What is the COVID-19 Molecular Laboratory Developed Test?

The Molecular LDT COVID-19 Authorized Test should be ordered for the detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider.
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What is the difference between a molecular test and rapid antigen tests for COVID-19?


Molecular tests are generally more accurate and mostly processed in a laboratory, which takes longer; antigen tests—or “rapid tests”—are processed pretty much anywhere, including at home, in doctors' offices, or in pharmacies.

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How accurate are COVID-19 PCR tests?

PCR tests are very accurate when properly performed by a health care professional, but the rapid test can miss some cases.
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What kind of tests are used to see if you have COVID-19?


Diagnostic tests can show if you currently are infected with SARS-CoV-2, the virus that causes COVID-19. There are two types of COVID-19 diagnostic tests: Molecular tests, such as polymerase chain reaction (PCR) tests. Antigen tests, often referred to as rapid tests.

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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.

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How the Molecular Diagnostics Lab Processes COVID-19 Tests



Which COVID-19 tests are more accurate PCR or antigen tests?


PCR tests are more accurate than antigen tests. "PCR tests are the gold standard for detecting SARS-CoV-2," says Dr. Broadhurst. "It is the most accurate testing modality that we have.

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Why PCR is better than the rapid COVID-19 test?


“PCR tests are more reliable and accurate due to testing the specific genetic material of the virus, eliminating the interference from other viruses,” said Heather Seyko, a Laboratory Services manager for OSF HealthCare.

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How accurate are rapid COVID-19 tests?


Positive results are usually highly accurate but negative results may need to be confirmed with a PCR test. Rapid tests are most effective one to five days after symptoms start.

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How does a rapid COVID-19 test work?

In both the rapid test and PCR test, specimens are collected using a nasal swab. A swab is inserted into each nostril, one side at a time, approximately one inch. The swab is then rotated around the inside of each nostril, approximately five times, to gather mucous.
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Are CT scans helpful for diagnosing COVID-19?

Along with laboratory testing, chest CT scans may be helpful to diagnose COVID-19 in individuals with a high clinical suspicion of infection.
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How long can you test positive on PCR for COVID-19?

According to the Centers for Disease Control and Prevention, some people who contract COVID-19 can have detectable virus for up to three months, but that doesnt mean they are contagious.
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What are consequences of a false negative COVID-19 test?

Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.
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What does it mean if I test negative for COVID-19?

A 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.

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Are molecular or rapid COVID-19 tests more accurate?


Molecular tests are generally more accurate and mostly processed in a laboratory, which takes longer; antigen tests—or “rapid tests”—are processed pretty much anywhere, including at home, in doctors' offices, or in pharmacies.

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Are at-home COVID-19 rapid antigen tests accurate?

Previous research by our study team and others suggests that over-the-counter tests are more likely to detect an infection among people who are actively contagious.
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Are COVID-19 rapid antigen tests accurate if no symptoms are present?


Antigen tests are still fairly accurate, particularly when someone is experiencing symptoms and their viral load is very high. However, they can be less accurate when someone has a lower viral load, such as in someone without symptoms. This could lead to false negative test results.

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Do the U.S. COVID-19 rapid antigen tests use a nasal swab?


The rapid antigen tests that most people are using in the U.S. are specifically designed for nasal swabs.

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What does a false-positive COVID-19 antigen test result mean?


A false-positive antigen test result means that the test says the person has COVID-19 but they are actually do not have COVID-19.

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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.

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Does a negative COVID-19 rapid antigen test mean I don't have COVID-19?


If you have a negative test, but have symptoms of COVID-19: You may have COVID-19, but tested before the virus was detectable, or you may have another illness, such as the flu.

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What is a false positive rate for a virus test?

The false positive rate — that is, how often the test says you have the virus when you actually do not — should be close to zero. Most false-positive results are thought to be due to lab contamination or other problems with how the lab has performed the test, not limitations of the test itself.
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Can you get a false negative COVID-19 antigen test?


The antigen level in specimens collected either before symptom onset, or late in the course of infection, may be below the tests' limit of detection, resulting in a false negative antigen test result, while a more sensitive test, such as most NAATs, may return a positive result.

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What is a PCR test in the context of COVID-19 testing?

A PCR test stands for polymerase chain reaction test. This is a diagnostic test that determines if you are infected by analyzing a sample to see if it contains genetic material from the virus.
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Can a PCR test detect the COVID-19 Omicron variant?

The good news is that, according to the World Health Organization (WHO), PCR and rapid antigen tests can still detect Omicron as well as previous variants.
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Can you get Paxlovid?

“Paxlovid is now available at many pharmacies and is government funded during the public health crisis,” Cutler said. “With a prescription from your doctor, Paxlovid is now fairly easily accessible.”
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