Illumina COVIDSeq Test (販売終了)

High-throughput next-generation sequencing test detects SARS-CoV-2 in patients suspected of COVID-19 and enables virus genome analysis in research use.

The Illumina COVIDSeq Test is intended for detection of SARS-CoV-2 viral RNA in authorized countries (Japan and US) under each country’s respective authorizing agency.* A  Research Use Only (RUO) version of this product is available for all other countries. 

Interested in bringing the Illumina COVIDSeq Test into your lab?

Overview

The Illumina COVIDSeq Test is an amplicon-based next-generation sequencing (NGS) diagnostic test that includes ARTIC v3 primers designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of having COVID-19. The test is intended for detection of SARS-CoV-2 virus RNA in authorized countries.* 

  • Detects 98 targets on SARS-CoV-2 viral sequence using ARTIC v3 primers 

  • Identifies SARS-CoV-2 virus RNA in a diagnostic test and provides viral genome analysis for research use 

  • Includes quality control features in every reaction 

Streamlined, integrated sample-to-results workflow

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. 


Intended use

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. 


Specifications

Applications

The Illumina COVIDSeq Test is a next-generation sequencing (NGS) in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 RNA from individuals suspected of COVID-19 by their healthcare provider. 

Example workflow


Related applications and methods

FAQs

This product is intended for detection of SARS-CoV-2 virus RNA in authorized countries (Japan and US.) under each country’s respective authorizing agency.* Depending on the region and country, additional data may be required to enable COVIDSeq to be used as a diagnostic test. A Research Use Only (RUO) version of this product is available for virus genome analysis for research use.

NovaSeq 6000 System: 

Up to 384 samples can be loaded per lane on a NovaSeq S4 and SP flow cell for a total of 1536 samples per S4 flow cell and 768 per SP flow cell. Two flow cells can be run simultaneously for a total of 3072 or 1536 samples per run, respectively. 

NextSeq 2000 System: 

Up to 384 samples per run. 

NextSeq 500/550/500Dx (in RUO mode) Systems: 

Up to 384 samples can be loaded per high-output flow cell. 

/

Frequently purchased

NextSeq 550Dx High Output Reagent Kit

医療機器届出済みのNextSeq 550Dx システム(届出番号:13B1X10303000001)専用のシークエンス試薬です。これらのシーケンス試薬キットは、臨床検査用にワークフローを簡素化して高いデータ品質を実現します。