Testing for SARS-CoV-2 Infection. The test has been run at Childrens Hospital of Philadelphia's lab, and the results have come back as NEGATIVE. If there are other people in your household who do not have COVID-19, please try to separate yourself from them in a different room or area of your household, and wear a face covering if you must be around other people (see CDC isolation instructions). Settings that involve close quarters and that are isolated from healthcare resources (e.g., fishing vessels, wildland firefighter camps, or offshore oil platforms). Pretest probability of disease should be based on a patient's exposure to someone with a confirmed or probable case, signs or symptoms of COVID-19, local or population-specific COVID-19 prevalence, and presence of an alternative diagnosis. Please see additional information if you are a RUSH employee or RUSH University student. More information is available, Recommendations for Fully Vaccinated People, Considerations for Testing in Different Scenarios, Public Health Surveillance Testing for SARS-CoV-2, multisystem inflammatory syndrome in children (MIS-C), Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States, In Vitro Diagnostics Emergency Use Authorizations, Isolation and Precautions for People with COVID-19, pretest probability and the likelihood of positive and negative predictive values, additional information for healthcare providers who are using diagnostic tests in screening asymptomatic individuals, required laboratories and testing facilities to report, have been exposed to persons with COVID-19, Ending Isolation and Precautions for People with COVID-19: Interim Guidance, COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), National Wastewater Surveillance System (NWSS), CDCs Diagnostic Multiple Assay for Flu and COVID-19 at Public Health Laboratories and Supplies, Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems, Infection Prevention and Control Recommendations for Healthcare Personnel, Interim Guidelines for COVID-19 Antibody Testing, people who are up to date with their vaccines, Case Series of Multisystem Inflammatory Syndrome in Adults Associated with SARS-CoV-2 Infection United Kingdom and United States, March-August 2020, Racial and ethnic inequities in the early distribution of U.S. COVID-19 testing sites and mortality, https://www.epi.org/publication/black-workers-covid/, Modeling the effectiveness of healthcare personnel reactive testing and screening for the SARS-CoV-2 Omicron variant within nursing homes, National Center for Immunization and Respiratory Diseases (NCIRD), Post-COVID Conditions: Healthcare Providers, Decontamination & Reuse of N95 Respirators, Purchasing N95 Respirators from Another Country, Powered Air Purifying Respirators (PAPRs), U.S. Department of Health & Human Services. If these symptoms are severe and you are having a medical emergency, you should call 911. A leaf plot provides a visual representation of pre- and posttest probability based on test sensitivity and specificity. The test has been run at Childrens Hospital of Philadelphia's lab, and the results have come back as POSITIVE. Search dates: September 17 to October 6, 2020; December 8 to 12, 2020; January 12, 2021; and February 14, 2021. If you self-quarantine and/or mask for 10 days after your last exposure to someone diagnosed with COVID-19, and have developed no new or worsening symptoms, then you likely were not exposed enough to cause an infection. Serological testing is NOT indicated for diagnosis of acute infection. However, antigen tests and some molecular tests have lower sensitivity and thus greater potential for false-negative results.8,13 Percent agreement is reported in place of sensitivity or specificity when a nonstandard reference is used to evaluate a new test.14. Determination of prior vaccination. %%EOF Automatically removed upon final result of COVID-19 lab test, for both positive and negative results COVID-19 Applied automatically with positive COVID-19 test result Because molecular and genetic analyses require significant amounts of a DNA sample, it is nearly impossible for researchers to study isolated pieces of genetic material without PCR amplification. We also know that a test can sometimes pick up infection 2-3 days before you actually develop symptoms. Because false-negative results have implications for disease spread, clinicians should recommend isolation precautions despite a negative test result when pretest probability is high. If all of these are true, or if your child had a positive test but never had any symptoms, it is OK to stop home isolation after five days as long as your child is able to mask. To determine the posttest probability with a negative result, draw a vertical line down to the blue line, and see where it intersects the y-axis. However, a negative