COVID-19 rapid antigen test

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COVID-19 rapid antigen test
Lateral flow covid 19 negative and positive test.jpg
SARS-CoV-2 rapid tests.A negative and a positive test. Viral antigen detection lateral flow tests.
SynonymsCOVID-19 rapid antigen detection test (RADT), COVID-19 lateral flow test, COVID-19 lateral flow device, COVID-19 rapid test
PurposeTo diagnose SARS-CoV-2 infections (COVID-19)

COVID-19 rapid antigen tests or RATs, also frequently called COVID-19 lateral flow tests or LFTs, are rapid antigen tests used to detect SARS-COV-2 infection (COVID-19). They are quick to implement with minimal training, and offer significant cost advantages, costing a fraction of other forms of COVID-19 testing and give users a result within 5–30 minutes. Rapid antigen tests are used in several countries as part of mass testing or population-wide screening approaches.[1][2][3] They are thought to be valuable for identifying individuals who are asymptomatic and could potentially spread the virus to other people, who would otherwise not know they were infected.[4] This differs from other forms of COVID-19 testing, such as polymerase chain reaction (PCR), that are generally seen to be a useful test for symptomatic individuals, as they have a higher sensitivity and can more accurately identify cases.

History of development and deployment[edit]

COVID-19 rapid test being administered in Rwanda

Rapid tests for COVID-19 emerged from major investment by the United Kingdom's Moonshot program, a £100 billion program to systematically assess, develop and implement new technologies for COVID-19 testing.[5] Rapid tests initially sat within this systematic evaluation pipeline alongside many other putative COVID-19 testing technologies like Lamp, Lampore, point of care PCR, mass spectrometry and sample pooling. However, as evaluations continued, rapid tests emerged as the most successful form of COVID-19 testing within this program to complement existing PCR testing.[citation needed]

The early scientific rationale for the potential utility of rapid tests and global direction for rapid test technology development were boosted by interim guidance from the WHO that flagged the potential benefits.[6] The report noted that rapid tests were much easier to implement, and had cost benefits. The WHO recommended their use in outbreaks, for early identification of cases and to monitor disease trends.[6] Later, and subsequent to a rapidly increasing body of studies, this recommendation was expanded by the European Commission, which recommended the use of rapid test technology for population-wide screening where the proportion of test positivity is high or very high.[7] By January 2021, the European Commission agreed to strengthen their position, advocating much greater use of rapid tests, noting that "should research prove that rapid antigen tests can be conducted by the testee themselves.... self-testing with or without professional guidance could also be considered."[8]

Initial studies and launch[edit]

One of the definitive studies for rapid tests was completed by Public Health England, University of Oxford and University of Manchester, and launched by Professor Richard Body and Dr Lennard Lee. The Falcon-C19 study was launched within three days on September 17, 2020. The first patient was recruited at the Manchester City Etihad stadium carpark at a new COVID-19 testing research centre. The study rapidly extended to include 14 community research sites across the United Kingdom. The study closed on October 23, having completed testing of 878 individuals. The study was one of the fastest recruiting UK COVID-19 research studies in the country. The study provided definitive evidence that rapid test devices were able to pick up positive results with high accuracy. A total of 4 rapid tests, including the Innova SARS-CoV-2 Antigen Rapid Qualitative Test and the Orientgene COVID-19 IgG/IgM Rapid Test Cassette, were validated in this study, using swab samples from both symptomatic and asymptomatic individuals.[9]

Around the release of the interim analysis of this UK study, the US confirmed that 100 million rapid tests would be purchased from Abbott and shipped across the country to start similar US studies, to complement the University of Oxford initiated studies.[10]

Global regulatory approval[edit]

Rapid antigen test functioning by lateral flow assay.

Following the success of numerous studies around the world to analyse rapid tests from August 2020, rapid tests were approved by regulatory bodies around the world as part of a strategy to use testing as “a new approach to combat the pandemic”. On 16 December, the FDA became the first authority to approve the Abbott rapid test.[11] Subsequent approvals were given for the Ellume COVID-19 home test.[12] However, on October 5, 2021, the FDA issued a Class I recall of more than 2.2 million (2,212,335) Ellume's home tests because "they have higher-than-acceptable false positive test results for SARS-CoV-2".[13]

Rapid tests were also approved by Health Canada with their advisor, Professor David Juncter noting “the best rapid tests are highly accurate at detecting contagious individuals“ and Infectious disease specialist Jean Longtin noting "It will allow us to move faster than the virus and find the person's contacts in an hour or two, instead of waiting 24 hours".[14][15]

