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Accurate Are The Covid-19 Test

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Last Updated: 02 July 2021

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General | Latest Info

As the number of nationwide COVID-19 cases begins to climb again, US Food and Drug Administration has called upon healthcare providers to give clear, step-by-step instructions to patients WHO self-collect nasal samples for SARS-CoV-2 testing in healthcare settings, such as clinics and other testing sites. Self-collect nasal swabs can make testing less invasive and more tolerable for patients than swabs taken by healthcare workers from the back of nose. For healthcare workers, self-collect nasal swabs can lower risk of exposure to SARS-CoV-2, virus that causes COVID-19. Healthcare workers can maintain at least 6 feet of separation from patients, which can help reduce use of personal protective equipment and preserve limited supplies, according to the FDA. But without proper instructions, patients may not collect adequate samples for testing. Samples that are not collected correctly may not contain a sufficient amount of virus to be detect, say FDA recommendations issued on October 7 2020. Without proper sample collection, test may give false-negative results and indicate that patient is not infect, when, in fact, they are infect. Health care providers have a critical role in helping patients perform self-collection accurately, recommendations say. Those recommendations call upon healthcare providers to personally give step-by-step explanations of how to effectively collect nasal samples to patients. In addition, FDA recommends providers give patients written or video instructions. In particular, healthcare providers should instruct patients to: put the entire swab tip inside nose and rub side of swab with moderate pressure against as much of wall of nostrilalso, called anterior naresas possible. Make four to five sweeping circles with the same swab in each nostril, for about 10-15 seconds per nostril. Both nostrils should be swabbed so that sufficient samples are collect. Simply twirling a swab against one part of the inside of the nose or leaving a swab in the nose for 10-15 seconds is not proper technique and may result in insufficient sample. FDA's recommendations direct providers to two examples of written instructions available from Audere's HealthPulse communication and Centers for Disease Control and Prevention. Recommendations also emphasize using the appropriate type of swab. Patients should only use swab that they provide and not substitute it with any other swab. Nasopharyngeal swabs and oropharyngeal specimens from the throat just behind the mouth are not appropriate for self-collection, FDA add. The Recommendations cite evidence that nasal specimens from nostrils provide similar information to those from the back of the nose and throat, as long as the specimen is of good quality. Evidence come from a French study of molecular detection of SARS-CoV-2 that found use of nasal swab specimens was nearly equivalent to detection using nasopharyngeal swabs, which are considered to be the gold standard. SARS-CoV-2 detection from nasal samples shows high sensitivity and specificity. A US study of 498 patients WHO both take their own nasal swabs and had nasopharyngeal swabs do by a healthcare professional reached a similar conclusion.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Diagnostic tests for current infection

Every COVID-19 test currently available in the United States has been approved by FDA under the agencys Emergency Use Authorization protocol. EUA permits FDA to allow unapproved medical products or unapproved uses of approved medical products to be used in Emergency to diagnose, treat, or prevent serious or life threatening diseases or conditions caused by chemical, biological, radiological and nuclear threat agents when there are no adequate, appropriate and available alternatives. That has allowed novel coronavirus tests to quickly hit the market without research and testing normally required for FDA approval. To date, FDA has approved 130 different RT-PCR, antigen, and antibody tests for new coronavirus. Doing full clinical trial takes a long time, but we need tests now, says Sherry Dunbar, PhD, senior director of global scientific affairs for Luminex Corporation, which manufactures a pair of PRC tests and has submitted an application to FDA for Emergency approval of a new antigen test.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Tests for past infection

