COVID-19 testing

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The U.S. CDC's COVID-19 laboratory test kit CDC 2019-nCoV Laboratory Test Kit.jpg
The U.S. CDC's COVID-19 laboratory test kit

COVID-19 testing can identify the SARS-CoV-2 virus and includes methods that detect the presence of the virus itself (RT-PCR, isothermal nucleic acid amplification, antigen) and those that detect antibodies produced in response to infection. Detection of antibodies (serological tests) can be used both for diagnosis and for population surveillance. Antibody tests show how many people have had the disease, including those whose symptoms were minor or who were asymptomatic, but may not find antibodies in someone with a current COVID-19 infection since antibodies may not show up for weeks. [1] An accurate mortality rate of the disease and the level of herd immunity in the population can be determined from the results of this test. However, the duration and effectiveness of this immune response are still unclear. [2]

Contents

Due to limited testing, as of March 2020 no countries had reliable data on the prevalence of the virus in their population. [3] As of 24 May, countries that publicised their testing data have typically performed many tests equal to 2.6 percent of their population, and no country has tested samples equal to more than 17.3% of its population. [4] There are variations in how much testing has been done across countries. [5] This variability is also likely to be affecting reported case fatality rates, which have probably been overestimated in many countries, due to sampling bias. [6] [7] [8]

Testing is often performed in automated, high-throughput centralized medical laboratories by medical laboratory scientists.

Test methods

Explanation of the underlying pathophysiology pertaining to diagnosis of COVID-19 Covid-19-Time-Course-05.gif
Explanation of the underlying pathophysiology pertaining to diagnosis of COVID-19

There are two broad categories of test: a viral test for a current infection, or an antibody test for the past presence of the virus. [10] The CDC does not currently recommend testing for COVID-19 using a CT scan or looking for low oxygen levels.

Current infection

Polymerase chain reaction

Polymerase chain reaction (PCR) is a process that causes a very small well-defined segment of DNA to be amplified, or multiplied many hundreds of thousands of times, so there is enough of it to be detected and analyzed. Viruses such as SARS-CoV-2 do not contain DNA but only RNA. [11] When a respiratory sample is collected from the person being tested it is treated with certain chemicals [12] [11] which break down extraneous substances and allow the RNA to be removed from the sample and tested. Reverse transcription polymerase chain reaction (RT-PCR) is a technique that first uses reverse transcription to convert the extracted RNA into DNA and then uses PCR to amplify a piece of the resulting DNA, creating enough to be examined in order to determine if it matches the genetic code of SARS-CoV-2. [11] Real-time PCR (qPCR) [13] provides advantages during the PCR portion of this process, including automating it and enabling high-throughput and more reliable instrumentation, and has become the preferred method. [14] [15] Altogether, the combined technique has been described as real-time RT-PCR [16] or quantitative RT-PCR [17] and is sometimes abbreviated qRT-PCR [18] or rRT-PCR [19] or RT-qPCR, [20] although sometimes just RT-PCR or PCR is used as an abbreviation. The Minimum Information for Publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines propose that the term RT-qPCR be used, [21] but not all authors adhere to this. The test can be done on respiratory samples obtained by various methods, including a nasopharyngeal swab or sputum sample, [22] as well as on saliva. [23] Drosten et al. remarked that for 2003 SARS, "from a diagnostic point of view, it is important to note that nasal and throat swabs seem less suitable for diagnosis, since these materials contain considerably less viral RNA than sputum, and the virus may escape detection if only these materials are tested." [24] Results are generally available from within a few hours to two days. [25]

When testing an infected person the likelihood of detecting the virus depends on how much time has passed since the person was infected. According to Christian Drosten the RT-PCR test performed with throat swabs is reliable only in the first week of the disease. Later on the virus can disappear in the throat while it continues to multiply in the lungs. For infected people tested in the second week, alternatively sample material can then be taken from the deep airways by suction catheter, or coughed up material (sputum) can be used. [26]

Saliva has been shown to be a common and transient medium for virus transmission [27] and results provided to the FDA suggest that testing saliva may be as effective as nasal and throat swabs. [23] The FDA has granted Emergency Use Authorization for a test that collects saliva instead of using the traditional nasal swab. [28] It is believed this will reduce the risk for health care professionals, [29] will be much more comfortable for the patient, [28] and will enable quarantined people to collect their own samples more efficiently. [29] According to some experts it is too early to know the operating characteristics of the saliva test, and whether it will prove to be as sensitive as the nasopharyngeal swab test. [30] [27] Some studies suggest that the diagnostic value of saliva depends on how saliva specimens are collected (from deep throat, from oral cavity, or from salivary glands). [27] A recent test conducted by the Yale University School of Public Health found that saliva yielded greater detection sensitivity and consistency throughout the course of infection when compared with samples taken with nasopharyngeal swabs. [31] [32]

Isothermal amplification assays

There are a number of isothermal nucleic acid amplification methods that, just like PCR, amplify a piece of the virus's genome, but are faster than PCR because they don't involve repeated cycles of heating and cooling the sample. These tests typically detect the amplified virus sequences using fluorescent tags, which have to be read out with specialized machines. In one new development, the CRISPR gene editing technology was modified to detect the viral sequences instead: if the modified CRISPR enzyme attaches to the sequence, it releases a signal which colors a paper strip. The researchers expect the resulting test to be cheap and easy to use in patient-care settings. [33] [34]

Antigen

An antigen is the part of a pathogen that elicits an immune response. The antigen tests look for proteins from the surface of the virus. In the case of a coronavirus, these are usually proteins from the surface spikes, and a nasal swab is used to collect samples. [35] One of the difficulties has been finding a protein target unique to SARS-CoV-2. [36]

Antigen tests are seen as one way to scale up testing to levels necessary to detect acute infection on the scale required. [35] Isothermal nucleic acid amplification tests, can process only one sample at a time per machine. RT-PCR tests are accurate but it takes too much time, energy and trained personnel to run the tests. [35] "There will never be the ability on a [PCR] test to do 300 million tests a day or to test everybody before they go to work or to school," Deborah Birx, head of the White House Coronavirus Task Force, said on 17 April. "But there might be with the antigen test." [37]

An antigen test works by taking a nasal swab from a patient and exposing that to paper strips containing artificial antibodies designed to bind to coronavirus antigens. Any antigens that are present will bind to the strips and give a visual readout. The process takes less than 30 minutes, can deliver results on the spot, and does not require expensive equipment or extensive training. [35]

In respiratory viruses often there is not enough of the antigen material present in the nasal swab to be detectable. [36] This would especially be true with people who are asymptomatic and who have very little if any nasal discharge. Unlike the RT-PCR test, which amplifies very small amounts of genetic material so there is enough to detect, there is no amplification of viral proteins in an antigen test. [35] [38] According to the World Health Organization (WHO) the sensitivity of similar antigen tests for respiratory diseases like the flu ranges between 34% and 80%. "Based on this information, half or more of COVID-19 infected patients might be missed by such tests, depending on the group of patients tested," the WHO said. Many scientists doubt whether an antigen test can be made reliable enough in time to be useful against COVID-19. [38] According to the FDA, positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. Therefore, negative results from an antigen test may need to be confirmed with a PCR test. [39]

Medical imaging

Chest CT scans and chest x-rays are not recommended for diagnosing COVID-19. Radiologic findings in COVID-19 are not specific. [40] [41] Typical features on CT initially include bilateral multilobar ground-glass opacities with a peripheral or posterior distribution. [41] Subpleural dominance, crazy paving, and consolidation may develop as the disease evolves. [41] [42]

Past infection

Antibody tester.jpg
Corona antibody test.jpg
Left: Automated analyzer for immunoassays, used, for example, to find SARS-CoV-2 antibodies. Right: Example of quantitative results for SARS-CoV-2 antibody test.