The United Kingdom's MHRA confirmed their approval of the Innova rapid test for self-use testing on 23 December. Following the clear global success of this global development of rapid tests, Sir John Bell, Regius professor of medicine at the University of Oxford said “Rapid tests were a central bit of good defence against coronavirus because they were fast, cheap and available for repeat use”.[16] In June 2021, the Food and Drug Administration in the US has issued a Class 1 recall of more than 77,000 Innova LFT's as the product had not been evaluated by the FDA.[17] A week after the FDA's recall notice on Innova LFT, UK's MHRA cleared the rapid diagnostic's use and extended its authorization, noting “We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time,” said Graeme Tunbridge, director of devices for the MHRA.[18] Innova's LFT has been approved in 16 countries globally, including UK, Germany, France and Italy.

Later COVID-19 strains[edit]

On 22 December 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, VOC-202012/01. The strain rapidly spread around the world. With widespread global use of this form of COVID-19 testing, there was a concern that this variant would render rapid testing obsolete. As part of the UK's accelerated technology evaluation of lateral flow, within 24 hours, Public Health England laboratories were able to confirm rapid test in global development were not affected and they could identify the new variant. This was because rapid test generally targets the nucleocapsid protein and not the spike protein.[19] Some strains however, have recently been identified that do affect some rapid tests' sensitivity up to 1,000-fold.[20] Fortunately, the frequency of these nucleocapsid mutations (specifically D399N) is still relatively low globally at ~0.02%.[citation needed]

In the United States[edit]

Having initially invested considerably in rapid test technology development along with the United Kingdom, further evaluation of rapid tests as part of mass testing approaches in the US stalled as a result of the impasse around the $900 billion in COVID-19 relief contained within the 2020 Consolidated Appropriations Act, 2021. The bill was criticised for not specifically ring-fencing investment in rapid tests as a cost-economical and effective form of population-wide testing.[21] Scientists in the US, such as epidemiologist Professor Michael Mina of Harvard University, noted that tests were a “very powerful adjunct to everything else that people are already doing” and that "home tests for COVID-19 could slash infection rate".[22] This view was reinforced by Professor William A. Haseltine, also of Harvard, in an article in Forbes magazine proposing "rapid, self-administered testing could stem the ever-surging tide of disease and death"[23] and an article by Professor Annie Sparrow of Mount Sinai, New York proposing "Cheap Mass Testing is Vital for Pandemic Victory" in view of "the emergency of the highly contagious and fast-spreading B117 strain in the UK, and a similar strain from South Africa".[24] Nevertheless, rapid home tests for COVID-19 were publicly available to individuals in January 2021, following the earlier FDA approval.[25][26] These tests were reimbursed by providers of health insurance in the United States for people with COVID-19 symptoms, or those who have had close contact with an infected person or with someone showing symptoms.[27] An article in the Washington Post proposed that the maximum benefit of rapid tests in the US might not be realised until the "federal government covered testing for asymptomatic people because transmission by those people is such a huge part of the outbreak", as testing these individuals was not covered by health insurance.[26][28] Following the inauguration of a new president in January 2021, the US restarted investment in rapid test technology development with the publication of presidential executive orders.[29][30]

Valuation studies[edit]

Contents of a box of free COVID-19 rapid antigen lateral flow tests provided by the NHS Test and Trace system.

On 2 November 2020, Slovakia became the first country in the world to initiate country-wide mass testing using rapid tests. Five million rapid tests were performed by 60,000 staff who used the SD Biosensor antigen test and performed swabbing on the population.[31][32] This then led the European Commission to recommend that rapid tests be used as part of population-wide screening.[1] Two research studies published in early 2021, one by professor Martin Kahanec from Central European University and his coauthors and another one by Martin Pavelka from the London School of Hygiene & Tropical Medicine and his team suggest that the effects of the Autumn wave of rapid antigen mass testing in Slovakia helped to suppress the pandemic in the country, although according to the former study the effect of mass testing on the pandemic was temporary and started to dissipate after about two weeks.[33][34]

The United Kingdom continued their ongoing rapid test development programme using the Innova rapid test, with increasing urgency as COVID-19 cases increased across Europe. On 6 November, the Prime Minister, Boris Johnson, started city-wide screening of Liverpool as part of the accelerated technology evaluation.[35] Further expansion of rapid tests pilots were also launched for many sectors where testing had not been previously available. These included students at Universities who had been particularly hit by outbreaks. This initially started at Durham University, who had the infrastructure and expertise to manage the rapid test programme,[36] but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.[37] Rapid tests were also implemented within the National Health Service (NHS) for staff to reduce possible transmission to patients,[38] local authorities [39][40] and care homes to enable visits to visit residents.[41][42] On 18 November 2020, Wales completed the first whole borough testing at Merthyr Tydfil.[43][44] At this time, testing was also implemented across schools in the US for students with symptoms [45] and across Portuguese care homes and schools.[46]

