Materiały źródłowe

• #1 COVID-19 clinical and laboratory diagnosis overview

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8371420/

  COVID-19 was identified in Wuhan, China, in December 2019, and rapidly spread worldwide, being declared global pandemic on the 11th of March 2020. […] The 2019 novel corona virus (2019-nCoV) or SARS-CoV-2 is the causative agent of COVID-19. 2019-nCoV genetic sequence was rapidly identified within few days since the first reported cases and RT-PCR kits became available for COVID-19 diagnosis. However, RT-PCR diagnosis carries a risk of false-negative results; therefore, additional serologic tests are needed. In this review, we summarize the clinical scenario that raises suspicion of COVID-19 and available laboratory diagnostics. […] The most important approach in the battle against COVID-19 is rapid diagnosis of suspicious cases, timely therapeutic intervention and isolation to avoid community spread. Diagnosis depends mainly on PCR testing and serological tests. However, even in the context of negative lab test results and clinical suspicion of COVID-19 infection, clinical decision should be based on clinical suspicion.

• #1 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Viral tests, including nucleic acid amplification tests (NAATs) and PCR tests, as well as antigen tests, are used as diagnostic tests to detect current infection with SARS-CoV-2, determine the need for prevention measures, and inform a person’s medical care. […] Positive viral test results indicate current infection and the person with COVID-19 should take steps to prevent spreading COVID-19 to others. […] Negative viral test results mean the test did not detect the virus, but this doesn’t rule out that the person could have an infection. […] Antibody (or serology) tests are used to test for the presence of antibodies from previous infection or vaccination and can aid in fulfilling the case definition for multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A). Antibody testing does not diagnose current infection.

• #1 COVID-19: Diagnosis – UpToDate

  https://www.uptodate.com/contents/covid-19-diagnosis

  COVID-19: Diagnosis […] This topic will discuss the diagnosis of COVID-19. […] The management of COVID-19 is also discussed in detail elsewhere:

• #1 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in individuals who are symptomatic and for activating public health measures. […] Antigen rapid detection tests detect viral proteins and, although they are less sensitive than molecular tests, have the advantages of being easier to do, giving a faster time to result, of being lower cost, and able to detect infection in those who are most likely to be at risk of transmitting the virus to others. […] All three types of COVID-19 test continue to have a crucial role in the transition from pandemic response to pandemic control.

• #1 COVID-19 – Wikipedia

  https://en.wikipedia.org/wiki/COVID-19

  COVID19 can provisionally be diagnosed on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) or other nucleic acid testing of infected secretions. […] Along with laboratory testing, chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection. […] The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests, which detects the presence of viral RNA fragments. […] The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used. […] Results are generally available within hours. […] Chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection but are not recommended for routine screening.

• #1 COVID-19 clinical and laboratory diagnosis overview

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8371420/

  Clinical diagnosis requires epidemic exposure, in addition to two clinical findings of the following: fever, radiographic features, normal or lowered white blood cells, or reduced lymphocyte count. […] The current diagnostic test for COVID-19 is RT-PCR assay. It would not be possible to do PCR test to all suspected individuals, so the Centers for Disease Control and Prevention (CDC) released guidance for priorities for COVID-19 PCR testing. […] The recommended specimen for testing is lower respiratory tract specimen: sputum and/or endotracheal aspirate or bronchoalveolar. […] High viral loads in both upper and lower respiratory tract are detected 5-6 days of the onset of symptoms. Lower respiratory tract specimens yield highest viral loads for the diagnosis of COVID-19. […] Available RT-PCR testing targets two genes in the virus genome: the E and RdRP genes.

• #1 In Vitro Diagnostics EUAs – Molecular Diagnostic Tests for SARS-CoV-2 | FDA

  https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2

  Tests with „multiple targets” in the attribute column are: designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome; more likely to continue to perform well when new variants emerge. […] On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. […] The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. […] On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter.

• #1 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  Point-of-care molecular SARS-CoV-2 testing has been increasingly employed in certain settings for quicker turnaround as compared to standard laboratory-based RT-PCR tests. One study comparing an early point-of-care NAAT to laboratory-based RT-PCR found the median reporting time to be 2.6 versus 26.4 hours with an effective sensitivity of 96.9% and specificity of 100%. […] Viral antigen testing has been widely employed to detect infection with respiratory pathogens, including SARS-CoV-2. While RT-PCR detects RNA, antigen tests are immunoassays that detect the presence of viral antigens in nasal or nasopharyngeal specimens. The most commonly used are rapid lateral flow assays that can be employed at home or at the point-of-care, although laboratory-based SARS-CoV-2 antigen assays are also available at some institutions.

• #1 Testing for COVID-19 | COVID-19 | CDC

  https://www.cdc.gov/covid/testing/index.html

  COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] Antigen tests are rapid tests that usually produce results in 15-30 minutes. Positive results are accurate and reliable. However, in general, antigen tests are less likely to detect the virus than NAAT tests, especially when symptoms are not present. Therefore, a single negative antigen test cannot rule out infection.

• #1 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  COVID-19 testing plays a critical role in the fight against the virus. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs. […] There are different types of COVID-19 tests diagnostic tests and antibody tests. […] Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. There are two common types of COVID-19 diagnostic tests: […] Samples for COVID-19 diagnostic tests are typically collected using an anterior nares (nasal) swab sample. […] Depending on the intended use, COVID-19 diagnostic tests can be performed at a laboratory, a standalone testing site, a doctors office or health clinic, or at home. […] Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests.

• #1 COVID-19 diagnostic testing – Mayo Clinic

  https://www.mayoclinic.org/tests-procedures/covid-19-diagnostic-test/about/pac-20488900

  COVID-19 diagnostic testing shows current infection with the virus that causes coronavirus disease 2019 (COVID-19). The U.S. Food and Drug Administration (FDA) approved the following types of tests for diagnosing COVID-19. […] PCR tests are more accurate than the other type of COVID-19 test, called an antigen test. […] Antigen tests are accurate, but they are less accurate than PCR tests. […] A COVID-19 diagnostic test can have a false-negative result. This means that the test didn’t show you have the virus even though you do. […] The FDA requires that rapid antigen diagnostic tests catch at least 80% of infections. […] Rarely, COVID-19 rapid antigen tests can give false-positive results. […] Don’t use at-home COVID-19 tests that the FDA has not cleared for use. They may give the wrong results. […] Your COVID-19 diagnostic test result could be positive or negative. […] Positive test results most often are correct, even if you have no symptoms. […] Negative result means that you likely don’t have an infection with the COVID-19 virus. But you may have a false-negative test result.

• #1 Testing for COVID-19 | COVID-19 | CDC

  https://www.cdc.gov/covid/testing/index.html

  To be confident you do not have COVID-19, FDA recommends 2 negative antigen tests for individuals with symptoms or 3 antigen tests for those without symptoms, performed 48 hours apart. A single NAAT test can be used to confirm an antigen test result. […] After a positive test result, you may continue to test positive for some time. Some tests, especially NAAT tests, may continue to show a positive result for up to 90 days. […] Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. […] A positive COVID-19 test means the virus was detected and you have or recently had an infection. […] A negative COVID-19 test means the test did not detect the virus, but this doesn’t rule out that you could have an infection. If you used an antigen test, follow FDA recommendations for repeat testing.

