HK1254360B - Modular testing device for analyzing biological samples - Google Patents

Description

Modular test device for analyzing biological samples

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No. 62/138,157, filed on March 25, 2015, and entitled “Modular Test Device for Analyzing Biological Samples,” the disclosure of which is incorporated herein by reference in its entirety.

Background Art

The present invention relates to devices capable of analyzing biological samples, and in particular, to modular testing devices for analyzing biological samples.

After collecting biological samples in the field, they are typically tested in a laboratory. After the sample has been collected, many steps are taken to prepare the sample, including mixing the sample with reaction buffer, dye, and any other chemical solutions needed to prepare the sample for testing. During or after sample preparation, the testing equipment also needs to be prepared. This may include heating equipment, calibration equipment for running a specific test, and running the equipment used through any other initial steps required for the specific test. Once the sample and equipment are ready, the prepared sample can be placed in the equipment for testing.

The typical process for testing the above-mentioned biological samples has significant disadvantages. One disadvantage is that the biological samples need to be collected in the field, brought to the laboratory, and then tested. This can cause the following problems. First, the biological sample can become contaminated between the time it is collected and the time it is tested. Second, it may be found that not enough biological sample can be collected in the field, preventing the test from being completed. Third, it may be found later that the collected biological sample is otherwise unsuitable for testing. If a biological sample is unsuitable for testing due to any of the above reasons, additional biological samples will need to be collected in order to complete the test. This requires additional time, money, and other resources to complete.

To address the issues discussed above, portable testing devices are available for analyzing biological samples in the field. One such device is disclosed in PCT application No. PCT/US14/59487, filed on October 7, 2014, and entitled "Portable Testing Device for Analyzing Biological Samples," the disclosure of which is incorporated herein by reference in its entirety. To be portable, testing devices need to be small enough so that they can be easily transported. This limitation on the size of portable testing devices limits the number of biological samples that can be tested at one time.

Summary of the Invention

The modular testing device includes a base unit and an expansion unit in communication with the base unit. The expansion unit includes a housing, a container in which a sample holder containing a biological sample and a reagent mixture can be placed, and an optical assembly positioned within the housing. The optical assembly is configured to amplify and detect signals from the biological sample and reagent mixture. Data collected in the optical assembly is transmitted to the base unit.

The modular testing device includes a base unit and an expansion unit in communication with the base unit. The base unit includes a housing with an integrated touch screen display, a container in which a sample holder containing a biological sample and a reactant mixture can be placed, and an optical assembly positioned in the housing. The optical assembly is configured to amplify and detect signals from the biological sample and the reactant mixture. The expansion unit includes a housing, a container in which a sample holder containing a biological sample and the reactant mixture can be placed, and an optical assembly positioned in the housing. The optical assembly is configured to amplify and detect signals from the biological sample and the reactant mixture.

A method for analyzing a biological sample and a reactant mixture in a modular test device includes preparing the biological sample and reactant mixture for testing and placing the biological sample and reactant mixture in a sample holder. The sample holder is placed in a container in an extension unit. An excitation and detection test sequence is initiated to analyze the biological sample and reactant mixture in the extension unit. Data is collected from the excitation and detection test sequence in the extension unit. The data is transferred from the extension unit to the base unit.

BRIEF DESCRIPTION OF THE DRAWINGS

1A is an illustration of a first embodiment of a modular testing device including a base unit and an expansion unit.

1B is an illustration of a second embodiment of a modular testing device including a base unit and an expansion unit.

1C is an illustration of a third embodiment of a modular testing device including a base unit and an expansion unit.

FIG2A is a perspective view of a base unit.

2B is a perspective view of the base unit when a sample holder in the form of a tube array is placed in the base unit.

FIG3 is a block diagram of the base unit.

FIG4 is a perspective view of an extension unit.

FIG5 is a block diagram of an extension unit.

FIG6A is a perspective view of an optical assembly.

