What do results mean for a COVID-19 PCR test? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. In other words, NAATs can reliably detect small amounts of SARS-CoV-2 and are unlikely to return a false-negative result of SARS-CoV-2. A: Some COVID-19 tests require a prescription and some do not. endstream endobj startxref hbbd```b``f K@$ND(Ig0 If you are feeling symptoms (fevers, chills, cough, shortness of . In cases of discordant test results from different types of tests, results from laboratory-based NAATs should be prioritized over any POC or self-administered test. In this context, "confirmation" does not require documentation of the type of test performed; the provider's documentation that the individual has COVID-19 is sufficient. Presumptive positive: A presumptive positive test result (also known as inconclusive or indeterminate) indicates that you had a marginal trace of the COVID-19 virus . You should self-isolate. Negative results mean that the virus was not detected at the time of the tests. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. State laws should be consulted to see exactly who can order a COVID-19 test. NAATs for SARS-CoV-2 specifically identify the RNA (ribonucleic acid) sequences that comprise the genetic material of the virus. As such, State licensing laws may need to be consulted to determine exactly who can use or order an EUA-authorized COVID-19 test. @HI(' See CDCs Collecting and Handling of Clinical Specimens for COVID-19 Testing. no viral or human nucleic acids were detected). Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Does not involve reporting test results to a patient or their health care provider. This means the sample is from an infected individual. 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. Bva[VHYysKCm]m8B:n=r?7")Lj! Give Light and the People Will Find Their Own Way. s^6g=t2'-LHe\?;} F(f~AU``QcV7Q(m.XgE!Kgqaw6el\F: aAH@kxA*Ply * jX8Th(\ Facilities, including point-of-care settings such as health clinics, that perform COVID-19 testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or. A negative test result means that antigen for COVID-19 was not detected in the specimen. Is generally used to monitor for an occurrence, such as an infectious disease outbreak, in a population or community, or to characterize the occurrence once detected, such as looking at the incidence and prevalence of the occurrence. Each EUA-authorized test has a Letter of Authorization (LOA) and Instructions for Use (or an EUA Summary for tests developed by a laboratory) available on the In Vitro Diagnostics EUA page that states if the test requires a prescription. are negative. endstream endobj startxref %%EOF e ?{oYNMzZ^4xIS0'ffIb Z_-RY;d>LC,*xH}(9qb>>KM/d^|{hsYDz'tpVBn9tS/w>H1&&}hRe'l/:h,|u9Tup#]p N.Q zb7.oPR7>y (t\J,]zI[|b_.hmQt(R~RQ%$|Mpl2gInv&P$2vcc6Ot")U^.g1up#UIz0D6 O }emY`g6`2?]|)WT+7N=WInTj,ts? 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 Tests authorized for home use can generally also be used for self-testing in settings outside of the home, such as offices or schools. Negative results mean that the virus was not detected at the time of the tests. Additionally, your local health department may also contact you. Research is underway to find out whether antibodies protect you from future infections. Download in PDF format This may mean you are either very early in your COVID infection and the amount of virus is just beginning to rise, or you are later in your COVID infection and the overall amount of virus is declining. There is no risk of infecting others. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. For additional details on testing results and steps to take while awaiting results, please see this link. There are grammar debates that never die; and the ones highlighted in the questions in this quiz are sure to rile everyone up once again. Isolation is what you do if you have COVID-19 symptoms, or have tested positive for COVID-19. An example of surveillance testing is a testing plan developed by a State Public Health Department to randomly select and sample 1% of all individuals in a city on a rolling basis to determine local infection rates and trends. 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. %PDF-1.6 % You should self- isolate. New loss of taste or smell. The settings authorized in the EUAs are also noted in the EUA tables on the In Vitro Diagnostics EUA page. NAATs detect genetic material (nucleic acids). Therefore, if the same sample from an individual is tested with two different tests, or even the same test from different lots, they are likely to return different Ct values, even if both tests return a "positive" test result. The primers only amplify genetic material from the virus, so it is unlikely a sample will be positive if viral RNA is not present. ?3i:>Q,SJVn: fc ibIwF^n+cWt f2x7B'kX.DV)].N7}mv(hytk-C. &&$I>9`2D`2DJm Centers for Disease Control and Prevention. Muscle or body aches. Sa jnhB@%-">9Qt-=A2"JUk[0jmr*"JF=AB/(VU-X.UFM YN)&p=J\fe)P@{)==m:-{X~i]I7''h5 uE If you have symptoms: You may have COVID-19, but tested before the virus was detectable, or you may have another illness. Cough. endstream Sample collection: A swab is taken from the inside of the nose or back of the throat. Quarantine is what you do if you have been exposed to COVID-19. @/w>9;!