A positive test means you have COVID-19 antibodies in your blood, which indicate past infection with the virus. It's possible to have positive test result even if you have never had any symptoms of COVID-19. False-positive test results can occur. It may be that the test detected antibodies to coronavirus closely related to the COVID-19 virus or that test quality was a flaw. Negative. A Negative test means that you have no COVID-19 antibodies, so you probably were not infected with the COVID-19 virus in the past. Because it takes time for antibodies to develop, false-negative test results can happen if blood sample is collected too soon after your infection start. In some cases, test may be flaw. People WHO have had COVID-19 or tested positive for antibodies should not assume they're protected from getting COVID-19 infection again. Researchers are trying to determine if antibodies provide some immunity to the COVID-19 virus, what level of protection is and how long immunity may last. Until more is know, even if your test results show that you have COVID-19 antibodies, continue to take precautions, including wearing a face mask in public, frequently washing your hands and practicing social distancing to avoid the risk of spreading viruses A Positive test result shows you may have antibodies from infection with the virus that causes COVID-19. However, there is a chance that a positive result means you have antibodies from infection with different virus from the same family of viruses. Note: Other coronaviruses cannot produce positive results on viral test for SARS-CoV-2. Having antibodies to virus that cause COVID-19 may provide protection from getting infected with virus again. But even if it does, we do not know how much protection antibodies may provide or how long this protection may last. Confirm and suspected cases of reinfection have been report, but remain rare. Talk with your healthcare provider about your test result and the type of test you take to understand what your result means. Your provider may suggest you take a second type of antibody test to see if the first test was accurate. You should continue to protect yourself and others since you could get infected with virus again. If you work in a job where you wear personal protective equipment, continue wearing PPE. You may test positive for antibodies even if you have never had symptoms of COVID-19. This can happen if you had infection without symptoms, which is called asymptomatic infection. You may not have ever had COVID-19. Talk with your healthcare provider about your test result and the type of test you take to understand what your result mean. You could have a current infection or have been recently infect. The test may be negative because it typically takes 1-3 weeks after infection for your body to make antibodies. Its possible you could still get sick if you have been exposed to viruses recently. This means you could still spread the virus.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

The bottom line

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Clearly defined settingDemographic characteristics describedFollow-up length was sufficientTransmission outcomes assessedMain biases are taken into consideration
YesYesN/AN/APartly

I 'll start with the bottom line: Until this week there have been no Deaths in Solano County directly caused by COVID-19. Ive been following, with keen interest, report COVID-19 death toll in Solano County since the novel Coronavirus first appear. Although I am not a doctor or scientist, it seems logical to me that a good way to assess the seriousness of any virus might be based on the number of deaths directly and specifically caused by the virus. Under COVID-19 Pandemic banner recent headline shout, Deaths climb to 37 in Solano. Bury in the story, like many of these articles with horrific headlines, are find statements that deaths were COVID-link or COVID-relate but never COVID-cause. Digging further into details on 37 reported Deaths we find that all of these people were elderly with multiple pre-existing health conditions. Nearly half of these 37 were receiving hospice care. Hospices are called in to assist people who are dying and have, in most cases, just weeks to live. From what I can gather, none of these 37 die directly from COVID-19 but lose their lives through complications of their serious multiple pre-existing health conditions such as cancer and heart disease. The fact that they test positive for COVID-19 during the final few days of their lives does not equate to a virus causing their death. Headlines suggesting that COVID-19 caused these Deaths are just as misleading as if these 37 seniors had all visited Tanning Salon week before their demise and the headlines read 37 Die After Visiting Tanning Salon. Another recent headline bellow, California officials report first virus death of child. When we read children in headlines, do anyone picture a 17-year-old who has legally become an adult in one year? Reading fine print we find this child was 17 years old with other health conditions. Again, COVID-19 did not cause this teenager's death. This is the second such headline reporting COVID-related child death in California. The first report has been buried After mayor of the town where another 17-year-old boy was reported as first child COVID-19 death actually Die of septic shock after being admitted into hospital with respiratory issues. There are nearly 450 000 people living in Solano County, many of whom have lost jobs, been put out of business, with lives turned upside down, because of what many believe to be an overreaching response to this virus. Without a single report COVID-cause death in this County, our government leaders have closed businesses and schools, forbid people to attend their places of worship, dug up sports fields and put fear of the grim reaper into the minds of everyone. At the same time, they have allowed gatherings of hundreds or even thousands, in close proximity, to rally and protest specific social issues. Government leaders ' actions that keep COVID-fear drama alive through politically drive mandates are indefensible.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Nucleic Acid Amplification Testing (NAAT)

