AZURESEQ

ONE STEP UNIVERSAL RT-qPCR Kit
SARS-CoV-2

Get high multiplex performance in an American-made product. Excellent sensitivity with CDC-recommended primers. All enzymes are synthesized in the United States. Fast turn-around times for customization that fits your workflow and format.

TWO FORMATS
Wet & Lyophilized*

Multiplex – 3 targets per reaction well
Made in America
EUA-FDA Validated
*Coming Soon, RUO Not for Diagnostics

  • Choose your format – Lyophilized or Wet

  • Increase your throughput 25% to 300%

  • Fewer steps reduce potential user error

  • Easy shipping & storage

  • Excellent for automation

  • Supply chain continuity with American products

Targets

2 regions of SARS-CoV-2 virus N nucleocapsid protein gene plus control region of RNaseP gene

Sample

100ng to 1pg using CDC recommended extraction protocols

Dyes/Cycles

N1=FAM, N2=HEX, RNaseP=TxRed/ROX, 40 Amplification cycles,
LoD: 5-10 copies

Lyophilized vs. Wet Comparison

 SpeedEaseTemperature
Lyophilized FormatFastest: Less than 90 minEasiest: Resuspend - GoRoom Temp: Stable at 37ºC
Wet FormatFast: Less than 120 minEasy: 8 pipetting stepsFrozen: Store at -20ºC

Enable daily processing of hundreds of samples.

Accurate detection with reduced complexity, time and waste.

The lyophilized kit demonstrates longer-term stability and lower risk with sensitive samples.

Low copy number (5-10 copies) delivers a reliable, highly sensitive one-step RT-qPCR solution for rapid testing.

Compatible with CDC recommended RNA extraction kits and qPCR instruments.

Available in user-friendly, custom formats.

PERFORMANCE EVALUATION

Contrived Clinical Samples

Competitor Comparison

AzureSeq was determined to be compatible with RNA extraction workflow at concentrations at or near LoD. Pooled negative OP swabs were spiked with genomic RNA. Input volume for extraction was 250 μl and elution volume was 80 μl. A 5 μl aliquot of the eluate was added to the PCR reaction.

Wet vs. Lyophilized

AzureSeq (wet) and AzureSeq Lyo (lyophilized) show comparable results using CDC specified primers and probes for nCoV2 N1 and N2 and RPP controls using CDC recommended testing protocol.

nCoV2 N1

nCoV2 N2

Detection on nCoV2 N1 and N2 genes: 50 copies of genomic RNA added in a 20 μl reaction. Reaction set-up and RT-qPCR protocol were in accordance with CDC guidance.

ORDERING INFORMATION

For prescription use only. For in-vitro diagnostic use only. Only for use under Food and Drug Administration Emergency Use Authorization.

Depending on your cycler, approximately 70′-75′.

For N1, FAM (absorption 493nm, emission 517nm)

For N2, HEX (absorption 533nm, emission 559nm)

For RnaseP, ROX/Tx Red (absorption 583nm, emission 603nm)

Yes. Our FDA Facility Registration number is 10076042

Yes, we can make AzureSeq in tube and 96/384-well format.

  • We anticipate mid-August 2020. Samples are available now for testing.
  • Will you submit for EUA? Yes, assuming validation data is comparable or superior to the wet version. It is currently RUO- Not For Diagnostic Use.

As of Jul 12, 2020 we can provide 2M reactions/week. This can be further scaled with 10 days notice. Please contact us for the most up-to-date information.

Both are available.

Omega Total RNA Spin Columns and KingFisher MagMax

For validation N1=5 copies/rxn, N2=10 copies/rxn.

1000 cp/ul RNaseP, 200 cp/ul of N

60mer-70mer

N1, N2 capsid and RP-P

It was validated using standard qPCR instruments including: QuantStudio series, BioRad FX.

It is EUA-Validated, not EUA-Authorized. At this time, CLIA users may choose to submit their own EUA. Upon request, we will send the FDA EUA Submission for AzureSeq.

Product Disclaimer

Download SDS Sheets

DOING OUR PART

By highlighting threatened or endangered species, SeqOnce hopes to draw attention to conservation efforts. As biologists, we believe humanity is better served when ecologies are maintained and there is diversity of life.

SeqOnce supports protecting and conserving endangered and threatened species.

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