CPT: U0003

Drexel Medicine Diagnostics is authorized by the FDA to conduct testing for SARS-CoV-2, the causative agent of COVID-19, under an emergency use authorization (EUA220099). We use a modified Tetracore assay for the qualitative detection of nucleic acid from SARS-CoV-2 in mid-turbinate nasal swab specimens from individuals suspected of COVID-19 by their health care provider. Due to the continuing COVID-19 public health emergency, the FDA has authorized the emergency use of in-vitro diagnostics for detection and/or diagnosis of SARS-CoV-2, the virus that causes COVID-19.

SARS-CoV-2 causes COVID-19, a serious or life-threatening condition, including severe respiratory illness. We use an in vitro real-time reverse transcription polymerase chain reaction (rRT-PCR) test to detect the presence of SARS-CoV-2 RNA in nasal samples. In this test, nucleic acid is first extracted, isolated and purified from mid-turbinate nasal swab specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. SARS-CoV-2 RNA is generally detectable in mid-turbinate nasal swab 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. Laboratories within the United States and its territories are required to report all test 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/or epidemiological information.

Sample Stability: 7 days at 37°C and 50°C, 14 days at room temperature, as well as refrigerated and frozen temperatures.

Turnaround Time: 98% < 72 hours, 50% < 24 hours

Directorship: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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