Your lab results may also include one of these terms: Tests that measure various organs and systems often give results as reference ranges, while tests that diagnose or rule out diseases often use the terms listed above. Meaning, if you are tested for the coronavirus and get either a 'positive' or a result saying 'detected' you are infected with the virus and should be quarantined whether you have symptoms. The new Broad test looks for two distinct locations, or targets, on the virus; until now the test had just one target. m1&=8*.7|f{OI24ga3MiG+.=j,{Ta.L|[mx:Pg.8}C[uT$bJZ}[ivg). Now consider what will occur if this exceptionally accurate test is massively deployed in the context of 1% prevalence (which is a prevalence that that is likely higher than the current prevalence of active COVID-19 infections). You should try to stay at home and avoid contact with other people for 5 days after the day you took the test. Can these partial viral particle cause infection, probably not. This blood test is not used to diagnose active COVID-19. 66 0 obj <>/Filter/FlateDecode/ID[<0FEF48DE2E47034D803200630DEDB473><74EAE38578C2554DB15C6DB53F9735BE>]/Index[41 42]/Info 40 0 R/Length 118/Prev 113109/Root 42 0 R/Size 83/Type/XRef/W[1 3 1]>>stream Analysis of clinical specimens to obtain information about the health of a patient. When both of these locations are identified the test is read as positive. Your health care provider may order one or more lab tests to: Lab results are often shown as a set of numbers known as a reference range. A Positive is a Positive, No Matter How Faint the Line. Available from: Lab Tests Online [Internet]. ] 1 /`]| ' D2$H"\%`=` f?*lczl/Q$'$00l&#L? Required fields are marked *. Either target 1 alone or both targets 1 and 2 were detected (our lab partners do not specifically call out if you tested positive for target 1 alone or target 1 and 2 as it is not relevant, either scenario is positive). But if the prevalence is low, even a highly accurate test in the sense of delivering low false positive and false negative rates can be misleading. Coordinator for Health Information Technology (ONC), Each submitted Data Element has been evaluated based on the following 4 criteria. Altered sense of smell. If you test negative for COVID-19: The virus was not detected. Since I went, my results came and the funny thing is that I have never heard of such things and it was just like a shock for me because the results came saying insufficient. BMJ [Internet]. Have your BC PHN, date of birth and the date of your test ready when you call to get your test results. Yes, you need a Northwell account with verification in order to view your results. Johannesburg resident Thabo Mbhata, who works as a security guard, was asked by his company to go for a COVID-19 test. Undetected (ie, negative) results do not rule out COVID-19 in patients and should not be used as the sole basis for treatment or other patient management decisions. Will mask mandate enthusiasts please confront the data? Can happen when the test is done too early to detect the disease or when sample collection is poor. CityMD recommends the CDC's most up to date return to work recommendation of the rule of 10/3. 8, 9 Molecular tests, such as reverse transcriptase polymerase chain reaction. The overall Level classification is a composite of the maturity based on these individual criteria. For instance, you might also experience fever, chills, shortness of breath, fatigue, nausea, vomiting and diarrhea, the CDC says. In their new guidance, the WHO reminds PCR users that: disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases (2). Without going into the mathematics of it, what we require for doing this are three things: 1) the false negative rate; 2) the false positive rate; and 3) the prevalence of the disease in the population. Washington D.C.: American Association for Clinical Chemistry; c20012018. Your Lab Results Decoded; [cited 2018 Jun 19]; [about 4 screens]. This does not mean that you take the same specimen and run it through the test machine a second time; the false positive might have occurred owing to contamination of the specimen or from mis-labeling of the specimen. Runny nose. A positive RT-PCR test for covid-19 test has more weight than a negative test because of the test's high specificity but moderate sensitivity A single negative covid-19 test should not be used as a rule-out in patients with strongly suggestive symptoms Clinicians should share information with patients about the accuracy of covid-19 tests A reference range is just a guide. But in some cases, medical tests are used in the absence of symptoms, as a screening tool. Science's COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.. 