This qualitative in vitro diagnostic multiplex test detects the presence of ribonucleic acid (RNA) from Influenza A virus, Influenza B virus, and Respiratory Syncytial Virus. RNA is extracted from nasal or nasopharyngeal swab samples and analyzed via real-time reverse transcription polymerase chain reaction (RT-PCR) using primer and probe sets designed to detect the matrix 1 gene of Influenza A virus, nonstructural 2 gene of Influenza B virus, and matrix gene of Respiratory Syncytial Virus (RSV).
Laboratory developed test (LDT): This test was developed, and its performance characteristics were determined by Monarch Global Labs that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and is qualified to perform high complexity testing.
Influenza A Virus Not detected
Influenza B Virus Not detected
Respiratory Syncytial Virus (RSV) 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.
Swab specimens should be collected using swabs with a synthetic tip (e.g., polyester,
Dacron®, etc.) and an aluminum or plastic shaft.
24 hours from date/time of receipt
Monarch Global Labs
1901 S Harbor City Blvd, Melbourne FL, 32901
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