PeakV™ Instrument (in pipeline)
Sponsored by the NIH RADx program, Star Array Pte. Ltd. and OnsiteGene Inc. proudly introduce the groundbreaking PeakV™ instrument. This innovative device is the first of its kind, offering multiple breakthrough technologies from open-assay cartridge, zero manual user steps before instrument run, superfast PCR, sample-to-answer nucleic acid analyzer integrated with a user-programmable nested PCR and pre-amplification for both large multiplex test panels and a single target test to achieve exceptional nucleic acid detection sensitivity. These unique features, for the first time, allow users to freely convert their manual laboratory testing to automated sample-to-answer testing, and such conversion can be done in a short time without much supervision or restriction from Star Array.
PeakV™ is capable of running PCR panels of all sizes, from single target and small multiplex PCR panels to large multiplex PCR panels of up to 64 targets over 16 PCR tubes integrated in a cartridge, at a substantially lower cartridge cost than those in the market. Its LEGO-like editable or expandable PCR panel shown in the following figure is a part of PeakV’s open-assay cartridge capability to allow users to add PCR tubes containing newly developed assays. This LEGO-like panel technology provides easy and fast assay development, regulatory clearance and user adoption.
(a)
(b)
Top view of an uncovered PeakV™ cartridge containing a PCR panel of up to 16 PCR tubes and up to 64 targets, integrated with magnetic beads extraction reagents and PCR and nested PCR reagents. (a) An existing PCR test panel consisting of assays in three PCR tubes cleared with FDA; (b) Another PCR tube containing a newly FDA cleared assay is added easily by users or suppliers to form a new PCR test panel, without repeating validation of the existing assays in the three PCR tubes.
In another aspect, since a different number of PCR tubes can be assembled by users or by suppliers, PeakV™ can be used as a dual-function instrument for both single PCR tube testing (or a few PCR tubes) in emergency and large syndromic panel tests in ICU and cancer testing.
To achieve onsite testing in a POCT site or shorten laboratory testing time, PeakV™ supports a superfast RT-PCR process, with sample processing and total turn-around-time under 30 minutes, within whichRT-qPCR of 40 cycles in approximately 9 minutes, and qPCR of 40 cycles in approximately 7 minutes.
For maximum ease of use, before running PeakV™, no manual steps are required for sample transfer from a sample tube to the cartridge, nor requiring a user to open the cap of the sample tube or the cartridge. Operators simply insert a capped sample tube into the cartridge and load the cartridge into the PeakV™ instrument or directly insert the sample tube into PeakV™ instrument.
Additional features include large sample volume processing capacity (1-5mL) for high detection sensitivity, extensive PCR array multiplexing capabilities, and ability to process most of sample types, from swab, blood, sputum, urine, to tissue, making PeakV™ an ideal test platform for infectious diseases and cancers.
Demo of PeakV™ Workflow for Users
To achieve our vision of making highest lab-quality nucleic acid testing affordable to all populations, we developed a unique cartridge technology that significantly reduces cartridge material cost and production cost. PeakV cartridges are designed using a fluidic control principle that differs from conventional microfluidics. This design eliminates drawbacks of microfluidics cartridges such as high production cost, low operational reliability, and difficulty scaling up production. PeakV cartridges are made through simple assembly of large-sized parts produced by widely available regular injection molding.
As the PeakV cartridge design deviates from microfluidics, it is free from microchannels, microvalves, and microchambers. This enables the cartridge to handle large volumes of reagents and samples in spacious chambers, without the restrictions of microchannels and microchambers during liquid transfer and mixing. These features ensure that the PeakV cartridge achieves the same high-quality technical performance as a manual test operation in a laboratory.
PeakV Instrument Specifications
PeakV is a cutting-edge, full-range multiplexing, fully automated sample-to- answer qPCR instrument. With no need for user liquid or sample handling, PeakV offers sample preparation (RNA/DNA magnetic bead extraction/purification), open PCR or panel assay capabilities, and sophisticated multiple-site nested PCR and pre- amplification. The sample-to-answer turnaround time is less than 30 minutes. Key specifications of the PeakV instrument include:
1. Sample-to-answer system running on an Open-assay Cartridge of single target to large plex panel tests (World's First):
Easily run any third-party lab-based fluorescent probe PCR assay on PeakV to achieve sample-to-answer testing with minimum assay adaptation effort for ready conversion of manual tests to auto test on PeakV.