82 0 obj <>stream Maybe you swabbed for less time or in only one nostril when your test instructions say to swab both. A recent paper in The New England Journal of Medicine ( Nov. 26, 2020) indicated that PCR tests applied to an individual with COVID-19 are just as likely to give a positive result after their period of infectiousness as compared to before or during their period of infectiousness. Reference ranges are based on the normal test results of a large group of healthy people. This means the sample is from an infected individual. The lateral flow test features two letters on the device where the swab is inputted into. The testing platforms used are Roche Cobus or Hologic Panther, both with Emergency Use Authorization by the FDA. result type are flagged according to rules defined in theLIS by ARUP. If the test identifies the presence of the Covid-19 virus in the sample, a second line should appear next to the "T" within the next 15 to 30 minutes. Copyright 2023 Deseret News Publishing Company. Either too early or too late to detect the virus properly and it is recommended in all international literature that a re-test should be done.. If you have symptoms of COVID-19: You may have received a false negative test result and still might have COVID-19. In screening students for Covid infection it is important that a second confirmatory test is applied and the second test must have a high sensitivity. Madison (WI): University of Wisconsin Hospitals and Clinics Authority; c2018. All rights reserved, Report a technical issue or content update. Get advice about what to do if you have tested positive for COVID-19 False negative COVID-19 tests could be more likely in those who have immunity, You shouldnt always trust a negative COVID test, doctors say, 4 main omicron variant symptoms to expect. Rationale for Separate Consideration. 99 0 obj <>stream He says this is having a negative impact on his finances because he cant report for duty until his test results come back and for every day he doesnt work, he doesnt get paid. A negative result means it's likely you are not infectious. If you have some results at the high or low end of normal, ask your doctor if you should repeat the test or investigate them further. This is because the virus has a long tail and a low level of the virus remains for a long time after infectiousness, even though the individual has ostensibly recovered during this time. In other words, if they do not have any symptoms or reason to expect that they are infected, and if they receive a positive COVID test, they are just as likely to be disease free as they are to have the disease. Some lab tests are used to help diagnose, screen, or monitor a specific disease or condition. 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. False negative: You are infected, but test negative. It doesnt mean its an invalid result, what it does mean is that perhaps the timing of the test was at the wrong time. < 0.80 U/mL: This is a negative result for anti SARS CoV-2S. #H/k~b4bq, When testing, the COVID-19 proteins adhere to the line and show a band, said Dr. Amy Mathers, associate professor of medicine and pathology and associate director of clinical microbiology at the University of Virginia School of Medicine, according to the . Even though false negatives and positives are uncommon, your provider may need to do multiple tests to make sure your diagnosis is correct. Test positive for many weeks. endstream endobj startxref HL7 interpretation code system and value set - this is one of the few code systems that has been harmonized acros ALL HL7 product families (v2, CDA and FHIR), This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders, I assume this is in wide use to support physician alerting and it is a CLIA requriement, so should be part of pretty much every lab report. Please note, a small percentage of patients with active infection may be completely asymptomatic. A blood test detects antibodies to the virus that usually start to appear when a person is recovering. This test has not been FDA cleared or approved. This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity.. Consider an exceptionally accurate and sensitive test; one with a 0% false negative rate and only a 1% false positive rate (of note, many PCR tests appear to have a false positive rate lower than 1% this value is used for illustrative purposes). s3z Thanks to Adrian Staub, Carlo Dallapiccola, Rosemary Cowell, and William Cowell for helpful discussion and comments. On the issue of viral load, the WHO writes: careful interpretation of weak positive results is needed (1). You will not receive a reply. 