Leading the fight against COVID-19

Cue’s COVID-19 test simplifies the testing process so you can respond to situations quickly, improving the health and workflow of your organization.

COVID-19 test results delivered to your mobile device in about 20 minutes.

0%

Sensitivity

Low occurrence of false negatives. Average was 98.7% across 4 clinical studies.

0%

Specificity

Low occurrence of false positives. Average was 97.6% across 4 clinical studies.

0

Limit of Detection

Competitively low limit of detection. 20 genome copies per sample.

Flexibility to fit your workflow

No matter what industry you’re in, Cue empowers you to make timely, informed decisions and avoid costly disruptions with our rapid, accurate, easy-to-use system.

The Cue Sample Wand goes directly from the patient’s nasal cavity into the reader with no additional manipulation necessary.

In addition to direct swabs, Cue’s FDA EUA allows for testing samples collected in VTM.

COVID-19 Report

You can count on Cue to perform when it matters most. See how we stack up in the fight against COVID-19.

Limit-of-Detection Study

Scope

Estimation of the Limit-of-Detection (LoD) of the Cue Health Monitoring System with Cue COVID-19 cartridge with associated Cue sample wand and Cue health mobile application per CLSI EP17-A2.

Experimental Design

Gemonic RNA from SARS-CoV-2 (strain USA-WA1/2020) was tested at 4 low level concentrations with 2 Cue COVID-19 cartridge lots over 3 days by 2 operators. 3 replicates were tested per concentration/cartridge lot/day/operator for a total of 144 test results (pos/neg/invalid). An additional 20 replicates were run on a single lot of cartridges to confirm the LoD (defined as ≥ 95% positive or at least 19/20 replicates per FDA Guidance(1).

Sample Type

SARS-CoV-2 genomic RNA spiked into pooled negative nasal matrix. Concentrations in genome equivalents/mL were provided by the vendor (BEI). 10 μl of matrix + genomic RNA was applied to a Cue sample wand.

Results

The confirmed LoD is 20 genome copies/sample wand in natural nasal matrix.

SARS-CoV-2 Genome Copies Per Wand

Cartridge Lot 1

Detected / Tested
% Agreement

Cartridge Lot 2

Detected / Tested
% Agreement

Genome Copies / Wand

Confirmation Detected/Tested

500
18/18100%
18/18100%
2020/20
100
18/18100%
18/18100%

Samples with a WE1 (IC) value of ≥ -500 nanoamps were considered invalid and replaced by an additional replicate on the same day.

20
18/18100%
18/18100%
4
15/1883.3%
15/1883.3%

Innovation at lightning speed

Product support & documentation for the Cue COVID-19 Test

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Cue is committed to keeping health data safe

We protect all health data in accordance with the highest industry standards, including HIPAA and FERPA.

Learn more