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COVID-19 rapid antigen test

November 26, 2023

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, cost a fraction of other forms of COVID-19 testing, and give users a result within 5–30 minutes. RATs have been used in several countries as part of mass testing or population-wide screening approaches.[1] Many RATs can be used for self-testing, in which an individual "collects their own specimen… and interpret[s] their test result themselves".[2]

COVID-19 rapid antigen test
Negative (left, showing Control line) and positive (right, showing Control and Test lines) results
SynonymsSARS-CoV-2 or COVID-19 antigen test, rapid antigen detection test (RADT), lateral flow test (LFT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test[a]
PurposeTo diagnose SARS-CoV-2 infections (COVID-19)
LOINC94558-4, 95209-3, 96119-3, 97097-0

False positives are very rare; the tests' specificity is 98%-99%.[3][4][5] However, the tests have a sensitivity of 70%-72%,[3][4][5] which is lower than COVID-19 polymerase chain reaction (PCR) tests' sensitivity of 88%-96%.[6][7][b] Despite this, COVID-19 RATs remain valuable in finding people who would otherwise not know they were infected, helping to prevent further transmission. The tests are more sensitive in the symptomatic and transmissive stages of disease when the viral load is higher.[3][4][5][8][9]

Uses edit

Use in diagnosis edit

COVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The World Health Organization (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a "confirmed case of SARS-CoV-2 infection" in two ways.[10] First, the person with a positive Antigen-RDT could meet a "probable case definition" such as having recent loss of smell or taste without any known cause, or could meet certain "suspect criteria" such as having a severe acute respiratory illness.[10] Second, the person with a positive Antigen-RDT could be asymptomatic but a "contact of a probable or confirmed case."[10] Nevertheless, individual countries may have different case definitions of COVID-19; for example, in New Zealand a positive PCR test (not just a RAT) is necessary for a person to be considered a "confirmed case."[11]

Use in screening edit

Between mid-2020 and early 2021, studies using mathematical models estimated the benefit of frequent RATs in screening populations for COVID-19. Paltiel et al studied a hypothetical college campus with 5000 students.[12] Screening all students every two days with a "low-sensitivity, high-specificity test" (such as a RAT) would be able to control an outbreak of COVID-19.[12] Mina et al theorized that higher-frequency screening using lower-sensitivity RATs may be more useful than lower-frequency screening using higher-sensitivity PCR tests because the former would "capture most infections while they are still infectious."[13] The quick results of RATs would serve to limit asymptomatic spread.[13] Larremore et al simulated various COVID-19 population screening strategies.[14] The researchers found that "effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity."[14]

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.[15] 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,[16] 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.[17][18] 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".[19]

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,[20] and a free music concert held in Barcelona for individuals who took a rapid test.[21] A similar approach was taken in Albania to enable music festivals.[22] However, many experts were unsure of this approach believing that "rapid tests are not the solution to restart normal life"[23] but might be used in conjunction with other infection control techniques.[24]

Concerns about use edit

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

False negatives (low sensitivity) edit

Although the specificity of RATs are high (98%-99%),[3][4][5] in 2020 RATs were criticized for having a sensitivity as low as 50%; that is, if people with COVID-19 as determined by a positive PCR test were also tested with a RAT, about half the time the RAT would be negative.[25][26][27] As of 2022, systematic reviews determined that the pooled sensitivities of RATs were 70%-72%.[3][4][5] In one systematic review, the range of sensitivities across studies was 37%-90%.[3] As WHO recommends RATs with "≥ 80% sensitivity",[28] many RATs do not meet the WHO recommendation.

In the systematic reviews, the sensitivity was higher for symptomatic people (76%-82%) than for asymptomatic people (57%-68%).[3][4][5] RATs were more sensitive when samples had more viral load, as measured by a low PCR "cycle threshold," and less sensitive when the samples had less viral load.[3][4][5]

A 2022 study followed 225 adults and children with COVID-19 over 15 days using PCR tests, viral cultures, and home RATs.[29] It found that the sensitivity of the RAT (Quidel QuickVue) increased from 0% two days prior to symptom onset or first positive PCR test to 77% four days after symptom onset or first positive PCR test, with an overall sensitivity of 50%.[29] Compared with PCR tests collected the same day, the RAT sensitivity was 64%; compared with viral cultures collected the same day, the RAT sensitivity was 84%.[29] The sensitivity of the RAT was lower in persons who were vaccinated against COVID-19 than in persons who were not vaccinated against COVID-19.[29]