Global efforts to step up evaluations of rapid tests were initiated by the World Health Organization (WHO) Emergencies Department who launched a major rapid diagnostic test implementation project on the 10th of November, aided by agreement from the Bill and Melinda Gates Foundation that limited costs for low- and middle-income countries.[47][48]

Austria started country-wide mass testing on 5 December and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).[49][50]

By the middle of December, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,[51] the United Kingdom,[52] and the US.[53] These studies all enabled rapid tests to enter standard national COVID-19 testing strategies. Global piloting of rapid tests was now common place in schools in Canada,[54] travel hubs in Indonesia,[55] and across India.[56]

Humanitarian uses[edit]

In addition to routine community use, rapid tests have also been utilised as part of humanitarian efforts during the pandemic. Following the flooding in Jakarta in Indonesia on 2 December 2020, rapid tests were made available in flood shelters.[57] Furthermore, following the closure of national borders in Europe following the emergence of the Alpha variant just before Christmas 2020, nearly 6,000 lorry drivers were stranded without food,[58] effectively stopping Christmas food deliveries. Rapid tests were deployed by French firefighters within 24 hours at the Channel. Rapid tests enabled lorries to get on the road and complete their deliveries and return to their families for Christmas, demonstrating the potential global utility of having an easily implementable COVID-19 test.[59][60] Médecins Sans Frontières strongly endorsed the use of rapid tests in lower- and middle-income countries, noting "COVID-19 antigen tests can deliver rapid and actionable results, ensuring timely identification of people infected with the virus at the community level".[61]

Use for "return to normal"[edit]

Spain became the first country to use rapid tests to facilitate a return-to-normal with rapid tests being widely available in pharmacies in December 2020,[62] and a free music concert held in Barcelona for individuals who took a rapid test.[63] A similar approach was taken in Albania to enable music festivals.[64] However, many experts were unsure of this approach believing that “rapid tests are not the solution to restart normal life”[65] but might be used in conjunction with other infection control techniques.[66]

Concerns about use[edit]

Many individuals have raised concerns that the accuracy of rapid tests was not as good as the existing form of COVID-19 testing PCR. Data released from the United Kingdom's City-wide screen in Liverpool illustrated that army operators of the test did obtain the test performance of trained laboratory scientists,[16] following other pilots in India.[67] This caused minor issues within the scientific-psychological community where there was a debate about whether rapid tests might lead to false reassurance and a change in behaviour. However, a shift in thinking about the use of rapid tests was confirmed following a publication from the US. Professor Michael Mina theorised that rapid tests would still be useful as it identified infectious individuals,[68] and potential benefits observed from repeating rapid test and getting a result much quicker than other forms of testing.[69][70] The United Kingdom's chief clinical medic, Dr Susan Hopkins, also noted that rapid tests provided a means to find “people that...we couldn't otherwise find”.[71]

Noting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the European commission met on 11 December and developed a common European framework for “use, validation and mutual recognition of rapid tests”, committing 100 million euros for the purchase of tests from Roche and Abbott. Stella Kyriakides, commissioner for Health and Food Safety said "Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic."[72]

Other individuals have raised concerns about the slow uptake and deployment of rapid tests and potential loss of life that might have occurred as a result. An academic group from Canada noted that half the deaths in care homes in the early part of the pandemic could have been prevented with rapid tests.[73]

A certification of quality for a COVID-19 rapid antigen home test.

Global market value[edit]

Following the widespread use of rapid tests around the world, rapid tests have a market value of $15 billion; however, the market is expected to cease from 2024 due to the vaccination of the global population by the end of 2023.[74] In the US, the market for rapid tests was US$3.9 billion with a >20% growth rate in hospitals, clinics, Asia Pacific but also as end-user tests.[75] International market analysts have predicted that manufacturers of rapid tests will face an ongoing increase in demands as more individuals and countries start to use rapid tests to identify individuals with milder symptoms.[76] A number of commentators and scientists from the US have raised concerns whether the global manufacturing network were able to meet global demand and manufacture the hundreds of millions of tests that would be needed for frequent rapid testing.[77][78]

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