Serology tests rely on drawn blood, not a nasal or throat swab, and can identify people who were infected and have already recovered from COVID-19, including those who did not know they had been infected. [43] As of April 2020, most serology tests were in the research stage of development. [44]

Part of the immune response to infection is the production of antibodies including IgM and IgG. According to the FDA, IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. [45] IgG antibodies to SARS-CoV-2 generally become detectable 10–14 days after infection although they may be detected earlier, and normally peak around 28 days after the onset of infection. [46] [47] Since antibodies are slow to present they are not the best markers of acute infection, but as they may persist in the bloodstream for many years they are ideal for detecting historic infections. [35]

Antibody tests can be used to determine the percentage of a population that have contracted the disease and are therefore presumably immune. However, it is still not clear how broad and how long and how effective this immune response is. [2] [48] As of April 2020 "[s]ome countries are considering issuing so-called immunity passports or risk-free certificates to people who have antibodies against Covid-19, enabling them to travel or return to work assuming that they are protected against reinfection." [49] However, according to the World Health Organization as of 24 April 2020, "There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection." [50] One of the reasons for the uncertainty is that most, if not all, of the current COVID-19 antibody testing done at large scale is for detection of binding antibodies only and does not measure neutralizing antibodies. [51] [52] [53] A neutralizing antibody (NAb) is an antibody that defends a cell from a pathogen or infectious particle by neutralizing any effect it has biologically. Neutralization renders the particle no longer infectious or pathogenic. [54] A binding antibody will bind to the pathogen but the pathogen remains infective; the purpose can be to flag the pathogen for destruction by the immune system. [55] It may even enhance infectivity by interacting with receptors on macrophages. [56] Since most COVID-19 antibody tests will return a positive result if they find only binding antibodies these tests cannot indicate that the person being tested has generated any NAbs which would give him or her protection against re-infection. [52] [53]

It is normally expected that if binding antibodies are detected the person also has generated NAbs [53] and for many viral diseases total antibody responses correlate somewhat with NAb responses [57] but this is not yet known for COVID-19. A study of 175 people in China who had recovered from COVID‑19 and had mild symptoms reported that 10 individuals had produced no detectable NAbs at the time of discharge, nor did they develop NAbs thereafter. How these patients recovered without the help of NAbs and whether they were at risk of re-infection of SARS-CoV-2 was left for further exploration. [52] [58] An additional source of uncertainty is that even if NAbs are present, several viruses, such as HIV, have evolved mechanisms to evade NAb responses. While this needs to be examined in the context of COVID-19 infection, past experiences with viral infection, in general, argue that in most recovered patients NAb level is a good indicator of protective immunity. [51]

The issue of NAbs was implicated when five sailors from the USS Theodore Roosevelt (CVN-71) who tested positive went through two weeks of isolation, then tested negative twice, and thereafter again tested positive. [59] IgG antibodies normally peak around 28 days after the onset of infection [46] and the time frame of these events is not available.

It is presumed that once a person has been infected his or her chance of getting a second infection two to three months later is low, but how long that protective immunity might last is not known. [52] One study determined that reinfection at 29 days post-infection could not occur in SARS-CoV-2 infected rhesus macaques. [60] Studies have indicated that NAbs to the original SARS virus (the predecessor to the current SARS-CoV-2) can remain active in most people for two years [61] and are gone after six years. [62] Nevertheless, memory cells including Memory B cells and Memory T cells [63] can last much longer and may have the ability to greatly lessen the severity of a reinfection. [62]

Infectivity

United States Centers for Disease Control and Prevention (CDC) updated the following information and recommendation in a "Decision Memo" on 3 May. [64] At this time, data are limited regarding how long after infection people continue to shed infectious SARV-CoV-2 RNA, and can therefore still infect others. Key findings are summarized here.

  1. Viral burden measured in upper respiratory specimens declines after onset of illness. [65]
  2. At this time, replication-competent virus has not been successfully cultured more than nine days after onset of illness. The statistically estimated likelihood of recovering replication-competent virus approaches zero by 10 days. [66]
  3. As the likelihood of isolating replication-competent virus decreases, anti-SARS-CoV-2 IgM and IgG can be detected in an increasing number of persons recovering from infection. [67]
  4. Attempts to culture virus from upper respiratory specimens have been largely unsuccessful when viral burden is in low but detectable ranges (i.e., Ct values higher than 33-35) [64]
  5. Following recovery from clinical illness, many patients no longer have detectable viral RNA in upper respiratory specimens. Among those who continue to have detectable RNA, concentrations of detectable RNA three days following recovery are generally in the range at which replication-competent virus has not been reliably isolated by CDC. [68]
  6. No clear correlation has been described between length of illness and duration of post-recovery shedding of detectable viral RNA in upper respiratory specimens. [69]
  7. Infectious virus has not been cultured from urine or reliably cultured from feces; [70] these potential sources pose minimal if any risk of transmitting infection and any risk can be sufficiently mitigated by good hand hygiene.

For an emerging pathogen like SARS-CoV-2, the patterns and duration of illness and infectivity have not been fully described. However, available data indicate that shedding of SARS-CoV-2 RNA in upper respiratory specimens declines after onset of symptoms. At 10 days after illness onset, recovery of replication-competent virus in viral culture (as a proxy of the presence of infectious virus) is decreased and approaches zero. Although persons may produce PCR-positive specimens for up to six weeks, [71] it remains unknown whether these PCR-positive samples represent the presence of infectious virus. After clinical recovery, many patients do not continue to shed SARS-CoV-2 viral RNA. Among recovered patients with detectable RNA in upper respiratory specimens, concentrations of RNA after three days are generally in ranges where virus has not been reliably cultured by CDC. These data have been generated from adults across a variety of age groups and with varying severity of illness. Data from children and infants are not presently available. [64]

Minimum testing necessary

According to epidemiologists, as lockdown measures are being relaxed effective containment of the pandemic in the United States will not be possible until all infected people can be rapidly located and isolated before they have a chance to infect others, and this will require widespread testing of people before they even begin to show symptoms. [72] The contagiousness of a disease is indicated by the basic reproduction number (R0) of the disease. The R0 (pronounced "R naught") [73] of SARS-CoV-2 in general is thought to be from 2.2 to 2.5, [74] [75] meaning that in a population where all individuals are susceptible to infection, each infected person is expected to infect 2.2 to 2.5 other people. [76] However this can vary from location to location. [77] In New York state the R0 is 3.4 to 3.8. [78] One factor that increases the difficulty of blocking the spread of SARS-CoV-2 is that, on average, an infected person begins showing symptoms five days after becoming infected (the "incubation period") and begins infecting others two to three days before symptoms appear. [74] [79] According to a recent study, an estimated 44% of viral transmissions occur within this period. [74] [80] In addition to this, a significant number of infected people never show symptoms but are nevertheless contagious. [80] [75] Therefore, if transmission of this disease is to be blocked effectively, people must be tested and isolated before they begin to show symptoms.

According to Harvard's Global Health Institute, the U.S. should be doing more than 900,000 tests per day as a country. [81] [82] Other organizations have given varying estimates of up to 23 million tests per day. [83] [84] [85] [86] For the week ending 30 May there were an average of 387,000 tests per day in the United States. [87] According to the World Health Organization if more than 10% of the tests given are coming back positive then not enough testing is being done. [88] How close each state is to the minimum number of tests it should be performing according to the Harvard Global Health Institute estimate, and to the 10% target, as of 6 May, is shown here.

According to some epidemiologists, this huge increase in testing will require that states build a much-expanded testing infrastructure. This would include mobile testing programs and neighborhood testing sites, allowing special attention to be given to high-risk groups such as those in long term-care facilities; the homeless and those working in shelters; employees in high-density workplaces; and anyone who has had close contact with a known COVID-19 patient. Such people would be tested every five days. [72]

Paul Romer believes the U.S. already has the technical capacity to scale up to 20 million tests per day, which is his estimate as to the number that will be necessary to fully remobilize the economy. [84] The Edmond J. Safra Center for Ethics estimated on 4 April that this capacity could be available by late July if the necessary steps were taken. [89] Romer points to the Single-molecule real-time sequencing equipment from Pacific Biosciences, which is in use in 20 laboratories in the U.S. [90] [84] and to the Ion Torrent Next-Generation Sequencing equipment from ThermoFisher Scientific, which is in use in 16 laboratories in the U.S. [91] [84] According to Romer, "Recent research papers suggest that any one of these has the potential to scale up to millions of tests per day." He adds that this plan would also require removing restrictive regulatory hurdles managed by the FDA. Romer estimates that this amount of testing would require that the Congress allocate $100 billion to generate a revenue stream for labs to rapidly expand testing capability. [84]

Also according to Paul Romer, even a relatively inaccurate test, if administered frequently enough, can produce successful results. He ran simulations in which 7% of the population is tested every day with a test that has a 20% false negative rate (20% of the people who are actually infected will get a negative test result because of a bad swab or a very low level of virus in the early stage of infection) and a 1% false positive rate. The average person would be tested roughly every two weeks and those who tested positive would go into quarantine. Romer concluded that the fraction of the population that is currently infected (known as the attack rate) peaks early, reaching roughly 8% of the population in about thirty days and then gradually declines, in most runs reaching zero at 500 days, with the cumulative fraction of the population that is ultimately infected kept below 20%. Romer adds that these results are indicative, not predictive about the true behavior of the spread of the virus, and should not be taken as being something one can rely on. [92]

Approaches to testing

A sample collection kiosk for COVID-19 testing in India Covid-testing kiosk.jpg
A sample collection kiosk for COVID-19 testing in India
Timeline of total number of tests in different countries Full-list-cumulative-total-tests-per-million.svg
Timeline of total number of tests in different countries
A temporary drive-in testing site for COVID-19 set up with tents in a parking lot BGSU COVID-19 Drive-Thru Testing Site Close Up.jpg
A temporary drive-in testing site for COVID-19 set up with tents in a parking lot

After issues with testing accuracy and capacity during January and February, the United States was conducting an average of 363,000 tests per day for the week ending 17 May. [87] [94] In comparison, several European countries have been conducting more daily tests per capita than the United States. [95] [96] Three European countries are aiming to conduct 100,000 tests per day—Germany by mid-April, the United Kingdom by the end of April and France by the end of June. Germany has a large medical diagnostics industry, with more than a hundred testing labs that provided the technology and infrastructure to enable rapid increases in testing. The UK sought to diversify its life sciences companies into diagnostics to scale up testing capacity. [97]