result on an initial NAAT followed by a positive result on a subsequent test does not necessarily mean a person has been reinfected, as this can occur due to intermittent detection of viral RNA. Please note that this is a PCR test, or a lab-based test that performs similar to a PCR test. What do results mean for a COVID-19 PCR test? The nature of covid-19, the time it takes for someone to develop symptoms and the varied ways the virus affects people make each test a snapshot in time more than a definitive answer. Laboratories that perform screening or diagnostic testing for SARS-CoV-2 must have a CLIA certificate and meet regulatory requirements. If you had a positive COVID-19 test, please self-isolate at home as much as possible according to CDC instructions. How and when they will receive test results, What actions need to happen after someone has a negative or positive result, The performance specifications and any limitations associated with the test, The difference between diagnostic testing and screening testing, Who will receive the results and how they may be used, Any consequences for declining to be tested, The manufacturer, name, and type of the test. What COVID-19 serology tests does UW offer? Positive results: You have tested positive for Sars-CoV-2, the virus causing COVID-19. PCR was invented in the 1980s and is now used in a variety of ways, including DNA fingerprinting, diagnosing genetic disorders and detecting bacteria or viruses. COVID-19 testing uses a modified version of PCR called quantitative polymerase chain reaction (qPCR). This can be due to a variety of reasons. Example of Presumptive Positive Test Result What does it mean if I have a presumptive positive test result? This is why, regardless of testing, public health experts continue to stress wearing masks in public and physical distancing. xGr rFKYU cuZk/(_!5;#fTEe\p8eWm{}}M5QtmWokRG_n^?~_}?~wWz?/y8~Gg.CSR"9|[sWceoYm?&gP64CnS c.s{.r We have to make decisions about the risk we want to take on.. The pretest probability of COVID-19 should be based on the patient's exposure to someone with a confirmed or probable case, signs or symptoms of COVID-19, local or population-specific COVID-19 prevalence, and presence of an alternative diagnosis. Individuals tested are required to receive patient fact sheets as part of the tests Emergency Use Authorization (EUA). Steven Johnson contributed to this report. A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the This means the sample is from an infected individual. If you are NOT up-to-date on your COVID-19 vaccination, you should self-quarantine for five days. Molecular tests are generally more sensitive than antigen tests because they amplify collected nucleic acids and thus can detect even small amounts of virus.9,10 Serologic tests detect antibodies (immunoglobulin [Ig] M or G) produced after acute infection or vaccination and are not used to diagnose current SARS-CoV-2 infection.9,11. For more information, including on retesting persons previously infected with SARS-CoV-2, visit Ending Isolation and Precautions for People with COVID-19: Interim Guidance. These cookies may also be used for advertising purposes by these third parties. Interpreting SARS-CoV-2 Diagnostic Tests: Common Questions and - AAFP As of March 15, 2021, there were 256 molecular tests and 15 antigen tests with U.S. Food and Drug Administration (FDA) Emergency Use Authorization.12 This article addresses common questions about SARS-CoV-2 testing and presents an approach to interpreting diagnostic test results. This is not a rapid antigen test. If you have symptoms including fever, cough or shortness of breath, you can schedule a COVID-19 PCR test online. You were recently tested for COVID-19. %PDF-1.6 % If a person tests positive on a screening test and is referred for a confirmatory test, they should isolate until they receive the results of their confirmatory test. Researchers at RUSH and elsewhere are working hard to answer this question. Its how many are determining their risk of contracting or spreading the virus to someone else. In addition, completeness of race and ethnicity data is an important factor in understanding the impact the virus has on racial and ethnic minority populations. 158 0 obj <>/Filter/FlateDecode/ID[<0A6D6B97DA3217408287A0178D9FC1D6><20B4D17B15294C418C433040610A02DA>]/Index[116 71]/Info 115 0 R/Length 172/Prev 232741/Root 117 0 R/Size 187/Type/XRef/W[1 3 1]>>stream You should still be very careful with who you are around, and as always, be ESPECIALLY good about your social distancing, masking, hand-washing, and monitoring for new symptoms. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data, Expert opinion, one systematic review of low-quality studies with inconsistent results, One systematic review of low-quality studies; consensus and disease-oriented evidence, Reverse transcriptase polymerase chain reaction and nucleic acid amplification tests, Viral proteins (e.g., nucleocapsid protein), Electronic laboratory reporting is more common, A process is needed to report point-of-care results to public health departments, Sofia SARS Antigen FIA (Quidel), with symptoms, Sofia SARS Antigen FIA (Quidel), without symptoms. Limitations of Charting Systems . Settings that should be prioritized for screening testing include facilities and situations where transmission risk is high and the population served is at high risk of severe outcomes from COVID-19 or there is limited access to healthcare, including: Serial screening testing is less effective at reducing COVID-19s impacts in settings where disease rates are lower, risk of spread is lower, and risk of severe illness is lower. The test has been run at Childrens Hospital of Philadelphia's lab, and the results have come back. 3 0 obj All information these cookies collect is aggregated and therefore anonymous. This means the sample did not contain any virus. Test Results Swab Testing (testing for current infection) A nurse collects a nasal swab to look for active infection with the novel coronavirus (SARS-CoV-2, the virus that causes COVID-19). This result means that you were likely infected with COVID-19 in the past. However, all tests, including the COVID-19 antibody test, can produce negative results that are incorrect (i.e., false negative results). In a university population of 1,098 samples (Table 213,17), an evaluation of the Sofia SARS Antigen FIA test, which has FDA Emergency Use Authorization, found a sensitivity of 80.0% (95% CI, 64.4% to 90.9%) and specificity of 98.9% (95% CI, 96.2% to 99.9%) in symptomatic people (n = 227). A leaf plot offers an alternative through visual representation of pre- and posttest probability based on designated test sensitivity and specificity.30 Figure 1 shows three leaf plots with the same specificity (98%) but different sensitivities: 70%, 90%, and 99%. Viral tests can also be used as screening tests to reduce the transmission of SARS-CoV-2 by identifying infected persons who need to isolatefrom others. Some adults with severe illness may produce replication-competent virus beyond 10 days that may warrant extending duration of isolation and precautions. Were just not there yet with the accuracy of the antibody test, Wilson said. Only get a repeat test before medical procedures, or if your child develops new symptoms after three months from their initial COVID-19 infection. PCR is sometimes called molecular photocopying, and it is incredibly accurate and sensitive. In the District, fewer than 6 percent of residents have tested positive for antibodies from the coronavirus out of 13,706 blood samples. Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results % The virus is still so new. Heres what you need to know. Learn infection prevention strategies, what to do in case of exposure, and what to do if you or a family member are sick. Frequently Asked Questions About COVID-19 Testing for Providers & Clients This is screening testing that happens on a situational basis, for example, testing yourself before you visit an older relative who is at high risk of getting very sick from COVID-19. z G.? jF[m9gy6[\"|vPc.F4FDO(ETgny2.*A3-SSP4"N%&rI+T"UQv &bs_d"q8'DCD)0!LN%Z$]ALH|.no57bvL=Q8?hhpI~CCQTWPNm=x]Az!|w>4k$Hw>#G!%|^>t? CDCs COVID-19 Community Levels recommendations include implementing screening testing in high-risk settings at the medium and high levels. Based on evolving evidence, CDC recommends fully vaccinated people get tested 5-7 days after close contact with a person with suspected or confirmed COVID-19. Antibody tests may help identify past SARS-CoV-2 infection if performed two to four weeks after symptom onset. At CHOP, we try to contact all patients who have an invalid result to work with you to reschedule your test. In the meantime, we recommend that you wear a face mask in public, practice frequent hand hygiene and follow social distancing recommendations, just as you were doing before antibody testing. A positive result happens when the SARS-CoV-2 primers match the DNA in the sample and the sequence is amplified, creating millions of copies. If someone has become newly symptomatic after having had COVID-19 within the past 30 days,* antigen tests should be used to identify a new infection. The timing of testing after exposure also matters. 