FIG6B is a cross-sectional view of the optical assembly.

FIG7 is an exploded view of the heating portion of the optical assembly.

FIG8 is an exploded view of the lens portion of the optical assembly.

FIG. 9 is an exploded view of the housing portion of the optical assembly.

10A is a partially exploded view of a first optical mounting portion of an optical assembly.

10B is a partially exploded view of the second optical mounting portion of the optical assembly.

10C is a partially exploded view of the first optical mounting portion and the second optical mounting portion of the optical assembly.

FIG. 11 is a flow chart illustrating steps for operating a modular testing device.

DETAILED DESCRIPTION

In general, the present disclosure relates to modular testing devices for analyzing biological samples. In the embodiments described below, the modular testing device can test biological samples using an isothermal amplification process (e.g., NEAR chemistry, LAMP chemistry, RPA chemistry, or NASBA chemistry). This eliminates the need for thermal cycling as a means of amplifying nucleic acid products for terminal detection.

Figure 1A is an illustration of a modular test device 100 including a base unit 102 and an expansion unit 106. Figure 1B is an illustration of a modular test device 100 including a base unit 102 and an expansion unit 106. Figure 1C is an illustration of a modular test device 100 including a base unit 104 and an expansion unit 106.

Modular test device 100 includes a base unit (including any one of base unit 102 or base unit 104) and one or more expansion units 106. In Figure 1A to Figure 1B, modular test device 100 is shown with base unit 102. Base unit 102 can be used for analyzing biological samples (also referred to as biological samples and reactant mixtures) mixed with reaction mixtures. Base unit 102 includes an optical assembly to amplify, excite and detect biological samples placed in base unit 102 for testing. Base unit 102 also includes a power supply for powering base unit 102, an electronic assembly including components capable of running a test protocol, and a display screen, wherein a user can interface with the display screen to select parameters for the test protocol and the display screen can display the data actually collected. In Figure 1C, modular test device 100 is shown with base unit 104. In the embodiment shown, base unit 104 is a desktop computer, but in alternative embodiments, it can be a laptop computer, a tablet computer, a mobile phone, a smart watch, an embedded PC or any other suitable computer. The base unit 104 includes a power source to power the base unit 104, an electronic assembly including components capable of running a test protocol, a machine-readable code reader, and a display screen with which a user can interface to select parameters for the test protocol and which can display the data actually collected.

In the embodiment shown in Figures 1A to 1C, three expansion units 106 are shown. In alternative embodiments, any number of expansion units 106 may be used. Each expansion unit 106 includes an optical assembly to amplify, excite, and detect biological samples placed in the base unit 102 for testing. In the embodiment shown in Figures 1A to 1C, each expansion unit 106 also includes a power supply for supplying power to the expansion unit 106. In alternative embodiments, the expansion units 106 do not have a power supply but are instead powered by the base unit. Each expansion unit 106 also includes an electronic assembly that includes components capable of transmitting data to the base unit. Each expansion unit 106 interfaces with and is controlled by a base unit, which may be either base unit 102 or base unit 104. The base unit communicates with the expansion unit 106 to indicate which test to run in the expansion unit 106 and when to initiate the test. The expansion unit 106 may be connected to the base unit using a hardwired connection or may be connected to the base unit using a wireless connection. Optical components can be used to complete testing in each extension unit 106 and transmit data collected during testing to the base unit. Before the data is transmitted to the base unit, it can be processed in the extension unit 106, or it can be transmitted to the base unit before processing. In any case, the data can also be processed in the base unit.

In the embodiment shown in Figures 1A and 1C, the first extension unit 106 is connected to the base unit, the second extension unit 106 is connected to the first extension unit 106, and the third extension unit 106 is connected to the second extension unit 106. In the embodiment shown in Figure 1B, the extension units 106 are each connected to the base unit. In addition, in an alternative embodiment, the extension units 106 can be connected to each other or the base units can be connected to each other. In one embodiment, for example, the first base unit 102 can be connected to the second base unit 102. The first base unit 102 can transmit to the second base unit 102 what test to run and when to start the test. The first base unit 102 and the second base unit 102 can be tested simultaneously or at different times. In each of Figures 1A to 1C, the extension unit 106 and the base unit can be connected using a hardwired connection or a wireless connection.