Potential for false negative results due to new variants edit

In November 2020, a new, marginally more infectious strain of SARS-CoV-2 was identified in the United Kingdom, the SARS-CoV-2 Alpha variant. 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 that RATs in global development were not affected (i.e., that they could identify the new variant). This was because rapid test generally targets the capsid protein and not the spike protein.[30] Some strains have been identified with a nucleocapsid mutation (D399N) that does decrease the sensitivity of at least one RAT (Quidel Sofia 2) up to 1,000-fold.[31] Fortunately, the frequency of mutation D399N was still relatively low globally at ~0.02% as of May 2021.[31] A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70.0%-92.9% for the Delta variant and 69.6%-78.3% for the Omicron variant across a range of viral loads; however, for Omicron samples with a low viral load, the sensitivities were 0.0%-23.1%.[32]

False positive results when instructions not followed edit

If a COVID-19 RAT is used outside manufacturer recommendations, the result can be false positive. Beginning in December 2020, TikTok videos demonstrated how to use soft drinks to create false positive COVID-19 RAT results.[33] Later, researchers found that introducing fruit juices, alcoholic beverages, bottled water, and other products directly into an Abbott Panbio COVID-19 RAT without the manufacturer's recommended buffer solution produced false positives.[34] In contrast, a different RAT (BD Veritor) produced no false positive results under the same conditions.[34]

Slow deployment and uptake edit

Some have raised concerns about the slow deployment and uptake of RATs, and the potential loss of life that might have occurred as a result. A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available.[35]

Methods edit

An antigen is a foreign molecule or molecular structure that can cause an immune response. COVID-19 rapid antigen tests (RATs) detect antigenic proteins on the surface of the SARS-CoV-2 coronavirus. Of the COVID-19 RATs that had received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) by January 2022, all detected nucleocapsid proteins, and one also detected the receptor-binding domain of the coronavirus spike protein.[36]: Table S1  Similarly, almost all tests on the European Union common list of COVID-19 RATs target nucleocapsid proteins.[37]

 
Rapid antigen test functioning by lateral flow assay.

A typical COVID-19 RAT is a lateral flow test (LFT).[36]: Table S1 [38] For a LFT, a liquid sample (such as from a nasal swab) is placed on a pad at one end of a porous paper-like strip.[39][40] The liquid passes to the other end of the paper by wicking (capillary action). At a "conjugate pad," antibodies with gold nanoparticles attach to any SARS-CoV-2 antigens present in the sample.[38] At the test line (which may be labelled "T"), antibodies specific to SARS-CoV-2 are present.[38] At the control line (which may be labelled "C"), antibodies that can attach to the antibodies with nanoparticles are present.[38] If only the control line is visible, the test is negative; if both the control and test lines are visible, the test is positive.[38][39][40]

History of development and deployment edit

2020 edit

 
COVID-19 rapid test being administered in Rwanda

In May 2020, the US Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for a COVID-19 RAT, the Sofia 2 test manufactured by Quidel.[41]

In August 2020, the United States Department of Health and Human Services announced that the US government would be purchasing 150 million BinaxNOW RATs produced by Abbott Laboratories "to expand strategic, evidence-based testing."[42] Later the agency announced that 100 million of the tests were to be sent to governors to use "at their discretion," for example to reopen schools.[43]

By September 2020, it was reported that the United Kingdom's Moonshot program would be investing £100 billion to systematically assess, develop and implement new technologies for COVID-19 testing, including RATs for COVID-19.[44] In that month, the World Health Organization (WHO) released interim guidance on COVID-19 "antigen-detecting rapid diagnostic tests" (Ag-RDTs) including recommendations for their use, selection, and implementation.[45] The interim guidance noted that Ag-RDTs were easier to implement and less expensive than nucleic acid amplification tests (NAATs).[45] WHO recommended the use of Ag-RDTs in outbreaks, in monitoring disease trends, and in early identification of cases.[45]

Health Canada approved its first COVID-19 RAT in October 2020, the Abbott Panbio test.[46] As of October 2020, there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs.[47][48] RATs began to be rolled out across Portuguese schools and care homes.[49]