4 0 obj Additional information is available on sensitivity, specificity, positive and negative predictive values forantigen testsandantibody tests, and the relationship between pretest probability and the likelihood of positive and negative predictive values. Antibody testing is not currently recommended to assess a persons protection against infection or severe COVID-19 following COVID-19 vaccination or prior infection, or to assess the need for vaccination in an unvaccinated person. The COVID-19 (PCR) test uses a nasopharyngeal swab to test your nasal secretions for traces of COVID-19. FACT SHEET FOR PATIENTS - Food And Drug Administration If you are having trouble breathing and need emergent care, please call 911 or visit your nearest emergency department to get immediate care. More information can be found on the CDC COVID-19 website. The U.S. Food and Drug Administration, Infectious Diseases Society of America, and Centers for Disease Control and Prevention websites were reviewed. hb```f``z/ B@16) Monitor your symptoms throughout the day. Overview of Testing for SARS-CoV-2, the virus that causes COVID-19 - CDC If you have questions about your quarantine, and how long it should last, please get in touch with your local department of public health. Disease prevalence affects the predictive value, or the likelihood a person truly does or does not have a disease based on a test result.8,13 Higher disease prevalence increases the predictive value of a positive test result but decreases the predictive value of a negative test result (Table 213,17). To evaluate for evidence of previous infection in a vaccinated individual, an antibody test specifically evaluating IgM/IgG to the nucleocapsid protein should be used (e.g., for public health surveillance or the diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) or Multisystem Inflammatory Syndrome in Adults (MIS-A)). Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. CDCs COVID-19 Response Health Equity Strategyoutlines a plan to reduce the disproportionate burden of COVID-19 among racial and ethnic minority populations and other population groups (e.g., essential and frontline workers, people living in rural or frontier areas) who have experienced a disproportionate burden of COVID-19. Right now, we dont really know what a positive antibody test means in terms of the degree to which youre protected, Bergstrom said. For more on surveillance conducted by CDC: MMWR: Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems. On top of all this, the rising demand for more testing has led to week-long delays for results. We dont know if people who have had COVID-19 and who do not develop antibodies are at risk of infection with COVID-19 in the future. Pretest probability should be based on a patient's exposure to someone with a confirmed or probable case, signs or symptoms of COVID-19, local or population-specific COVID-19 prevalence, and presence of an alternative diagnosis.8,25,27. FACT SHEET FOR HEALTHCARE PROVIDERS - Food And Drug Administration Bergstrom said some just want to know whether that bad cold they had a few months ago was actually the novel coronavirus. If someone had exposure to another person with COVID-19, but the exposed individual has had COVID-19 within the past 30-90 days,* consider using antigen tests (rather than an NAAT, such as a PCR test) to identify a new infection. 0 A negative test means that we have NOT found evidence of the virus which causes coronavirus disease (COVID-19) on the swab from the back of your nose/mouth. If the results take five days to come back, theres only so much a person can do to protect those around them. A leaf plot can aid in visualizing how pretest probability and test characteristics impact posttest probability. Experts say the backlog in some parts of the country makes the results useless for efforts to control the spread of the virus. They said you can not get it twice Test Name Result Flag Reference Range Lab SARS-CoV-2, NAA SARS-CoV-2, NAA Detected ABNORMAL Not Detected 01 This nucleic acid amplification test was developed and its performance characteristics determined by LabCorp Laboratories. Almost all positive results are true positives. Before going in for care, please let any doctors offices, emergency rooms, etc. If youve been in contact with someone who has covid-19 but you dont have any symptoms, Wilson said, you should consider a 14-day self-quarantine and discuss whether to get tested with your health-care provider. <>>> 8, 9 Molecular tests, such as reverse transcriptase polymerase chain reaction. Some could be rapid in 15 minutes, Short turnaround time for NAAT POC tests, but few available, Usually does not need to be repeated to confirm results, Short turnaround time (approximately 15 minutes). COVID-19 Testing: What You Need to Know | CDC It is important to remember that in rare circumstances it is still possible to develop the disease up to 14 days from exposure and even you stop strict quarantining early based on current guidance. }jO?vHXvuH,avpGbRehLa]8#@j=HV>9O%Q ZV;c]ZtV Z>ZVgj.'T-X2]0NMHm[qu5Pvc.N_O9T^hQPLg8McE[/C83 8_o~cIMZHE,#7Z K~)"o4-^ v&o5im8;//Ul)=Hs w&7 Le| ug L%kN@S{ww!?7Z1`+gCPR.mo"__w~h @so!3&o! Continue symptom monitoring. What does it mean if I have a positive test result? CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. 