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. Download in PDF format I doubt it. Thinks/writes on digital, quality, safety, Covid. Story continues after box UAB insurance and antibody testing The range helps show what a typical normal result looks like. Your email address will not be published. Inside or outside of the reference range of what is most common for . Asymptomatic screening for infectious diseases is less common, with HIV screening a notable exception. e The other kind of error is a false positive, which is a positive test even though the individual does not have the disease. Opinion: How did COVID-19 start? Please note, it may take 14-21 days to produce detectable levels of IgG following infection. This can occur either if the test result is too slow in arriving or if the test is administered after the individual has already gone through their infectious stage of the disease, but still has enough virus to yield a low viral load positive test. What does this mean? A faint line could mean you've collected less virus this time around. Defining the line: The short answer is yes. Test again. Your Spike Protein Antibody results will be reported as a reference range: >/= 0.80 U/mL: This is a positive result for anti-SARS CoV-2S. A positive result shows past infection with the virus. Please be re-evaluated immediately for worsening symptoms such as shortness of breath or lightheadedness. You may see something like this on your results: "normal: 77-99mg/dL" (milligrams per deciliter). These incorrect results don't happen often, but they are more likely to happen with certain of types tests, or if testing was not done right. Nausea or vomiting. Clearly if a second LFD could be used instead of a PCR test this delay could be avoided. The presence of antinuclear antibodies is a positive test result. This will produce a massive disruption to the community and entail serious consequences for mental health if 26% of the population can expect a false positive diagnosis at some point. Common Lab Tests; [cited 2018 Jun 19]; [about 4 screens]. You should follow advice on how to avoid catching and spreading the virus. 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 ( "Leave the interpretation up to your doctor.". To encourage thoughtful and respectful conversations, first and last names will appear with each submission to CBC/Radio-Canada's online communities (except in children and youth . New test result type. 2015 Dec 3 [cited 2018 Jun 19]; 351(h):5552. If your results fall outside the reference range, or if you have symptoms despite a normal result, you will likely need more testing. Health Information: Understanding Lab Test Results: Results; [updated 2017 Oct 9; cited 2018 Jun 19]; [about 4 screens]. This result means that you were likely infected with COVID-19 in the past. Test Interpretation (Abnormal Flag) Description. This seems to indicate an alarming increase in local infections. However, even HIV screening fails to come close to the level of screening that is currently deployed for COVID-19. Parents can call to receive results for their children. AARP [Internet]. PCR tests use cycles (Ct) to amplify the signal to a set threshold and after many cycles even a very low viral load will be detected. Rule Out COVID-19 Applied automatically when COVID-19 lab test is orderedfor all patients, except outpatientsbeing screened prior to procedures. If you did not have symptoms at the time of your PCR nasal swab, you may return to work in 10 days (provided you do not have a fever 3 days prior to return to work). These include: If you have any questions about your lab tests or what your results mean, talk to your health care provider. What do abnormal lab results mean? endstream endobj 100 0 obj <>stream hb``g``Z8*`bd1q(f`Hfgl39ScSfOX 8_V )cI 0#@f: This test does not give information about past infections or future immunity. An example is a negative strep test. Testing patients who may have had COVID-19 or exposure to SARS-CoV-2 more than 10 days ago. Available from: UW Health [Internet]. Available from: Lab Tests Online [Internet]. Update: The current turnaround time is averaging 2-3 days to receive your COVID-19 PCR (nasal swab) results. The cycle threshold (Ct) needed to detect virus is inversely proportional to the patients viral loadAction to be taken: Provide the Ct value in the report to the requesting health care provider.. Neither target 1 or target 2 were detected. To support the re-opening of schools in the UK a regime of testing was introduced from early March 2021, using lateral flow devices (LFD), which give a result quickly without the need for the samples to go to a laboratory. If the follow-up test is negative and you are experiencing COVID-19 symptoms, Yale Health will manage your case individually. Considering that the goal of COVID-19 screening is to identify those who are infected before they spread the disease, there is in fact a third kind of error, which is a true positive result that comes too late. it is often used in alerting for patient care. A few weeks ago they told us that they wanted us to get tested so that we dont infect others. Available from: National Cancer Institute [Internet]. True positive: You are currently infected. Should you trust an at-home test? Some lab tests are used to help diagnose, screen, or monitor a specific disease or condition. If taken during the right timeframe, though, a positive antibody test also referred to as a reactive antibody test means you likely have been infected with SARS-CoV-2. In my area, a hospital applied LFD test is taken at gospel regardless of symptoms or medical signs. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI, - Must be represented by a vocabulary standard or an element of a published technical specification, - Used in limited production environments, 1 or 2 different systems, - Demonstrates exchange between 2 or 3 organizations with different EHR/HIT systems, - Used by many, but not most, patients, providers or events requiring its use, Interoperability Standards Advisory (ISA), Sources of Security Standards and Security Patterns, State and Local Public Health Readiness for Interoperability, Unique Device Identifier(s) for a Patients Implantable Device(s), Administrative Transaction Acknowledgements, Enrollment and Disenrollment in a Health Plan, Health Care Eligibility Benefit Inquiry and Response, Health Care Eligibility Benefit Inquiry and Response for Retail Pharmacy Coverage, Administrative Transactions to Financial Exchanges, Electronic Funds Transfer for Payments to Health Care Providers, Health Care Payment and Remittance Advice, Health Plan Premium Payments for Covered Members, Administrative Transactions to Support Clinical Care, Health Care Attachments to Support Claims, Referrals and Authorizations, Referral Certification and Authorization for Pharmacy Transactions, Referral Certification and Authorization Request and Response for Dental, Professional and Institutional Services, Health Care Claims and Coordination of Benefits, Health Care Claim Status Request and Response, Health Care Claims or Equivalent Encounter Information for Dental Claims, Health Care Claims or Equivalent Encounter Information for Institutional Claims, Health Care Claims or Equivalent Encounter Information for Professional Claims, Health Care Claims or Equivalent Encounter Information for Retail Pharmacy Claims, Health Care Claims or Equivalent Encounter Information for Retail Pharmacy Supplies and Professional Services, Operating Rules to Support Administrative Transactions, Operating Rules for Enrollment and Disenrollment, Operating Rules for Electronic Funds Transfer (EFT) and Electronic Remittance Advice (ERA), Operating Rules for Prior Authorization and Referrals, Operating Rules to Support Claim Status Transactions, Operating Rules to Support Electronic Prescribing Transactions, Operating Rules to Support Eligibility Transactions, Appendix I Sources of Security Standards and Security Patterns, Appendix III - Educational and Informational Resources, Understanding Emerging API-Based Standards, Understanding Observations and Observation Values, Appendix IV - State and Local Public Health Readiness for Interoperability, Sending a Notification of a Long-Term Care Patients Admission, Discharge and/or Transfer Status to the Servicing Pharmacy, Sending a Notification of a Patients Admission, Discharge and/or Transfer Status to Other Providers, Sending a Notification of a Patients Encounter to a Record Locator Service, Referral from Acute Care to a Skilled Nursing Facility, Referral to a Specialist - Request, Status Updates, Outcome, Referral to Extra-Clinical Services - Request, Updates, Outcome, Documenting and Sharing Care Plans for a Single Clinical Context, Documenting and Sharing Medication-Related Care Plans by Pharmacists, Documenting Care Plans for Person Centered Services, Domain or Disease-Specific Care Plan Standards, Sharing Patient Care Plans for Multiple Clinical Contexts, Communicate Appropriate Use Criteria with the Order and Charge to the Filling Provider and Billing System for Inclusion on Claims, Provide Access to Appropriate Use Criteria, Clinical Quality Measurement and Reporting, Reporting Aggregate Quality Data for Quality Reporting Initiatives, Reporting Patient-level Quality Data for Quality Reporting Initiatives, Sharing Quality Measure Artifacts for Quality Reporting Initiatives, Establishing the Authenticity, Reliability, and Trustworthiness of Content Between Trading Partners, Exchanging Diet and Nutrition Orders Across the Continuum of Care, Family Health History (Clinical Genomics), Representing Family Health History for Clinical Genomics, Format for Sharing Social Care Services Information, Format for Structuring and Sharing Social Care Directory