One of the early large studies of COVID-19 lateral flow devices (LFDs) was completed by Public Health England and University of Oxford, with a preliminary report released in November 2020.[50] The researchers undertook an evaluation of 64 LFDs that proceeded in several phases.[51] Of the four LFDs with "desirable performance characteristics," one (Innova) had a sensitivity of 78.8% and a false positive rate of 0.32%.[51]

 
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.[52][53] Two research studies on the Slovakia experience were 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. Both studies suggested that rapid antigen mass testing 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.[1][54]

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 2020, the Prime Minister, Boris Johnson, started city-wide screening of Liverpool as part of the accelerated technology evaluation.[55][56] 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,[57] but was expanded to the majority of UK universities and enabled the national evacuation-style plan to get students safely home for Christmas.[58] Rapid tests were also implemented within the National Health Service (NHS) for staff to reduce possible transmission to patients,[59] local authorities [60] and care homes to enable visits to visit residents.[61][62] On 18 November 2020, Wales completed the first whole borough testing at Merthyr Tydfil.[63][64]

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 2020, aided by agreement from the Bill and Melinda Gates Foundation that limited costs for low- and middle-income countries.[65][66]

Austria started country-wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest (aka Orientgene).[67][68]

By the middle of December 2020, there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID-19 including studies in the Netherlands,[69] the United Kingdom,[70] and the US.[71] 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,[72] travel hubs in Indonesia,[73] and across India.[74]

In the US in December 2020, Professor Michael Mina of Harvard University noted that home tests were a "very powerful adjunct to everything else that people are already doing."[75] This view was reinforced by Professor William A. Haseltine, also of Harvard, in an article in Forbes magazine asserting that "rapid, self-administered testing could stem the ever-surging tide of disease and death."[76] However, further deployment 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 Consolidated Appropriations Act, 2021. The bill was criticized for not specifically supporting COVID rapid self-tests.[77] Meanwhile, the FDA authorized the Abbott BinaxNOW RAT "for prescription use at home."[78][79] Subsequent approval was given for the first COVID-19 at-home RAT available without a prescription, by Ellume.[80]

In the UK in December 2020, the Medicines and Healthcare products Regulatory Agency approved the Innova rapid test for self-testing of asymptomatic people.[81] The United Kingdom's chief clinical medic, Dr Susan Hopkins, noted that rapid tests provided a means to find "people that...we couldn't otherwise find".[82]

Noting the ability to identify cases more rapidly, and considering the ensuing escalation in cases in Europe, the European Commission (EC) met in December 2020 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.[83] 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."[83]

2021 edit

By January 2021, the Council of the European Union advocated 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."[84] In the US, newly inaugurated US president Joe Biden released a national strategy for COVID-19 that pledged to "fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available."[85] In March 2021, the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription.[86]

Innova voluntarily launched a Class I recall in the US of more than 77,000 of its RATs in April 2021.[87] Two months later, the FDA warned Americans to stop using the test because it had "significant concerns that the performance of the test has not been adequately established."[87] A week after the FDA's warning about the Innova test, UK's Medicines and Healthcare products Regulatory Agency (MHRA) cleared the rapid diagnostic's use and extended its authorization.[88]

In October 2021, WHO updated its interim guidance on Ag-RDTs.[28] Among other changes, the 2021 WHO interim guidance included updated information on test performance, uses selection, and storage.[28] Also in October 2021, Ellume recalled more than 2.2 million of its home tests because of "higher-than-acceptable false positive test results for SARS-CoV-2".[89]

In December 2021, US president Biden announced that the government planned to purchase and distribute for free 500 million at-home COVID-19 RATs.[90] In response, Dr Leana Wen was quoted as saying that the number of tests "does not come even close to what's needed."[90]

2022 edit

US president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution.[91] In March 2022, WHO issued interim guidance on self-testing with Ag-RDTs.[2] WHO made a strong recommendation that COVID-19 Ag-RDT self-testing "should be offered in addition to professionally administered testing services."[2] An April 2022 warning from the US FDA concerned two counterfeit at-home COVID-19 RATs.[92]