In Germany, the National Association of Statutory Health Insurance Physicians said on 2 March that it had a capacity for about 12,000 tests per day in the ambulatory setting and 10,700 had been tested in the prior week. Costs are borne by the health insurance when the test is ordered by a physician. [98] According to the president of the Robert Koch Institute, Germany has an overall capacity for 160,000 tests per week. [99] As of 19 March drive-in tests were offered in several large cities. [100] As of 26 March, the total number of tests performed in Germany was unknown, because only positive results are reported. Health minister Jens Spahn estimated 200,000 tests per week. [101] A first lab survey revealed that as of the end of March a total of at least 483,295 samples were tested and 33,491 samples (6.9%) tested positive for SARS-CoV-2. [102]

By the start of April, the United Kingdom was delivering around 10,000 swab tests per day. It set a target for 100,000 per day by the end of April, eventually rising to 250,000 tests per day. [97] The British NHS has announced that it is piloting a scheme to test suspected cases at home, which removes the risk of a patient infecting others if they come to a hospital or having to disinfect an ambulance if one is used. [103]

In drive-through testing for COVID‑19 for suspected cases, a healthcare professional takes sample using appropriate precautions. [104] [105] Drive-through centers have helped South Korea do some of the fastest, most-extensive testing of any country. [106] Hong Kong has set up a scheme where suspected patients can stay home, "[the] emergency department will give a specimen tube to the patient", they spit into it, send it back and get a test result a while after. [107]

In Israel, researchers at Technion and Rambam Hospital developed and tested a method for testing samples from 64 patients simultaneously, by pooling the samples and only testing further if the combined sample is found to be positive. [108] [109] [110] Pool testing was then adopted in Israel, Germany, South Korea, [111] and Nebraska, [112] and the Indian states Uttar Pradesh, [113] West Bengal, [114] Punjab, [115] Chhattisgarh, [116] and Maharashtra. [117]

In Wuhan a makeshift 2000-sq-meter emergency detection laboratory named "Huo-Yan" (Chinese :火眼, "Fire Eye") was opened on 5 February 2020 by BGI, [118] [119] which can process more than 10,000 samples a day. [120] [119] With the construction overseen by BGI-founder Wang Jian and taking 5-days, [121] modelling has show cases in Hubei would have been 47% higher and the corresponding cost of tackling the quarantine would have doubled if this testing capacity had not come into operation.[ citation needed ] The Wuhan Laboratory has been promptly followed by Huo-Yan labs in Shenzhen, Tianjin, Beijing, and Shanghai, in a total of 12 cities across China. By 4 March the daily throughput totals were 50,000 tests per day. [122]

Open source, multiplexed designs released by Origami Assays have been released that can test as many as 1122 patient samples for COVID-19 using only 93 assays. [123] These balanced designs can be run in small laboratories without the need for robotic liquid handlers.

By March, shortages and insufficient amounts of reagent has become a bottleneck for mass testing in the EU and UK [124] and the U.S. [125] [126] This has led some authors to explore sample preparation protocols that involve heating samples at 98 °C (208 °F) for five minutes to release RNA genomes for further testing. [127] [128]

On 31 March it was announced United Arab Emirates was now testing more of its population for Coronavirus per head than any other country, and was on track to scale up the level of testing to reach the bulk of the population. [129] This was through a combination of drive-through capability, and purchasing a population-scale mass-throughput laboratory from Group 42 and BGI (based on their "Huo-Yan" emergency detection laboratories in China). Constructed in 14 days, the lab is capable of conducting tens of thousands RT-PCR tests per day and is the first in the world of this scale to be operational outside of China. [130]

On 8 April 2020, In India, the Supreme Court of India ruled that private labs should be reimbursed at the appropriate time for COVID-19 tests [131] However private labs have stated that they are unable to scale up the testing because of the price cap put on the testing and labs being forced to make advance payment to suppliers while they receive deferred payment from hospitals. [132]

University of California San Francisco conducted PCR tests of 1,845 people in Bolinas, California on 20–24 April, almost the entire town. No active infections were detected. Antibody testing was also performed but the results are not yet available. [133]

In a Stanford study led by Jay Bhattacharya, an antibody test was conducted on 5,603 major league baseball employees and 0.7% tested positive, showing they had been infected in the past. 70% of those who tested positive had had no symptoms. [134] [135] [136]

Production and volume

Number of tests done per day in the United States.
Blue: CDC lab
Orange: Public health lab
Gray: Data incomplete due to reporting lag
Not shown: Testing at private labs; total exceeded 100,000 per day by 27 March. Lab-specimens-tested.jpg
Number of tests done per day in the United States.
Blue: CDC lab
Orange: Public health lab
Gray: Data incomplete due to reporting lag
Not shown: Testing at private labs; total exceeded 100,000 per day by 27 March.

Different testing recipes targeting different parts of the coronavirus genetic profile were developed in China, France, Germany, Hong Kong, Japan, the United Kingdom, and the United States. The World Health Organization adopted the German recipe for manufacturing kits sent to low-income countries without the resources to develop their own. The German recipe was published on 17 January 2020; the protocol developed by the United States Centers for Disease Control and Prevention (CDC) was not available until 28 January, delaying available tests in the U.S. [138]

China [139] and the United States [140] had problems with the reliability of test kits early in the outbreak, and these countries and Australia [141] were unable to supply enough kits to satisfy demand and recommendations for testing by health experts. In contrast, experts say South Korea's broad availability of testing helped reduce the spread of the novel coronavirus. Testing capacity, largely in private sector labs, was built up over several years by the South Korean government. [142] On 16 March, the World Health Organization called for ramping up the testing programmes as the best way to slow the advance of COVID‑19 pandemic. [143] [144]

High demand for testing due to wide spread of the virus caused backlogs of hundreds of thousands of tests at private U.S. labs, and supplies of swabs and chemical reagents became strained. [145] On 25 May 2020, the U.S. federal government released details on testing that required each state to be responsible for carrying out its own planning and supply needs, which it said would be sufficiently address capacity issues. The proposal was panned for creating competition amongst the states to navigate national and international supply chains. [146]

Available tests

All tests that have received an Emergency Use Authorization are listed at the FDA website. PCR-based and isothermal nucleic amplification tests are listed with “Molecular” in the technology column. Antibody tests are listed with “Serology” as the technology.

PCR based

Some community-based testing sites in the United States are listed at the HHS website. Additional testing sites can be found here as well as at state and local health department websites. Nearby testing sites can also be located on Apple maps [147] and Google maps [148] by searching for "COVID-19 test".

When scientists from China first released information on the COVID‑19 viral genome on 11 January 2020, the Malaysian Institute for Medical Research (IMR) successfully produced the "primers and probes" specific to SARS-CoV-2 on the very same day. The IMR's laboratory in Kuala Lumpur had initiated early preparedness by setting up reagents to detect coronavirus using the RT-PCR method. [149] The WHO reagent sequence (primers and probes) released several days later was very similar to that produced in the IMR's laboratory, which was used to diagnose Malaysia's first COVID‑19 patient on 24 January 2020. [150]

Public Health England developed a test by 10 January, [151] using real-time RT-PCR (RdRp gene) assay based on oral swabs. [152] The test detected the presence of any type of coronavirus including specifically identifying SARS-CoV-2. It was rolled out to twelve laboratories across the United Kingdom on 10 February. [153] Another early PCR test was developed by Charité in Berlin, working with academic collaborators in Europe and Hong Kong, and published on 23 January. It used rtRT-PCR, and formed the basis of 250,000 kits for distribution by the World Health Organization (WHO). [154] The South Korean company Kogenebiotech developed a clinical grade, PCR-based SARS-CoV-2 detection kit (PowerChek Coronavirus) approved by Korea Centers for Disease Control and Prevention (KCDC) on 4 February 2020. [155] It looks for the "E" gene shared by all beta coronaviruses, and the RdRp gene specific to SARS-CoV-2. [156]

In China, BGI Group was one of the first companies to receive emergency use approval from China's National Medical Products Administration for a PCR-based SARS-CoV-2 detection kit. [157]

In the United States, the CDC distributed its SARS-CoV-2 Real Time PCR Diagnostic Panel to public health labs through the International Reagent Resource. [158] One of three genetic tests in older versions of the test kits caused inconclusive results due to faulty reagents, and a bottleneck of testing at the CDC in Atlanta; this resulted in an average of fewer than 100 samples a day being successfully processed throughout the whole of February 2020. Tests using two components were not determined to be reliable until 28 February 2020, and it was not until then that state and local laboratories were permitted to begin testing. [159] The test was approved by the FDA under an EUA.[ citation needed ]

U.S. commercial labs began testing in early March 2020. As of 5 March LabCorp announced nationwide availability of COVID‑19 testing based on RT-PCR. [160] Quest Diagnostics similarly made nationwide COVID‑19 testing available as of 9 March. [161]

In Russia, the first COVID‑19 test was developed by the State Research Center of Virology and Biotechnology VECTOR, production began on 24 January. [162] On 11 February 2020 the test was approved by the Federal Service for Surveillance in Healthcare. [163]

On 12 March 2020, Mayo Clinic was reported to have developed a test to detect COVID‑19 infection. [164]

On 18 March 2020, the FDA issued EUA to Abbott Laboratories [165] for a test on Abbott's m2000 system; the FDA had previously issued similar authorization to Hologic, [166] LabCorp, [165] and Thermo Fisher Scientific. [167] On 21 March 2020, Cepheid similarly received an EUA from the FDA for a test that takes about 45 minutes on its GeneXpert system; the same system that runs the GeneXpert MTB/RIF. [168] [169]

On 13 April, Health Canada approved a test from Spartan Bioscience. Institutions may "test patients" with a handheld DNA analyzer "and receive results without having to send samples away to a [central] lab". [170] [171]

Isothermal nucleic amplification

U.S. President Donald Trump displays a COVID-19 testing kit from Abbott Laboratories in March 2020. President Trump Delivers Remarks During a Coronavirus Update Briefing (49720569077).jpg
U.S. President Donald Trump displays a COVID-19 testing kit from Abbott Laboratories in March 2020.

