The IVD Reagent Platform is a lyophilization system specifically designed for the ambient-temperature transport of in vitro diagnostic reagents. Utilizing precise temperature control and vacuum dehydration technologies, it converts liquid reagents into solid lyophilized beads or powders, thereby preserving biological active ingredients and significantly enhancing reagent stability and shelf life. This platform integrates fully automated lyophilization production processes to ensure batch-to-batch consistency; it supports a wide temperature control range of -70°C to 35°C and achieves extremely low residual moisture levels (≤1%). Adaptable for the large-scale production of various biological reagents—including enzymes, antibodies, and antigens—the system effectively meets the demands of medical, research, and POCT (Point-of-Care Testing) settings for diagnostic reagents that are highly efficient, suitable for long-term storage, and convenient to use.

The flow path switching valve is capable of establishing corresponding fluidic connections—via its first or second inlet/outlet—with the respective fluid ports of multiple containment chambers. This arrangement facilitates the transfer of contents housed within the chambers between the switching valve and the chambers themselves. All associated fluid channels are integrally constructed within the preparation cartridge, resulting in a simple, compact structural design that enhances the efficiency of liquid transfer operations. Since the entire liquid transfer process takes place internally within the cartridge, users need only introduce the sample into the device; the accompanying instrument then automatically executes the subsequent steps—including sample processing, waste fluid recovery, and real-time fluorescence amplification detection. This streamlined workflow simplifies operational procedures, safeguards the safety of laboratory personnel, and eliminates the potential for human error, thereby enabling users to perform diagnostic testing after receiving only minimal training.

The core temperature control module comprises a flat plate and a top cover; the top cover is positioned opposite the flat plate and integrally connected to it. The top cover features multiple wells designed to accommodate reaction consumables. On the side of the top cover facing the flat plate, a containment cavity is formed between any two adjacent wells; these cavities are interconnected and filled with a phase-change heat transfer medium. The use of this phase-change medium accelerates heating and cooling rates and significantly enhances the temperature uniformity of the temperature control module within the bioreaction instrument, thereby reducing the duration of biochemical reactions. Furthermore, by dispensing with the structural designs found in the prior art, the temperature regulation performance of the module no longer relies excessively on the machining and assembly precision of associated components, thereby enhancing the overall reliability of the module.

Leveraging the Rocgene multi-color fluorescence platform, the standard probe-based method enables the simultaneous detection of five targets within a single tube. Furthermore, by utilizing our proprietary rapid enzymatic reaction system in conjunction with fluorescence probe melting curve technology, we can detect over 15 targets in a single tube; notably, the melting curve analysis (spanning 50–90°C) is completed in less than 8 minutes. The system is compatible with nested PCR, thereby significantly enhancing the sensitivity and specificity of ultra-multiplex detection. Moreover, drawing upon our independently established pathogen database and primer evaluation system, we are able to identify the optimal combinations of primer and probe sequences, thereby ensuring the robust performance of ultra-multiplex qPCR assays.

To prevent cross-interference between optical paths during detection, the optical reading head performs an arc-shaped scan, sequentially traversing the 96 wells while simultaneously and rapidly switching between multiple internal optical channels. When a light source is activated, it excites the reaction system within the corresponding EP tube situated beneath it, inducing a Stokes shift in fluorescence. The emitted fluorescence is then collected by a detector located at the top; after undergoing photoelectric conversion into an electrical signal, it is converted via an A/D converter into a digital signal for transmission to a computer. During detection, the optical path configuration is designed such that when the focusing lens of one specific optical path is aligned with the cap of a PCR reaction tube on the rack, all other optical paths are simultaneously aligned with the interstitial spaces of the rack—rather than with any other PCR reaction tubes—thereby effectively preventing cross-interference between the optical paths.

Acquire the data packet generated upon the completion of a PCR amplification experiment, wherein the data packet comprises multiple sets of arrays, with each array consisting of corresponding pairs of cycle numbers and fluorescence values. When the number of such arrays exceeds a first threshold, perform point-fitting on these multiple sets of arrays to generate an amplification curve for analysis. Based on the quality of the fit of the amplification curve under analysis, assess its validity to obtain a first determination result. If the first determination result indicates a valid amplification curve, determine the background value based on the fluorescence values ​​contained within the data packet. Subsequently, utilizing both the fluorescence values ​​and the background value from the data packet, re-evaluate the validity of the amplification curve under analysis to obtain a second determination result. This method enables the identification of valid amplification curves, thereby ensuring the accuracy of the data used for the qualitative and quantitative analysis of test samples, while simultaneously excluding invalid amplification curves to prevent futile or erroneous analyses.