Cue Health False Positive

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FDA: Cue Health COVID tests may return false positive, negative r…

(4 days ago) People also askDoes Cue Health report test results?The Cue Health Mobile Application (Cue Health App) automatically reports test results according to the reporting guidelines of the appropriate public health authorities. What does it mean if the specimen tests negative for the virus that causes COVID-19?FACT SHEET FOR HEALTHCARE PROVIDERS - U.S. Food and Drug Administrationfda.govWhy did Cue Health (HLTH) stock go down?Cue Health ( NASDAQ: HLTH) shares extended a multi-day decline in the premarket Tuesday after the U.S. Food and Drug Administration (FDA) warned against using the company’s COVID-19 tests due to the increased risk of false results.Cue Health slips as FDA warns against COVID-19 testsmsn.comDoes cue's Test match PCR results?The findings revealed a 99.4% match between results from Cue’s test and the reference PCR tests, including 100% clinical sensitivity to detect positive cases, yielding no false negatives. Of this testing population, 98.7% was asymptomatic at varying stages of infection and viral load.Independent Study Shows Cue Health’s Molecular COVID-19 Test is as cuehealth.comIs a cue health test a feasible solution for a POC solution?These facilities are often staffed by nurses or other health care providers who are inexperienced with laboratory testing; therefore, the Cue Health test for SARS-CoV-2 can be considered a feasible solution to implement at sites requiring a POC solution.Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV-2 nucl…ncbi.nlm.nih.govFeedbackNews about Cue Health False Positive bing.com/newsCue Health, COVID-19✕About this resultThis title and these news articles are related to your search term(s).Articles come from a variety of sources across the web.Titles are algorithmically generated based on content related to your search term(s).STAT · 1dCue Health’s Covid-19 tests could give false results, FDA warnsT he Food and Drug Administration warned consumers Monday to not use Cue Health’s at …

https://www.naplesnews.com/story/news/2024/05/14/cue-health-covid-tests-false-negatives-positive/73682273007/#:~:text=The%20U.S.%20Food%20and%20Drug%20Administration%20%28FDA%29%20warned,you%20false%20results%20and%20should%20be%20thrown%20out.

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Do Not Use Cue Health’s COVID-19 Tests Due to Risk of …

(3 days ago) WEBIf you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100. The FDA …

https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication

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Cue Health's Covid-19 tests lead to false results, FDA …

(9 days ago) WEBCue Health’s Covid-19 tests could give false results, FDA warns. T he Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home …

https://www.statnews.com/2024/05/13/cue-health-covid-19-test-fda-warning-false-positives/

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Cue Health’s COVID-19 Tests May Produce False Results, FDA Says

(5 days ago) WEBFDA Warns Against Using Cue Health’s COVID-19 Tests. The United States Food and Drug Administration (FDA) has issued a warning not to use Cue Health’s at …

https://healthnews.com/news/cue-health-covid-tests-false-results/

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FDA Safety Communication: Do Not Use Cue Health’s …

(9 days ago) WEBReport any problems you experience with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use to the FDA, including suspected false positive …

https://www.drugs.com/fda/fda-safety-communication-do-not-cue-health-s-covid-19-tests-due-risk-false-results-14677.html

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FACT SHEET FOR PATIENTS - Cue Health

(6 days ago) WEBCue® Health Inc. Updated: March 26, 2021 Cue COVID-19 Test Coronavirus Disease 2019 (COVID-19) 1 give a positive result that is wrong (a false …

https://cuehealth.com/static/docs/Cue_COVID-19_Test_Labeling/Cue_COVID-19_Test_Fact_Sheet_for_Patients.pdf

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FDA Issues Warning Against Using Cue Health COVID Tests

(9 days ago) WEBThe FDA encourages reporting any issues with Cue Health tests, including suspected false positives or negatives, to help monitor and address the reliability of …

https://clpmag.com/disease-states/infectious-diseases/covid-19/fda-issues-warning-against-using-cue-health-covid-tests/

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FDA warns of false results from Cue Health COVID tests

(2 days ago) WEBTopics. COVID-19. The Food and Drug Administration (FDA) yesterday urged home test users, caregivers, and health providers not to use Cue Health's COVID-19 …

https://www.cidrap.umn.edu/covid-19/fda-warns-false-results-cue-health-covid-tests

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HCP Fact Sheet - Cue Health

(8 days ago) WEBThe Cue COVID-19 Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to …

https://cuehealth.com/static/docs/Cue_COVID-19_Test_Labeling/Cue_COVID-19_Test_Fact_Sheet_for_Healthcare_Providers.pdf

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Cue COVID-19 Test for Home and Over The Counter …

(1 days ago) WEBCue Health Inc. March 5, 2021 Cue COVID-19 Test for Home and Over The Counter (OTC) Use this test can give a positive result that is wrong (a false positive result) …

https://www.fda.gov/media/146469/download

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The FDA says you can’t trust COVID-19 tests from Cue Health