On 27 March 2020, the FDA issued an Emergency Use Authorization for a test by Abbott Laboratories, called ID Now COVID-19, that uses isothermal nucleic acid amplification technology instead of PCR. [172] The assay amplifies a unique region of the virus's RdRp gene; the resulting copies are then detected with "fluorescently-labeled molecular beacons". [173] The test kit uses the company's "toaster-size" ID Now device which costs $12,000-$15,000. [174] The device can be used in laboratories or in patient care settings, and provides results in 13 minutes or less. [173] As of 28 March 2020, there were 18,000 ID Now devices in the U.S. and Abbott began manufacturing for 50,000 test kits per day. [175]

All visitors to U.S. President Donald Trump are required to undergo the test on site at the White House. [176]

Antigen tests

On 8 May 2020, the FDA granted the first Emergency Use Authorization for a COVID-19 antigen test: "Sofia 2 SARS Antigen FIA" by Quidel Corp. [177] [39] It is a lateral flow test which uses monoclonal antibodies to detect the virus's nucleocapsid (N) protein. [178] The result of the test is read out by the company's Sofia 2 device using immunofluorescence. [178] The test, simpler and cheaper but less accurate than available PCR tests, can be used in laboratories or in patient care settings and gives results in 15 minutes. [177] A negative test result may occur if the level of antigen in a sample is below the detection limit of the test and should be confirmed with an RT-PCR test. [178]

Serology (antibody) tests

As of 4 May, eleven tests had been approved for diagnosis in the United States, all under FDA Emergency Use Authorization (EUA). [179] The tests are listed and described at the Johns Hopkins Center for Health Security. Other tests have been approved in other countries. [180]

In the United States, as of 28 April, Quest Diagnostics made a COVID-19 antibody test available for purchase to the general public through the QuestDirect service. Cost of the test is approximately US$130. The test requires the individual to visit a Quest Diagnostics location for a blood draw. Results are available days later. [181] An antibody test is also available through LabCorp.

A number of countries are beginning large scale surveys of their populations using these tests. [182] [183] A study in California conducted antibody testing in one county and estimated that the number of coronaviruses cases was between 2.5 and 4.2% of the population, or 50 to 85 times higher than the number of confirmed cases. [184] [185]

In late March 2020, a number of companies received European approvals for their test kits. The testing capacity is several hundred samples within hours. The antibodies are usually detectable 14 days after the onset of the infection. [186]

In May 2020, Roche received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for a selective ELISA serology test to detect COVID-19 antibodies. [187] [188] [189] [190]

WHO Emergency Use Listing

Diagnostic tests accepted by the WHO for procurement
Date listedProduct nameManufacturer
3 April 2020Cobas SARS-CoV-2 qualitative assay for use on the cobas 6800/8800 Systems Roche Molecular Systems
7 April 2020Coronavirus (COVID-19) genesig rtPCR assay Primerdesign
9 April 2020Abbott Realtime SARS-CoV-2 [191] Abbott Molecular
24 April 2020PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay [191] SYM-BIO LiveScience

As of 7 April 2020, the WHO had accepted two diagnostic tests for procurement under the Emergency Use Listing procedure (EUL) for use during the COVID‑19 pandemic, in order to increase access to quality-assured, accurate tests for the disease. [192] Both in vitro diagnostics, the tests are genesig Real-Time PCR Coronavirus (COVID‑19) manufactured by Primerdesign, and cobas SARS-CoV-2 Qualitative assay for use on the cobas® 6800/8800 Systems by Roche Molecular Systems. Approval means these tests can also be supplied by the United Nations and other procurement agencies supporting the COVID‑19 response.[ clarification needed ]

Testing accuracy

The location of sample collection impact on sensitivity for COVID-19 in 205 Wuhan patients [193]
Samples from ...Positive rate
Bronchoalveolar lavage fluid specimens93% (n=14)
Sputum72% (n=75)
Nasal swabs63% (n=5)
Fibrobronchoscope brush biopsy46% (6/13)
Pharyngeal swabs32% (n=126)
Feces29% (n=44)
Blood1% (n=3)

PCR-based test

Detection of SARS-CoV-2 by nasal swab over six weeks in patients who experienced mild to moderate illness Fig4-positivity-rate(1).png
Detection of SARS-CoV-2 by nasal swab over six weeks in patients who experienced mild to moderate illness

RT-PCR is considered the gold standard of diagnosis for COVID-19 and other viruses. [139] Although it has high sensitivity and specificity in a laboratory setting, in one study the sensitivity dropped to 66-88% clinically. [194] Most experts believe improper sample collection, exemplified by failure to acquire enough sample and failure to insert a swab deep into the nose, are to blame for the low clinical sensitivity. The time course of infection also affects the accuracy, for being too late or too early to be tested can lead to a viral load that is too low to be detected, whereas RNA breakdown due to improper storage for too long time could also lead to wrong results. [195] In one study a positive test result was highest at week one (100%), followed by 89.3%, 66.1%, 32.1%, 5.4% and zero by week six. [196] [197]

Early in March 2020, China has been reporting the problems with accuracy in their test kits. [139] A paper published in JAMA researched the RT-PCR sensitivity for COVID-19 in 1070 samples from 205 Wuhan patients, shows a varied sensitivity according to the methods and location of sample collection, where samples from bronchoalveolar lavage fluid specimens tested with the highest sensitivity for COVID-19. [193] The authors argued that CT scan shows a higher sensitivity for testing for COVID-19. [198] Spain purchased test kits from Chinese firm Shenzhen Bioeasy Biotechnology Co Ltd, but found that results were inaccurate. The firm explained that the incorrect results may be a result of a failure to collect samples or use the kits correctly. The Spanish ministry said it will withdraw the kits that returned incorrect results, and would replace them with a different testing kit provided by Shenzhen Bioeasy. [199]

Different test kits also shows inconsistent sensitivity. According to a Dutch CDC-led laboratory investigation comparing 7 PCR test kits from different countries, [200] test kits made by BGI from Shenzhen, China, shows the highest sensitivity compared to the test kits from other countries. [201] The test kits with the highest sensitivity, including those from R-Biopharm AG, BGI, KH Medical, and Seegene, are recommended to diagnose people with low viral loads, while all the other test kits are still satisfying when used for those routine diagnostics of symptomatic patients, according to the research. [200] In the United States, the test kits developed by the CDC had "flaws;" the government then removed the bureaucratic barriers that had prevented private testing. [140]

Isothermal nucleic amplification test

In a study conducted by the Cleveland Clinic, the ID Now COVID-19 test detected the virus in only 85.2% of the samples that contained it. According to the director of the study a test should be at least 95% reliable. Abbott said the issue could have been caused by storing the samples in a special solution instead of inserting them directly into the testing machine. [202] Another study, by researchers at NYU Langone Medical Center, concluded that the machine was unacceptable in their clinical setting as it missed too many infections. [203] The FDA announced on 14 May that they have received and are reviewing 15 adverse event reports about the Abbott ID Now device that suggest some users are receiving inaccurate negative results. [204]

Antibody test

The test results from some of the FDA-authorized COVID-19 antibody tests can be viewed at the FDA website.