March 30 2020-CMS announces it will allow hospitals, Laboratories, and Other entities to perform Tests For COVID-19 on People at Home and in Other community-base settings outside of hospital. This will both increase Access To Testing and reduce risks of exposure. New Guidance allows healthcare systems, hospitals, and communities to set up testing sites exclusively for the purpose of identifying COVID-19-positive patients in a safe environment. March 27 2020-Abbott announces that US FDA has issued Emergency Use Authorization For fastest available molecular Point-Of-Care Test For Detection Of Novel Coronavirus, delivering positive results in as little as 5-minutes and negative results in 13-minutes. The Test will run on the Company's ID NOW Platform, providing Rapid results in a wide range of healthcare settings such as physicians' offices, urgent Care Clinics, and Hospital Emergency Departments. Mar. 26 2020-Henry Schein, Inc. Announced availability of Antibody Rapid blood Test, know as Standard Q COVID-19 IgM / IgG Rapid Test, intended to be administered at Point Of Care. The test delivers results within 15 minutes from pinprick with no instrumentation require. Health Care professionals can use results of test, along with patients ' medical history, symptoms, and results of other relevant testing, to make informed decisions about patient treatment and care. March 25 2020-study led by UnitedHealth Group Research & Development and OptumCare clinicians has demonstrated that a simple, self-collect Test is as effective in identifying COVID-19 infections as the current clinician-collect Test. Study found tests using self-administer Swab Tests accurately detect COVID-19 in more than 90 % of positive patients, which is consistent with clinician-administered Test. The US FDA has Update its Guidance based on UnitedHealth Group Research, allowing patients nationwide to self-administer Swab Tests For COVID-19. March 24 2020-Q2 Solutions announces its collaboration with University Of Texas Medical Branch to develop Novel Assay For COVID-19 Tests, essential tool for Rapid Development Of Coronavirus vaccine. Once a viable assay is develop, Q2 Solutions labs will produce it for use in Clinical trials to determine the effectiveness of the COVID-19 vaccine. March 23 2020-Heat Biologics, Inc. Report that it is collaborating with the University Of Miami to develop the proprietary UM COVID-19 Point-Of-Care Diagnostic Test. The new, patient-friendly test will require simple pharyngeal throat Swab to deliver On-spot results on paper strip in under 30 minutes. March 21 2020-Cepheid announces it has received Emergency Use Authorization from US Food & Drug Administration For Xpert Xpress SARS-COV-2, Rapid molecular Diagnostic Test For Qualitative Detection Of SARS-COV-2, virus causing COVID-19. The Test has been designed to operate on any of Cepheid's more than 23 000 automated GeneXpert Systems worldwide, with a Detection time of approximately 45 minutes. March 20 2020-Daxor Corporation announces first use of its BVA-100 Test To guide volume Treatment in patients infected with COVID-19 virus. The Company also announced the release of Clinical protocol For fluid Guidance When utilizing BVA-100 Diagnostic Test For COVID-19 patients.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Antibody Testing

As the name suggest, these tests look for antibodies made by your immune system in response to infection with the new Coronavirus. Antibodies can take several days or weeks to develop after you have an infection and may stay in your blood for several weeks after recovery, according to the Food and Drug Administration. Because of THIS, antibody tests should not be used to diagnose active Coronavirus infection. Ideally, positive antibody test would tell you that youve recovered from COVID-19 or Coronavirus infection and have immunity from future infections, allowing you to return to work, travel, and socialization without risk of transmitting infection or becoming sick again yourself. However, researchers do yet know whether the presence of antibodies means that you have immunity, whether you could still get sick from different strains of viruses or how long immunity lasts. Antibody tests are problematic because they can be misused easily, says Volk. You may think if you have a positive antibody test that you dont have to wear a mask or conform to social distancing, but antibodies dont tell us that you have immunological armor against future infections. The job of antibodies is to stick to things, so they can create positive test results if they react to different types of Coronavirus, said Wojewoda. Antibody tests show most promise if the way human body controls Coronavirus is with antibody response, Wojewoda add. If NOT, it doesnt make any difference. For example, she say, it is T cells, not antibodies, that help the body fight HIV infection. That is another piece of data that needs to be figured out before testing can be figured out, Wojewoda say.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Antigen test (aka rapid test)