Economic aspects edit

Costs and cost-effectiveness edit

In late 2020, it was noted that in the US RATs cost US$5-$23, in contrast with PCR tests which cost at least $75.[47] In a Danish study published in 2021, RATs cost about $5.70 per test, as opposed to PCRs at $10.80 per test.[93] A 2021 study from Germany found that monitoring health care workers exposed to COVID-19 with RATs saves money compared with sending them into quarantine.[94] A 2021 study concluded that if the US is willing to pay $100,000 per year of life lost averted, then weekly or monthly testing of the population using RATs is likely to be cost-effective.[95] Another 2021 study estimated incremental cost-effectiveness ratios of "$7890 per infection averted and $1 430 000 per death averted" if weekly screening with home-based RATs were performed in the entire US population over a 60-day period.[96]

Global market value edit

Estimates of value of the worldwide market for RATs vary. One estimate was that the market size was $28 billion in 2021 with a compound annual growth rate (CAGR) of -21.7%, leading to a size of $14 billion in 2028.[97] A second estimate suggested that the market value was $4.6 billion in 2021, with a CAGR of -26.3%, leading to a value of $743 million in 2027.[98] A third estimate found a value of $5.3 billion in 2020, which was "anticipated to grow with a healthy growth rate of more than 6.7% over the forecast period 2021-2027."[99]

See also edit

Notes edit

  1. ^ "Point of care test" and "rapid test" could refer to "rapid antigen test" but could also refer to tests that use PCR or other technologies.
  2. ^ The study by Pecoraro et al found a pooled false-negative rate for PCR of 0.12, which implies a sensitivity of 0.88.