Antibody tests have a low positive predictive value (PPV) when the prevalence in the population of people with antibodies is low. For example, suppose there is a population in which 5% of the people have at some point been infected and so should test positive for antibodies. Select 100 people at random and administer an antibody test that has a specificity of 95%, meaning that 5 people who are actually negative will be expected to test positive. Since 5% of the people actually do have antibodies those five people will also test positive giving us 10 people testing positive, with an incorrect result being returned for half of them. So even though the specificity of the test is high, the PPV of the test in this population is only 50%, [205] and a person would receive as much assurance that he is actually positive by flipping a coin. However, the odds can be improved. In this situation conducting a second independent test in sequence when the first test yields a positive result will increase the PPV to 94.5%, meaning that only about 5% of those testing positive would receive an incorrect result. [206] A person could also increase the odds by using a test having a higher specificity. In this population a test with a specificity of 99% would yield a PPV of 84%. [207] If the prevalence of antibodies in the population is 52% a test with a specificity of 95% will yield a PPV greater than 95%. [206] In a low-prevalence setting the negative predictive value (NPV) of a test increases. [206] The actual prevalence of SARS-CoV-2 antibody positive individuals in the U.S. population is not currently known. [207] The test results at the FDA website list the PPV and NPV for each test assuming a prevalence of antibodies in the population of 5%. [207] Antibody survey results from various tests have found that from 2% to 30% of the populations tested have COVID-19 antibodies. [208] The World Health Organization, on preliminary data, concluded that 2% to 3% of the world's population has developed antibodies. [209]

Nearly two million antibody tests imported into Australia and costing $20 million were declared unusable. [210] [211] [212] 80% of test kits for COVID-19 blood antibody that the Czech Republic purchased from China gave wrong results. [213] [214] Slovakia purchased 1.2 million antibody-based test kits from China which were found to be inaccurate. [215] China accused the Czech Republic and Slovakia of incorrect use of antibody-based tests, after Slovakian Prime Minister said the kits should be "dumped into the Danube". [216] Ateş Kara of the Turkish Health Ministry said the antibody-based test kits Turkey purchased from China had a "high error rate" and did not "put them into use". [217] [218] The UK purchased 3.5 million antibody test kits from China but in early April 2020 announced these were not usable. [219] [220] [221] On 21 April 2020, the Indian Council of Medical Research (ICMR) has advised Indian states to stop using the rapid antibody test kits purchased from China after receiving complaints from one state. Rajasthan health minister Raghu Sharma on 21 April said the kits gave only 5.4 percent accurate results against the expectation of 90 percent accuracy. [222] The Chinese embassy in India described the decision to oust Chinese test kits to be "unfair and irresponsible" and "look at issues with pre-emptive prejudice" when responding to ICMR's decision, and explained that antibody tests are only for "surveillance purposes". [223]

Confirmatory testing

The WHO recommends countries that do not have testing capacity and national laboratories with limited experience on COVID‑19 send their first five positives and the first ten negative COVID‑19 samples to one of the 16 WHO reference laboratories for confirmatory testing. [224] [225] Out of the sixteen reference laboratories, seven are in Asia, five in Europe, two in Africa, one in North America and one in Australia. [226]

Clinical effectiveness

Testing, followed with quarantine of those who tested positive and tracing of those with whom the SARS-CoV-2 positive people had had contact, resulted in positive outcomes.[ clarification needed ].[ citation needed ]

Italy

Researchers working in the Italian town of , the site of the first COVID‑19 death in Italy, conducted two rounds of testing on the entire population of about 3,400 people, about ten days apart. About half the people testing positive had no symptoms, and all discovered cases were quarantined. With travel to the commune restricted, this eliminated new infections completely. [227]

Japan

Unlike other Asian countries, Japan did not have a pandemic of SARS or MERS, so the PCR testing system was not well equipped. [228] [229] That made Japan preferentially test patients with severe illness and those who were in close contact with infected people at the beginning. The Novel Coronavirus Expert Meeting chose the cluster measures to quickly detect and destroy clusters, a group of infected people. [228] [229] At the same time, the Expert Meeting analyzed the outbreak from Wuhan, which became the first wave of COVID-19 in Japan, and discovered the conditions under which clusters occur, so-called "Three C's" (Closed spaces, Crowded spaces and Close-contact settings), and asked the whole nation to avoid such sites. [229] [230] In January, contact tracers at public health centers across Japan took action shortly after the first infection was found. Since then, they have been tracking the movements of the disease. [230] Only administrative tests were carried out at first, but PCR test was covered with insurance on March 6, and private companies began to test, and the test system was gradually expanded. [228] [231] On April 3, the people testing positive were legally permitted to recuperate at home or in a hotel if they had asymptomatic or mild illness, which solved the lack of beds. [232] While succeeding in containing the first wave from China (identified in May by epidemiological survey of coronavirus genomic molecules), [233] the second wave caused by returnees from Europe and the US occurred in mid-March, which led to the spread of infection in April. [229] On April 7, Japan declared a state of emergency, which is not as strict as a lockdown because it is not legal in Japan to block cities or restrict outing. [229] [232] [234] On May 13, COVID-19's Antigen Test Kits, which can check whether infected or not in in a little more than ten minutes although have low sensitivity, started to be covered by insurance, and was used in combination with PCR test for confirmed diagnosis. [235] [236] The number of PCR tests per 100,000 people in Japan is far smaller than in other countries although the positive rate is lower. Because of that, some pointed out that COVID-19 might be mixed in patients with pneumonia, but there were no pandemics and no excess mortality occurred until March. [230] [234] [237] The Expert Meeting said, "The Japanese health care system originally carries out pneumonia surveillance, allowing it to detect most of the severely ill patients who develop pneumonia. There are a large number of CT scanners in Japan and they have spread to small hospitals all over the country, so pneumonia patients are rarely missed. In that sense, it meets the same standards as other countries that mainly carry out PCR tests." [230] [237] Expert Meeting believe that it would be better to use CT scans data and doctor's findings to detect coronavirus, not just PCR tests, by the experiences such as the COVID-19 pandemic on Diamond Princess. [238] [239] In Diamond Princess, there were many cases in which the people testing negative later tested positive. On the other hand, half of coronavirus-positive who remained mild or asymptomatic had pneumonia findings on CT scans and their CT image showed a frosted glass shadow that is characteristic of the new coronavirus pneumonia. [240] [241]

Singapore

With aggressive contact tracing, inbound travel restrictions, testing, and quarantining, the COVID-19 pandemic in Singapore has proceeded much more slowly than in other developed countries [ dubious ], but without extreme restrictions like forced closure of restaurants and retail establishments. Many events have been cancelled, and Singapore advised residents to stay at home on 28 March, but schools reopened on time after holiday break on 23 March, [242] even though schools did close moving to "full home-based learning" on 8 April. [243]

Russia

On 27 April, Russia tested 3 million people and had 183,000 people under medical supervision because they were suspected of having the virus [244] with 87,147 people having tested positive for the virus and total confirmed deaths at 794. [245] On 28 April Anna Popova head of Federal Service for Surveillance in Healthcare (Roszdravnadzor) in a presidential update said there were now 506 laboratories testing; 45% of those tested positive had no symptoms; incidence of pneumonia reduced from 25% to 20%; and only 5% of patients had a severe form. 40% of infections were from family members. The speed of people reporting illness has improved from six days to the day people find symptoms. Antibody testing was carried out on 3,200 Moscow doctors and 20% have immunity. [246]

The United States of America

New York State

New York State's new coronavirus control measures consisted of three major pillars: (1) increasing the number of PCR tests, (2) reducing the density of people, (3) strengthening the capabilities of medical systems. On February 29, before the first case, the state allowed testing at the Wordsworth Center by having the CDC approve tests at state laboratories and by having the FDA approve a test kit used by the state of NY. New York Gov. Andrew Cuomo said the state would increase testing capabilities and increase the number of tests as soon as possible to curb the spread of the infection. The theory is that the more tests are carried out, the more positives can be identified and quarantined. The governor also said the tests were important not to know how many people were infected, but to know the hospitalization rate that determines the capacity of the health care system. These expansions have resulted in more than 1,000 daily tests in the state on March 13 and 10,000 on March 19. When the number of cases was the second highest in the US after Washington, Cuomo said that the numbers were about the same, but the number of fatalities was quite small. In April, the number of tests per day exceeded 20,000, and the number of tests seen in the population ratio far higher than in other countries. However, it was pointed out that the rapid expansion of testing has flooded many people into hospitals and accelerated the spread of infection. Citizens rushed to medical institutions because of anxiety, even for those who were infected or who had no symptoms. The testing did not progress easily. There were many people who queued up at the hospital, or who went to the hospital every day until their turn came. On 21 March, New York City health officials directed medical providers to stop testing patients for the coronavirus, except for diseases that require hospitalization, saying wider testing is exhausting supplies of protective equipment. The demand for unnecessary testing contributed to a shortage of masks, gowns, collection swabs and other supplies, as all of those had to be disposed by health care workers after each test. On March 24, a medical worker working at a hospital in New York City died of COVID-19. Colleagues working at the same hospital posted a picture of themselves wearing garbage bags instead of medical scrubs on Facebook, claiming the hospital lacked PPE. [247] [248] [249] [250] [251]

U.S. aircraft carrier

After 94% of the 4,800 crew had been tested, roughly 60 percent of the 600-plus sailors who tested positive did not have symptoms. [252] Sailors who test positive must spend at least two weeks in isolation and then test negative twice in a row, with the tests separated by at least a day. Five sailors who went through this process and had been admitted back onto the ship subsequently developed flu-like symptoms and again tested positive. [59]

Others

Several other countries, such as Iceland [253] and South Korea, [254] have also managed the pandemic with aggressive contact tracing, inbound travel restrictions, testing, and quarantining, but with less aggressive lock-downs. A statistical study has found that countries that have tested more, relative to the number of deaths, have much lower case fatality rates, probably because these countries are better able to detect those with only mild or no symptoms. [6] A subsequent study has also found that countries that have tested more widely also have a younger age distribution of cases, relative to the wider population. [255]

Research and development

A test which uses monoclonal antibodies which bind to the nucleocapsid protein (N protein) of the SARS-CoV-2 is being developed in Taiwan, with the hope that it can provide results in 15 to 20 minutes just like a rapid influenza test. [256] The World Health Organization raised concerns on 8 April that these tests need to be validated for the disease and are in a research stage only. [257] The United States Food and Drug Administration approved an antibody test on 2 April, [258] but some researchers warn that such tests should not drive public health decisions unless the percentage of COVID‑19 survivors who are producing neutralizing antibodies is also known. [48]

Virus testing statistics by country

The figures are influenced by the country's testing policy. If two countries are alike in every respect, including having the same spread of infection, and one of them has a shortage of testing capability, it may test only those showing symptoms while the other country having greater access to testing may test both those showing symptoms and others chosen at random. The country that tests only people showing symptoms will have a higher figure for "% (Confirmed cases as percentage of tested samples or tested cases)" than the country that also tests people chosen at random. [259] If two countries are alike in every respect, including which people they test, the one that tests more people will have a higher "Confirmed / million people".

