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COVID-19 testing

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Statistics of testing
Country or region
Total
tests[a]
 Positive
[b] 		As of
Tests /
million
Positive /
1,000
 Ref.
United Arab Emirates United Arab Emirates 125,000 98 16 Mar 13,020 0.8 [1][2]
Bahrain Bahrain 13,282 155 16 Mar 8,463 11.7 [3]
Italy Italy Veneto Veneto 35,478 2,704 17 Mar 7,292 76 [4]
Iceland Iceland 2,278 220 17 Mar 6,254 97 [5][6]
Indonesia Indonesia 1,255 172 18 Mar 4.5 137.6 [7]
South Korea South Korea 286,716 8,320 16 Mar 5,545 29 [8]
Norway Norway 28,522 1,423 18 Mar 5,314 50 [9]
Italy Italy Lombardy Lombardy 43,565 14,649 16 Mar 4,355 336 [10]
Italy Italy Friuli Venezia Giulia Friuli Venezia Giulia 4,851 386 16 Mar 3,993 79.6 [10]
Australia Australia 83,138 565 18 Mar 3,299 6.9 [11]
Slovenia Slovenia 6,712 253 16 Mar 3,205 37.7 [12]
Italy Italy Emilia-Romagna Emilia-Romagna 13,096 3,522 16 Mar 2,976 268 [10]
Mainland China Mainland China Mainland China Guangdong 320,000 20 Feb 2,820 1.4 [13]
Canada Canada Alberta Alberta 10,527 74 16 Mar 2,395 7.0 [14]
Italy Italy 137,962 27,980 16 Mar 2,284 202 [10]
Belarus Belarus 16,000 36 16 Mar 1,683 2.25 [15]
United States United States Washington (state) Washington 12,486 904 16 Mar 1,657 72 [16]
Republic of Ireland Ireland 6,636 292 17 Mar 1,374 44 [17]
Denmark Denmark 7,620 1,024 17 Mar 1,309 134 [18]
Canada Canada British Columbia British Columbia 6,326 73 13 Mar 1,247 11.5 [19]
Austria Austria 10,278 1,132 17 Mar 1,142 110 [20]
Israel Israel 10,864 420 18 Mar 1,138 40.2 [21]
Malta Malta 889 21 15 Mar 1,114 22 [22]
Estonia Estonia 2,020 258 18 Mar 1,554 128 [23]
Canada Canada 34,750 424 16 Mar 919 12.2 [24]
Latvia Latvia 1,538 60 17 Mar 801 56 [25]
Taiwan Taiwan 18,812 77 17 Mar 791 4 [26]
Russia Russia 116,061 93 17 Mar 790 0.8 [27]
United Kingdom United Kingdom 50,442 1,950 17 Mar 745 38 [28][29]
Czech Republic Czechia 7,664 464 18 Mar 723 60 [30]
Canada Canada Ontario Ontario 10,178 172 16 Mar 694 17 [31]
Canada Canada Quebec Quebec 4,852 74 17 Mar 594 15.25 [32]
United States United States New York (state) New York 10,049 1,374 16 Mar 516 136 [33]
State of Palestine Palestine 2,519 16 Mar 514 [34]
Switzerland Switzerland 4,000 254 7 Mar 467 63 [35]
Netherlands Netherlands 6,000 7 Mar 340 [36]
Kazakhstan Kazakhstan 5,093 3 13 Mar 276 0.6 [37]
Armenia Armenia 813 1 18 Mar 274 [38][39]
Belgium Belgium 3,128 9 Mar 272 [40]
France France 15,018 1,784 10 Mar 224 118 [41]
Lithuania Lithuania 624 14 16 Mar 223 22 [42]
Slovakia Slovakia 1595 72 16 Mar 287 45 [43]
Romania Romania 4,150 222 17 Mar 213 53.5 [44]
Poland Poland 9,515 246 18 Mar 250 26 [45]
Malaysia Malaysia 7,647 790 18 Mar 233 103 [46]
Croatia Croatia 724 46 15 Mar 190 63.5 [47]
Panama Panama 756 13 Mar 189 [48]
Finland Finland 900 11 Mar 163 [49][50]
United States United States 31,878 4,226 17 Mar 97 204 [51][52]
Hungary Hungary 1,470 39 17 Mar 147 20 [53]
Japan Japan 15,354 868 18 Mar 121 56.5 [54]
New Zealand New Zealand 522 8 15 Mar 109 15 [55]
Vietnam Vietnam 14,950 68 18 Mar 154 0.7 [56]
Thailand Thailand 7,566 212 18 Mar 109 28.2 [57]
United States United States Washington (state) California 3,487 472 16 Mar 88 135 [58]
South Africa South Africa 3070 116 16 Mar 52 37.79 [59]
Colombia Colombia 1,730 54 14 Mar 36 31 [60]
Turkey Turkey 2,900 10 Mar 35 [61]
Philippines Philippines 2,000 9 Mar 20 [62]
Brazil Brazil 2,927 200 13 Mar 13.9 68.25 [63]
Ukraine Ukraine 500 5 16 Mar 11 10 [64]
India India 12,351 145 18 Mar 9 11.7 [65]

