It is intended to be used in the home or similar environment by a lay person. =Qd"kQxqsjmNM!| k0V_~Up!_Al;_DuL#Iy{)IoTv%hs$Tm)Eo\W}Yg1lT,(i ,K-%?T3qR\Ma\/?Y @1$=0WPQuo8?Iri_n3fvuK$O`d.9~O&%B7MKTHYSw*nF5 (X(96gFl:)d9okmDDg~*)%1fSK/H{`6T4qbb$Nt!6Q\UHGEz5Xu1ss!pAr.t_egF;1(=Q$5eCAL}j=Qrjty@Pdn?.-i~A6i{tv|kLw1mK%vC%lHXn?r4ve7uJd*. e 122 0 obj <>/Filter/FlateDecode/ID[<9ABF9AAAC6BD644799536C23185BF49D>]/Index[88 61]/Info 87 0 R/Length 147/Prev 111411/Root 89 0 R/Size 149/Type/XRef/W[1 3 1]>>stream Others may be sent to a lab for analysis. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. These documents include FDA requirements regarding ordering the test. x+c*;@TD @ * A sample taken from a person that is shown be presumptive positive is labeled that way if the sample was tested by a lab not run by the state of Maine. hb``P```:8]01G3033}] /p{O_krX#*#o(rJ1Ap;g>H310^=TU %PDF-1.6 % 148 0 obj <>stream Resources for persons who have tested positive for COVID-19. ]t{U%BM**W8;Q~l!BdyZ!6qDww7OP 5FSP{G29$dUZ|_"%N/5o5mrgUj 'FX|kq s3z Based on preliminary data and expert opinion. hbbd```b`` "gH&=>o;0[LH6f09,DJM`=d VWV "`5 70VT vl - LEfEWl"?}LHE``sBA$7 7a04\4@ P Ct values indicate the number of amplification cycles needed to reach the threshold at which a molecular diagnostic test can detect a positive signal. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under the Clinical Laboratory Improvement Amendments (CLIA), section 353 of the Public Health Service Act (42 USC 263a), use of that test is limited to laboratories that are certified under CLIA, and meet the requirements to perform tests of high-complexity, and at the point-of-care (POC) when covered by such a laboratory's CLIA certificate. False positive: You are not infected, but test positive (very rare). %PDF-1.6 % Neither target 1 or target 2 were detected. The intent of screening tests is to identify infected people before they develop symptoms or who may never develop symptoms so that steps can be taken to prevent those people from infecting others. However, saliva specimen quality can be highly variable, which can affect the performance of the test. 2ZQB;t/2l'.k_Zw*o}^wINXxae?9-Og?>:,8]p2ks;dvT5M[1q?iw4qYpri%w|4sj{W{UC.TKWwoDs}HgU3g?"\- ?|"S2V7C$yqy|33$S:Nix&u5 ( Laboratories performing molecular diagnostic COVID-19 tests for the qualitative detection of SARS-CoV-2 report test results as being positive or negative. CDC twenty four seven. However, a negative result does not rule out 2019-nCoV infection and should not be used as the sole basis for treatment or patient management decisions. Isolation is what you do if you have COVID-19 symptoms, or have tested positive for COVID-19. False negative: You are infected, but test negative. Generally, any time a patient-specific result is to be reported by a facility, it must first obtain a CLIA certificate appropriate to the test system the laboratory intends to use and meet all requirements to perform testing. A: Diagnostic testing for COVID-19 looks for infections in individual people when there is a reason to suspect that a specific person may be infected. hbbd```b``f K@$ND(Ig0 When results are available, Color will notify patients through SMS and/or email (using the mobile phone number and/or email provided through the registration process) that results are available. It does not test for immunity or if you had the virus in the past. Such tests include "Home Collection" in the Attributes column in the EUA tables. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. A positive antigen test result is considered accurate when instructions are carefully followed. A Nucleic Acid Amplification Test, or NAAT, is a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19. (9/27/22), CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS, Q: Do all COVID-19 tests require a prescription? If symptoms . 1 Identify testing demand and complete application, Identify testing demand in your community or organization, 6 Ship collected samples for processing. The level of sensitivity for the detection of SARS-CoV-2 genetic material in a specimen also varies depending on the methods and application of the NAAT. @2-[;mzhm$dVU7Pded=p#bnCJ!u&k3hf?83Z)f/BIuJ5U+5JQF8&i!`d)u)CyR*V*&jb@}>V/~vWm_g0^?Xz]qa~VXl h[on}w/u_~o6;YW!w}>/g_xnWw?'n~wVnC-{Eko~y w_{y3yH57goj_yBo[8pWwp^k.5NMw4Yh_]-}}sf/l2|..|w^!{r9J/v\a&c6@kLG:QCirP 4{=e>z @cP~Xi,T@a! Congestion or runny nose. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA to perform high complexity and/or moderate complexity tests. 0 *$Xe{~3#Ev5adE[5HU_52j& !r2d[(cZ=I{(wF%NvmuVAN18ef0zgbbyhYhc(/Vhm5ac4H&(.Z>nf0v/v^T;f2\rG?:.4O[sL?~sV Elc{nAb(CiD)`.O\D.Ol%}Kecd2l:k`K08h5~~+JgyQ )^c'cdkdwnK)e<9aSoml`&M0@1L5v@{yb&Lwz!a2no:O(r6r#~W/L/";+fm-|>o-=y~EJng;-%e7>v,>8N~uvEjSofvBXb$kUL,C;fg'enNA0uM_m^Ng>,\|#5#WrNY::W~WmnB~"Z i\Km*_.0)pgB(^iajxKkDp."_-4k-zk!/8S+RPl e>@>iM[l~@P) A Nucleic Acid Amplification Test, or NAAT, is a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19. Under CLIA regulatory requirements, such laboratories must have a written or electronic request for patient testing from an individual authorized under State law to order tests and/or receive test results. A negative test result means that antigen for COVID-19 was not detected in the specimen. A presumptive positive test result (also known as inconclusive or indeterminate) indicates that you had a marginal trace of the COVID-19 virus in your specimen. You can contact your medical provider or local health department authorities for further instructions. x1 AQ1DIt-~+qc U/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J R/ )@J _3 You will be asked to submit a new specimen so another test can be run. hVn8:$@iAC%&FPr/`H9sHd)2b MVuir If you