2. Contamination-free:
The fully sealed cartridge technology, closed-cap processing of sample tubes, and minimal or no user manual handling of sample liquid ensure a contamination-free operation.
3. Hands-free operation:
A user directly loads a sample tube containing sample into a cartridge or instrument without liquid handling or opening a cap on the sample tube by the user. The rest is a fully automated process in PeakV, including sample transfer from a sample tube to the cartridge, magnetic bead sample preparation, pre-amplification, and PCR panel results. Since no sample handling is involved, a user can run a test without reading a user manual.
4. Ultra-sensitive detection:
Integrated multiple-site nested PCR (MS-nPCR) or multiple-site pre-amplification (MS-preAmp) provide significantly higher sensitivity and specificity in PCR tests compared to traditional qPCR devices. MS-nPCR and MS-preAmp enable much more uniform PCR enrichment of targets in multiple PCR tubes during the first round of nested PCR or preAmp step. These automated steps make PeakV the ideal device for low copy detection applications, such as cancer testing and infectious disease testing.
5. Superfast turnaround time:
Since there is no user hands-on steps, one can obtain sample-to-answer results in less than 30 minutes for most sample types. With direct PCR or extraction-free testing protocols, turnaround time can be as little as 10 minutes.
6. Flexible multiplexing with full panel size coverage:
A user can assemble a PCR panel at ease to perform single target tests, small and medium panel tests, and a large syndromic panel tests of up to 64 pathogen targets (16 tubes in the panel) in a single run.
7. Sample versatility:
Process most sample types, including swabs, saliva, sputum, blood, feces, urine, and tissue with minimal hands-on steps by the user.
8. Superfast qPCR:
Complete 40 thermal cycles in as little as 5 minutes and a sensitive qPCR and RT-qPCR detection in less than 10 minutes.
9. Large sample volume:
Accommodate 1mL samples, upgradable to 5mL.
10. Integrable to a centrifugation workflow:
Seamless integration of a centrifugation step into PeakV user workflow without manual liquid handling of sample or reagent tubes by the user.
11. Integrable to a bead beating workflow:
Seamless integration of bead beating step into PeakV user workflow without manual liquid handling of sample or reagent tubes by the user.
12. Low cartridge cost:
The innovative cartridge design enables simple and efficient manufacturing processes, leading to low-cost and reliable cartridge production, as compared to regular microfluidics cartridge production processes.
13. High cartridge operation reliability:
The straightforward cartridge design, free from microchannels, microvalves, and microchambers, ensures dependable operation.
14. Random access with multiple sample processing on PeakV4 and PeakV8 instrument options:
Upgradeable between 4 and 8 sample random access testing capabilities.
15. Open PCR panel design:
Easily insert third-party PCR assays or LDT assays into PeakV cartridges for new test panels.
PeakV Instrument Specifications
Instrument Workflow
Sample to answer using a sealed cartridge to test a panel of up to 64 targets
User workflow
Inserting a sample tube. No user manual step for liquid handling.
Technology
Cartridge integrated magnetic beads extraction and full range multiplexing qPCR panel with automated nested and pre-amplification
Multiplexing
Single target, small plex, medium plex and large plex up to 64 targets in a panel
PCR panel size
1-16 PCR tubes in a panel on each cartridge. User flexible to form a panel size.
Optical channels
4 channels, including FAM, VIC/HEX/SUN, ROX/Texas Red, Cy5.
Detection Sensitivity
Integrated and automated nested PR and pre-amplification for panel test
TAT
30 minutes
Sample types
Swab, blood, sputum, urine, tissue, etc.
Sample volume
100ul – 1000ul, upgradable to 5mL
Integration with other sample processing tools
Seamless integration with the following tools without liquid handling by users: centrifuge, beads beater, vortex shaker, spectrometer, etc.
Open-assay development by third parties
Open-accessible cartridge and user programmable workflow for open assay development free from interference from instrument manufacturer.
Open-assay development by third parties
Open-accessible cartridge and user programmable workflow for open assay development free from interference from instrument manufacturer.
Controls built in a cartridge
NC, PC, IC
Weight (Kg)
23.0
Dimensions W x D x H (cm)
32 x 60 x 51
Star Array is actively seeking collaborations with third-party PCR assay developers to expand the PeakV platform's capabilities for both clinical and non-clinical applications. Please Contact Us.