Testing for the respiratory illness coronavirus disease 2019 (COVID-19) and the associated SARS-CoV-2 virus is possible with two main methods: molecular recognition and serology testing. Molecular methods leverage polymerase chain reaction (PCR) along with nucleic acid tests, and other advanced analytical techniques, to detect the genetic material of the virus. The Centers for Disease Control (CDC) in particular has developed a real-time reverse transcription polymerase chain reaction for diagnostic purposes. Serology testing, leverages ELISA antibody test kits to detect the presence of antibodies produced by the host immune system against the virus. The CDC runs two ELISA tests against two different proteins produced by the virus. If either test is positive, a microneutralization assay test is performed to confirm the positive result. The microneutralization assay is highly specific, but significantly more labor and time intensive. Since antibodies continue to circulate even after the infection is cleared, serology tests continue to be positive for individuals who have been previously exposed and developed an immune response, which means a positive test may not indicate an active infection. As such, the CDC is using serology antibody testing for surveillance and investigational purposes only while the molecular test methodologies are used to diagnosis active infections.

Test methods

As of 6 March 2020, WHO listed the development laboratories and protocols[66]
Country Institute Gene targets
China China CDC ORF1ab and Nucleoprotein (N)
Germany Charité RdRP, E, N
Hong Kong HKU ORF1b-nsp14, N
Japan National Institute of Infectious Diseases,
Department of Virology III		 Pancorona and multiple targets,
Spike protein (Peplomer)
Thailand National Institute of Health N
US US CDC Three targets in N gene
France Pasteur Institute Two targets in RdRP

PCR

One of the early PCR tests was developed at Charité in Berlin in January 2020 using real-time reverse transcription polymerase chain reaction (rRT-PCR), and formed the basis of 250,000 kits for distribution by the World Health Organization (WHO).[67]

The South Korean company Kogenebiotech developed a clinical grade, PCR-based SARS-CoV-2 detection kit (PowerChek Coronavirus) on 28 January 2020.[68][69] It looks for the "E" gene shared by all beta coronaviruses, and the RdRp gene specific to SARS-CoV-2.[70] Other companies in the country, such as Solgent and Seegene, also developed versions of clinical grade detection kits, named DiaPlexQ and Allplex 2019-nCoV Assay, respectively, in February 2020.

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.[71]

In the United States, the Centers for Disease Control and Prevention is distributing the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel to public health labs through the International Reagent Resource.[72] One of three genetic tests in older versions of the test kits caused inconclusive results, and a bottleneck of testing at the CDC in Atlanta; tests using two components were determined to be reliable on 28 February 2020, allowing state and local laboratories to complete testing quickly.[73] The test was approved by the Food and Drug Administration under an Emergency Use Authorization.

US commercial labs began testing in early March 2020. As of 5 March 2020 LabCorp announced nationwide availability of COVID-19 testing based on RT-PCR.[74] Quest Diagnostics similarly made nationwide COVID-19 testing available as of 9 March 2020.[75] No quantity limitations were announced; specimen collection and processing must be performed according to CDC requirements.

On 12 March 2020, Mayo Clinic was reported to have developed a test to detect COVID-19 infection.[76]

On 13 March 2020, Roche Diagnostics received FDA approval for a test which could be performed within 3.5 hours, thus allowing one machine to do approximately 4,128 tests in a 24-hour period.[77]

Immunoassay

Further information: Immunoassay

As of 26 February 2020, there were no antibody tests or point-of-care tests though efforts to develop them are ongoing.[78]

On 28 February 2020, a South Korean company called PCL filed a request to Ministry of Food and Drug Safety of South Korea for their antibody-based detection kit, COVID-19 Ag GICA Rapid. Unlike an RT-PCR-based detection kit, PCL claims that their antibody-based kit could make a diagnosis within 10 min.