used an antigen test, see FDA instructions on repeat testing. An official website of the United States government, : Quarantine means you stay home negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen. Surveillance testing for COVID-19 includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data, essential to planning, implementing, and evaluating public health practice. They help us to know which pages are the most and least popular and see how visitors move around the site. A negative test result (also referred to as not detected) means that COVID-19 virus was not detected in your specimen at the time of your test. CDC recommends confirming negative antigen test results with a PCR test especially if you are symptomatic or had a known exposure to a person confirmed to have COVID-19. Such laboratories may perform tests for which they meet the qualifications of the authorized settings included in the EUA. Quarantine is what you do if you have been exposed to COVID-19. What do results mean for a COVID-19 PCR test? 254 0 obj <>stream There is no risk of infecting others. Shortness of breath or difficulty breathing. His boss, who he admires, is waiting to meet with him about the big project. You can contact your medical provider or local health department authorities for further instructions. Laboratories authorized to use such tests are subject to various conditions that can be found in the EUA. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. You will not receive a reply. %%EOF &&$I>9`2D`2DJm This includes broad screening of people without symptoms (asymptomatic) without known exposure to COVID-19 with the intent of making individual decisions based on the test results. If you are feeling symptoms (fevers, chills, cough, shortness of . If your antibody test result was negative, this means that the test did not detect any COVID-19 antibodies in your blood. Sa jnhB@%-">9Qt-=A2"JUk[0jmr*"JF=AB/(VU-X.UFM YN)&p=J\fe)P@{)==m:-{X~i]I7''h5 uE A positive test result (also referred to as detected) means that the COVID-19 virus was detected in your specimen. Ct values are not comparable between tests and may not be comparable between different lots of the same test, as they are dependent on various factors such as the specimen collection, storage, transport, time from collection, nucleic acid target, primers and probes, extraction method, amplification method, instruments used, etc. The site is secure. That test would then need to be sent to a state or federal lab to be confirmed as positive . xA 0 @L endobj %PDF-1.6 % cHHDq&xAG"H{'x)&2 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. endstream endobj startxref Tests offered prior to or without an EUA, as described in the Policy for Coronavirus Disease-2019 Tests, are limited, under CLIA, to use in laboratories certified under CLIA that meet requirements to perform high-complexity testing, including testing at the point-of-care (POC) where the site is covered by such a laboratory's CLIA certificate. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. (9/27/22), Q: What is the difference between diagnostic, screening, and surveillance testing for COVID-19? According to the Center for Disease Control (CDC), a presumptive positive result is when a patient has tested positive by a local public health laboratory, but results are still pending confirmation at a CDC lab. endstream endobj 100 0 obj <>stream After the Bell County Public Health Department reported their first "presumptive positive" case of COVID-19, some viewers were left wondering what that actually means. In addition, all OTC COVID-19 tests are listed on the At-Home OTC COVID-19 Diagnostic Tests web page. The FDA regulates COVID-19 diagnostic tests as in vitro diagnostic devices and has provided recommendations and information regarding EUA requests for COVID-19 diagnostic tests in the EUA templates referenced in the Policy for Coronavirus Disease-2019 Tests. are negative. Saving Lives, Protecting People, Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the, The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. Is primarily used to gain information for a population of people (population level data), rather than for an individual person. no viral or human nucleic acids were detected). Using a long nasal swab to get a fluid sample, some antigen tests can produce results in minutes. Test accuracy for asymptomatic cases is unclear as it is not known where they are in the disease timeline. For enquiries,contact us. 0 Please be re-evaluated immediately for worsening symptoms such as shortness of breath or lightheadedness. New loss of taste or smell. Some do not develop symptoms. Negative results for all antigen tests are considered presumptive negative. Sample collection: A swab is taken from the inside of the nose or back of the throat. Patients can also access their results by clicking on the link from their email or text notification. Those tested too early will be unaware of infection and may infect others, Up to half of those tested will get a false negative result and may infect others, May take longer to recover from severe disease. Can happen when the test is done too early to detect the disease or when sample collection is poor. Muscle or body aches. @HI(' This page is part of the FAQs on Testing for SARS-CoV-2 and provides answers to frequently asked questions related to uses for different types of COVID-19 tests and the settings in which they can be used. Do they need to be ordered by a physician? (702 KB, 1 page), Organization: Public Health Agency of Canada. m8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p a8 0 H $g 3 @p 18n e>0> The FDA generally does not regulate surveillance tests.