Technology

The groundbreaking PeakV™ instrument boasts patented innovations that have been granted protection in the US, Europe, and China. These innovations showcase inventive approaches to user handling of sample tubes, sample processing and RT-qPCR execution. The design of the cartridge and instrument sets PeakV apart from other sample-to-answer nucleic acid testing instruments.

PeakV has five innovative technology pillars:

1. Superfast thermal cycling enables turnaround time (TAT) of less than 30 minutes with full extraction using magnetic beads, and 10 minutes using an extraction-free lysis buffer

PeakV's superfast qPCR module can complete 40 thermal cycles in as little as 5 minutes for both small and large qPCR panel testing. The temperature ramping rate reaches up to 67°C/s for heating and 82°C/s for cooling. Premium sensors ensure precise temperature control in thermal blocks for optimal accuracy and reproducibility. The fully integrated magnetic bead-based nucleic acid extraction can be completed in less than 15 minutes on PeakV.

PeakV's hands-free capabilities before instrument run further shorten TAT. Users simply insert a capped sample tube into the PeakV instrument, eliminating the need for manual liquid handling, such as transferring samples to a cartridge or managing reagents. The capped sample tube is processed inside the PeakV instrument without opening the cap, preventing contamination. These innovative features make PeakV an ideal solution for next-generation laboratory and POCT applications, offering simple user operation or even unmanned testing operation, short TAT, large panel testing capabilities, and paving the way for future self-tests with the highest laboratory quality.

2. Editable PCR panel and full panel size coverage

A PeakV cartridge features a panel of 16 PCR tubes mounted on a black color rack. This panel is editable, meaning users can easily remove or replace each PCR tube containing a specific assay. The panel of PCR tubes on the back rack can be small or large, enabling full PCR panel size coverage from one PCR tube (1-4 targets) to 16 PCR tubes (64 targets). All different sizes of PCR panels on each cartridge can be run in the same PeakV unit, integrated with magnetic bead extraction. Additionally, cartridges of different sizes (containing varying numbers of reagent tubes and PCR panel sizes) can be used on the same PeakV instrument.

Each PeakV instrument can accommodate cartridges of different PCR panel sizes. The picture shows an uncovered cartridge containing a large panel of 16 PCR tubes (64 targets). Other cartridges contain a panel of 8 PCR tubes (32 targets) and 4 PCR tubes (16 targets) for a variety of test applications.

3. Multiple-site nested PCR or multiple-site pre-amplification

Featuring integrated multiple-site nested PCR (MS-nPCR) or multiple-site pre- amplification (MS-preAmp), PeakV provides 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 solution for low copy detection applications, such as cancer testing and infectious disease testing.

Innovative and sophisticated user-programmable multiple-site nested PCR and pre-amplification strategies on PeakV achieve ultra-high detection sensitivity and specificity, as well as unbiased enrichment of all targets in the first round of PCR.

(a) Regular PCR panel

(b) PCR panel with a single-site pre-amp or nested PCR/pre-Amp

Auto-nested PCR increases LOD of HBV cccDNA testing in whole blood sample

Auto-nested PCR increases LOD of COVID-19 testing in swab sample

4. Excellent optical uniformity

PeakV features 16 optical imaging sites, each containing 4 colors. Different customized cartridges with varying PCR panel sizes can be run on the same instrument. The optimized optical design ensures excellent site-to-site or tube-to- tube fluorescent imaging uniformity.

Tube to tube uniformity - FAM (over 16 tubes)

Tube to tube uniformity - ROX (over 16 tubes)

Tube to tube uniformity - HEX (over 16 tubes)

Tube to tube uniformity - Cy5 (over 16 tubes)

5. Hands-free sample handling

For both POCT and lab applications, PeakV can integrate liquid handling-free centrifugation and bead beating into the user protocol without requiring manual handling of sample or reagent tubes by the user. This expands PeakV's applicability to a wide variety of sample types.

6. Open-Assay Cartridge Functionality

PeakV's contamination-free Open-Assay Cartridge offers universal assay capabilities, enabling third-party assay developers to seamlessly integrate their assays onto the PeakV cartridge for sample-to-answer POCT functionality. With no modifications required to the PeakV instrument or cartridge, users enjoy a smooth and efficient experience during application transitions.

7. Lower Cost Cartridge with Innovative Design and Technology

PeakV's cartridges employ a unique fluidic control principle, deviating from traditional microfluidics. This innovative design eliminates drawbacks such as high production costs, low operational reliability, and challenges in scaling up production. PeakV cartridges are assembled from large-sized parts produced through widely available regular injection molding.

8. Enhanced Reliability Compared to Conventional Microfluidics Cartridges

PeakV's cartridge design, which moves away from microfluidics, eliminates the need for microchannels, microvalves, and microchambers. This allows the cartridge to handle large volumes of reagents and samples in spacious chambers, free from the limitations of microchannels and microchambers during liquid transfer and mixing. These features ensure PeakV cartridges deliver the same high-quality technical performance and reliability as manual laboratory test operations.

OnsiteGene is actively pursuing collaborations with third-party PCR assay developers to broaden the capabilities of the PeakV platform for both clinical and non-clinical applications.