COVID-19 testing statistics by country
CountryDate [lower-alpha 1] TestedUnits [lower-alpha 2] Confirmed
(cases)
%Tested/
million
people
Confirmed/
million
people
Ref.
Flag of Afghanistan.svg Afghanistan 31 May38,460samples15,20539.5988391 [260]
Flag of Albania.svg Albania 30 May14,269samples1,0997.74,984384 [261]
Flag of Algeria.svg Algeria 2 June18,928cases9,51350.3434218 [262]
Flag of Argentina.svg Argentina 23 May125,893samples10,6498.52,774235 [263]
Flag of Armenia.svg Armenia 24 May50,3976,66113.217,0742,257 [264]
Flag of Australia (converted).svg Australia 30 May1,430,143samples7,1850.5056,305283 [265]
Flag of Austria.svg Austria 3 June462,95816,6783.652,0031,873 [266]
Flag of Azerbaijan.svg Azerbaijan 31 May298,6485,4941.830,173555 [267]
Flag of Bahrain.svg Bahrain 23 May276,5528,8023.2176,2105,608 [268]
Flag of Bangladesh.svg Bangladesh 24 May243,636samples33,61013.81,479204 [269]
Flag of Barbados.svg Barbados 23 May4,664922.016,249321 [270]
Flag of Belarus.svg Belarus 23 May434,618samples35,2448.145,7893,713 [271]
Flag of Belgium (civil).svg Belgium 23 May768,706samples56,8107.466,7524,933 [272]
Flag of Bhutan.svg Bhutan 23 May15,293samples240.1620,61932 [273]
Flag of Bolivia.svg Bolivia 23 May21,205cases5,91527.91,855518 [274]
Flag of Bosnia and Herzegovina.svg Bosnia and Herzegovina 2 June66,722samples2,5353.819,501741 [275]
Flag of Brazil.svg Brazil 2 June10,650,264samples526,4474.950,6802,505 [276] [277]
Flag of Bulgaria.svg Bulgaria 24 May74,096samples2,4273.310,661349 [278]
Flag of Burkina Faso.svg Burkina Faso 21 May6,642samples81412.331839 [279] [280]
Flag of Cameroon.svg Cameroon 10 May10,2682,57925.138797 [281]
Flag of Canada (Pantone).svg Canada 2 June1,724,250cases92,4105.445,5012,439 [282]
Flag of Chile.svg Chile 1 June599,330samples105,15917.531,4265,514 [283]
Flag of Colombia.svg Colombia 21 May222,210samples18,3308.24,605380 [284]
Flag of Costa Rica.svg Costa Rica 23 May22,910samples9184.04,583184 [285]
Flag of Croatia.svg Croatia 24 May61,482cases2,2443.615,083551 [286]
Flag of Cuba.svg Cuba 22 May92,6291,9312.18,178170 [287]
Flag of Cyprus.svg Cyprus [lower-alpha 3] 23 May99,733samples9270.93115,5301,074 [288]
Flag of the Czech Republic.svg Czechia 31 May442,866samples9,2862.141,413868 [289]
Flag of Denmark.svg Denmark 29 May516,141cases11,7932.387,0521,989 [290]
Flag of the Democratic Republic of the Congo.svg DR Congo 2 June9,5083,19533.610635.7 [291]
Flag of Ecuador.svg Ecuador 6 May81,392samples29,42036.14,7641,722 [292]
Flag of Egypt.svg Egypt 2 June141,002samples26,38418.71,409264 [293]
Flag of El Salvador.svg El Salvador 4 May32,0305871.84,93890 [294]
Flag of Estonia.svg Estonia 16 May68,840samples1,7702.651,8231,332 [295]
Flag of Ethiopia.svg Ethiopia 26 May87,264samples7010.807596.1 [296]
Flag of Finland.svg Finland 20 May160,177samples6,4934.128,8961,171 [297]
Flag of France.svg France [lower-alpha 4] 24 May1,048,065149,07114.215,6382,224 [298] [299]
Flag of Germany.svg Germany 26 May3,952,971samples179,3644.547,5412,157 [300]
Flag of Ghana.svg Ghana 7 May137,9243,0912.24,43999 [301]
Flag of Greece.svg Greece 10 May98,877samples4,0154.19,182373 [302]
Flag of Grenada.svg Grenada 5 May1,781samples2110.31,570162 [303]
Flag of Guinea.svg Guinea 6 May7,369cases1,85625.2561141 [281]
Flag of Hungary.svg Hungary 3 June191,572samples3,9312.119,831407 [304]
Flag of Iceland.svg Iceland 25 May58,856samples1,8043.1161,5774,953 [305]
Flag of India.svg India 3 June4,103,233samples207,6155.13,033153 [306] [307]
Flag of Indonesia.svg Indonesia 1 June223,624cases26,47324.483599 [308]
Flag of Iran.svg Iran 31 May935,894samples151,46616.211,2511,821 [309]
Flag of Iraq.svg Iraq 7 May120,604samples2,5432.12,99863 [310]
Flag of Ireland.svg Ireland 1 June348,416samples25,0667.270,7955,093 [311]
Flag of Israel.svg Israel 3 June593,49917,3422.964,6861,890 [312]
Flag of Italy.svg Italy 1 June3,910,133samples233,1976.064,7813,863 [313]
Flag of Cote d'Ivoire.svg Ivory Coast 25 May18,3032,42313.269492 [281]
Flag of Jamaica.svg Jamaica 12 May7,465samples5076.82,739186 [314]
Flag of Japan.svg Japan 29 May471,829samples16,7193.53,740133 [315]
Flag of Kazakhstan.svg Kazakhstan 31 May812,881samples10,8581.343,578582 [316]
Flag of Kenya.svg Kenya 10 May32,097samples6722.167514 [317]
Flag of Kosovo.svg Kosovo 29 May14,635samples1,0647.38,084588 [318]
Flag of Kyrgyzstan.svg Kyrgyzstan 5 May58,030samples8431.59,082132 [319]
Flag of Latvia.svg Latvia 22 May96,366samples1,0301.050,191536 [320]
Flag of Lebanon.svg Lebanon 12 May53,2698701.67,804127 [321]
Flag of Libya.svg Libya 2 June6,871cases1562.31,00123 [322]
Flag of Lithuania.svg Lithuania 2 June309,725samples1,6820.54110,841602 [323]
Flag of Luxembourg.svg Luxembourg 2 June78,026samples4,0205.2124,6216,421 [324]
Flag of Madagascar.svg Madagascar 2 June11,311cases8267.343131 [325]
Flag of Malawi.svg Malawi 5 May961samples414.3502.1 [326]
Flag of Malaysia.svg Malaysia 1 June560,738cases7,8571.417,110240 [327]
Flag of Maldives.svg Maldives 22 May17,174samples1,2747.443,7583,246 [328]
Flag of Malta.svg Malta 27 May64,334samples6120.95130,3471,240 [329]
Flag of Mauritius.svg Mauritius 2 June120,358samples3350.2895,071265 [330]
Flag of Mexico.svg Mexico 30 May231,998cases87,51237.71,803680 [331]
Flag of Montenegro.svg Montenegro 5 May8,534samples3243.813,520513 [332]
Flag of Morocco.svg Morocco 2 June221,154cases7,8593.65,992213 [333]
Flag of Mozambique.svg Mozambique 10 May3,923912.31262.9 [334]
Flag of Myanmar.svg Myanmar 31 May24,710samples2240.914544.1 [335]
Flag of Nepal.svg Nepal 2 June185,6731,8110.986,60964 [336]
Flag of the Netherlands.svg Netherlands 5 May306,460cases44,44714.517,5872,551 [337]
Flag of New Zealand.svg New Zealand 26 May267,435samples1,1540.4353,663232 [338]
Flag of Nigeria.svg Nigeria 2 June65,885samples10,57816.132252 [339]
Flag of North Korea.svg North Korea 17 April740cases00290 [340]
Flag of North Macedonia.svg North Macedonia 1 June30,3022,3157.614,5881,115 [341]
Flag of the Turkish Republic of Northern Cyprus.svg Northern Cyprus [lower-alpha 5] 30 May31,3461080.3496,153331 [342]
Flag of Norway.svg Norway 20 May223,045cases8,2683.741,5541,540 [343]
Flag of Oman.svg Oman 31 May100,000samples11,43711.421,5172,461 [344]
Flag of Pakistan.svg Pakistan 1 June577,97476,39813.22,669353 [345]
Flag of Palestine.svg Palestine 7 May34,511samples5471.66,831108 [346]
Flag of Panama.svg Panama 6 May38,0147,73120.39,1011,851 [347]
Flag of Paraguay.svg Paraguay 7 May13,096samples4623.51,83665 [348]
Flag of Peru.svg Peru 2 June1,092,646samples174,88416.033,2885,328 [349]
Flag of the Philippines.svg Philippines 1 June366,269samples18,6385.13,627185 [350]
Flag of Poland.svg Poland 1 June931,520samples23,9872.624,267625 [351]
Flag of Portugal.svg Portugal 23 May689,705samples30,4714.467,1142,965 [352]
Flag of Qatar.svg Qatar 2 June231,098cases60,25926.180,21320,916 [353]
Flag of Romania.svg Romania 28 May410,000samples18,7914.621,132969 [354]
Flag of Russia.svg Russia 31 May10,923,108samples414,8783.874,4362,827 [355] [356]
Flag of Rwanda.svg Rwanda 7 May38,8342710.702,99821 [357]
Flag of Saint Lucia.svg Saint Lucia 25 May898182.04,93799 [358]
Flag of Saudi Arabia.svg Saudi Arabia 8 May418,72235,4328.512,0271,018 [359]
Flag of Senegal.svg Senegal 11 May22,4811,8868.41,418119 [360]
Flag of Serbia.svg Serbia 28 May233,479cases11,3004.833,5281,623 [361]
Flag of Singapore.svg Singapore 1 June408,495samples35,2928.671,6216,188 [362] [363]
Flag of Slovakia.svg Slovakia 2 June181,629samples1,5250.8433,278279 [364]
Flag of Slovenia.svg Slovenia 15 May70,220samples1,4652.133,533700 [365]
Flag of South Africa.svg South Africa 2 June742,742cases35,8124.811,942609 [366]
Flag of South Korea.svg South Korea 3 June910,929cases11,5411.317,616223 [367]
Flag of Spain.svg Spain 28 May4,063,843samples284,9867.086,9596,098 [368] [369]
Flag of Sri Lanka.svg Sri Lanka 24 May53,092cases1,0942.12,45050 [370]
Flag of Sudan.svg Sudan 2 June7,825samples5,17366.1178118 [371]
Flag of Sweden.svg Sweden 2 Jun275,500cases38,58914.026,6763,736 [372]
Flag of Switzerland.svg Switzerland [lower-alpha 6] 25 May372,146samples30,7468.343,2293,572 [373]
Flag of the Republic of China.svg Taiwan [lower-alpha 7] 3 June72,683cases4430.613,07919 [374]
Flag of Tanzania.svg Tanzania 29 April65248073.6118.0 [281]
Flag of Thailand.svg Thailand 7 May89,791cases2,9923.31,29343 [375]
Flag of Trinidad and Tobago.svg Trinidad and Tobago 9 May2,271samples1165.11,66585 [376]
Flag of Tunisia.svg Tunisia 2 June52,874cases1,0862.14,47492 [377]
Flag of Turkey.svg Turkey 1 June2,070,719cases164,7698.024,9021,981 [378]
Flag of Uganda.svg Uganda 15 May70,117samples2030.291,5334.4 [379]
Flag of Ukraine.svg Ukraine 23 May277,712samples20,5807.46,607490 [380]
Flag of the United Arab Emirates.svg United Arab Emirates 31 May2,253,65734,5571.5234,7723,600 [381]
Flag of the United Kingdom.svg United Kingdom 2 June4,615,146samples277,9856.068,3264,116 [382]
Flag of the United States.svg United States 2 June17,757,8381,823,26910.354,1005,555 [383] [384]
Flag of Uruguay.svg Uruguay 9 May39,469samples9582.411,373276 [385]
Flag of Uzbekistan.svg Uzbekistan 7 May371,000samples2,2980.6210,90068 [386]
Flag of Venezuela.svg Venezuela 25 May832,526samples1,1770.1428,82041 [387]
Flag of Vietnam.svg Vietnam 1 June261,004samples3280.132,6443.3 [388]
Flag of Zimbabwe.svg Zimbabwe 10 May8,244340.415552.3 [389]
  1. Local time.
  2. For some countries it is unclear whether they report samples or cases. One person tested twice is recorded as one case and two samples.
  3. Excluding Northern Cyprus.
  4. Testing data from 4 May to 17 May is missing because of the transition to the new reporting system SI-DEP.
  5. Northern Cyprus is not recognized as a sovereign state by any country except Turkey.
  6. Includes data for Liechtenstein.
  7. The UN does not recognize Taiwan as a sovereign state