• #1 COVID-19 Testing and Diagnosis | American Lung Association

  https://www.lung.org/lung-health-diseases/lung-disease-lookup/covid-19/covid-19-testing

  There are two kinds of tests available to diagnose COVID-19: tests for current infection (viral tests) and tests for past infection (antibody tests). […] COVID-19 tests are widely available at pharmacies nationwide. […] Viral tests look for a current COVID-19 infection. They use respiratory samples, such as a swab from inside your nose or saliva from your mouth, to determine if you are currently infected with SARS-CoV-2, the virus that causes COVID-19. […] Antibody tests are performed by drawing blood and conducting a laboratory test to check for antibodies that would only be present if you had a past infection of SARS-CoV-2, the virus that causes COVID-19. An antibody test should not be used to determine current infection as it can take your body one to three weeks after infection to make antibodies. […] Results from your antibody test will be positive if you were previously infected with COVID-19 and negative if you have not been previously infected.

• #1 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or not, to reduce your risk of a false negative test result. […] Antibody (or serology) tests look for antibodies in your blood that your immune system produced in response to SARS-CoV-2, the virus that causes COVID-19. Antibody tests should not be used to diagnose a current SARS-CoV-2 infection or COVID-19 and, at this time, should also not be used to check for immunity. […] Samples for antibody tests are typically collected by a doctor or other medical professional by taking blood from a finger stick or your vein.

• #1 COVID-19 clinical and laboratory diagnosis overview

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8371420/

  It should be well clear that one or more negative results do not rule out the possibility of COVID-19 virus infection, as false negative result in an infected individual may be caused by several factors: (1) poor quality of the specimen; (2) timing of specimen collection, late or very early in the infection; (3) inappropriate specimen handling and/or and shipping; and (4) technical error in the test. […] Serological testing detects antigens and antibodies directed against the virus. […] The average time for seroconversion in reported studies is 12 days, while positive RT-PCR is detected 5-6 days from the onset of symptoms, making antibody testing still inferior to RT-PCR in COVID-19 diagnosis but more likely used when RT-PCR is not available or accessible. […] A systematic review including 55 publications analyzing 8526 SARS-CoV-2 patients samples concluded that results for IgG, IgM, IgA, total antibodies, and IgG/IgM, all showed low sensitivity during the first week from onset of symptoms (less than 30.1%), rose in the second week and reached their highest values in the third week.

• #1 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  IDSA has released Version 2.0 of the Diagnosis of COVID-19: Serologic Testing guidelines. Key recommendations advise against early serologic testing, discourage routine testing for those previously infected or vaccinated, and suggest specific antibody tests three to five weeks after symptom onset. […] The panel recommends against serologic testing to diagnose SARS-CoV-2 infection in the first two weeks after symptom onset (strong recommendations, low certainty of evidence). Serologic testing should not be used to provide evidence of COVID-19 in symptomatic patients with a high clinical suspicion and repeatedly negative nucleic acid amplification test results (strong recommendation, very low certainty of evidence). […] To seek evidence for prior SARS-CoV-2 infection, the panel suggests testing for IgG, IgG/IgM, or total antibodies to nucleocapsid protein three to five weeks after symptom onset (conditional recommendation, low certainty of evidence).

• #1 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  If there is sustained clinical suspicion owing to an epidemiological link and other clinical or radiological findings, but the repeat molecular testing is negative, the patient could be further evaluated using an antibody test, but only for the purpose of documenting retrospectively a recent infection with SARS-CoV-2. […] The choice of which test to use in what setting requires careful consideration of the purpose of testing and the resources available, while also balancing test characteristics of accuracy, accessibility, affordability, and the rapidity with which results are needed. For COVID-19 case detection, molecular tests with their high sensitivity and high specificity are the test of choice.

• #1 Overview of Testing for SARS-CoV-2 | COVID-19 | CDC

  https://www.cdc.gov/covid/hcp/clinical-care/overview-testing-sars-cov-2.html

  Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT. […] Vaccination does not affect the results of someone’s SARS-CoV-2 NAAT, antigen, or other diagnostic tests. […] Antibody testing is not currently recommended to assess a person’s protection against SARS-CoV-2 infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person.

• #1 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  A recent Cochrane Review of rapid, point-of-care tests for diagnosis of SARS-CoV-2 infection reported that the average sensitivity across 48 published studies evaluating antigen tests was 72.0% among symptomatic participants and 58.1% among asymptomatic participants. […] Given variable sensitivity, viral antigen testing is sometimes considered adjunctive to RT-PCR testing, and current CDC guidelines recommend considering confirmatory testing using laboratory-based NAAT in certain settings. The Infectious Diseases Society of America continues to recommend NAATs as the diagnostic method of choice for SARS-CoV-2 given these limitations; however, antigen testing can be helpful when molecular testing is not readily available. […] In general, viral shedding appears to be greater in the nasopharynx than in the oropharynx, and more prevalent in specimens obtained from the lower respiratory tract than in specimens obtained from the upper respiratory tract. Clinical studies have confirmed that nasopharyngeal sampling is more sensitive than oropharyngeal sampling.

• #1 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  The IDSA panel suggests that for symptomatic individuals suspected of having COVID-19, anterior nasal (AN) and MT swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or healthcare providers (conditional recommendation, moderate certainty evidence). […] The IDSA panel suggests using either rapid or standard laboratory-based NAATs in symptomatic individuals suspected of having COVID-19 (conditional recommendation, moderate certainty of evidence). […] The IDSA panel suggests performing a single NAAT and not repeating testing routinely in symptomatic or asymptomatic individuals suspected of having COVID-19 whose initial NAAT result is negative (conditional recommendation, very low certainty of evidence). […] For individuals who have clinical or epidemiologic reasons that might make testing desirable, the IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, moderate certainty evidence).

• #1 Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea

  https://www.annlabmed.org/journal/view.html?doi=10.3343/alm.2020.40.5.351

  The collection of specimens for diagnosis is recommended within seven days of symptom onset. […] The collection of both nasopharyngeal swabs and oropharyngeal swabs is recommended; these should be placed together in the same viral transport medium (VTM) to increase the sensitivity. […] The guidelines for the prevention of infection and control for aerosol-producing procedures should be followed when collecting specimens using aerosol-producing procedures, such as sputum collection, tracheal aspiration, and bronchoscopy. […] The test method should comply with the standard operating procedures used by each laboratory and the manufacturers instructions. […] All results of negative control or positive control are invalid regardless of target gene and internal control amplification; retest is necessary. […] KSLM recommends a determination of a positive result only when all genes are detected. […] If the upper respiratory tract specimens test negative, lower respiratory tract specimens should be collected and tested.

• #1 Update of Guidelines for Laboratory Diagnosis of COVID-19 in Korea

  https://www.annlabmed.org/journal/view.html?uid=3333&vmd=Full

  KSLM and KDCA recommend real-time reverse transcription (rRT)-PCR as a molecular test for diagnosing COVID-19. In addition to rRT-PCR, there are various isothermal amplification methods, including loop-mediated isothermal amplification and clustered regularly interspaced short palindromic repeats-based tests. However, meta-analyses of these methods revealed insufficient performance or insufficient data; therefore, they should be used with caution in Korea at present. […] KSLM and KDCA generally do not recommend using self-collected respiratory specimens for diagnosing asymptomatic patients. Studies have investigated diagnosing COVID-19 using self-collected respiratory specimens, such as saliva, anterior nasal swabs (ANS), and mouthwash, as alternatives to nasopharyngeal and oropharyngeal swabs. The advantage of these specimens is that they are easily obtained. However, recent prospective studies have revealed that the test sensitivities for saliva and ANS in asymptomatic patients were significantly lower than those for nasopharyngeal swabs.

