These multifunctional measurement capabilities have been made possible by innovative system integration of two different fluidic subsystems, a high resolution optical system comprising uniquely capable optical sensor arrays, and a versatile electronic system and software, generating the Indexus-H5F multifunction blood analyzer. Due to its versatile design architecture, the Indexus-TriSense Dx platform can be operated as an automated hematology analyzer delivering CBC with extended 5-part differential, or can be used as a cellular immunoassay analyzer to perform tests such as the CD4 count or confirmatory immunophenotyping assays for lymphoma and leukemia, or operated as a sensitive immunoassay analyzer to detect antibodies and antigens employing bead-based immunoassay protocols. Further details of the TriSense Dx instrument platform can be viewed by clicking on the "More Info" tab below. The key applications of this platform are also described further down on this page.
Integrated Multifunction Blood Analysis Platform Technology (patent pending)
Combining hematology, fluorescence flow cytometry and immunoassays on a single, compact, easy-to-use, and affordable platform for the primary care laboratory
At Indexus Biomedical we are addressing the above problem by developing a uniquely powerful platform technology that is able to identify and enumerate cells based on differences in morphologies, surface receptors, and nucleic acid content of the cells. In addition, this sensitive platform is able to also identify small molecules such as antibodies, antigens, and nucleic acid fragments in blood and other bodily fluid.
The Indexus TriSense Dx platform identifies cells based on Cellular Morphology and Cellular Immuno-phenotypes; it is also able to detect non-Cellular Analytes (Protein Biomarkers).
Complete Blood Count (CBC) is one of the most frequently prescribed in-vitro diagnostic (IVD) tests. Over a billion CBCs performed each year worldwide. This has made the automated hematology analyzer one of the most essential equipment in IVD laboratories. Hematology Analyzers count thousands of blood cells in whole blood within a minute, delivering accurate results based on cell morphology (size, shape and internal structure). However, none of the hematology analyzers currently in the market for use in the small to medium sized laboratories can provide any information on the immunophenotypes of the cells. As a result, important diagnostic information such as the CD4 lymphocyte cell count, for example, cannot be obtained from those hematology analyzers. And obviously they are also incapable of detecting any protein biomarkers, such as antibodies or antigens, that may be present in a blood or serum samples. For such measurements, other equipment must be purchased at significant additional capital and operating costs.
Indexus Biomedical LLC is pioneering the development of advanced hematology and flow cytometry technologies that will enable us to bring reference laboratory caliber IVD tests into the small laboratories at the primary care level in a highly affordable manner.
Our patent pending technology portfolio, comprising instrumentation, reagents and assay protocols, will allow the healthcare provider to perform important hematology and immunodiagnostic tests on a single, easy-to-use, compact and low-cost instrument. By making available a broader menu of critical IVD tests at the primary care laboratories closer to the patients' homes, this multifunction platform will deliver faster test results, accurate ealy diagnosis of diseases, and as a result, a better treatment outcome. The test menu can be expanded in the future without any further hardware changes.
This multifunction system is designed specifically for the small decentralized laboratories, such as those associated with the urgent care and primary care centers, physicians' offices, small clinics and hospitals, rural health clinics and certain mobile health clinics. However, our core technologies are also easily scalable and, in the future, the same technologies can be used to build large and very high throughput systems for the high-volume reference laboratories.
TriSense Dx Technologies
5-Part Differential Technology using 3 Light Scatter Detectors (patent pending)
Low Power Laser, Inexpensive Photodiodes, Miniature Electronics, and High Performance Reagents
Innovative reagent strategies deliver improved extended differential analysis capabilities beyond the standard 5-part Differential
A key to building a compact and low-cost multifunction analyzer that performs both hematology and immunoassays is to be able to design a core hematology analysis capability for 5-part differential that itself is simple, small and inexpensive. Our patent pending TriSense Dx multi-angle light scatter sensor and reagent technologies deliver such a capability. offering high resolution differential analysis beyond the five major leukocyte populations (extended 5-part differential). Compared to hematology analyzers from major manufacturers, this system utilizes the least number of light scatter sensors and a simple flow cell. A hallmark of this design is the excellent resolution of eosinophils from the neutrophils and basophils without having to use complex biochemical staining or expensive radiofrequency detection, as is done in many other competitive products. The system is also capable of identifying immunologically significant sub-populations of lymphocytes based on light scatter, using proprietary reagents that does not require expensive antibodies.
RBC and Platelet Analysis (patent pending)
Indexus TriSense Dx multi-angle light scatter sensors and its proprietary RBC diluent together allow RBC and Platelets to be identified and enumerated with accuracy. It is well known that when normal whole blood sample is run through a flow cytometer and its forward or side scatter is measured, bimodal distribution results for each parameter (see the left-hand figure below). Our proprietary RBC diluent and low-noise light scatter detectors generate high resolution data that produces unimodal distributions and resolves the RBC and Platelet populations clearly and reproducibly (see right-hand figure below).
Cellular Immunophenotyping (CD4 Counts and others cellular immunoassays)
Bead-based Fluorescence Immunoassays (Antibody and Antigen tests)
Sensitive fluorescence flow cytometry technology enables immunoassays to be performed, employing bead-based sandwich immunoassay format
Leukemia and Lymphoma Diagnosis by CBC and Immunophenotyping
Cellular immunophenotyping capabilities the Indexus TriSense Dx platform opens opportunities for rapid and accurate diagnosis of hematological cancers
Indexus TriSense Dx system includes integrated multi-color fluorescence detectors that allow gold-standard fluorescence flow cytometry analysis at a fraction of the cost of commercial flow cytometers and POC instruments that are in the market as dedicated CD4 analyzers. Results comparable to BD FACSCalibur has been achieved.
Sensitive Fluorescence Detectors Allow Gold-Standard Flow Cytometry CD4 Counts at a Fraction of the Cost of Competitive Instruments
Indexus TriSense Dx system's fluorescence flow cytometry and multi-angle light scatter technologies have been used to detect antibodies and antigens in human serum and plasma using bead-based immunoassay protocols. Results comparable to ELISA plate readers have been achieved for HIV testing.
Currently, confirmatory diagnosis of hematological malignancies requires multiple blood draws and testing in specialty laboratories that can take weeks before results are available to the prescribing physician. Indexus H5F system will change this into a single-sample, same-day process at the primary care laboratory. With the high resolution multi-angle light scatter technologies on the TriSense Dx platform, early detection of immature and abnormal cells often indicative of hematological malignancies are made easier. Additionally, the instrument system's multi-wavelength fluorescence flow cytometry capability will enable the laboratory to perform confirmatory diagnosis of lymphoma sub types (T- and B-cell Lymphoma) and leukemia using the same sample. The system will also perform tests on whole blood as well as lymph-node aspirates as appropriate.