Invented by Adnan Esmail, Tal Raz, John Healy, Tony Hung, Sepehr Kiani, Pascaline Mary, Bio Rad Laboratories Inc

The market for integrated microfluidics systems, methods, and kits for performing assays has been growing rapidly in recent years. These systems are designed to provide a highly efficient and automated way to perform a wide range of assays, including those used in medical diagnostics, drug discovery, and environmental monitoring. Integrated microfluidics systems are based on the principles of microfluidics, which involves the manipulation of small volumes of fluids using microscale channels and structures. These systems typically consist of a microfluidic chip, which contains the channels and structures, and a control unit, which regulates the flow of fluids and performs the necessary analysis. One of the key advantages of integrated microfluidics systems is their ability to perform assays with very small sample volumes. This is particularly important in medical diagnostics, where the amount of sample available may be limited. By using microfluidics, it is possible to perform assays with sample volumes as small as a few microliters. Another advantage of integrated microfluidics systems is their high level of automation. Many of these systems are designed to be fully automated, with the control unit performing all of the necessary steps in the assay process. This reduces the risk of human error and increases the speed and efficiency of the assay. The market for integrated microfluidics systems, methods, and kits is expected to continue to grow in the coming years. This growth is being driven by a number of factors, including the increasing demand for more efficient and automated assay systems in medical diagnostics and drug discovery. In addition, the development of new microfluidic technologies is also driving growth in this market. For example, the development of droplet-based microfluidics has opened up new possibilities for performing high-throughput assays with very small sample volumes. Overall, the market for integrated microfluidics systems, methods, and kits for performing assays is a rapidly growing and exciting area of research and development. As new technologies continue to emerge, we can expect to see even more innovative and efficient systems being developed to meet the needs of a wide range of applications.

The Bio Rad Laboratories Inc invention works as follows

The invention provides a microfluidic device, method, and kit for performing assays. The system could include a microfluidic device, a detector, and the assay results can be read by a detector. An assay can include one or more chemical reactions or biological reactions against or performed on a sample. During the performance of an assay, the sample(s) could become larger or smaller. The sample(s), which may be contained within a vessel or on a carrier inside a vehicle in the microfluidic system, may change size during the assay. A cascading assay could consist of several assays. Each assay can be identical or different. Additionally, each assay within the series may include one or more steps or processes.

Background for Integrated microfluidics system, method, and kit for performing assays.

In most biological or chemical laboratories (e.g. genetics and molecular biology laboratories), tests or processes (referred as?assays?) are performed. Each step is handled in separate process steps. Each step can be manually or robotically moved between processing elements. In nucleic acid assays for example, PCR amplification is performed before any additional steps such as hybridization and fluorescent labeling. Another example is that of proteomic assays where the sample can interact with one reagent first and then another in a second step to produce the readable output. Each step, whether it is robotic or manual, introduces delays in processing and increases the chance of making mistakes. A system that can efficiently and reliably perform assays is needed.

The present invention is a system, method, and kit that allows for efficient and reliable chemical and biological assays.

The citation or identification of any document within this application does not mean that it is admissible as prior art for the present invention.

The invention generally relates to a system for performing experiments. The present invention relates to a microfluidic device that can perform biological and chemical assays. One embodiment of the system could include a microfluidic device as well as a detector. One aspect of this embodiment is that the assay produces results that can be read by a detector, and then analyzed by the system. Another aspect of this embodiment allows for the selection of an assay from either a chemical or biological assay. Another aspect of this embodiment is that the assay can include one or more reactions against or performed on a sample. One embodiment may result in the sample becoming larger during the assay. Another embodiment may see the sample shrinking during the assay.

In another embodiment, the sample could be contained within a microfluidic device. One aspect of this embodiment is that the vehicle might grow during the assay. Another aspect of this embodiment is that the vehicle could shrink during the performance. Another embodiment may allow a sample to be placed on the carrier’s surface. One aspect of this embodiment is that the sample could be found on the surface a carrier in a microfluidic device.

In another embodiment, multiple samples are used for the assay. Another embodiment of the assay uses multiple samples. One aspect of this embodiment is that the cascading test consists of multiple assays. Each assay can be identical or different and each assay within the series may also include one or more steps.

The present invention also covers methods of performing assays using the system described earlier and further herein.” Further, the present invention includes a kit that contains the system and the reagents required to perform the methods of the invention as described above and further herein.

It should be noted that terms such as “comprises?”, ‘comprised? or?comprising” are used in this disclosure, and in particular in the claims and/or paragraphs. The meaning of terms like?comprises?, or?comprised? can be attributed to them in U.S. Patent Law. ?consists essentially? They have the same meaning as U.S. Patent Law, e.g. they permit elements not explicitly recited but exclude elements found in prior art or that impact a fundamental or novel characteristic of the invention.

These and other embodiments can be disclosed or made obvious by the following detailed description.

The present invention generally relates to a system for performing chemical and biological assays. They are collectively called ‘assays’. The invention can be used to perform any type of test or process in a biological or chemical laboratory (e.g. genetics, molecular biology and biochemistry laboratories). An assay can be defined as any biological or chemical reaction that is performed against a sample or on it. The results may be read by a detector, and the system may then analyze them according to the invention.

A sample(s), one or more samples, or sample(s), of interest?” These terms are interchangeable in plural or singular form. They are not meant to be restricted to any one quantity. The user may use any molecule or substance to obtain information. During the assay, a sample can become larger or smaller by inflation or partitioning. A sample can be amplified or subdivided during an assay.