References edit

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November 26, 2023
covid, rapid, antigen, test, rats, also, frequently, called, covid, lateral, flow, tests, lfts, rapid, antigen, tests, used, detect, sars, infection, covid, they, quick, implement, with, minimal, training, cost, fraction, other, forms, covid, testing, give, us. 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 cost a fraction of other forms of COVID 19 testing and give users a result within 5 30 minutes RATs have been used in several countries as part of mass testing or population wide screening approaches 1 Many RATs can be used for self testing in which an individual collects their own specimen and interpret s their test result themselves 2 COVID 19 rapid antigen testNegative left showing Control line and positive right showing Control and Test lines resultsSynonymsSARS CoV 2 or COVID 19 antigen test rapid antigen detection test RADT lateral flow test LFT lateral flow device LFD antigen detecting rapid diagnostic test Ag RDT antigen rapid diagnostic test Antigen RDT point of care POC test rapid test a PurposeTo diagnose SARS CoV 2 infections COVID 19 LOINC94558 4 95209 3 96119 3 97097 0False positives are very rare the tests specificity is 98 99 3 4 5 However the tests have a sensitivity of 70 72 3 4 5 which is lower than COVID 19 polymerase chain reaction PCR tests sensitivity of 88 96 6 7 b Despite this COVID 19 RATs remain valuable in finding people who would otherwise not know they were infected helping to prevent further transmission The tests are more sensitive in the symptomatic and transmissive stages of disease when the viral load is higher 3 4 5 8 9 Contents 1 Uses 1 1 Use in diagnosis 1 2 Use in screening 1 3 Humanitarian uses 1 4 Use for return to normal 2 Concerns about use 2 1 False negatives low sensitivity 2 2 Potential for false negative results due to new variants 2 3 False positive results when instructions not followed 2 4 Slow deployment and uptake 3 Methods 4 History of development and deployment 4 1 2020 4 2 2021 4 3 2022 5 Economic aspects 5 1 Costs and cost effectiveness 5 2 Global market value 6 See also 7 Notes 8 ReferencesUses editUse in diagnosis edit COVID 19 rapid antigen tests RATs have been widely used for diagnosis of COVID 19 The World Health Organization WHO COVID 19 Case Definition states that a person with a positive RAT also known as an antigen rapid diagnostic test or Antigen RDT can be considered a confirmed case of SARS CoV 2 infection in two ways 10 First the person with a positive Antigen RDT could meet a probable case definition such as having recent loss of smell or taste without any known cause or could meet certain suspect criteria such as having a severe acute respiratory illness 10 Second the person with a positive Antigen RDT could be asymptomatic but a contact of a probable or confirmed case 10 Nevertheless individual countries may have different case definitions of COVID 19 for example in New Zealand a positive PCR test not just a RAT is necessary for a person to be considered a confirmed case 11 Use in screening edit Between mid 2020 and early 2021 studies using mathematical models estimated the benefit of frequent RATs in screening populations for COVID 19 Paltiel et al studied a hypothetical college campus with 5000 students 12 Screening all students every two days with a low sensitivity high specificity test such as a RAT would be able to control an outbreak of COVID 19 12 Mina et al theorized that higher frequency screening using lower sensitivity RATs may be more useful than lower frequency screening using higher sensitivity PCR tests because the former would capture most infections while they are still infectious 13 The quick results of RATs would serve to limit asymptomatic spread 13 Larremore et al simulated various COVID 19 population screening strategies 14 The researchers found that effective screening depends largely on frequency of testing and speed of reporting and is only marginally improved by high test sensitivity 14 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 15 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 16 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 17 18 Medecins Sans Frontieres 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 19 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 20 and a free music concert held in Barcelona for individuals who took a rapid test 21 A similar approach was taken in Albania to enable music festivals 22 However many experts were unsure of this approach believing that rapid tests are not the solution to restart normal life 23 but might be used in conjunction with other infection control techniques 24 Concerns about use edit nbsp A certification of quality for a COVID 19 rapid antigen home test False negatives low sensitivity edit Although the specificity of RATs are high 98 99 3 4 5 in 2020 RATs were criticized for having a sensitivity as low as 50 that is if people with COVID 19 as determined by a positive PCR test were also tested with a RAT about half the time the RAT would be negative 25 26 27 As of 2022 systematic reviews determined that the pooled sensitivities of RATs were 70 72 3 4 5 In one systematic review the range of sensitivities across studies was 37 90 3 As WHO recommends RATs with 80 sensitivity 28 many RATs do not meet the WHO recommendation In the systematic reviews the sensitivity was higher for symptomatic people 76 82 than for asymptomatic people 57 68 3 4 5 RATs were more sensitive when samples had more viral load as measured by a low PCR cycle threshold and less sensitive when the samples had less viral