Information, Format of Medical Imaging Reports for Exchange and Distribution, Format of Radiation Exposure Dose Reports for Exchange and Distribution, Format of Radiology Reports for Exchange and Distribution, Medical Image Formats for Data Exchange and Distribution, Exchange InVitro Diagnostics (IVD) Orders and Results, Transmit Laboratory Directory of Services to Provider System, Medical Device Communication to Other Information Systems/Technologies, Transmitting Patient Vital Signs from Medical Devices to Other Information Systems/Technologies, Clinical Information Systems to Request Context-Specific Clinical Knowledge From Online Resources, Patient Identity/Identification Management, Recording Patient Preferences for Electronic Consent to Access and/or Share their Health Information with Other Care Providers, Allows Pharmacy Benefit Payers to Communicate Formulary and Benefit Information to Prescriber Systems, Allows a Long Term or Post-Acute Care to Request to Send an Additional Supply of Medication, Allows a Pharmacy to Notify a Prescriber of Prescription Fill Status, Allows a Pharmacy to Request Additional Refills, Allows a Pharmacy to Request a Change to a Prescription, Allows a Pharmacy to Request a New Prescription For a New Course of Therapy or to Continue Therapy, Allows a Pharmacy to Request, Respond to or Confirm a Prescription Transfer, Allows a Prescriber or a Pharmacy to Request a Patients Medication History, Allows a Prescriber to Cancel a Prescription, Allows a Prescriber to Communicate Drug Administration Events, Allows a Prescriber to Communicate with a REMS Administrator, Allows a Prescriber to Prescribe Medication Using Weight-Based Dosing, Allows a Prescriber to Recertify the Continued Administration of a Medication Order, Allows a Prescriber to Request a Patients Medication History from a State Prescription Drug Monitoring Program (PDMP), Allows a Prescriber to Request, Cancel or Appeal Prior Authorization for Medications, Allows a Prescriber to Send a New Prescription to a Pharmacy, Allows a Prescriber to Send a Prescription to a Pharmacy for a Controlled Substance, Allows for Communication of Prescription Information Between Prescribers and Dispensers, Allows for the Exchange of State Prescription Drug Monitoring Program (PDMP) Data, Data Submission for Title X Family Planning Annual Reporting, Electronic Transmission of Reportable Laboratory Results to Public Health Agencies, Exchanging Immunization Data with Immunization Registries, Newborn Screening Results and Birth Defect Reporting to Public Health Agencies, Reporting Antimicrobial Use and Resistance Information to Public Health Agencies, Reporting Birth and Fetal Death to Public Health Agencies, Reporting Cancer Cases to Public Health Agencies, Reporting Death Records to Public Health Agencies, Reporting Syndromic Surveillance to Public Health (Emergency Department, Inpatient, and Urgent Care Settings), Sending Health Care Survey Information to Public Health Agencies, Data Collection for Submission to Registries and Reporting Authorities, Prepopulation of Research Forms from Electronic Health Records, Submission of Clinical Research Data Contained in EHRs and Other Health IT Systems for General Purpose or Preserving Specific FDA Requirements, Submission of Clinical Research Data to FDA to Support Product Marketing Applications, Submit Adverse Event Report from an Electronic Health Record to Drug Safety Regulators, Support a Transition of Care or Referral to Another Health Care Provider, Defining a Globally Unique Device Identifier, Representing Unique Implantable Device Identifiers, An Unsolicited "Push" of Clinical Health Information to a Known Destination and Information System User, An Unsolicited Push of Clinical Health Information to a Known Destination Between Systems, Push Communication of Vital Signs from Medical Devices, Remote Patient Monitoring to Support Chronic Condition Management, Patient Education and Patient Engagement, Providing Patient-Specific Assessments and Recommendations Based on Patient Data for Clinical Decision Support, Retrieval of Contextually Relevant, Patient-Specific Knowledge Resources from Within Clinical Information Systems to Answer Clinical Questions Raised by Patients in the Course of Care, Consumer Access/Exchange of Health Information, Collection and Exchange of Patient-Reported Outcomes, Patient Exchanging Secure Messages with Care Providers, Push Patient-Generated Health Data into Integrated EHR, Remote Patient Authorization and Submission of EHR Data for Research, View, Download and Transmit Data from EHR, Listing of Providers for Access by Potential Exchange Partners, Exchanging Images Outside a Specific Health Information Exchange Domain, Exchanging Images Within a Specific Health Information Exchange