• #1 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  The COVID-19 pandemic response has led to the use of testing outside of health-care settings on an unprecedented scale, as a public health tool to ensure a safe environment for schools, workplaces, and mass gatherings for sports, music, religious, and social events. […] Diagnostic tests are useful to confirm the clinical diagnosis in patients presenting with symptoms consistent with COVID-19, regardless of their vaccination status. […] For individuals presenting within the first 2 weeks of onset of symptoms that are consistent with COVID-19, a specimen should be collected for molecular testing to confirm the clinical diagnosis. […] Given the high sensitivity and high specificity of molecular tests, false-positive or false-negative test results are rare. A positive result confirms the diagnosis and should trigger patient management procedures and public health measures such as self-isolation and contact tracing.

• #1 What tests could potentially be used for the screening, diagnosis and monitoring of COVID-19 and what are their advantages and disadvantages?  | The Centre for Evidence-Based Medicine

  https://www.cebm.net/covid-19/what-tests-could-potentially-be-used-for-the-screening-diagnosis-and-monitoring-of-covid-19-and-what-are-their-advantages-and-disadvantages/

  ELISA tests to detect antibodies are detecting the antibody response to COVID-19 infection. […] A negative result (no colour change) would mean that the patient has not been infected with COVID-19 and may have no immunity against it. […] ELISA antigen tests may be developed in the future to detect current infections. Such an antigen test using ELISA would show a positive result (colour change) if a patient has COVID-19 in their blood. […] Four main types of tests are being used or being developed to test for SARS-CoV-2, the virus causing COVID-19. […] Each test type has its own distinct advantages and disadvantages inherent to the underlying technology.

• #1 The role of chest imaging in the diagnosis, management, and monitoring of coronavirus disease 2019 (COVID-19) | Insights into Imaging | Full Text

  https://insightsimaging.springeropen.com/articles/10.1186/s13244-021-01096-1

  Coronavirus disease 2019 (COVID-19) pandemic has posed a major public health crisis all over the world. The role of chest imaging, especially computed tomography (CT), has evolved during the pandemic paralleling the accumulation of scientific evidence. Current evidence is against the use of chest imaging for routine screening of COVID-19 contrary to the initial expectations. It still has an integral role to play, however, in its work up and staging, especially when assessing complications or disease progression. Chest CT is gold standard imaging modality for COVID-19 pneumonia; in some situations, chest X-ray or ultrasound may be an effective alternative. […] Chest imaging is not recommended for routine screening of COVID-19 in a resource-abundant environment. […] Chest imaging is useful for assessing complications, disease progression, and prognostication of COVID-19.

• #1 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Molecular testing is recommended to confirm the diagnosis. […] Antigen testing is recommended in settings likely to have the most impact on early detection of cases for care and contact tracing, and where test results are most likely to be correct. […] Serology cannot be used as a standalone diagnostic test for acute SARS-CoV-2 infections, and should not be used to establish the presence or absence of acute infection. […] Imaging should be used as one element of the diagnostic workup that otherwise includes clinical and laboratory data. […] The WHO recommends chest imaging (chest x-ray, chest CT, or lung ultrasound) in the following scenarios: Symptomatic patients with suspected COVID-19 when RT-PCR is not available, RT-PCR test results are delayed, or initial RT-PCR testing is negative but there is a high clinical suspicion for COVID-19 (for diagnosis).

• #1 COVID-19 – Wikipedia

  https://en.wikipedia.org/wiki/COVID-19

  Bilateral multilobar ground-glass opacities with a peripheral, asymmetric, and posterior distribution are common in early infection. […] Characteristic imaging features on chest radiographs and computed tomography (CT) of people who are symptomatic include asymmetric peripheral ground-glass opacities without pleural effusions.

• #1 The role of chest imaging in the diagnosis, management, and monitoring of coronavirus disease 2019 (COVID-19) | Insights into Imaging | Full Text

  https://insightsimaging.springeropen.com/articles/10.1186/s13244-021-01096-1

  For these patients, imaging provides a baseline for future comparison, may reveal an alternative diagnosis, may establish manifestations of important comorbidities in patients with risk factors for disease progression, and may influence treatment strategy and the intensity of monitoring for clinical worsening. […] The sensitivity of chest X-ray depends mainly on two factors, i.e., symptom severity and disease stage. […] In summary, for the general population, chest X-ray is not recommended as the first-line imaging modality for early disease or asymptomatic or mildly symptomatic patients because of limited sensitivity compared to CT. […] In contrast, for those with progressed or moderate to severe disease, chest X-ray may be an effective alternative for assessing disease progression; the need for chest CT may be negated with positive chest X-ray findings.

• #1 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Order the following laboratory investigations in hospitalized patients: complete blood count, comprehensive metabolic panel, arterial blood gas, thyroid function tests, blood glucose level, coagulation screen, inflammatory markers, cardiac biomarkers, serum creatine kinase, and blood and sputum cultures for other pathogens. […] Prioritize a chest x-ray in patients who are seriously ill with suspected pneumonia. Consider a computed tomography (CT) scan of the chest if chest x-ray is uncertain or normal. […] COVID-19 care pathways should be established at local, regional, and national levels for people with suspected or confirmed COVID-19. […] Suspect the diagnosis in patients with the following signs/symptoms: a new continuous cough, fever, altered sense of taste or smell, sore throat, fatigue, headache, dyspnea, myalgia, arthralgia, rhinorrhea, nasal congestion, sneezing, malaise, expectoration, or chest tightness/pain, particularly if the person has been in contact with a suspected or confirmed case.

• #1 The role of chest imaging in the diagnosis, management, and monitoring of coronavirus disease 2019 (COVID-19) | Insights into Imaging | Full Text

  https://insightsimaging.springeropen.com/articles/10.1186/s13244-021-01096-1

  With experience lung ultrasonography can be as useful as chest CT and superior to standard chest X-ray for evaluation of pneumonia and/or adult respiratory distress syndrome. […] The appropriate use of ultrasonography could decrease chest X-ray and CT use in patients in the ICU. […] A meta-analysis by Barssoum et al. showed a sensitivity of lung ultrasound of 6893.3% and of NPV of 5294.1%, highlighting the value of lung ultrasound as a screening test to rule out COVID-19 pneumonia. […] The use of categorical CT grading systems facilitates objective and uniform interpretation of CT and smooth communication with professionals from different fields and with different experiences. […] Chest imaging is not recommended for routine screening of COVID-19 in a normal clinical situation. It still has an integral role to play, however, in its work up and staging, especially when assessing complications or disease progression. The most important role of radiologists in this context is to be able to identify those patients at greatest risk of imminent clinical decompensation by learning to stratify cases of COVID-19 on the basis of radiologic imaging in the most efficient and timely fashion possible.