+yL *(&FnL1|0F+kQ\ C5z+]zTm,K6 1jSNl&\UNQ2S5}]Ls(eqP6-6XzEo6fyGc^@\fT[xy5BlJRy{j[PL|4`s4_}NZ}71uW@1;[l&ktgO8\7{f9U{)>)q| The Louisiana Department of Health explains that a 'presumptive positive' case is conducted by the State Lab in Baton Rouge, and 'presumptive' becomes 'confirmed' after the state's test is . fIai6H2&3HsG&A"f h"nP+$md`V,8LO O NAATs have been authorized for use in different settings, such as in laboratory facilities by trained personnel (laboratory-based) or in point-of-care (POC) settings. A Nucleic Acid Amplification Test, or NAAT, is a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19. . CDC twenty four seven. However, a negative result does not rule out 2019-nCoV infection and should not be used as the sole basis for treatment or patient management decisions. This COVID-19 test detects certain proteins in the virus. Nausea or vomiting. Patients can use their date of birth and the barcode number associated with their sample (which is provided on a take-away card for sites that will be provided kits by the state) to access their results through Colors HIPAA compliant . To receive email updates about COVID-19, enter your email address: We take your privacy seriously. If the patient loses their Color barcode for their test, they can call the Color support hotline. endobj hb```f``z B@Q99 rbxdz\6v%ld9N_P[TT^^@.#*mZdg`~}Hk6RSlw0dxkq',,X|gg@rKbU7DfdeTeP;T-@2e`[xXx\&~ L This material may not be published, broadcast, rewritten, or redistributed. The NAAT procedure works by first amplifying or making many copies of the viruss genetic material, if any is present in a persons specimen. For example, a test run in a lab affiliated with MaineHealth would be labeled as presumptive positive. Sore throat. Some NAATs can even be self-administered at home or in other non-healthcare locations. A negative test result for this test means that SARS- . The Centers for Disease Control and Prevention added XBB.1.16 - referred to as . The intent of screening tests is to identify infected people before they develop symptoms or who may never develop symptoms so that steps can be taken to prevent those people from infecting others. *$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 negative result does not mean a person does not have COVID-19/Influenza A/Influenza B. A negative test result for this test means that 2019-nCoV RNA was not present in the specimen above the limit of detection. (9/27/22). You can contact your medical provider or local health department authorities for further instructions. Negative test result True negative: You are not currently infected. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 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. Amplifying those nucleic acids enables NAATs to detect very small amounts of SARS-CoV-2 RNA in a specimen, making these tests highly sensitive for diagnosing COVID-19. It could also mean you are infected with COVID, but the sample that was taken for testing only captured a minimal amount of the virus when swabbing. zkS|"n5U&?G Isolation means you stay home and away from others (including household members) for the recommended period of time to avoid spreading illness. False positive: You are not infected, but test positive (very rare). endstream endobj 100 0 obj <>stream Laboratories authorized to use such tests are subject to various conditions that can be found in the EUA. 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. That test would then need to be sent to a state or federal lab to be confirmed as positive . 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. 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. False negative: You are infected, but test negative. True positive: You are currently infected. An official website of the United States government, : A positive antigen test result is considered accurate when instructions are carefully followed. It is intended to be used in the home or similar environment by a lay person. A Ca!t6:D#m These cookies may also be used for advertising purposes by these third parties. For example, there is a condition in the LOAs that the manufacturer comply with 21 CFR 809.10(a)(4), which states that, among other things, the label of an in vitro diagnostic product shall include certain references to: (1) "Rx," (2) a statement regarding the restriction to sale by or on the order of a physician, dentist, veterinarian or (3) with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device. However, saliva specimen quality can be highly variable, which can affect the performance of the test. An invalid test result (also referred to as failed or unsatisfactory) means that the lab was unable to confirm the presence or absence of COVID-19 in your specimen. There are three levels the CDC uses to classify a potential case of COVID-19: Coronavirus cases reported to the CDC include both CDC-confirmed cases and presumptive positive cases reported by the states. #H/k~b4bq, 254 0 obj <>stream Do they need to be ordered by a physician? These documents include FDA requirements regarding ordering the test. If youre feeling symptoms (fevers, chills, cough, shortness of breath, muscle and body aches, fatigue, headache, sore throat, new loss of taste or smell, runny nose, congestion, nausea, vomiting and diarrhea),contact a doctor and ask whether you should be retested because (1) you may have contracted the virus after your test, or; (2) your test may have been a false negative. False negative: You are infected, but test negative. See Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers for more information. His boss, who he admires, is waiting to meet with him about the big project. Ff!T8$I$I$I The FDA generally does not regulate surveillance tests.