About the COVID 19
The COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to the Center for Esoteric Testing, Burlington, NC, or other laboratories designated by LabCorp that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the COVID-19 RT-PCR test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR is only for use under the Food and Drug Administration’s Emergency Use Authorization.
LabCorp COVID-19 RT-PCR test EUA Summary
DEVICE DESCRIPTION AND TEST PRINCIPLE
The COVID-19 RT-PCR Test is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test uses three primer and probe sets to detect three regions in the SARS-CoV-2 nucleocapsid (N) gene and one primer and probe set to detect human RNase P (RP) in a clinical sample. RNA isolated from upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) is reverse transcribed to cDNA and subsequently amplified using Applied Biosystems QuantStudio7 Flex (QS7) instrument with software version 1.3. During the amplification process, the probe anneals to a specific target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5’ nuclease activity of Taq polymerase degrades the bound probe, causing the reporter dye (FAM) to separate from the quencher dye (BHQ1), generating a fluorescent signal. Fluorescence intensity is monitored at each PCR cycle by QS7.
INSTRUMENTS USED WITH TEST
The COVID-19 RT-PCR test is to be used with the Roche MagNA Pure-96 (MP96) using MagNA Pure 96 DNA and Viral NA Small Volume Kit and Applied Biosystems QuantStudio7 Flex (QS7) instrument with software version 1.3.
Same Day Visits
Clean your hands often
Wash your hands often with soap and water for at least 20 seconds, especially after you have been in a public place, or after blowing your nose, coughing, or sneezing.
If soap and water are not readily available, use a hand sanitizer that contains at least 60% alcohol. Cover all surfaces of your hands and rub them together until they feel dry.
Avoid touching your eyes, nose, and mouth with unwashed hands.
Illustration: Woman quarantined to her home
Avoid close contact
Avoid close contact with people who are sick
Put distance between yourself and other people if COVID-19 is spreading in your community. This is especially important for people who are at higher risk of getting very sick.
Stay home if you’re sick
Stay home if you are sick, except to get medical care. Learn what to do if you are sick.
woman covering their mouth when coughing
Cover coughs and sneezes
Cover your mouth and nose with a tissue when you cough or sneeze or use the inside of your elbow.
Throw used tissues in the trash.
Immediately wash your hands with soap and water for at least 20 seconds. If soap and water are not readily available, clean your hands with a hand sanitizer that contains at least 60% alcohol.
Wear a facemask if you are sick
If you are sick: You should wear a facemask when you are around other people (e.g., sharing a room or vehicle) and before you enter a healthcare provider’s office. If you are not able to wear a facemask (for example, because it causes trouble breathing), then you should do your best to cover your coughs and sneezes, and people who are caring for you should wear a facemask if they enter your room. Learn what to do if you are sick.
If you are NOT sick: You do not need to wear a facemask unless you are caring for someone who is ill (and they are not able to wear a facemask). Facemasks may be in short supply, and they should be saved for caregivers.
cleaning a counter
Clean and disinfect
Clean AND disinfect frequently touched surfaces daily. This includes tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
If surfaces are dirty, clean them: Use detergent or soap and water before disinfection.
The most common EPA-registered household disinfectants will work. Use disinfectants appropriate for the surface.
Diluting your household bleach.
To make a bleach solution, mix:
Five tablespoons (1/3rd cup) bleach per gallon of water
Four teaspoons bleach per quart of water
Follow the manufacturer’s instructions for application and proper ventilation. Check to ensure the product is not past its expiration date. Never mix household bleach with ammonia or any other cleanser. Unexpired household bleach will be effective against coronaviruses when adequately diluted.
Ensure the solution has at least 70% alcohol.
Other common EPA-registered household disinfectants.
Products with EPA-approved emerging viral pathogens pdf icon[7 pages]external icon claims are expected to be effective against COVID-19 based on data for harder to kill viruses. Follow the manufacturer’s instructions for all cleaning and disinfection products (e.g., concentration, application method and contact time, etc.).
Disease 2019 (COVID-19)
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