• #1 Coronavirus Disease 2019 (COVID-19): Diagnosis and Management Journal of Clinical Practice and Research

  https://jcpres.com/article/2605

  Invited Review Coronavirus Disease 2019 (COVID-19): Diagnosis and Management […] Family of coronavirus has significant human and animal pathogens. In the end of December 2019, a new coronavirus was recognized as the reason of a group of pneumonia cases of unidentified etiology in Wuhan, a city in the Hubei Province of China. […] Coronavirus disease 2019 (COVID-19) is spread through large droplets produced during coughing and sneezing by symptomatic patients as well as asymptomatic individuals before starting of their symptoms. […] The usual clinical characteristics involve fever, dry cough, fatigue, sore throat, rhinorrhea, conjunctivitis headache, myalgia, dyspnea, nausea, vomiting and diarrhea. […] Hence, there are no unique clinical features that yet dependably differentiate COVID-19 disease from other upper/lower airway viral infections. […] Aim is here to discuss the COVID-19 disease beginning from virology, epidemiology and continuing with clinical manifestations, diagnosis, its complications and to finish with available therapeutic options and conclusion.

• #1 Azthena logo with the word Azthena

  https://www.news-medical.net/news/20250501/COVID-19-leaves-longer-lasting-symptoms-than-flu-or-pneumonia-study-finds.aspx

  In a recent study published in the journal PLOS One, researchers at the University of Texas Southwestern Medical Center, USA, assessed the associations between the severity of coronavirus disease 2019 (COVID-19) and the risk of post-acute symptoms. […] According to the United States Centers for Disease Control and Prevention, long COVID is defined as sequelae that persist for at least three months following the initial infection. However, other studies suggest post-acute COVID-19 as symptoms lasting up to 120 days after recovery. […] The primary outcome was the presence or absence of symptoms four weeks, three months, and six months after COVID-19 diagnosis. […] The findings corroborate prior observations that fatigue, dyspnea, and joint pain are the most common persistent symptoms after acute COVID-19. […] Overall, COVID-19 symptomatology cannot be perfectly described by pneumonia or influenza symptomatology, and there are differences in symptom prevalence and the time to resolution that better characterize long COVID, indicating that this persistence is unique to COVID-19.

• #1 Immunologic aspects of characteristics, diagnosis, and treatment of coronavirus disease 2019 (COVID-19) | Journal of Biomedical Science | Full Text

  https://jbiomedsci.biomedcentral.com/articles/10.1186/s12929-020-00663-w

  Detection of viral RNA in the secretions from the respiratory tract of infected patients by reverse transcription-polymerase chain reaction (RT-PCR) test is currently the standard method for diagnosis of COVID-19. […] Tests based on antibodies are obviously another option for diagnosis and screening. […] A combination of nucleic acid and serological test significantly increased the diagnosis rate from 66 to 78% even within 1 week of illness. […] In the early stage (containment) of COVID-19 pandemic, there was a strong interest for rapid diagnosis and thus prototypes of rapid viral antigen or antibody tests were being developed for point-of-care use. […] Finally, the issue of antibody cross-reactivity with other human coronaviruses warrants discussion.

• #1

  https://journals.lww.com/ccejournal/fulltext/2020/09000/molecular_diagnosis_of_coronavirus_disease_2019.18.aspx

  The novel SARS-CoV-2 genome has a unique sequence about 1,378 nucleotide base pairs long that is not found in other related coronaviruses. […] Approved strategies rely on RT-PCR designed to detect unique viral sequences in respiratory specimens during the acute phase of infection. […] Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. […] Importantly, RT-PCR alone is a presumptive test result; WHO recommends confirmation with Sanger sequencing. […] Positive results do not rule out bacterial infection or coinfection with other viruses. […] Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.

• #1 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). […] The IDSA’s goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. […] Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public response to the COVID-19 pandemic. […] The panel agreed on 12 diagnostic recommendations. […] The IDSA panel recommends a SARS-CoV-2 NAAT in symptomatic individuals suspected of having COVID-19 (strong recommendation, moderate certainty evidence). […] For symptomatic individuals suspected of having COVID-19, the IDSA panel suggests collecting and testing swab specimens from either the nasopharynx, anterior nares, oropharynx, or mid-turbinate (MT) regions; saliva, or mouth gargle (conditional recommendation, low certainty evidence).

• #1 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  The IDSA panel suggests using either rapid or laboratory-based NAATs in asymptomatic individuals with known exposure to SARS-CoV-2 infection (conditional recommendation, moderate certainty of evidence). […] The IDSA panel suggests against routine SARS-CoV-2 NAAT in asymptomatic individuals without a known exposure to COVID-19 who are being hospitalized (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests against routine SARS-CoV-2 NAAT of asymptomatic individuals without a known exposure to COVID-19 who are undergoing a medical or surgical procedure (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests against routinely repeating NAAT before medical or surgical procedures in patients with a recent history of COVID-19 (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests against routinely repeating NAAT in patients with COVID-19 to guide release from isolation (conditional recommendation, very low certainty evidence). […] The IDSA panel suggests neither for nor against home-testing for SARS-CoV-2 (evidence gap).

• #1 COVID-19 diagnosis coding explained in a flowchart | AAFP

  https://www.aafp.org/pubs/fpm/blogs/inpractice/entry/covid_diagnosis_flowcharts.html

  Then there is the question of using serologic (antibody) testing for diagnosing COVID-19. At the time the ICD-10 code was introduced, only RT-PCR testing was available. Now, physicians have more access to serologic tests; however, there is the issue of how to interpret these tests and their use in diagnosing patients with COVID-19. According to the Centers for Disease Control and Prevention (CDC), serologic testing can be offered to support a diagnosis of COVID-19 for patients who present late. A positive serologic test result indicates past or present COVID-19 infection. But it could be a false positive; therefore, serologic testing should not be the only factor in diagnosing COVID-19. […] Without having a diagnosis code for both lab-confirmed COVID-19 and clinically diagnosed COVID-19, we only have one option: U07.1 COVID-19. For purposes of vital statistics reporting, the CDCs National Center for Health Statistics (NCHS) has confirmed that U07.1 can be used for both lab-confirmed and clinically diagnosed patients who have died. But the CDCs broader guidance on coding for living patients again leaves room for interpretation. CDC has stated, Code only a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result. In this context, confirmation does not require documentation of the type of test performed; the providers documentation that the individual has COVID-19 is sufficient. […] Different diagnosis algorithms can be used for diagnosing patients with COVID-19. Physicians should take prevalence and incidence in their own community into consideration when assigning a clinical diagnosis, especially in the absence of a positive test.

• #1 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  No single sign or symptom can accurately diagnose COVID-19, and neither the absence or presence of specific signs or symptoms are accurate enough to rule in or rule out disease. […] A Cochrane review found that the presence of anosmia and/or ageusia may be useful as a red flag for diagnosis. Cough or fever may also increase the probability of diagnosis to an extent that is clinically relevant and should prompt further testing. […] The diagnostic accuracy of molecular tests and rapid antigen tests does not appear to be influenced by the Omicron variant. […] Testing strategies vary widely between countries, and you should consult your local public health authority for advice when deciding which test to use. […] The choice of which test to use in which setting requires careful consideration of the purpose of testing and the resources available, while also balancing test characteristics of accuracy, accessibility, affordability, and the rapidity with which results are needed.

