Using real-time reverse transcription polymerase chain reaction (RT-PCR), this test detects the presence of SARS-CoV-2, the RNA virus that causes COVID-19. This test has been authorized only for the qualitative detection of nucleic acid from SARS-CoV-2 and not for any other viruses or pathogens.
This assay has been authorized for emergency use by the US Food and Drug Administration (FDA) under an emergency use authorization (EUA) for use by authorized laboratories.
SARS-CoV-2 Not detected
Nasal or nasopharyngeal swab collected in Hardy viral transport media
1 swab in transport media
Swab specimens should be collected using swabs with a synthetic tip (e.g., polyester, Dacron®, etc.) and an aluminum or plastic shaft.
Room Temperature (20-25°C): 24 hours. Ship with ice packs.
Refrigeration (2-8°C): 72 hours . Ship with ice packs.
Frozen (-90 to -70°C): 7 days. Ship with dry ice.
Swabs with cotton tips and wooden shafts. Specimens collected with swabs made of calcium alginate are not acceptable. Throat and lower respiratory samples. Transport tube with the swab inverted or no swab at all.
24 hours from date/time of receipt
Monarch Global Labs
1901 S Harbor City Blvd, Melbourne FL, 32901
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