnesota is mailing reverse transcriptase-polymerase chain reaction (RT-PCR) test kits to patients at home for supervised self-collection of saliva via a video telemedicine appointment. The sample then needs to be mailed back to a laboratory for processing. They can be ordered directly by consumers.
A rapid, standalone COVID-19 antigen test was granted an EUA in August. Abbott’s BinaxNOW test uses a testing card to yield results from a nasal swab within minutes after a reagent is applied. Like some home pregnancy tests, a positive result is indicated by the presence of two lines on the test card, while one line indicates that the result is negative.
Antigen tests are generally less sensitive than molecular tests, so the Centers for Disease Control and Prevention (CDC) recommends using clinical circumstances to decide whether confirmatory molecular diagnostic tests are required. (RELATED: Rapid standalone COVID antigen test nabs EUA, Regulatory Focus  27 August 2020)
Although Abbott’s test is not currently authorized for home use, it costs just around $5 and has an accompanying phone app that can effectively serve as a “digital health pass.” Some have advocated taking advantage of the ease of use, low cost, and digital interoperability of this type of test-app combination for widespread home self-testing as an important public health intervention during the pandemic.
The ability to have half of the US population perform home antigen testing about every 4 days would cost $5 billion and effectively achieve “vaccine-like ‘herd effects,’” according to a 17 November opinion piece authored by epidemiologist and immunologist Michael Mina, MD, PhD, published in Time magazine. The National Institutes of Health reports that the US has thus far spent about $2 billion on Moderna’s vaccine candidate alone. (RELATED: NIH director: Efficacy for co-developed Moderna vaccine nears 95%, Regulatory Focus 16 November 2020)
“The cost is so low...that not trying should not even be an option for a program that could turn the tables on the virus in weeks,” Mina wrote, noting that Slovakia has seen dramatic case reductions with just 2 weeks of such a program. From a public health perspective, the lower sensitivity and specificity of antigen tests are worth the tradeoff, if there are plans for confirmatory testing when appropriate, Mina added.
Rapid molecular tests like Lucira’s  “will be crucial fo[r] entry screening when very high sensitivity/confirmation is needed,” as for nursing home entry, Mina noted in a in a Twitter thread on authorization of the Lucira at-home LAMP test.
Mina also advocates making all COVID-19 testing available without a prescription. “No COVID test today should require a prescription,” Mina wrote on Twitter, tagging the FDA.
A role for antigen testing in the EU
Meanwhile, the European Commission (EC) has issued recommendations on the use of rapid antigen tests to detect SARS-CoV-2.
In a document emphasizing the importance of harmonization among European Union (EU) member states, the EC’s commissioner for health and food safety, Stella Kyriakides, recommended that rapid antigen tests be used in addition to RT-PCR testing “in clearly defined settings where the deployment of antigen tests is appropriate,” both for disease detection and to enable member states to limit isolation and quarantine measures.
The EC recommends using rapid antigen tests with sensitivity of at least 80% and specificity of at least 97%, and ensuring that only CE-marked tests be put into clinical use. The recommendation also sets forth scenarios where testing of asymptomatic members of the population may be appropriate, as when a local community has high prevalence of COVID-19.
Validation and mutual recognition guidelines are also put forward by EC, with the intent of ensuring both reliability of results and comparability across test types and between member nations, Kyriakides said. “Results performed with tests that have been validated at national level by one Member State and that meet the criteria of sensitivity and specificity of this Recommendation, should be recognized by other Member States.”


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Tags: coronavirus, EU, FDA, US

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