It is season to spend hours waiting in line to get test for coronavirus. Florida recently reported line of cars 150 deep waiting for COVID-19 Testing, while one drive-up site in Illinois is averaging more than 1 000 visitors a day. And these scenes are being played out over and over again across the country as people rush to get tests ahead of the Thanksgiving holiday. Indeed, American Clinical Laboratory Association has warned that the surge in test orders means that many labs are facing delays in delivering test results, with Quest DGX,-1. 32 % also recently echoing that they expect turnaround times to grow as COVID-19 cases surge across the country. It should be noted that a negative test only proves you were infected with the virus on the day you were test, however, and someone with a negative result can still contract and spread the virus while traveling for Thanksgiving, or while spending time with family and friends indoors. This is one reason why the US Centers for Disease Control and Protection has strongly urged Americans to stay home for holiday this year, whether your test comes up negative or not. But there is a lot of misinformation and confusion surrounding COVID-19 Testing. So MarketWatch has pulled together the most up-to-date information on COVID-19 Testing from CDC, Food and Drug Administration and Johns Hopkins University to highlight what the test entail, as well as answers to some of the most common questions about test results.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Rapid Antigen Testing for SARS-CoV-2

The US Food and Drug Administration is alerting Clinical Laboratory staff and health care providers that false positive results can occur with Antigen Tests, including when users do not follow instructions for use of Antigen Tests for Rapid detection of SARS-CoV-2. Generally, Antigen Tests are indicated for qualitative detection of SARS-CoV-2 antigens in authorized specimen types collected from individuals WHO are suspected of COVID-19 by their healthcare provider within a certain number of days of symptom onset. The FDA is aware of reports of false positive results associated with Antigen Tests use in nursing homes and other Settings and continue to monitor and evaluate these reports and other available information about device safety and performance. FDA reminds Clinical Laboratory staff and health care providers about the risk of false positive results with all Laboratory Tests. Laboratories should expect some false positive results to occur even when very accurate Tests are used for screening large populations with low prevalence of infection. Health care providers and Clinical Laboratory staff can help ensure accurate Reporting of Test Results by following authorized instructions for use of Test and key steps in the Testing process as recommended by Centers for Disease Control and Prevention, including routine follow-up Testing with molecular assay when appropriate, and by considering expect occurrence of false positive Results when interpreting Test Results in their patient populations.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Which test is best?

Unfortunately, it is not clear exactly how accurate any of these tests are. There are several reasons for this: we dont have precise measures of accuracy for these tests, just some commonly quoted figures for false negatives or false positives, such as those reported above. False negative tests provide false reassurance, and could lead to delayed treatment and relaxed restrictions despite being contagious. False positives, which are much less likely, can cause unwarranted anxiety and require people to quarantine unnecessarily. How carefully a specimen is collected and stored may affect accuracy. None of these tests is officially approved by FDA. They are available because FDA has granted their makers emergency use authorization. And that means usual rigorous testing and vetting has not happen, and accuracy results have not been widely publish. A large and growing number of laboratories and companies offer these tests, so accuracy may vary. At the date of this posting, more than 170 molecular tests, two antigen tests, and 37 antibody tests are available. All of these tests are new because the virus is new. Without a long track record, assessments of accuracy can only be approximate. We dont have a definitive gold standard test with which to compare them.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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