• #1 Diagnostics for SARS-CoV-2 infections | Nature Materials

  https://www.nature.com/articles/s41563-020-00906-z

  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread to nearly every corner of the globe, causing societal instability. The diagnosis of SARS-CoV-2 infection is often confused with that of influenza and seasonal upper respiratory tract viral infections. Due to available treatment strategies and required containments, rapid diagnosis is mandated. This Review brings clarity to the rapidly growing body of available and in-development diagnostic tests, including nanomaterial-based tools. […] Precise diagnostic tests detect viral nucleic acids, viral antigens or serological tests are required to affirm SARS-CoV-2 infection. […] Accurate viral detection is a starting point to contain the COVID-19 pandemic. Lapses affect public safety, enabling infection spread aided by false-negative test results. Improving test sensitivity and specificity remains an urgent need.

• #1 Analysis of factors associated early diagnosis in coronavirus disease 2019 (COVID-19) | medRxiv

  https://www.medrxiv.org/content/10.1101/2020.04.09.20059352v1

  The accuracy of early diagnosis is critical in the control of the spread of the virus. Although the real-time RT-PCR detection of the virus nucleic acid is the current golden diagnostic standard, it has high false negative rate when only apply single test. […] Multiple logistic regression analysis showed age, contact history and decreasing lymphocyte count could be used as individual factor that has diagnostic value (p0.05). […] Single RT-PCR test has relatively high false negative rate. When first RT-PCR test show negative result in suspected patients, the chest CT scan, contact history, age and lymphocyte count should be used combinedly to assess the possibility of SARS-CoV-2 infection.

• #1 An Analysis Review of Detection Coronavirus Disease 2019 (COVID-19) Based on Biosensor Application

  https://www.mdpi.com/1424-8220/20/23/6764

  An Analysis Review of Detection Coronavirus Disease 2019 (COVID-19) Based on Biosensor Application […] Timely detection and diagnosis are essentially needed to guide outbreak measures and infection control. […] In this narrative review, the detection of coronavirus disease 2019 (COVID-19) technologies is summarized and discussed with a comparison between them from several aspects to arrive at an accurate decision on the feasibility of applying the best of these techniques in the biosensors that operate using laser detection technology. […] AI techniques have been used to diagnose and classify COVID-19 via x-ray and CT scan images. […] A study has been developed using a biosensor based on a field effect transistor (FET) method of detecting SARS-CoV-2 virus. […] Diagnosis methods of coronavirus disease (COVID-19) based on the application of biosensors are evaluated according to data extracted from literature studies. […] The outbreak of coronavirus disease COVID-19 indulges challenges on the continuance of activities globally. […] This review summarizes a comprehension of infection transmission of SARS-CoV-2 and knowledge of the state of art diagnostic methods approach based on biosensor applications, artificial imaging techniques and mentioned challenges with a viewpoint. […]

• #1 Artificial intelligence–enabled rapid diagnosis of patients with COVID-19 | Nature Medicine

  https://www.nature.com/articles/s41591-020-0931-3

  For diagnosis of coronavirus disease 2019 (COVID-19), a SARS-CoV-2 virus-specific reverse transcriptase polymerase chain reaction (RT-PCR) test is routinely used. However, this test can take up to 2d to complete, serial testing may be required to rule out the possibility of false negative results and there is currently a shortage of RT-PCR test kits, underscoring the urgent need for alternative methods for rapid and accurate diagnosis of patients with COVID-19. […] Chest computed tomography (CT) is a valuable component in the evaluation of patients with suspected SARS-CoV-2 infection. Nevertheless, CT alone may have limited negative predictive value for ruling out SARS-CoV-2 infection, as some patients may have normal radiological findings at early stages of the disease. […] In this study, we used artificial intelligence (AI) algorithms to integrate chest CT findings with clinical symptoms, exposure history and laboratory testing to rapidly diagnose patients who are positive for COVID-19.

• #1 Artificial intelligence–enabled rapid diagnosis of patients with COVID-19 | Nature Medicine

  https://www.nature.com/articles/s41591-020-0931-3

  The AI system also improved the detection of patients who were positive for COVID-19 via RT-PCR who presented with normal CT scans, correctly identifying 17 of 25 (68%) patients, whereas radiologists classified all of these patients as COVID-19 negative. […] When CT scans and associated clinical history are available, the proposed AI system can help to rapidly diagnose COVID-19 patients. […] Chest CT is a valuable tool for the early diagnosis and triage of patients suspected of SARS-CoV-2 infection. […] In the current climate of stress on healthcare resources due to the COVID-19 outbreak, including a shortage of RT-PCR test kits, there is an unmet need for rapid, accurate and unsupervised diagnostic tests for SARS-CoV-2. […] Rapid detection of patients with COVID-19 is imperative because an initial false negative could both delay treatment and increase risk of viral transmission to others.

• #1 Artificial intelligence–enabled rapid diagnosis of patients with COVID-19 | Nature Medicine

  https://www.nature.com/articles/s41591-020-0931-3

  Our goal was to design an AI model that can identify SARS-CoV-2 infection based on initial chest CT scans and associated clinical information that could rapidly identify COVID-19 (+) patients in the early stage. […] The joint model using both clinical data and CT imaging achieved an 84.3% sensitivity (95% confidence interval (CI) 77.1%, 90.0%), an 82.8% specificity (95% CI 75.6%, 88.5%) and 0.92 AUC (95% CI 0.887, 0.948). […] The AI model could be deployed as an application that can run on a simple workstation alongside the radiologists. Use of the AI tool would require integration with the radiology picture archiving and communication systems and clinical database systems or other image storage database, which is relatively easy to achieve in modern hospital systems. […] We believe the AI model proposed, which combines CT imaging and clinical information and shows equivalent accuracy to a senior chest radiologist, could be a useful screening tool to quickly diagnose infectious diseases such as COVID-19 that does not require radiologist input or physical tests.

• #1 What tests could potentially be used for the screening, diagnosis and monitoring of COVID-19 and what are their advantages and disadvantages?  | The Centre for Evidence-Based Medicine

  https://www.cebm.net/covid-19/what-tests-could-potentially-be-used-for-the-screening-diagnosis-and-monitoring-of-covid-19-and-what-are-their-advantages-and-disadvantages/

  Many diagnostic tests for coronavirus disease 2019 (COVID-19) are available so far, with more gaining emergency approval every day. These tests are largely based on four different techniques, 1) reverse transcription polymerase chain reaction (RT-PCR) the current standard test for COVID-19, 2) loop-mediated isothermal amplification (LAMP) a simple, but less developed testing method, 3) lateral flow hand-held single-use assays providing results for an individual patient in as short as 15 minutes, and 4) enzyme-linked immunosorbent assay (ELISA) quick and technically simple assays that are easily read and offer relatively high throughput. […] A range of molecular techniques ranging from central laboratory testing to point-of-care tests are under development or already available for the diagnosis and management of COVID-19 patients.

• #1

  https://journals.lww.com/ccejournal/fulltext/2020/09000/molecular_diagnosis_of_coronavirus_disease_2019.18.aspx

  Timing of sampling seems to be critical. […] Reports suggest that upper respiratory tract samples may provide higher yield early in the course, whereas lower respiratory tract sampling may have higher yield later in the course of disease. […] Detection of the pathogen involves reliable molecular or serologic detection of viral particles or/and components. […] The specificity of the primers was verified in isolates or patient samples from 297 patients with various other respiratory infections. […] This formed the basis of shipments of 250,000 kits, which the WHO dispatched to 159 laboratories across the globe. […] This PCR-based protocol has since been selected by the WHO as the standard for molecular diagnosis, but it is not being widely used in the United States. […] SARS-CoV-2 RNA detection can be achieved using various approaches including real-time RT-PCR, digital droplet polymerase chain reaction (PCR), next generation sequencing, and employing metagenomic nucleic acid analysis as a routine diagnostic and surveillance tool.