2 0 obj An alternative diagnosis, such as influenza, decreases pretest probability, whereas absence of an alternative diagnosis increases it.27. So if you . Employers, community-based, and faith-based organizations can be important partners to increase the number of free, community-based testing sites. A Cochrane review, with limited applicability to clinical settings, included 13 evaluations of four SARS-CoV-2 molecular tests, including ID Now and Xpert Xpress (Table 213,17), on 2,255 samples and found an average sensitivity of 95.2% (95% CI, 86.7% to 98.3%) and specificity of 98.9% (95% CI, 97.3% to 99.5%).13 The range of sensitivity was 68% to 100%. The conversion to posttest probability with a positive result is the increase in height to the red line. We're here to help! Some must be performed in a laboratory by trained personnel, some can be performed at the point of care, and others can be . If youd like to consult with a provider about your symptoms, getting approval to return to work/school, or about whether or not you require re-testing, please start an on-demand video visit. If you have concerns about new symptoms, please call your primary care doctor. What does it mean if I have a positive test result? For example, a negative test result from a resident of a skilled nursing facility where a known outbreak is occurring has a lower negative predictive value because of the high disease prevalence. Some strategies to achieve health equity in testing access and availability include: Positive test results using a viral test (NAAT, antigen or other tests) in persons with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19, independent of vaccination status of the person. If a person has received one or more COVID-19 vaccinations, it does not affect the results of their SARS-CoV-2 diagnostic or screening tests (nucleic acid amplification tests [NAAT], antigen or other diagnostic tests). Molecular and antigen tests can detect current SARS-CoV-2 infection and are used to diagnose COVID-19. Overall, false negative results are much more likely than false positive results. SARS-CoV-2 is the novel coronavirus that causes COVID-19. You may have had an infection in the past caused by another virus in the coronavirus family. A pregnancy test can detect only certain hormones after a certain number of days or weeks, but it doesnt mean youre not pregnant. Table 1 summarizes some characteristics of NAATs and antigen tests to consider for a testing program. Some people should receive treatment. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Please select the appropriate directions below based on your test results. Monitor yourself for any symptoms of COVID-19 such as fever, cough or shortness of breath. Pretest probability should be based on a patient's exposure to someone with a confirmed or probable case, signs or symptoms of COVID-19, local or population-specific COVID-19 prevalence, and presence of an alternative diagnosis. Genomic research has been central to understanding and combating the SARS-CoV-2 (COVID-19) pandemic. Monitor your symptoms throughout the day. Because of this, Bergstrom said positive antibody tests shouldnt be used as a license to return to the office or other group activities. Persons who are placed under active monitoring should follow instructions provided by their physician or local health department. 1 0 obj Equivocal antibody test results mean that the results could not be interpreted as positive or negative. Here are the top five things to know. For more information, see the antigen test algorithm. (Video: The Washington Post), Right now, we dont really know what a positive antibody test means in terms of the degree to which youre protected.. If your antibody test result was negative, this means that the test did not detect any COVID-19 antibodies in your blood. LMS]~3r ^]>z4LsVv=`&\u, #"G/Q^ U9 3#FE PG.= ] P##hB]piT !w\o//U~'Dh !0{. The problem is this virus is a strange virus, Bergstrom said. At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polymerase chain reaction (PCR) tests and other nucleic acid amplification tests. Bergstrom added the results become absolutely useless for efforts to quarantine or to trace contacts. It takes time for the coronavirus to replicate to a critical mass for a swabbing test to detect it. If you have a presumptive positive test result, it is very likely that you have COVID-19. In this setting, it would seem reasonable to flag positive results as high and not flag negative results. A symptom-based approach is preferred over a test-based approach for discontinuing isolation precautions for most patients with COVID-19 because prolonged shedding of viral RNA does not necessarily correlate with infectivity. Avoid using public transportation, ride-sharing, or taxis. If you would like to talk to a RUSH social worker about coping with COVID 19 or connections to resources, please call 1-800-757-0202. For more information about COVID-19 vaccines and antibody test results, refer toInterim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. To read a leaf plot, the pretest probability is selected on the positive sloped central line (leaf's vein). All population groups, including racial and ethnic minority groups, should have equal access to affordable, quality and timely SARS-CoV-2 testingwith fast turnaround time for resultsfor diagnosis and screening. