Technology

DASH™ Characteristics

The Science

The DASH™ Rapid PCR System

Workflow

Clinical Research

DASH™ Rapid PCR System Characteristics:

Accuracy

Central lab quality, quantitative PCR results

Multiplex

Designed to be multiplex-capable in a single cartridge*

Time to Result

15 minutes

Method

Quantitative PCR and reverse transcription, real-time PCR (RT-qPCR)

Easy to Use

Intuitive user interface with only 1 minute of actual hands on time

Specimen Preparation

Paramagnetic particle purification

Sample Types

Built to run a wide variety of sample types*

Qualitative Report

Positive, negative or invalid

The Science

DASH™ is a sample-to-answer quantitative PCR system that is designed to automatically identify viral and bacterial agents in only 15 minutes. During the first 10 minutes, samples are extracted and purified with sequence-specific capture probes. Paramagnetic particles (PMP) bind the target probe complex. Targets are then separated magnetically from the swab extraction buffer, washed and transported to the PCR chamber. During the last 5 minutes of the assay, 40 PCR temperature cycles are performed. During the 40 cycles, fluorescence is measured with a four-channel optical system.

DASH™ Rapid PCR System:

The DASH™ Rapid PCR System is a point of care (POC) in vitro diagnostic (IVD) device that is designed to detect nucleic acids of target pathogens from various sample types. The system consists of an electromechanical instrument, barcode scanner and test cartridges.

The DASH™ Instrument automates the process of sequence-specific capture sample prep and RT-qPCR amplification, detects the presence of target pathogens and reports the result. The instrument weighs less than 10 pounds and has been designed with a very small footprint (15″D x 11″H x 4″W) so that it can fit on any desktop in a wide variety of care settings, from hospitals, to urgent care and outpatient clinics, to emergency rooms, to physician’s offices and decentralized labs. The DASH™ Instrument requires no ongoing maintenance.

The DASH™ Cartridge contains all reagents necessary to perform a test and is built to be multiplex-capable.* DASH™ Cartridges use stabilized reagents for storage at room temperature.

The DASH™ Rapid PCR System delivers central lab quality results at the point of care, is simple and easy to use, and can be operated with minimal training.

The DASH™ interface walks the user
through all the steps, making it just
as easy to use as a coffee maker.

Chad Achenbach, M.D.

Associate Director of Infectious Diseases at Feinberg School of Medicine,
Northwestern University, Chicago, IL.

Fierce BioTech – 10/3/22

Workflow

DASH™ Rapid PCR System cartridge barcode reading

Step 1. Scan

Step 2. Add

DASH™ Rapid PCR System cartridge insertion

Step 3. Load

Step 4. Report

Clinical Research

Clinical research results from a recently published
clinical trial¹:

313 participants

Concordant results for 307 tests¹

96% sensitivity

98% specificity

Overall agreement for DASH of 98% compared
to Cepheid GeneXpert

Thus, we believe that DASH performed equivalent to laboratory-based PCR testing and displays its potential as a rapid and highly sensitive POC option to supplement or replace current PCR platforms in real-life clinical settings and eventually the community.

DASH is an important advancement in molecular POC diagnostics for SARS-CoV-2 with potential applications beyond many non-PCR NAAT technologies. DASH could decentralize PCR diagnostics by bringing molecular testing to a wider range of community settings in the U.S. and throughout the world.

CONCLUSION:

“DASH POC SARS-CoV-2 PCR was accurate, easy to use, and provided fast results (approximately 15 minutes) in real-life clinical settings with an overall performance similar to a EUA-approved laboratory-based PCR.”

Read the full research article here

Achenbach CJ, Caputo M, Hawkins C, Balmert LC, Qi C, Odorisio J, et al. (2022) Clinical evaluation of the Diagnostic Analyzer for Selective Hybridization (DASH): A point-of-care PCR test for rapid detection of SARS-CoV-2 infection. PLoS ONE 17(6):e0270060. https://doi.org/10.1371/journal.pone.0270060.

Six discordant tests between DASH and Xpert all had high CT values (>30) on the respective positive assay — 2 participants with negative DASH testing and positive Xpert testing and 4 participants with positive DASH testing and negative Xpert testing. All 6 of these individuals had at least one COVID-19 symptom and/or known positive PCR testing for COVID prior to enrollment. Both false negatives had high Ct values (>35 cycles) on Xpert testing, and 3 of the 4 false positives had high Ct values (>35 cycles) or an indeterminate result (one of two SARS-CoV-2 gene targets detected) on the tiebreaker assay. Five of these individuals with discordant results were late in their course of infection (at least 4 days from onset of symptoms or prior positive PCR testing).

Intended Use

The DASH SARS-CoV-2/S Test is a real-time RT-PCR assay intended for the qualitative detection of RNA from SARS-CoV-2 in direct anterior nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider. 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. The agent detected may not be the definite cause of disease.

*This product has not been FDA cleared or approved. It has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. Additional indications beyond SARS-CoV-2 will require separate FDA clearances, and are not commercially available at this time.

This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The emergency use of this product 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(bx1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

Sponsored Research

Nuclein is proud to work with select universities to sponsor research projects aimed at improving diagnostic testing in low- and middle-income countries. In these cases, Nuclein provides support for indirect costs up to a maximum rate of 20% of the total direct costs of the project. This maximum rate applies uniformly across all sponsored research project.