In one embodiment, a sample is contained within a microfluidic device. One aspect of this embodiment allows multiple samples to be present in one vehicle. However, they can also be separated from each other at any time during an assay. A vehicle that contains one or more samples can become larger or smaller during an assay (e.g. by inflation or partitioning). During an assay, a vehicle can be amplified or subdivided multiple times. The present invention also allows for a “cascading assay”, which may include multiple assays. Each assay can be identical or different and may contain one or more steps. One aspect of this embodiment is that the sample is contained in a container within a microfluidic device.

?Inflation?”, as used herein refers to the increase in volume or contents of a vehicle through injecting or using other means of transferring fluids or other components into it. In the case of samples, this refers to increasing volume or content by amplification (e.g. PCR, cell division, or any other mechanism for increasing a sample’s content or size) so that it becomes significantly larger than before inflation. Partitioning, as it is used herein, refers, in essence, to the subdividing and/or partitioning of a sample/vehicle so that its size, volume, and/or contents are significantly smaller than before partitioning.

According to one example, a sample contained in a vehicle can be amplified (e.g. by PCR, cell divide or other mechanism for increasing a sample’s content) one, twice or more times and/or divided one, two, or multiple times into individual samples within a cascading test. Another example is to inflate a vehicle with a sample one, two, or more times, and/or divide one, two, or multiple times into multiple cars. Each vehicle could contain one or more samples within a cascading test. Another example is to inject a sample from a first vehicle into a second vehicle. The second vehicle could contain one or more additional samples. Another example is where a sample can be amplified on a carrier’s surface (e.g., bead). This example shows that the carrier could also be present in a vehicle with multiple carriers. Each carrier has at least one sample and each sample is separated from the other. The vehicle is then partitioned within a cascading process, which results in selective partitioning of one or several samples from the remaining samples. After a sample has been separated from its carrier, it may be possible for the carrier to be removed from the vehicle when the vehicle is partitioned.

FIG. “FIG. The system receives samples and processes them through a cascading process. A detection system generates a signal from the results and content of the assay at the end. The system then analyzes the signals to determine the result of the assay. The present invention also allows for the detection and sorting, according to user preference, of sample, vehicle, and/or results at all stages of a capillary assay. This allows only relevant, selected, or preferred information to be allowed through as a readout. This improves the throughput of a capillary assay.

The present invention allows any type of sample to be divided by injecting portions, parts or components into any vehicle. The present invention allows for the injection of one sample into many vehicles (e.g. droplets), and the process can be repeated in a cascading fashion. In this way, injected droplets can be reinjected into droplets to further partition or introduce new chemical reagents. The present invention also allows for multiple droplets to be injected into one droplet (sample joint). The preferred location for sample joining is at the junction of or between microfluidic channels. The relative pressure within the microfluidic channels that intersect determines the direction of injection.

FIG. “FIG. FIG. 2 illustrates the system 120. 2. A sample 121 is then injected by the user into the system 120. The user then divides the sample 121 into multiple?N? The sample 121 is then divided into multiple?N? segments 123. Upon which assay reagents can be added via injection or inflation (as illustrated by Reagent Set 1 127), one or more assays can be performed. The first three N segments 123, by way of illustration, are called?Assay 1. For the assay on the partitioned N segments 1 and 2, refer to?Assay 2. For the assay on partitioned segment 2, and?Assay 3, respectively. For the assay on partitioned segment 3 and?Assay 3?, respectively. FIG. 2.

Next, each N segment 123 previously assayed will be further divided into multiple?M? segments 125 into which assay reagents can be added by injection or inflation. Upon completion of further assays, the remaining N segments 123 are divided. Each assay on each M segment that is partitioned from N segments 1 to 125 is called?Assay 1-1′,?Assay 2 & 3?. each assay is referred to as?Assay 1-1?,?Assay 2?,?Assay 3?, and so on all the way up to?Assay 1-M? FIG. 2. Each assay on each M segment divided from N segment 2 is also referred to as “Assay 1”, “Assay 2”, or “Assay 3”. respective and?Assay 2?, and so on all the way to?Assay 2M? For the last assay on an M segment divided from N segment 2, Each assay on an M segment divided from N segment 3 is called?Assay 3-1,?Assay 2-3?. respective and so on all the way to?Assay 2M? FIG. 2. Each of the N segments (123) may be divided multiple times. This results in M segments 125. Each of these can be assayed any number of times. All the way to?Assay M-M? FIG. 2. The cascading process may be repeated multiple times using the system of invention as shown in FIG. 126. 2.

The integrated microfluidic device is one embodiment of the invention. As used herein, a “microfluidic device” is a device that allows the operation of a deterministic function on liquids or gases at small scales. These scales are typically in microliters (?L), microliters (?L), picoliters (pL), and femtoliters (fL) volumes, but can also be measured by physical scales such as micrometers (?all), millimeters (?mm), and micrometers (?all), as?micron (also called?micron) (also known as?micron) or?micron) (or?micron) (also?micron) (?micron) or?micron) (also?micron) or?micron) or?micron) or?? You can also find the nanometer (nm) and other functions. These functions may include mixing and splitting, sorting, heating, etc. As a way to transfer fluids or samples from one place to another, microfluidic devices can include microfluidic channels. They are usually uniform in cross section and have a mm,?m or nm range.

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