load 3 4 5 A 2022 study followed 225 adults and children with COVID 19 over 15 days using PCR tests viral cultures and home RATs 29 It found that the sensitivity of the RAT Quidel QuickVue increased from 0 two days prior to symptom onset or first positive PCR test to 77 four days after symptom onset or first positive PCR test with an overall sensitivity of 50 29 Compared with PCR tests collected the same day the RAT sensitivity was 64 compared with viral cultures collected the same day the RAT sensitivity was 84 29 The sensitivity of the RAT was lower in persons who were vaccinated against COVID 19 than in persons who were not vaccinated against COVID 19 29 Potential for false negative results due to new variants edit In November 2020 a new marginally more infectious strain of SARS CoV 2 was identified in the United Kingdom the SARS CoV 2 Alpha variant 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 that RATs in global development were not affected i e that they could identify the new variant This was because rapid test generally targets the capsid protein and not the spike protein 30 Some strains have been identified with a nucleocapsid mutation D399N that does decrease the sensitivity of at least one RAT Quidel Sofia 2 up to 1 000 fold 31 Fortunately the frequency of mutation D399N was still relatively low globally at 0 02 as of May 2021 31 A study published in 2022 found that the sensitivities of six rapid antigen detection tests were 70 0 92 9 for the Delta variant and 69 6 78 3 for the Omicron variant across a range of viral loads however for Omicron samples with a low viral load the sensitivities were 0 0 23 1 32 False positive results when instructions not followed edit If a COVID 19 RAT is used outside manufacturer recommendations the result can be false positive Beginning in December 2020 TikTok videos demonstrated how to use soft drinks to create false positive COVID 19 RAT results 33 Later researchers found that introducing fruit juices alcoholic beverages bottled water and other products directly into an Abbott Panbio COVID 19 RAT without the manufacturer s recommended buffer solution produced false positives 34 In contrast a different RAT BD Veritor produced no false positive results under the same conditions 34 Slow deployment and uptake edit Some have raised concerns about the slow deployment and uptake of RATs and the potential loss of life that might have occurred as a result A modelling study in Canada estimated that half the deaths in care homes in British Columbia in 2020 could have been prevented if rapid testing had been available 35 Methods editAn antigen is a foreign molecule or molecular structure that can cause an immune response COVID 19 rapid antigen tests RATs detect antigenic proteins on the surface of the SARS CoV 2 coronavirus Of the COVID 19 RATs that had received an Emergency Use Authorization EUA from the US Food and Drug Administration FDA by January 2022 all detected nucleocapsid proteins and one also detected the receptor binding domain of the coronavirus spike protein 36 Table S1 Similarly almost all tests on the European Union common list of COVID 19 RATs target nucleocapsid proteins 37 nbsp Rapid antigen test functioning by lateral flow assay A typical COVID 19 RAT is a lateral flow test LFT 36 Table S1 38 For a LFT a liquid sample such as from a nasal swab is placed on a pad at one end of a porous paper like strip 39 40 The liquid passes to the other end of the paper by wicking capillary action At a conjugate pad antibodies with gold nanoparticles attach to any SARS CoV 2 antigens present in the sample 38 At the test line which may be labelled T antibodies specific to SARS CoV 2 are present 38 At the control line which may be labelled C antibodies that can attach to the antibodies with nanoparticles are present 38 If only the control line is visible the test is negative if both the control and test lines are visible the test is positive 38 39 40 History of development and deployment edit2020 edit nbsp COVID 19 rapid test being administered in RwandaIn May 2020 the US Food and Drug Administration FDA issued the first Emergency Use Authorization EUA for a COVID 19 RAT the Sofia 2 test manufactured by Quidel 41 In August 2020 the United States Department of Health and Human Services announced that the US government would be purchasing 150 million BinaxNOW RATs produced by Abbott Laboratories to expand strategic evidence based testing 42 Later the agency announced that 100 million of the tests were to be sent to governors to use at their discretion for example to reopen schools 43 By September 2020 it was reported that the United Kingdom s Moonshot program would be investing 100 billion to systematically assess develop and implement new technologies for COVID 19 testing including RATs for COVID 19 44 In that month the World Health Organization WHO released interim guidance on COVID 19 antigen detecting rapid diagnostic tests Ag RDTs including recommendations for their use selection and implementation 45 The interim guidance noted that Ag RDTs were easier to implement and less expensive than nucleic acid amplification tests NAATs 45 WHO recommended the use of Ag RDTs in outbreaks in monitoring disease trends and in early identification of cases 45 Health Canada approved its first COVID 19 RAT in October 2020 the Abbott Panbio test 46 As of October 2020 there were questions in the US as to whether manufacturing capacity could keep up with the potential demand for hundreds of millions of RATs 47 48 RATs began to be rolled out across Portuguese schools and care homes 49 One of the early large studies of COVID 19 lateral