Domain, Exchanging Patient Identification Within and Between Communities, Transport for Immunization Submission and Query/Response, Data Element Based Query for Clinical Health Information, Query for Documents Outside a Specific Health Information Exchange Domain, Query for Documents Within a Specific Health Information Exchange Domain, Finding and Retrieving Human Services Information, Representing Patient Allergies and Intolerances; Environmental Substances, Representing Patient Allergies and Intolerances; Food Substances, Representing Patient Allergies and Intolerances; Medications, Representing Non-Imaging and Non-Laboratory Clinical Tests, Representing Patient Contact Information for Telecommunications, Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation, Representing Health Care Data for Emergency Medical Services, Representing Assessment and Plan of Treatment, Representing Patient Dental Encounter Diagnosis, Representing Patient Medical Encounter Diagnosis, Representing Patient Family Health History, Representing Patient Functional Status and/or Disability, Health Care Providers, Family Members and Other Caregivers, Representing Provider Role in Team Care Settings, Representing Relationship Between Patient and Another Person, Imaging (Diagnostics, Interventions and Procedures), Representing Imaging Diagnostics, Interventions and Procedures, Representing Clinical/Nursing Assessments, Representing Patient Problems for Nursing, Patient Clinical Problem List (i.e., "Conditions"), Representing Patient Clinical Problems (i.e., Conditions), Representing Patient Preferred Language (Presently), Representing Medical Procedures Performed, Public Health Emergency Preparedness and Response, Representing Hospital/Facility Beds Utilization, Representing Laboratory Operations (Population Laboratory Surveillance), Representing Population-Level Morbidity and Mortality, Representing Data for Biomedical and Health Services Research Purposes, Sex at Birth, Sexual Orientation and Gender Identity, Representing Patient-Identified Sexual Orientation, Social, Psychological and Behavioral Data, Representing Exposure to Violence (Intimate Partner Violence), Representing Social Connection and Isolation, Representing Patient Electronic Cigarette Use (Vaping), Representing Patient Secondhand Tobacco Smoke Exposure, Representing Patient Tobacco Use (Smoking Status), Representing Units of Measure (For Use with Numerical References and Values), Representing Job, Usual Work, and Other Work Information, http://www.hl7.org/implement/standards/product_brief.cfm?product_id=98 LRI: http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279 FHIR observation in US Core lab observation profile: https://build.fhir.org/ig/HL7/US-Core/Struct, http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279, https://build.fhir.org/ig/HL7/US-Core/StructureDefinition-us-core-observation-lab.html, https://art-decor.ihe-europe.net/art-decor/decor-templates--XDLAB-?section=templates&id=1.3.6.1.4.1.19376.1.3.1.6&effectiveDate=2008-08-08T00:00:00&language=en-US, https://terminology.hl7.org/CodeSystem-v3-ObservationInterpretation.html, CAP Comment on Test Interpretation (Abnormal Flag) Data Element. Although some positive tests show a clear . Reference Ranges and What They Mean; [updated 2017 Dec 20; cited 2018 Jun 19]; [about 2 screens]. The test strip has antibodies specific to the Covid-19 virus painted on it in a thin line. Bethesda (MD): U.S. Department of Health and Human Services; Blood Tests; [cited 2018 Jun 19]; [about 3 screens]. There is no risk of infecting others. Both platforms search for 2 targets; target 1 that is specific to SARS-CoV-2 (the coronavirus causing COVID-19) and target 2 for general Corona Viruses (including but not limited to SARS-CoV-2). For example, ARUP might flag a test result of positive as either abnormal or critical. Based on preliminary data and expert opinion. 0 "In general, a darker . Between March 4 and March 10, of the 2,762,775 LFD tests carried out on secondary schoolchildren (aged 11 to 18), just 1,324 were positive, representing 0.05% (Daily Telegraph March 19, 2021). You are likely actively contagious and should home quarantine (sleep alone in bed, if possible use your own bathroom, wipe down surfaces, and wear a mask when in the same room as others). Your Spike Protein Antibody results will be reported as a reference range: >/= 0.80 U/mL: This is a positive result for anti-SARS CoV-2S. All PCR testing is performed by one of our commercial lab partners. Isolate from others. This test has not been FDA cleared or approved. False negative test result: unaware of their infection and could infect others. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19, meaning you could possibly still have COVID -19 even though the test is negative.