Virus testing statistics by country subdivision

COVID-19 testing statistics by country subdivision
Country [lower-alpha 1] SubdivisionDate [lower-alpha 2] TestedConfirmed
(cases)
%Tested/
million
people
Confirmed/
million
people
Ref.
Flag of Australia (converted).svg AustraliaFlag of the Australian Capital Territory.svg Australian Capital Territory 27 May15,2531070.7038,019251 [390]
Flag of Australia (converted).svg AustraliaFlag of New South Wales.svg New South Wales 27 May464,3513,0890.6757,402382 [390]
Flag of Australia (converted).svg AustraliaFlag of the Northern Territory.svg Northern Territory 22 May7,369290.3929,971118 [390]
Flag of Australia (converted).svg AustraliaFlag of Queensland.svg Queensland 27 May180,3711,0580.5935,401208 [390]
Flag of Australia (converted).svg AustraliaFlag of South Australia.svg South Australia 27 May91,5974400.4852,291251 [390]
Flag of Australia (converted).svg AustraliaFlag of Tasmania.svg Tasmania 27 May25,6442280.8947,997427 [390]
Flag of Australia (converted).svg AustraliaFlag of Victoria (Australia).svg Victoria 30 May501,5651,6450.3376,055249 [390]
Flag of Australia (converted).svg AustraliaFlag of Western Australia.svg Western Australia 27 May78,3085700.7329,869217 [390]
Flag of Canada (Pantone).svg CanadaFlag of Alberta.svg Alberta 2 June266,3017,0572.760,3431,599 [391]
Flag of Canada (Pantone).svg CanadaFlag of British Columbia.svg British Columbia 2 June147,7572,6011.828,910509 [392]
Flag of Canada (Pantone).svg CanadaFlag of Manitoba.svg Manitoba 2 June45,0992970.6632,739216 [393]
Flag of Canada (Pantone).svg CanadaFlag of New Brunswick.svg New Brunswick 2 June30,6661330.4339,316171 [394]
Flag of Canada (Pantone).svg CanadaFlag of Newfoundland and Labrador.svg Newfoundland and Labrador 2 June12,4332612.123,847501 [395]
Flag of Canada (Pantone).svg CanadaFlag of the Northwest Territories.svg Northwest Territories 2 June2,23350.2249,728111 [396]
Flag of Canada (Pantone).svg CanadaFlag of Nova Scotia.svg Nova Scotia 2 June43,9181,0572.444,9311,081 [397]
Flag of Canada (Pantone).svg CanadaFlag of Nunavut.svg Nunavut 1 June9610024,5800 [398]
Flag of Canada (Pantone).svg CanadaFlag of Ontario.svg Ontario 1 June747,96428,7093.850,8411,951 [399]
Flag of Canada (Pantone).svg CanadaFlag of Prince Edward Island.svg Prince Edward Island 2 June6,740270.4042,616171 [400]
Flag of Canada (Pantone).svg CanadaFlag of Quebec.svg Quebec 1 June450,31751,59311.552,7456,043 [401]
Flag of Canada (Pantone).svg CanadaFlag of Saskatchewan.svg Saskatchewan 2 June48,5936461.341,122547 [402]
Flag of Canada (Pantone).svg CanadaFlag of Yukon.svg Yukon 2 June1,187110.9328,896268 [403]
Flag of the People's Republic of China.svg ChinaFlag of the People's Republic of China.svg Guangdong 13 May6,790,0002,0990.0365,09920 [404]
Flag of the People's Republic of China.svg ChinaFlag of Hong Kong.svg Hong Kong 27 April154,9891,0370.6720,714139 [405]
Flag of the People's Republic of China.svg ChinaFlag of the People's Republic of China.svg Wuhan, Hubei 1 June12,537,79252,4410.41,118,2484,677 [406] [407]
Flag of India.svg IndiaFlag of India.svg Andaman and Nicobar Islands 1 June7,805330.4219,66083 [408]
Flag of India.svg IndiaFlag of India.svg Andhra Pradesh 2 June395,6813,7910.967,57773 [409] [410]
Flag of India.svg IndiaFlag of India.svg Arunachal Pradesh 1 June8,768220.255,83014.6 [411]
Flag of India.svg IndiaFlag of India.svg Assam 31 May109,0971,6721.53,18149 [412]
Flag of India.svg IndiaFlag of India.svg Bihar 1 June78,0904,0495.265334 [413]
Flag of India.svg IndiaFlag of India.svg Chandigarh 1 June4,8162946.14,085249 [414]
Flag of India.svg IndiaFlag of India.svg Chhattisgarh 1 June69,3615470.792,41519 [415]
Flag of India.svg IndiaFlag of India.svg Dadra and Nagar Haveli and Daman and Diu 25 May20,780730.0212,6433.1 [416]
Flag of India.svg IndiaFlag of India.svg Delhi 1 June217,57320,8349.610,9811,051 [417]
Flag of India.svg IndiaFlag of India.svg Goa 1 June20,780730.3513,49447 [418]
Flag of India.svg IndiaFlag of India.svg Gujarat 1 June216,25817,2008.03,183253 [419] [420]
Flag of India.svg IndiaFlag of India.svg Haryana 1 June121,7792,3561.94,24782 [421]
Flag of India.svg IndiaFlag of India.svg Himachal Pradesh 31 May37,1683310.895,09245 [422]
Flag of India.svg IndiaFlag of India.svg Jammu and Kashmir 31 May171,0452,4461.412,955185 [423]
Flag of India.svg IndiaFlag of India.svg Jharkhand 31 May65,8666100.931,76116 [424]
Flag of India.svg IndiaFlag of India.svg Karnataka 2 June319,6283,7961.24,85858 [425]
Flag of India.svg IndiaFlag of India.svg Kerala 2 June71,0681,4122.02,02340 [426] [427]
Flag of India.svg IndiaFlag of India.svg Ladakh 28 May7,354771.025,099263 [428]
Flag of India.svg IndiaFlag of India.svg Madhya Pradesh 31 May167,8088,0894.82,04198 [429]
Flag of India.svg IndiaFlag of India.svg Maharashtra 1 June471,57372,30015.33,861592 [430]
Flag of India.svg IndiaFlag of India.svg Manipur 30 May8,991710.792,89823 [431]
Flag of India.svg IndiaFlag of India.svg Meghalaya 25 May6,553270.412,0338.4 [432]
Flag of India.svg IndiaFlag of India.svg Nagaland 31 May2,576431.72,99250 [433]
Flag of India.svg IndiaFlag of India.svg Odisha 31 May152,1311,9481.33,48445 [434] [435]