flow devices LFDs was completed by Public Health England and University of Oxford with a preliminary report released in November 2020 50 The researchers undertook an evaluation of 64 LFDs that proceeded in several phases 51 Of the four LFDs with desirable performance characteristics one Innova had a sensitivity of 78 8 and a false positive rate of 0 32 51 nbsp 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 52 53 Two research studies on the Slovakia experience were 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 amp Tropical Medicine and his team Both studies suggested that rapid antigen mass testing 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 1 54 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 2020 the Prime Minister Boris Johnson started city wide screening of Liverpool as part of the accelerated technology evaluation 55 56 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 57 but was expanded to the majority of UK universities and enabled the national evacuation style plan to get students safely home for Christmas 58 Rapid tests were also implemented within the National Health Service NHS for staff to reduce possible transmission to patients 59 local authorities 60 and care homes to enable visits to visit residents 61 62 On 18 November 2020 Wales completed the first whole borough testing at Merthyr Tydfil 63 64 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 2020 aided by agreement from the Bill and Melinda Gates Foundation that limited costs for low and middle income countries 65 66 Austria started country wide mass testing on 5 December 2020 and ordered seven million tests consisting of the SD Biosensor test and Siemens Clinitest aka Orientgene 67 68 By the middle of December 2020 there were many studies confirming the efficacy and success of using rapid tests to identify individuals with COVID 19 including studies in the Netherlands 69 the United Kingdom 70 and the US 71 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 72 travel hubs in Indonesia 73 and across India 74 In the US in December 2020 Professor Michael Mina of Harvard University noted that home tests were a very powerful adjunct to everything else that people are already doing 75 This view was reinforced by Professor William A Haseltine also of Harvard in an article in Forbes magazine asserting that rapid self administered testing could stem the ever surging tide of disease and death 76 However further deployment 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 Consolidated Appropriations Act 2021 The bill was criticized for not specifically supporting COVID rapid self tests 77 Meanwhile the FDA authorized the Abbott BinaxNOW RAT for prescription use at home 78 79 Subsequent approval was given for the first COVID 19 at home RAT available without a prescription by Ellume 80 In the UK in December 2020 the Medicines and Healthcare products Regulatory Agency approved the Innova rapid test for self testing of asymptomatic people 81 The United Kingdom s chief clinical medic Dr Susan Hopkins noted that rapid tests provided a means to find people that we couldn t otherwise find 82 Noting the ability to identify cases more rapidly and considering the ensuing escalation in cases in Europe the European Commission EC met in December 2020 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 83 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 83 2021 edit By January 2021 the Council of the European Union advocated 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 84 In the US newly inaugurated US president Joe Biden released a national strategy for COVID 19 that pledged to fund rapid test acquisition and distribution for priority populations work to spur development and manufacturing of at home tests and work to ensure that tests are widely available 85 In March 2021 the US FDA authorized the Abbott BinaxNOW RAT and the Quidel QuickVue RAT for use at home without a prescription 86 Innova voluntarily launched a Class I recall in the US of more than 77 000 of its RATs in April 2021 87 Two months later the FDA warned Americans to stop using the test because it had significant concerns that the performance of the test has not been adequately established 87 A week after the FDA s warning about the Innova test UK s Medicines and Healthcare products Regulatory Agency MHRA cleared the rapid diagnostic s use and extended its authorization 88 In October 2021 WHO updated its interim guidance on Ag RDTs 28 Among other changes the 2021 WHO interim guidance included updated information on test performance uses selection and storage 28 Also in October 2021 Ellume recalled more than 2 2 million of its home tests because of higher than acceptable false positive test results for SARS CoV 2 89 In December 2021 US president Biden announced that the government planned to purchase and distribute for free 500 million at home COVID 19 RATs 90 In response Dr Leana Wen was quoted as saying that the number of tests does not come even close to what s needed 90 2022 edit US president Biden announced in January 2022 the purchase of 500 million additional RATs for free distribution 91 In March 2022 WHO issued interim guidance on self testing with Ag RDTs 2 WHO made a strong recommendation that COVID 19 Ag RDT self testing should be offered in addition to professionally administered testing services 2 An April 2022 warning from the US FDA concerned two counterfeit at home COVID 19 RATs 92 Economic aspects editCosts and cost effectiveness edit In late 2020 it was noted that in the US RATs cost US 5 23 in contrast with PCR tests which cost at least 75 47 In a Danish study published in 