(9 days ago) WEBThe COVID-19 Test The FDA Now Says You Can't Trust. San Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo …

https://www.slashgear.com/1581698/covid-19-test-false-results-according-to-fda/

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FDA warns users not to use Cue Health’s at-home Covid-19 tests

(9 days ago) WEBThe Cue Health Covid-19 test for home and over-the-counter use was authorised by the FDA for point-of-care testing in June 2020, receiving an emergency …

https://finance.yahoo.com/news/fda-warns-users-not-cue-105158696.html

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Cue COVID-19 Test - Fact Sheet for Healthcare Providers

(Just Now) WEBThe Cue COVID-19 Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could …

https://www.hsdl.org/c/view?docid=843029

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Bluetooth at-home COVID-19 test could produce false results

(4 days ago) WEBA new flaw in a Bluetooth at-home COVID-19 test could produce false results. A security researcher has discovered a bug in Cue Health’s at-home COVID-19 …

https://techcrunch.com/2022/04/21/cue-health-covid-security-false-results/

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Cue Health slips as FDA warns against COVID-19 tests - MSN

(3 days ago) WEBCue Health (NASDAQ:HLTH) shares extended a multi-day decline in the premarket Tuesday after the U.S. Food and Drug Administration (FDA) warned against using the …

https://www.msn.com/en-us/health/other/cue-health-slips-as-fda-warns-against-covid-19-tests/ar-BB1mmBNj

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If I test positive using a test other than Cue’s, what - Cue Health

(7 days ago) WEBIf you test positive for COVID-19 using a non-Cue test, the only documentation required is a photo of your government-issued ID next to your positive test. You will be asked to …

https://help.cuehealth.com/en/articles/6928069-if-i-test-positive-using-a-test-other-than-cue-s-what-documentation-will-i-need-to-provide

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Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV …

(3 days ago) WEBPoint-of-care (POC) tests are in high demand in order to facilitate rapid care decisions for patients suspected of SARS-CoV-2. We conducted a clinical validation …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785428/

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Independent Study Shows Cue Health’s Molecular COVID-19 Test …

(4 days ago) WEBThe findings revealed a 99.4% match between results from Cue’s test and the reference PCR tests, including 100% clinical sensitivity to detect positive cases, …

https://cuehealth.com/about/press/independent-study-shows-cue-health's-molecular-covid-19-test-is-as-accurate-as-a

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Cue Health Inc. March 5, 2021 Disease 2019 Cue COVID-19 …

(3 days ago) WEBCue Health Inc. March 5, 2021 Cue COVID-19 Test for Home and Over The Counter (OTC) Use Coronavirus Disease 2019 (COVID-19) 1 this test can give a positive result that …

https://cuehealth.com/static/docs/home-otc/WS9100005-2_1.0_Fact_Sheet_Cue_COVID-19_OTC_Home_Use_-_Individuals.pdf

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Clinical evaluation of the Cue's COVID‑19 diagnostic test to detect

(8 days ago) WEBClinical evaluation of the Cue's COVID‑19 diagnostic test to detect SARS-CoV-2 in the upper respiratory tract. Tung Phan, Corresponding Author. Tung Phan …

https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.27805

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What diagnostic or health tests does Cue offer?

(3 days ago) WEBCue’s platform builds on a decade of development, with many more products and services on the way. Cue is developing additional tests in areas such as respiratory (including flu …

https://help.cuehealth.com/en/articles/5580800-what-diagnostic-or-health-tests-does-cue-offer

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FACT SHEET FOR HEALTHCARE PROVIDERS - U.S. Food and …

(1 days ago) WEBCue Health Inc. Updated: March 1, 2022 Cue COVID-19 Test Coronavirus Disease 2019 the event of a false positive result, risks to patients could include the …

https://www.fda.gov/media/138824/download

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FACT SHEET FOR HEALTHCARE PROFESSIONALS - U.S. Food …

(1 days ago) WEBCue Health Inc. February 9, 2022 Cue COVID-19 Test for Home and Over The Counter (OTC) Use Coronavirus In the event of a false positive result, risks to patients could …

https://www.fda.gov/media/146468/download

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FAQs Cue - Cue Health

(2 days ago) WEBContact Us. Still need help? Contact our customer support team directly. [email protected] 833.CUE.TEST (833.283.8378)

https://cuehealth.com/learn/faqs

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Cue Health Collaborates with Pfizer to Provide People who Test …

(Just Now) WEBThrough Cue Care, Cue’s same-day, at-home, test-to-treatment platform, individuals will be able to use the Cue Health App to access educational resources like …

https://investors.cuehealth.com/news-releases/news-release-details/cue-health-collaborates-pfizer-provide-people-who-test-positive

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IN9100005 2.0 IFU, Cue COVID-19 OTC Home Use Digital Use

(5 days ago) WEB9 IN9100005_2.0 2021-10. Step 5-5: Prepare the Cue COVID-19 Test Cartridge for a Test. Tear open the top of the cartridge foil pouch and remove the plastic tray with the Cue …

https://cuehealth.com/static/docs/home-otc/Cue_COVID-19_OTC_Test_Instructions_For_Use_(IFU).pdf

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