Illumina COVIDSeq Test (販売終了)

The Illumina COVIDSeq Test provides a streamlined, integrated workflow from extracted RNA to cDNA synthesis, through library preparation, sequencing, and data analysis to obtain fast, accurate SARS-CoV-2 sequence information. Scale up or down to accommodate different numbers of samples using the NovaSeq 6000, NextSeq 2000, or NextSeq 500/550/550Dx (in RUO mode) Systems and quickly analyze data using the DRAGEN COVID Lineage App in BaseSpace Sequence Hub. 

For In Vitro Diagnostic Use. 

* Authorizing agencies: Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the Food and Drug Administration in the US. 

EUA Approved Intended Use 

The Illumina COVIDSeq Test is a Next-Generation Sequencing (NGS) in vitro diagnostic test on the Illumina NovaSeq 6000 Sequencing System, NextSeq 2000 Sequencing System, NextSeq 500 Sequencing System, NextSeq 550 Sequencing System, or NextSeq 550Dx Instrument intended for the qualitative detection of SARS-CoV-2 RNA from nasopharyngeal (NP) swabs, oropharyngeal (OP) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. 

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. 

Results are for the 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate 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 epidemiological information.  

The Illumina COVIDSeq Test is intended for use by qualified and trained clinical laboratory personnel specifically trained in the use of the NovaSeq 6000 Sequencing System, the NextSeq 2000 Sequencing System, the NextSeq 500 Sequencing System, the NextSeq 550 Sequencing System, or the NextSeq 550Dx Instrument, as well as Next-Generation Sequencing workflows and in vitro diagnostic procedures. The Illumina COVIDSeq Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

For In Vitro Diagnostic Use 

Contact an Illumina representative for regional availability.