• #1 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  Technical guidance regarding specimen acquisition is available from CDC: For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting an upper respiratory tract specimen using a synthetic fiber swab with a plastic or wire shaft. […] Self-tests have become widely available in recent months. Self-tests or at-home tests can be antigen or molecular-based, and typically require either a nasal or saliva specimen. Early studies have suggested that some methods of self-collection may be comparable to clinician-collected samples. […] Recent guidance from the CDC recommends isolation and discussion with a healthcare provider after a positive self-test, particularly in the setting of a fully vaccinated, asymptomatic and/or unexposed individual. A negative antigen-based self-test result may represent a false-negative; for this reason, some kits recommend repeat testing 2 to 3 days after an initial negative test as serial testing may improve overall diagnostic accuracy.

• #1 Coronavirus Disease 2019 (COVID-19): Epidemiology, Pathogenesis, Diagnosis, and Therapeutics | SpringerLink

  https://link.springer.com/book/10.1007/978-981-15-4814-7

  This book provides a comprehensive overview of recent novel coronavirus (SARS-CoV-2) infection, their biology and associated challenges for their treatment and prevention of novel Coronavirus Disease 2019 (COVID-19). […] Discussing various aspects of COVID-19 infection, including global epidemiology, genome organization, immunopathogenesis, transmission cycle, diagnosis, treatment, prevention, and control strategies, it highlights host-pathogen interactions, host immune response, and pathogen immune invasion strategies toward developing an immune intervention or preventive vaccine for COVID-19. […] Clinical Characteristics and Differential Clinical Diagnosis of Novel Coronavirus Disease 2019 (COVID-19) […] Laboratory Diagnosis of Novel Coronavirus Disease 2019 (COVID-19) Infection.

• #1 Coronavirus Disease (COVID-19): Symptoms & Treatment

  https://my.clevelandclinic.org/health/diseases/21214-coronavirus-covid-19

  COVID-19 is an illness caused by the SARS-CoV-2 virus. […] COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus, a type of coronavirus. […] Healthcare providers diagnose COVID by swabbing your nose with a soft-tipped stick and testing it with a nucleic acid amplification test (NAAT), like a PCR test. […] COVID can be treated with antiviral medications. These include nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury) and molnupiravir (Lagevrio). […] Making sure youre up to date with a current COVID vaccine is the best way to reduce your risk of getting sick with COVID and reduce your risk of severe illness if you do get sick. […] Vaccinations and antiviral medications can help reduce your risk of severe illness.

• #1 Coronavirus disease 2019 (COVID-19) – Diagnosis Approach | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/3000168/diagnosis-approach

  Early recognition and rapid diagnosis are essential to prevent transmission and provide supportive care in a timely manner. Have a high index of clinical suspicion for COVID-19 in all patients who present with fever and/or acute respiratory illness; however, be aware that some patients may not present with signs or symptoms of a febrile respiratory illness. […] COVID-19 is a notifiable disease. Report all suspected or confirmed cases to your local health authorities. […] Isolate all suspected or confirmed cases immediately. Triage patients with a standardized triage tool and evaluate the severity of disease. Follow local infection prevention and control guidelines. […] Order a real-time reverse transcription polymerase chain reaction (RT-PCR) to confirm the diagnosis. Upper and lower respiratory specimens are preferred.

• #2 Artificial intelligence–enabled rapid diagnosis of patients with COVID-19 | Nature Medicine

  https://www.nature.com/articles/s41591-020-0931-3

  The AI system also improved the detection of patients who were positive for COVID-19 via RT-PCR who presented with normal CT scans, correctly identifying 17 of 25 (68%) patients, whereas radiologists classified all of these patients as COVID-19 negative. […] When CT scans and associated clinical history are available, the proposed AI system can help to rapidly diagnose COVID-19 patients. […] Chest CT is a valuable tool for the early diagnosis and triage of patients suspected of SARS-CoV-2 infection. […] In the current climate of stress on healthcare resources due to the COVID-19 outbreak, including a shortage of RT-PCR test kits, there is an unmet need for rapid, accurate and unsupervised diagnostic tests for SARS-CoV-2. […] Rapid detection of patients with COVID-19 is imperative because an initial false negative could both delay treatment and increase risk of viral transmission to others.

• #2 Coronavirus Disease 2019 (COVID-19) Workup: Approach Considerations, Laboratory Studies, CT Scanning

  https://emedicine.medscape.com/article/2500114-workup

  Signs and symptoms of coronavirus disease 2019 (COVID-19) may overlap with those of other respiratory infections; therefore, it is important to perform laboratory testing to specifically identify symptomatic individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). […] Three types of tests may be utilized to determine if an individual has been infected with SARS-CoV-2: Viral nucleic acid (RNA) detection, Viral antigen detection, Detection of antibodies to the virus. […] Viral tests (nucleic acid or antigen detection tests) are used to assess acute infection, whereas antibody tests provide evidence of prior infection with SARS-CoV-2. […] The FDA has advised against the use of antibody tests to ascertain immunity or protection from COVID-19, particularly in patients who have been vaccinated against the disease.

• #2 COVID-19 – Wikipedia

  https://en.wikipedia.org/wiki/COVID-19

  COVID19 can provisionally be diagnosed on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) or other nucleic acid testing of infected secretions. […] Along with laboratory testing, chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection. […] The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests, which detects the presence of viral RNA fragments. […] The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used. […] Results are generally available within hours. […] Chest CT scans may be helpful to diagnose COVID19 in individuals with a high clinical suspicion of infection but are not recommended for routine screening.

• #2 Diagnostics for SARS-CoV-2 infections | Nature Materials

  https://www.nature.com/articles/s41563-020-00906-z

  The first step in managing COVID-19 is the rapid and accurate detection of SARS-CoV-2 enabled by real-time reverse transcription-polymerase chain reaction (RT-PCR). RT-PCR detects SARS-CoV-2 nucleic acids present in nasopharyngeal fluids. […] Current diagnostic tests for the SARS-CoV-2 pandemic use nucleic acid, antibody and protein-based detections, but viral nucleic acid detection by RT-PCR remains the gold standard. […] Despite such limitations, the RT-PCR test remains the gold standard for SARS-CoV-2 diagnostics. […] The presence of SARS-CoV-2 RNA in saliva samples is not always associated with disease severity, compared to nasopharyngeal swabs. […] A rapid diagnostic assay was also developed to detect the presence of viral antigens expressed by SARS-CoV-2 in samples from the respiratory tract of infected individuals.

• #2 In Vitro Diagnostics EUAs – Molecular Diagnostic Tests for SARS-CoV-2 | FDA

  https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2

  On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. […] On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. […] All tests in this table are multiple target tests unless noted with an asterisk (*). Multiple target tests are designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge. Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

• #2 IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnostics/

  The IDSA panel suggests that for symptomatic individuals suspected of having COVID-19, anterior nasal (AN) and MT swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or healthcare providers (conditional recommendation, moderate certainty evidence). […] The IDSA panel suggests using either rapid or standard laboratory-based NAATs in symptomatic individuals suspected of having COVID-19 (conditional recommendation, moderate certainty of evidence). […] The IDSA panel suggests performing a single NAAT and not repeating testing routinely in symptomatic or asymptomatic individuals suspected of having COVID-19 whose initial NAAT result is negative (conditional recommendation, very low certainty of evidence). […] For individuals who have clinical or epidemiologic reasons that might make testing desirable, the IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, moderate certainty evidence).

