QA & Technology
ZiP systems will be commercially released using an ISO13485 and FDA CFR 820 compliant quality management system.
ZiP Diagnostics’ point-of-care (PoC) systems comprise a proprietary format isothermal molecular diagnostic technology. This approach provides sensitivity comparable to the Polymerase Chain Reaction (PCR). Sample to result is achieved in less than 30 minutes.
ZiP’s innovation and intellectual property covers sample preparation, assay and sample diagnostic chemistry, assay production, cartridge design, assay loading-cartridge production, instrument integration and assay algorithms that run on the instrument.
The ZiP instruments incorporate reliable high-sensitivity fluorescence detection optics that provide real-time quantitative data acquisition and scope for complex data analysis algorithms. Test assays are loaded in sealed low cost plastic cartridges. The instrument incorporates an intuitive touch screen user interface that guides the user through the workflow.
There is a wide range of applications for ZiP’s technology for human infectious diseases as well as animal and plant health. ZiP is building an extended test menu on its technology that includes viral hepatitis, respiratory viruses, vector-borne diseases and tuberculosis.
The ZiP-CoVx assay provides high sensitivity detection of viral RNA for SARS-CoV-2.
This assay provides low-cost diagnostic test system with high-sensitivity, comparable to gold standard Polymerase Chain Reaction (PCR). The ZiP-CoVx assay is highly specific and is not cross-reactive with other circulating coronaviruses and other respiratory infections such as influenza. This assay provides typical time to result of 15-30 minutes and incorporates a per-test, endogenous human gene internal control.
This product is in validation prior to regulatory submission. Currently for Research Use Only.
ZiP-CoVx-T1 Test System
The ZiP-CoVx-T1 test system is a fully sealed point-of-care cartridge that incorporates the ZiP-CoVx assay and integrated sample preparation. Designed to operate as true point-of-care, outside laboratories, the sealed T1 cartridge ensures there are no manual fluid transfers, thereby minimising biohazard risk. Samples types include nasal, nasal-pharyngeal or throat swabs that are added directly to the cartridge (saliva sample type currently in development). The ZiP-CoVx-T1 test system can operate with a dedicated single cartridge system or a four cartridge random access test instrument.
ZiP-CoVx-T1 allows point-of-care systems to be quickly deployed to almost any location to maximise impact on COVID-19 identification, containment and prevention management.
ZiP-CoVx-C2 Test System
The ZiP-CoVx-C2 test system implements the ZiP-CoVx assay in a low-cost cartridge format suitable for higher throughput test applications. Instruments can process up to eight cartridges with continuous random access. This system can provide throughput of 16-20 tests per hour and banks of instruments can be run by a single operator with software linked test data.
ZiP Onsite Test Centre
The ZiP Onsite Test Centre for SARS-CoV-2 is a portable Point-of-Care (PoC) high throughput, diagnostic test solution to aid in the control of COVID-19 outbreaks through a test, trace and isolate management regime. At the core of ZiP's Onsite Test Centre is the ZiP-CoVx molecular diagnostic assay and random access instruments. The Onsite Test Centre has a simple workflow and can be conducted by non-medical operatives. this system uses hepa-filter bio-safe loading stations to provide safe working environment without production aerosols and improved bio-hazard protection in addition to operator PPE. The system can be configured to run hundreds of tests per hour, with a data management backoffice software to manage secure encrypted data records, site administration, sample collection, test operation and communication of results to patients and stakeholders.
The ZiP CT-NG is a molecular diagnostic test system that is currently under development with collaborators to support antibiotic stewardship in low to middle-income countries and public health for chlamydia and gonorrhoea. The system’s planned commercial release is late 2021.