Our SARS-CoV-2 test targets three SARS-Cov-2 genomic loci; the S and N gene and the Orf1 region. The assay has been designed and developed to run on multiple high- and low-throughput PCR platforms that can be calibrated for the fluorophores FAM and HEX.

Intended Use

The QuantuMDx Severe Acute Respiratory Syndrome Virus coronavirus-2 (SARS-CoV-2) real-time reverse transcription polymerase chain reaction (RT-PCR) Detection Assay is a qualitative assay RT-PCR assay for the detection of SARS-CoV-2 genomic RNA from upper respiratory specimens (e.g. nasopharyngeal or oropharyngeal swabs, etc.) collected from individuals who meet criteria for SARS-CoV-2 testing.

Testing of nasopharyngeal or oropharyngeal swabs using the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay has been validated for the BioRad CFX96 Dx, controlled by CFX Manager Dx software v3.1 with equivalence demonstrated for the Qiagen Rotor-Gene Q, controlled by Rotor-Gene Q Series software 2.3.4. The assay should be compatible with other equivalent real-time thermocyclers.

Results are for the presumptive detection and identification of SARS-CoV-2 genomic RNA. SARS-CoV-2 genomic RNA is detectable in upper respiratory specimens during the initial acute phase of the infection and for a time after symptoms have abated. Positive results are indicative of active infection with SARS-CoV-2 but do not rule out co-infections with other viruses or bacteria. Clinical correlation with patient history and other diagnostic information is necessary to determine an individual’s infection status. The detection of SARS-CoV-2 genomic RNA may not indicate the definitive cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as a sole basis for treatment or other care management decisions. Negative results must be combined with clinical observations, the individual’s history and epidemiological data and information.

Testing with the QuantuMDx SARS-CoV-2 Detection Assay is intended for use by trained laboratorians who are proficient in performing tests.