The COVID-19 Key assay is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs from individuals suspected of COVID-19 by their healthcare provider. 

 

Results are for the detection and 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 treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

 

Testing with the COVID-19 Key assay is intended for use by qualified and trained laboratory personnel specifically instructed and trained in the techniques of real-time PCR assays. The COVID-19 Key assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

 

This product is not intended for individuals experiencing severe COVID-19 symptoms who should seek emergency medical care right away.  The test taker must be 18+.

 

General Symptoms:

• Fever between 100.4°F - 102°F

• Flu-like symptoms (chills, runny or stuffy nose, whole body aches, a headache, and/or feeling tired)

• New loss of taste or smell

 

Respiratory Symptoms:

• A new or worsening cough or sore throat

• Coughing

• Shortness of breath

Unfortunately, due to the nature of the specimens, there are no refunds for products.