ONE STEP UNIVERSAL RT-qPCR Kit
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.
Wet & Lyophilized*
Multiplex – 3 targets per reaction well
Made in America
*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
2 regions of SARS-CoV-2 virus N nucleocapsid protein gene plus control region of RNaseP gene
100ng to 1pg using CDC recommended extraction protocols
N1=FAM, N2=HEX, RNaseP=TxRed/ROX, 40 Amplification cycles,
LoD: 5-10 copies
Lyophilized vs. Wet Comparison
|Lyophilized Format||Fastest: Less than 90 min||Easiest: Resuspend - Go||Room Temp: Stable at 37ºC|
|Wet Format||Fast: Less than 120 min||Easy: 8 pipetting steps||Frozen: Store at -20ºC|
Contrived Clinical Samples
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.
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.
For prescription use only. For in-vitro diagnostic use only. Only for use under Food and Drug Administration Emergency Use Authorization.
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.
Positive control (RnaseP) plasmid is suggested. We can provide this if needed.
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 will need to submit their own EUA. Upon request, we will send the FDA EUA Submission for AzureSeq.
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