On 8 March 2020, Taiwan's Academia Sinica announced a monoclonal antibody specifically binding nucleocapsid protein (N protein) of the novel coronavirus had been successfully generated and tested in 19 days. If a rapid immune-based test kit can be developed it may be able to detect the disease within 15 to 20 minutes just like a rapid influenza test.[79]

BioMedomics of North Carolina, USA claims to have developed a rapid antibody test that will return results in 15 minutes.[80] It detects both IgM and IgG antibodies using blood drawn from veins or collected from finger pricks.[81] BioMedomics is waiting on FDA approval.[82]

Chest CT scan

Chest CT scans can sometimes help identify and characterize lung pathology, and have yielded non-specific findings with COVID-19 infection. A systematic review of chest CT scan findings in 919 patients described the typical early manifestation of COVID-19 as "bilateral multilobar ground-glass opacification (GGO) with a peripheral or posterior distribution".[83] One study found that the sensitivity of CT for COVID-19 infection was 98% compared to RT-PCR sensitivity of 71%; however, this was performed in Wuhan province of China and is not generalizable.[84] Most common CT scan findings were bilateral ground-glass attenuation (patchy or diffuse) with subpleural dominance, crazy paving and consolidations at later stages.[85] These findings are nonspecific and found as well in other types of pneumonia. A small study showed that Chinese radiologists demonstrated 72-94% sensitivity and 24-94% in differentiating COVID-19 from other types of viral pneumonia using CT imaging.[86] No study yet has validated the accuracy and discriminatory value of CT scans to distinguish COVID from other viral pneumonia. Therefore, the CDC does not recommend CT for initial screening, as emphasized in the COCA call on Thursday, 5 March. People with suspected COVID should be tested with RT-PCR, which is the most specific test.[citation needed]

  • Typical CT imaging findings

  • CT imaging of rapid progression stage.

CRISPR-based paper strips

A method based on CRISPR-Cas12a collateral single-stranded DNA (ssDNA) cleavage activity is under investigation.[87][88] Briefly, sample RNA is retrotranscribed to cDNA and amplified using recombinase polymerase amplification combined with reverse transcriptase enzyme. This amplification is isothermal, and thus requires much simpler equipment than PCR. If target RNA from SARS-CoV-2 is present in the sample, the corresponding cDNA binds to Cas12a and triggers collateral cleavage of a fluorescein-labeled single-stranded DNA probe. This cleavage emits a fluorescence signal that can be read on a plate reader, or alternatively detected on a paper strip (by lateral flow) in a portable manner. This method has been tested on simulated clinical samples (i.e., adding synthetic SARS-CoV-2 RNA fragments to saliva samples from a healthy donor) but has not been tested on patient samples.[88]

Sample collection

Using real time reverse transcription polymerase chain reaction (rRT-PCR)[89] the test can be done on respiratory samples obtained by various methods, including nasopharyngeal swab or sputum sample.[90] Results are generally available within a few hours to 2 days.[91]

Hong Kong has set up a scheme where suspected patients can stay home, "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.[92]

The British NHS has announced that it will start testing 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.[93]

In drive-through testing for COVID-19 for suspected cases, a healthcare professional takes sample using appropriate precautions.[94][95] Drive-through centers have helped South Korea do some of the fastest, most-extensive testing of any country.[96]

Production and volume of testing

Number of tests done per day in the United States.
Blue: CDC lab
Orange: Public health lab
Gray: Data incomplete due to reporting lag

China[97] and the United States[98] had problems with the reliability of test kits early in the outbreak, and these countries and Australia[99] 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.[100] On 16th March, the World Health Organization called for ramping up the testing programmes as the best way to slow the advance of Covid-19 pandemic.[101][102]

See also

Notes

  1. ^ Official figures only. Does not include commercial lab data.
  2. ^ Tests confirmed positive, official figures only. Does not include commercial lab data.

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External links

Classification
Retrieved from "https://en.wikipedia.org/w/index.php?title=COVID-19_testing&oldid=946158024"