• #2 Testing for COVID-19 | COVID-19 | CDC

  https://www.cdc.gov/covid/testing/index.html

  COVID-19 testing can help you know if you have COVID-19 so you can decide what to do next, like getting treatment to reduce your risk of severe illness and taking steps to lower your chances of spreading the virus to others. […] Viral tests look for a current infection with SARS-CoV-2, the virus that causes COVID-19, by testing specimens from your nose or mouth. […] Nucleic acid amplification tests (NAATs), including PCR tests, are more likely to detect the virus than antigen tests. NAATs tests are the gold standard for COVID-19 tests. […] Antigen tests are rapid tests that usually produce results in 15-30 minutes. Positive results are accurate and reliable. However, in general, antigen tests are less likely to detect the virus than NAAT tests, especially when symptoms are not present. Therefore, a single negative antigen test cannot rule out infection.

• #2 COVID-19 Test Basics | FDA

  https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics

  To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or not, to reduce your risk of a false negative test result. […] Antibody (or serology) tests look for antibodies in your blood that your immune system produced in response to SARS-CoV-2, the virus that causes COVID-19. Antibody tests should not be used to diagnose a current SARS-CoV-2 infection or COVID-19 and, at this time, should also not be used to check for immunity. […] Samples for antibody tests are typically collected by a doctor or other medical professional by taking blood from a finger stick or your vein.

• #2 COVID-19 – Infectious Diseases – Merck Manual Professional Edition

  https://www.merckmanuals.com/professional/infectious-diseases/covid-19/covid-19

  Point-of-care and home-based antigen testing can provide rapid results. This can be an important measure to identify asymptomatic cases and interrupt SARS-CoV-2 transmission. Point-of-care or home-based antigen detection tests are less sensitive than NAATs, particularly at the onset of infection when viral load may be lower. […] Acceptable specimens for COVID-19 diagnostic testing include nasopharyngeal, oropharyngeal, nasal mid-turbinate, anterior nares, and saliva. […] Serologic, or antibody, testing should not be used to diagnose acute COVID-19 illness, because antibodies most commonly become detectable only 1 to 3 weeks after symptom onset.

• #2 Update of Guidelines for Laboratory Diagnosis of COVID-19 in Korea

  https://www.annlabmed.org/journal/view.html?uid=3333&vmd=Full

  KSLM and KDCA recommend using a molecular test that targets two or more sites of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genome and to consider a COVID-19 diagnostic test positive only when all targets are positive. If the initial test result is inconclusive in a patient with no history of confirmed COVID-19, collecting a new specimen for retesting is recommended. […] KSLM and KDCA do not recommend using a SARS-CoV-2 antigen test for asymptomatic individuals. Considering the low sensitivity and specificity of the antigen tests and the relatively low prevalence of COVID-19 in Korea, SARS-CoV-2 antigen tests have a very limited role in the screening of asymptomatic patients in Korea. […] KSLM and KDCA do not recommend using an antibody test for diagnosing acute COVID-19 or for evaluating the risk of infection for individuals who have recovered from COVID-19 or who have been vaccinated for COVID-19.

• #2 COVID-19 clinical and laboratory diagnosis overview

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8371420/

  Therefore, antibody testing is not recommended as primary tool in COVID-19 diagnosis but provides complimentary diagnostic tool in RT-PCR test-negative patients presenting late or in detecting past infection when done 15 days or more after the onset of symptoms. […] COVID-19 available diagnostics puts the health authorities in challenging situation as diagnosis based on clinical symptoms alone is inaccurate, in addition to the presence of asymptomatic carriers and long incubation period of the virus. False negative RT-PCR results in infected patients adds to the challenge, necessitating the need for a rapid and sensitive technique to be available in most laboratories for swift detection of COVID-19 in order to limit spread and properly treat infected individuals.

• #2 IDSA Guidelines on the Diagnosis of COVID-19: Serologic Testing

  https://www.idsociety.org/practice-guideline/covid-19-guideline-serology/

  In individuals with previous SARS-CoV-2 infection or vaccination, we suggest against routine serologic testing given no demonstrated benefit to improving patient outcomes (conditional recommendation, very low certainty of evidence). […] The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. […] The current IDSA guideline includes two new recommendations. The first is a weak recommendation to use serologic assays that target nucleocapsid protein rather than spike protein when evidence of prior COVID-19 is desired. […] The second new recommendation suggests against routine serologic testing in patients with previous SARS-CoV-2 infection or vaccination, given that no demonstrated benefits for improving patient outcomes were identified.

• #2 Coronavirus Disease 2019 (COVID-19) and Diagnostic Error | PSNet

  https://psnet.ahrq.gov/primer/coronavirus-disease-2019-covid-19-and-diagnostic-error

  A recent Cochrane Review of rapid, point-of-care tests for diagnosis of SARS-CoV-2 infection reported that the average sensitivity across 48 published studies evaluating antigen tests was 72.0% among symptomatic participants and 58.1% among asymptomatic participants. […] Given variable sensitivity, viral antigen testing is sometimes considered adjunctive to RT-PCR testing, and current CDC guidelines recommend considering confirmatory testing using laboratory-based NAAT in certain settings. The Infectious Diseases Society of America continues to recommend NAATs as the diagnostic method of choice for SARS-CoV-2 given these limitations; however, antigen testing can be helpful when molecular testing is not readily available. […] In general, viral shedding appears to be greater in the nasopharynx than in the oropharynx, and more prevalent in specimens obtained from the lower respiratory tract than in specimens obtained from the upper respiratory tract. Clinical studies have confirmed that nasopharyngeal sampling is more sensitive than oropharyngeal sampling.

• #2 Testing for COVID-19 | COVID-19 | CDC

  https://www.cdc.gov/covid/testing/index.html

  To be confident you do not have COVID-19, FDA recommends 2 negative antigen tests for individuals with symptoms or 3 antigen tests for those without symptoms, performed 48 hours apart. A single NAAT test can be used to confirm an antigen test result. […] After a positive test result, you may continue to test positive for some time. Some tests, especially NAAT tests, may continue to show a positive result for up to 90 days. […] Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. […] A positive COVID-19 test means the virus was detected and you have or recently had an infection. […] A negative COVID-19 test means the test did not detect the virus, but this doesn’t rule out that you could have an infection. If you used an antigen test, follow FDA recommendations for repeat testing.

• #2 Coronavirus Disease 2019 (COVID-19) Workup: Approach Considerations, Laboratory Studies, CT Scanning

  https://emedicine.medscape.com/article/2500114-workup

  According to the agency, differences between antibodies that arise from prior SARS-CoV-2 infection and those induced by vaccination leave the tests unable to determine whether an individual has achieved protection through a vaccine. […] The American College of Radiology (ACR) recommends against using CT scanning for screening or diagnosis but instead reserving it for management in hospitalized patients. […] Various organizations, including the CDC, have published guidelines on COVID-19. […] Please see guidelines section of this article for summaries of relevant guidelines.