Flag of India.svg IndiaFlag of India.svg Puducherry 31 May7,255700.964,82447 [436]
Flag of India.svg IndiaFlag of India.svg Punjab 31 May87,8522,2632.62,96976 [437]
Flag of India.svg IndiaFlag of India.svg Rajasthan 2 June440,7899,3732.15,705121 [438] [439]
Flag of India.svg IndiaFlag of India.svg Sikkim 1 June3,52510.0313,0073.7 [440]
Flag of India.svg IndiaFlag of India.svg Tamil Nadu 2 June514,43324,5864.86,796325 [441] [442]
Flag of India.svg IndiaFlag of India.svg Tripura 2 June29,0664711.67,281118 [443]
Flag of India.svg IndiaFlag of India.svg Uttar Pradesh 30 May279,2888,0752.91,24136 [444]
Flag of India.svg IndiaFlag of India.svg Uttarakhand 31 May30,4389073.02,73281 [445]
Flag of India.svg IndiaFlag of India.svg West Bengal 31 May203,7515,5012.72,10357 [446]
Flag of Italy.svg ItalyFlag of Abruzzo.svg Abruzzo 1 June76,9243,2454.258,6502,474 [313]
Flag of Italy.svg ItalyFlag of Valle d'Aosta.svg Aosta Valley 1 June15,2301,1877.8121,1949,446 [313]
Flag of Italy.svg ItalyFlag of Apulia.svg Apulia 1 June119,6504,4983.829,6971,116 [313]
Flag of Italy.svg ItalyFlag of Basilicata.svg Basilicata 1 June29,9563991.353,220709 [313]
Flag of Italy.svg ItalyFlag of Calabria.svg Calabria 1 June70,8921,1581.636,408595 [313]
Flag of Italy.svg ItalyFlag of Campania.svg Campania 1 June203,8584,8062.435,138828 [313]
Flag of Italy.svg ItalyFictional Emilia-Romagna Flag.svg Emilia-Romagna 1 June329,35827,8098.473,8566,236 [313]
Flag of Italy.svg ItalyFlag of Friuli-Venezia Giulia.svg Friuli-Venezia Giulia 1 June135,4313,2742.4111,4462,694 [313]
Flag of Italy.svg ItalyFlag of Lazio.svg Lazio 1 June257,5637,7383.043,8101,316 [313]
Flag of Italy.svg ItalyFlag of Liguria.svg Liguria 1 June107,7879,7199.069,5116,268 [313]
Flag of Italy.svg ItalyFlag of Lombardy.svg Lombardy 1 June757,44689,01811.875,2898,848 [313]
Flag of Italy.svg ItalyFlag of Marche.svg Marche 1 June103,9946,7306.568,1814,412 [313]
Flag of Italy.svg ItalyFlag of Molise.svg Molise 1 June14,8194362.948,4891,427 [313]
Flag of Italy.svg ItalyFlag of Piedmont.svg Piedmont 1 June321,47630,6589.573,7947,037 [313]
Flag of Italy.svg ItalyFlag of Sardinia.svg Sardinia 1 June57,6871,3572.435,184828 [313]
Flag of Italy.svg ItalyFlag of Sicily (revised).svg Sicilia 1 June151,1863,4432.330,238689 [313]
Flag of Italy.svg ItalyFlag of South Tyrol.svg South Tyrol 1 June67,1212,5983.9125,9194,874 [313]
Flag of Italy.svg ItalyFlag of Trento Province.svg Trentino 1 June89,2354,4325.0164,8298,186 [313]
Flag of Italy.svg ItalyFlag of Tuscany.svg Tuscany 1 June253,84510,1074.068,0622,710 [313]
Flag of Italy.svg ItalyFlag of Umbria.svg Umbria 1 June70,7411,4312.080,2041,622 [313]
Flag of Italy.svg ItalyFlag of Veneto.svg Veneto 1 June675,93419,1542.8137,7813,904 [313]
Flag of Japan.svg JapanFlag of Tokyo Prefecture.svg Tokyo 19 May14,4645,07035.11,038364 [447]
Flag of Russia.svg RussiaFlag of Moscow, Russia.svg Moscow 3 June2,682,999187,2167.0211,62514,767 [448] [449]
Flag of Russia.svg RussiaFlag of Moscow oblast.svg Moscow Oblast 1 June423,79639,7239.455,1045,165 [450]
Flag of Russia.svg RussiaFlag of Nizhny Novgorod Region.svg Nizhny Novgorod Oblast 3 June258,05810,8504.279,7773,354 [448] [449]
Flag of Russia.svg RussiaFlag of Saint Petersburg.svg Saint Petersburg 3 June897,39217,0691.9166,2433,162 [448] [449]
Flag of South Africa.svg South Africa Flag of the Western Cape Province.png Western Cape 23 May114,86912,94711.316,7831,892 [451]
Flag of the United Kingdom.svg United KingdomFlag of Scotland.svg Scotland 24 May101,71315,10114.818,7042,777 [452]
Flag of the United States.svg United StatesFlag of California.svg California 1 June2,012,583113,0065.650,9362,860 [453]
Flag of the United States.svg United StatesFlag of Florida.svg Florida 1 June1,041,31856,8305.548,4842,646 [454]
Flag of the United States.svg United StatesFlag of Illinois.svg Illinois 1 June934,704122,84813.173,7629,695 [455]
Flag of the United States.svg United StatesFlag of Louisiana.svg Louisiana 1 June387,37040,34110.483,3278,678 [456]
Flag of the United States.svg United StatesFlag of Massachusetts.svg Massachusetts 1 June599,919100,81516.886,32514,507 [457]
Flag of the United States.svg United StatesFlag of Michigan.svg Michigan 1 June568,02357,53210.156,6865,741 [458]
Flag of the United States.svg United StatesFlag of New Jersey.svg New Jersey 1 June795,600160,91820.289,57318,117 [459]
Flag of the United States.svg United StatesFlag of New York.svg New York 1 June2,113,777371,71117.6108,65819,108 [460]
Flag of the United States.svg United StatesFlag of Texas.svg Texas 1 June990,21664,8806.634,1502,238 [461]
Flag of the United States.svg United StatesFlag of Washington.svg Washington 1 June365,27221,9776.047,9682,886 [462]
  1. To sort within countries, click the column you want to sort by, then click the Country column.
  2. Local time.

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PD-icon.svg This article incorporates  public domain material from the Centers for Disease Control and Prevention document: "Symptom-Based Strategy to Discontinue Isolation for Persons with COVID-19" . Retrieved 5 May 2020.

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