2021 RATs cost about 5 70 per test as opposed to PCRs at 10 80 per test 93 A 2021 study from Germany found that monitoring health care workers exposed to COVID 19 with RATs saves money compared with sending them into quarantine 94 A 2021 study concluded that if the US is willing to pay 100 000 per year of life lost averted then weekly or monthly testing of the population using RATs is likely to be cost effective 95 Another 2021 study estimated incremental cost effectiveness ratios of 7890 per infection averted and 1 430 000 per death averted if weekly screening with home based RATs were performed in the entire US population over a 60 day period 96 Global market value edit Estimates of value of the worldwide market for RATs vary One estimate was that the market size was 28 billion in 2021 with a compound annual growth rate CAGR of 21 7 leading to a size of 14 billion in 2028 97 A second estimate suggested that the market value was 4 6 billion in 2021 with a CAGR of 26 3 leading to a value of 743 million in 2027 98 A third estimate found a value of 5 3 billion in 2020 which was anticipated to grow with a healthy growth rate of more than 6 7 over the forecast period 2021 2027 99 See also editCOVID 19 testing Development of COVID 19 testsNotes edit Point of care test and rapid test could refer to rapid antigen test but could also refer to tests that use PCR or other technologies The study by Pecoraro et al found a pooled false negative rate for PCR of 0 12 which implies a sensitivity of 0 88 References edit a b Kahanec M Laffers L Schmidpeter B 2021 The impact of repeated mass antigen testing for COVID 19 on the prevalence of the disease J Popul Econ 34 4 1105 1140 doi 10 1007 s00148 021 00856 z PMC 8241209 PMID 34219976 a b c Use of SARS CoV 2 antigen detection rapid diagnostic tests for COVID 19 self testing Interim guidance World Health Organization 9 March 2022 Retrieved 4 July 2022 a b c d e f g h Khalid MF Selvam K Jeffry AJ Salmi MF Najib MA Norhayati MN et al 4 January 2022 Performance of Rapid Antigen Tests for COVID 19 Diagnosis A Systematic Review and Meta Analysis Diagnostics 12 1 110 doi 10 3390 diagnostics12010110 PMC 8774565 PMID 35054277 a b c d e f g Brummer LE Katzenschlager S McGrath S Schmitz S Gaeddert M Erdmann C et al 26 May 2022 Accuracy of rapid point of care antigen based diagnostics for SARS CoV 2 An updated systematic review and meta analysis with meta regression analyzing influencing factors PLOS Med 19 5 e1004011 doi 10 1371 journal pmed 1004011 PMC 9187092 PMID 35617375 a b c d e f g Tapari A Braliou GG Papaefthimiou M Mavriki H Kontou PI Nikolopoulos GK Bagos PG 4 June 2022 Performance of Antigen Detection Tests for SARS CoV 2 A Systematic Review and Meta Analysis Diagnostics 12 6 1388 doi 10 3390 diagnostics12061388 PMC 9221910 PMID 35741198 Pecoraro V Negro A Pirotti T Trenti T 2022 Estimate false negative RT PCR rates for SARS CoV 2 A systematic review and meta analysis Eur J Clin Invest 52 2 e13706 doi 10 1111 eci 13706 PMC 8646643 PMID 34741305 Pu R Liu S Ren X Shi D Ba Y Huo Y et al 2022 The screening value of RT LAMP and RT PCR in the diagnosis of COVID 19 systematic review and meta analysis J Virol Methods 300 114392 doi 10 1016 j jviromet 2021 114392 PMC 8629515 PMID 34856308 Oxford University and PHE confirm lateral flow tests show high specificity and are effective at identifying most individuals who are infectious Oxford University 11 November 2020 Guglielmi G 2020 Fast coronavirus tests what they can and can t do Nature 585 7826 496 498 Bibcode 2020Natur 585 496G doi 10 1038 d41586 020 02661 2 PMID 32939084 a b c WHO COVID 19 Case Definitions World Health Organization 16 December 2020 Retrieved 8 July 2022 Case definition and clinical testing guidelines for COVID 19 New Zealand Ministry of Health Manatu Hauora 30 June 2022 Retrieved 8 July 2022 a b Paltiel AD Zheng A Walensky RP 2020 Assessment of SARS CoV 2 Screening Strategies to Permit the Safe Reopening of College Campuses in the United States JAMA Netw Open 3 7 e2016818 doi 10 1001 jamanetworkopen 2020 16818 PMC 7395236 PMID 32735339 a b Mina MJ Parker R Larremore DB 2020 Rethinking Covid 19 Test Sensitivity A Strategy for Containment The New England Journal of Medicine 383 22 e120 doi 10 1056 NEJMp2025631 PMID 32997903 a b Larremore DB Wilder B Lester E Shehata S Burke JM Hay JA et al 2021 Test sensitivity is secondary to frequency and turnaround time for COVID 19 screening Science Advances 7 1 eabd5393 Bibcode 2021SciA 7 5393L doi 10 1126 sciadv abd5393 PMC 7775777 PMID 33219112 North Jakarta to provide rapid tests for people in flood shelters The Jakarta Post 2 December 2020 Retrieved 11 July 2022 Covid 19 Charities send food to stranded truckers BBC News 23 December 2020 Retrieved 11 July 2022 Rawlinson K Halliday J 24 December 2020 Army to take over Covid testing for hauliers trapped near Dover The Guardian ISSN 0261 3077 Retrieved 11 July 2022 COVID 19 Raw anger among lorry drivers in Dover as coronavirus testing fails to ease tensions Sky News 24 December 2020 Retrieved 11 July 2022 COVID 19 diagnostics MSF welcomes more affordable rapid 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Size study by Product amp Service Platforms Reagents amp Kits and Services by End Use Clinics amp Hospitals Home Care Diagnostic Labs and Others and Regional Forecasts 2021 2027 Market Study Report 17 July 2021 Archived from the original on 15 August 2022 Retrieved 10 July 2022 Retrieved from https en wikipedia org w index php title COVID 19 rapid antigen test amp oldid 1184804276, wikipedia, wiki, book, books, library,

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