• #2

  https://journals.lww.com/ccejournal/fulltext/2020/09000/molecular_diagnosis_of_coronavirus_disease_2019.18.aspx

  The novel SARS-CoV-2 genome has a unique sequence about 1,378 nucleotide base pairs long that is not found in other related coronaviruses. […] Approved strategies rely on RT-PCR designed to detect unique viral sequences in respiratory specimens during the acute phase of infection. […] Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. […] Importantly, RT-PCR alone is a presumptive test result; WHO recommends confirmation with Sanger sequencing. […] Positive results do not rule out bacterial infection or coinfection with other viruses. […] Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.

• #2 Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea

  https://www.annlabmed.org/journal/view.html?doi=10.3343/alm.2020.40.5.351

  COVID-19 real-time RT-PCR may be performed for the purposes of confirming cases of suspected COVID-19, deciding on the release of confirmed COVID-19 patients from quarantine, screening asymptomatic individuals in close contact with confirmed COVID-19 patients, and differential diagnosis of cases with unknown respiratory syndromes. […] Globally, various real-time RT-PCR protocols have been proposed for the diagnosis of COVID-19; these protocols differ in the genes they detect. […] Clinical laboratories are recommended not to use methods other than real-time RT-PCR (pan-coronavirus PCR, serological tests, etc.) for diagnostic purposes. […] As of March 13, 2020, several commercially available real-time RT-PCR reagents have been approved for emergency use in Korea for the in vitro diagnosis of COVID-19.

• #2 Analysis of factors associated early diagnosis in coronavirus disease 2019 (COVID-19) | medRxiv

  https://www.medrxiv.org/content/10.1101/2020.04.09.20059352v1

  The accuracy of early diagnosis is critical in the control of the spread of the virus. Although the real-time RT-PCR detection of the virus nucleic acid is the current golden diagnostic standard, it has high false negative rate when only apply single test. […] Multiple logistic regression analysis showed age, contact history and decreasing lymphocyte count could be used as individual factor that has diagnostic value (p0.05). […] Single RT-PCR test has relatively high false negative rate. When first RT-PCR test show negative result in suspected patients, the chest CT scan, contact history, age and lymphocyte count should be used combinedly to assess the possibility of SARS-CoV-2 infection.

• #2

  https://link.springer.com/article/10.1007/s00330-020-06829-2

  However, false-negative results caused by unstable specimen processing are relatively high in clinical practice, which has worsened the spread of the outbreak. […] To solve these problems, we hypothesize that a diagnostic model can be developed based on CT imaging and clinical manifestations alone, independent of the nucleic acid test. […] The CR model yielded a maximum AUC of 0.986 (95% CI 0.966~1.000) in the primary cohort with the highest accuracy and specificity, which was 0.936 (95% CI 0.866~1.000) in the validation cohort. […] In conclusion, 1745 lesions and 67 features were compared between pneumonia patients with and without COVID-19. […] A diagnostic model with AUC as high as 0.986 was developed and validated both in the primary and in the validation cohorts, which may help improve the COVID-19 diagnosis.

• #2 [2005.03227] Diagnosis of Coronavirus Disease 2019 (COVID-19) with Structured Latent Multi-View Representation Learning

  https://arxiv.org/abs/2005.03227

  Diagnosis of Coronavirus Disease 2019 (COVID-19) with Structured Latent Multi-View Representation Learning. […] Due to the large number of affected patients and heavy labor for doctors, computer-aided diagnosis with machine learning algorithm is urgently needed, and could largely reduce the efforts of clinicians and accelerate the diagnosis process. […] Chest computed tomography (CT) has been recognized as an informative tool for diagnosis of the disease. […] In this study, we propose to conduct the diagnosis of COVID-19 with a series of features extracted from CT images. […] Extensive experimental results show that the proposed method outperforms all comparison methods, and rather stable performances are observed when varying the numbers of training data.

• #2 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  The COVID-19 pandemic response has led to the use of testing outside of health-care settings on an unprecedented scale, as a public health tool to ensure a safe environment for schools, workplaces, and mass gatherings for sports, music, religious, and social events. […] Diagnostic tests are useful to confirm the clinical diagnosis in patients presenting with symptoms consistent with COVID-19, regardless of their vaccination status. […] For individuals presenting within the first 2 weeks of onset of symptoms that are consistent with COVID-19, a specimen should be collected for molecular testing to confirm the clinical diagnosis. […] Given the high sensitivity and high specificity of molecular tests, false-positive or false-negative test results are rare. A positive result confirms the diagnosis and should trigger patient management procedures and public health measures such as self-isolation and contact tracing.

• #2 The role of chest imaging in the diagnosis, management, and monitoring of coronavirus disease 2019 (COVID-19) | Insights into Imaging | Full Text

  https://insightsimaging.springeropen.com/articles/10.1186/s13244-021-01096-1

  Coronavirus disease 2019 (COVID-19) pandemic has posed a major public health crisis all over the world. The role of chest imaging, especially computed tomography (CT), has evolved during the pandemic paralleling the accumulation of scientific evidence. Current evidence is against the use of chest imaging for routine screening of COVID-19 contrary to the initial expectations. It still has an integral role to play, however, in its work up and staging, especially when assessing complications or disease progression. Chest CT is gold standard imaging modality for COVID-19 pneumonia; in some situations, chest X-ray or ultrasound may be an effective alternative. […] Chest imaging is not recommended for routine screening of COVID-19 in a resource-abundant environment. […] Chest imaging is useful for assessing complications, disease progression, and prognostication of COVID-19.

• #2 An Analysis Review of Detection Coronavirus Disease 2019 (COVID-19) Based on Biosensor Application

  https://www.mdpi.com/1424-8220/20/23/6764

  An Analysis Review of Detection Coronavirus Disease 2019 (COVID-19) Based on Biosensor Application […] Timely detection and diagnosis are essentially needed to guide outbreak measures and infection control. […] In this narrative review, the detection of coronavirus disease 2019 (COVID-19) technologies is summarized and discussed with a comparison between them from several aspects to arrive at an accurate decision on the feasibility of applying the best of these techniques in the biosensors that operate using laser detection technology. […] AI techniques have been used to diagnose and classify COVID-19 via x-ray and CT scan images. […] A study has been developed using a biosensor based on a field effect transistor (FET) method of detecting SARS-CoV-2 virus. […] Diagnosis methods of coronavirus disease (COVID-19) based on the application of biosensors are evaluated according to data extracted from literature studies. […] The outbreak of coronavirus disease COVID-19 indulges challenges on the continuance of activities globally. […] This review summarizes a comprehension of infection transmission of SARS-CoV-2 and knowledge of the state of art diagnostic methods approach based on biosensor applications, artificial imaging techniques and mentioned challenges with a viewpoint. […]

• #2 Diagnostics for COVID-19: moving from pandemic response to control

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8687671/

  Diagnostics have proven to be crucial to the COVID-19 pandemic response. There are three major methods for the detection of SARS-CoV-2 infection and their role has evolved during the course of the pandemic. Molecular tests such as PCR are highly sensitive and specific at detecting viral RNA, and are recommended by WHO for confirming diagnosis in individuals who are symptomatic and for activating public health measures. […] Antigen rapid detection tests detect viral proteins and, although they are less sensitive than molecular tests, have the advantages of being easier to do, giving a faster time to result, of being lower cost, and able to detect infection in those who are most likely to be at risk of transmitting the virus to others. […] All three types of COVID-19 test continue to have a crucial role in the transition from pandemic response to pandemic control.

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