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. Reasons for this may include: There is an immune response but it's not strong enough to give a positive result. Antigen tests work best if you have symptoms. A high number of cycles suggests a low viral load. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Some must be performed in a laboratory by trained personnel, some can be performed at the point of care, and others can be performed at homeor anywhere. Understanding COVID-19 PCR Testing - Genome.gov Please note that this is a PCR test and not a rapid antigen test. If your child attends school or daycare, have them remain home. Refers to point-of-care antigen tests only. The treatments described below will help your child feel better and help the body's own defenses fight the virus: Seek medical attention if your child's illness is worsening as described below. A negative test means that we have NOT found evidence of the virus which causes coronavirus disease (COVID-19) on the swab from the back of your nose/mouth. The range of sensitivity was 0% to 94%. Some tests provide results rapidly (within minutes); others require 1-3 days for processing. What antibody tests can provide is a broader understanding of the progression of an outbreak. The spectrum of asymptomatic, presymptomatic, and symptomatic SARS-CoV-2 transmission presents challenges for evaluating SARS-CoV-2 test performance for diagnostic or screening purposes and for interpreting test results. Long delays in getting test results hobble coronavirus response. People without symptoms and without known exposure to COVID-19 do not need to take any special actions while awaiting screening test results. Philadelphia, PA 19104, What to Do if Your Child Tests Positive for COVID-19, 5 Things to Know if Your Child Tests Positive for COVID-19, Know My Rights About Surprise Medical Bills. Please see FDA guidanceon the use of at-home COVID-19 antigen tests. Positive and negative predictive values of NAAT and antigen tests vary depending upon the pretest probability. After a five-day period of self-quarantine, we recommend that you wear a well-fitted mask around others for an additional five days. However, antigen tests generally have lower sensitivity and thus greater potential for false-negative results. If you must go to a medical appointment, call ahead and make arrangements. The clinician must judge what threshold of posttest probability determines infection status.25. Although prolonged positives have been detected by RT-PCR for up to 12 weeks, SARS-CoV-2 has not been cultured more than 10 days after symptom onset in patients with mild to moderate COVID-19.1,2123,33,34, A study of 193 symptomatic and 110 asymptomatic patients with SARS-CoV-2 infection found that viral RNA detection lasted a median of 17 to 19 days.35 Although viral load peaks near symptom onset and is similar between asymptomatic and symptomatic individuals, the probability of culturing SARS-CoV-2 from the upper respiratory tract decreases as time from symptom onset increases, falling to zero more than 10 days after symptom onset in patients with mild to moderate COVID-19.3,21,35 In addition to time after symptom onset, patients should have symptom improvement and no fever for 24 hours without antipyretics before discontinuing isolation.32, Current SARS-CoV-2 antibody tests detect IgM or IgG to viral spike or nucleocapsid proteins.11 Antibody tests may help identify past SARS-CoV-2 infection if performed two to four weeks after symptom onset.36,37 Antibody test results should not yet be used to infer immunity to SARS-CoV-2 infection or inform decisions to discontinue social distancing or use of face masks or personal protective equipment.37, A Cochrane review of 54 studies with 15,976 total samples (8,526 with known SARS-CoV-2 infection) from mostly hospitalized patients found that antibody tests may help confirm past SARS-CoV-2 infection in people who had symptoms more than two weeks before testing.36 However, the review found few data on the presence of antibodies beyond 35 days after symptom onset.
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