can a do tor report a patient to the cdc without results from a specimen first

by Mrs. Charlene Douglas 10 min read

Frequently Asked Questions: Laboratory Data Reporting

8 hours ago  · Reporting can be provider based, laboratory based, or both. Clinicians who are unsure of state and local reporting requirements should seek advice from state or local health department STI programs. STI and HIV reports are kept confidential. In most jurisdictions, such reports are protected by statute or regulation. Before conducting a follow ... >> Go To The Portal


Who is responsible for reporting COVID-19 tests?

The testing site that performs the COVID-19 test is responsible for reporting to the appropriate state or local public health department.

When is a COVID-19 case investigation initiated?

COVID-19 case investigations are typically initiated when a health department receives a positive SARS-CoV-2 test result report from a laboratory or a patient’s confirmed or probable diagnosis of COVID-19 from a healthcare provider.

Can you get a false negative COVID-19 diagnostic test?

There's a chance that your COVID-19 diagnostic test could return a false-negative result. This means that the test didn't detect the virus, even though you actually are infected with it.

Is it possible to test positive for COVID-19 after symptoms appear?

“The high percentage of positive antigen test results during the 5–9 days after symptom onset reinforces the importance of correct and consistent mask use during this period,” the CDC said.

Who is responsible for investigating COVID-19 cases and communicating who was exposed to them?

Health departments are responsible for conducting COVID-19 case investigations and contact tracing and often have legal mandates to investigate cases of communicable disease and a duty to notify contacts that they were exposed. Health departments should initiate investigations as quickly as possible.

What is contact tracing in the context of COVID-19?

Scientists and public health workers are also working to stop the spread of COVID-19 through contact tracing. In this strategy, public health workers talk to people with COVID-19 to learn about all the people they were physically close to while they were potentially able to spread the disease.

What should I do if I still have symptoms after a negative COVID-19 test result?

If you use an at-home test that comes back negative, and you do have symptoms that persist or get worse, it's a good idea to get a lab-based PCR test for COVID-19 and influenza. You also should stay home and isolate until you get the PCR test results back. The antigen test may have missed an early infection.

What does it mean if I test negative for COVID-19?

See full answerA negative test result means that the virus that causes COVID-19 was not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID- 19. You might test negative if the sample was collected early during your infection.You could also be exposed to COVID-19 after your sample was collected and then have become infected. In particular, people infected with COVID-19 but who have no symptoms may not shed enough virus to trigger a positive test. This means that you could possibly still have COVID-19 even though the test result is negative.

What is the most accurate diagnostic test to detect COVID-19?

Reverse transcription polymerase chain reaction (RT-PCR)-based diagnostic tests (which detect viral nucleic acids) are considered the gold standard for detecting current SARS-CoV-2 infection.

How long are you contagious after being sick with COVID-19?

Most people with COVID-19 are no longer contagious 5 days after they first have symptoms and have been fever-free for at least three days.

Can a person test negative and later test positive for COVID-19?

It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID- 19. This means that you could possibly still have COVID- 19 even though the test is negative. The amount of antigen in a sample may decrease the longer you have symptoms of infection.

Can at-home COVID-19 tests give a false positive?

False positives—when someone receives a positive test result even though they are not infected—are rare occurrences. They are most likely to occur when an at-home test is not administered according to the manufacturer's instructions.

My facility would like to begin SARS-CoV-2 testing. Do we need a Clinical Laboratory Improvement Ame...

Before conducting SARS-CoV-2 viral testing, a laboratory or other facility that performs testing must be CLIA-certified and meet applicable regulat...

What is the CLIA test complexity categorization of SARS-CoV-2 tests that do not have an Emergency Us...

Tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by the Food and Drug Administration (FDA), are not FDA-auth...

How do I apply for a CLIA certificate so that my testing facility can perform SARS-CoV-2 testing?

The federal CLIA program contracts with states to carry out certain oversight and recording functions of the CLIA program. The state in which the l...

Can a laboratory without a CLIA certificate conduct surveillance testing?

Yes. If a laboratory conducts surveillance testing on a specimen without a unique identifier and the results of that testing are not returned to th...

How does my laboratory assess the validity of a specimen that has been obtained through self-collect...

Self-collection of specimens, both unsupervised and supervised by a medical professional, is currently available for specific tests authorized by t...

Can test developers reference the EUA for CDC's diagnostic multiplex assay for flu and SARS-CoV-2 wh...

Yes. CDC has extended right of reference for manufacturers and clinical laboratories to cite the EUA for CDC’s Influenza SARS-CoV-2 (Flu SC2) Multi...

Where do test developers get the genomic RNA needed to validate test performance for FDA?

Currently, genomic RNA material can be used for validation purposes in biosafety level 2 laboratories (BSL-2). Genomic RNA material is available th...

What is the National Institutes of Health’s (NIH) BEI Resources Repository?

BEI Resources Repository was established by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health to provi...

What safety issues are there with PrimeStore® Molecular Transport Medium (MTM) when used with SARS-C...

PrimeStore MTM transport media contains guanidine thiocyanate, which produces a dangerous chemical reaction that releases cyanide gas when exposed...

What safety issues can occur when using a mixture of A549 and Mv 1 Lu cell lines (also referred to a...

It has been shown that Mv 1 Lu cells can support low level replication of SARS-CoV, which could result in the inadvertent growth of SARS-CoV-2. The...

Key Points

Regulatory Requirements For Rapid Testing in Point-Of-Care Settings

  • There are four different types of CLIA certificatespdf iconexternal icon, any one of which is appropriate for point-of-care testing. A CLIA certificate is required to perform point-of-care testing. A CLIA Certificate of Waiver is appropriate if SARS-CoV-2 point-of-care testing is the only testing being performed. It can be obtained as follows: 1. Complete an application (Form CMS-116pdf i…
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Tests That Can Be Used in Point-Of-Care Settings

  • Refer to the U.S. Food and Drug Administration (FDA) website for a list of the SARS-CoV-2 point-of-care and rapid tests that have received Emergency Use Authorization (EUA)external icon. Tests that have been authorized for use in a point-of-care setting will have a W, for Waived, in the Authorized Settings column of the FDA table. The laboratory or testing site must use a test auth…
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Reporting Requirements For Rapid Testing in Point-Of-Care Settings

  • A CLIA-certified laboratory or testing site must report all positive SARS-CoV-2 diagnostic and screening test results to the person who was tested or that person’s healthcare provider. CLIA-certified laboratories or testing sites are no longer required to report negative results for non-NAAT tests (rapid or antigen test results) or antibody tests, ...
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Specimen Collection & Handling of Rapid Tests in Point-Of-Care Settings

  • Each point-of-care test has been authorized for use with certain specimen types and should only be used with those specimen types. Proper specimen collection and handling are critical for all COVID-19 testing, including those tests performed in point-of-care settings. A specimen that is not collected or handled correctly can lead to an inaccurate or unreliable test result. Personnel colle…
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Learn More About Performing Rapid Tests in Point-Of-Care Settings

  • CDC has free training and tools to help you learn the basics about performing point-of-care testing. The companies that make the tests and testing systems also have free training resources designed to help you use the tests. Find links in this section to resources and training that will help you get ready to test.
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CDC Educational Materials For Rapid Testing in Point-Of-Care Settings

  • Many COVID-19 point-of-care and rapid tests fall into a category called waived tests, which are tests performed in a laboratory or at a testing site under a CLIA Certificate of Waiver. CDC has free educational and training resources for waived point-of-care testing, including: Ready? Set? Test!is an online training course that explains the waived testing process and how to help ensur…
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Tips For Using Rapid Antigen Tests

  • Below are links to documents for select SARS-CoV-2 specific antigen tests procured in large numbers by the U.S. government. Based on CDC experience with these tests, following these tips will help to ensure the tests are performed correctly. 1. Cue® Professional Antigen Testpdf icon[12 MB, 6 pages] 2. BD Veritor™ System for Rapid Detection of SARS-CoV-2pdf icon[7MB, 4 …
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