The expansion units 106 can test biological samples simultaneously or at different times. For example, each expansion unit 106 can be loaded with a biological sample. The base unit can then instruct each expansion unit 106 to start testing simultaneously. Alternatively, the first expansion unit 106 can be loaded with a biological sample, and the base unit can instruct the first expansion unit 106 to start testing. Then, the second expansion unit 106 can be loaded with a biological sample, and the base unit can then instruct the second expansion unit 106 to start testing.

The expansion unit 106 can test biological samples using turbidity, fluorescence, chemiluminescence, thermoluminescence, photometry, absorbance, or radiometry. The expansion unit 106 can also run different analytical methods, such as immunoassays, DNA amplification, mass spectrometry, or high-performance liquid chromatography. A single base unit can control expansion units 106 that use different tests and run different analytical methods.

The modular test set 100 is advantageous because it allows users to customize their modular test set 100 for different applications. The expansion unit 106 can be used with the base unit 102 when the user wants to perform testing in the field. The expansion unit 106 can then be used with the base unit 104 when the user is testing in a laboratory setting. The expansion unit 106 also allows the user to customize how many tests to run during a testing regimen. The modular test set 100 can also include a stand that can hold the expansion unit 106. The stand can be designed to fit over the base unit so that the expansion unit 106 can be positioned on the stand above the base unit.

FIG2A is a perspective view of base unit 102. FIG2B is a perspective view of base unit 102 with a sample rack in the form of tube array 108 positioned therein. Base unit 102 includes housing 110 (including first housing portion 112 and second housing portion 114), display 116, handle 118, lid 120, container 122 (shown in FIG2B ), and optical assembly 124 (shown in FIG2B ). FIG2B also shows tube array 108.

Base unit 102 is used to analyze biological samples (also referred to as biological samples and reactant mixtures) that have been mixed with reaction mixtures. Housing 110 forms the main body of base unit 102. Housing 110 includes a first housing portion 112 and a second housing portion 114. The first housing portion 112 forms the base portion of base unit 102 and the second housing portion 114 forms the top portion of base unit 102. Display 116 is located on the front top side of housing 110. In the embodiment shown, display 116 is a touch screen display, but in an alternative embodiment, it can be any suitable display. The user can use display 116 to select a test scheme and set the parameters for the test to be run in base unit 102. The user can also use display 116 to provide a sample and check the traceability information of base unit 102. Display 116 will also be displayed on the data collected during the test.

The housing 110 also includes a handle 118. In the illustrated embodiment, the handle 118 is located on the front side of the housing 110, but may be located in any suitable location in alternative embodiments. In the illustrated embodiment, the handle 118 is shown as an integrated handle with the housing 110, but may be attached to the base unit 102 in any suitable manner in alternative embodiments. The inclusion of the handle 118 on the base unit 102 allows the base unit 102 to be easily transported in the field.

As seen in FIG2B , in the illustrated embodiment, container 122 is located on the top side of base unit 102, but may be located in any suitable location in alternative embodiments. Container 122 is an opening in housing 110 of base unit 102. A sample rack containing a biological sample and a reagent mixture may be placed in container 122 for testing. In FIG2B , container 122 is configured to accommodate tubing array 108. In alternative embodiments, container 122 may be configured in any manner capable of accommodating a sample rack.

The housing 110 also includes a lid 120. In the illustrated embodiment, the lid 120 is located on the top side of the housing 110, but in alternative embodiments, it may be located at any suitable location. The lid 120 is included on the base unit 102 to seal the container 122. When the sample holder is placed in the container 122 of the base unit 102, it will be positioned in the optical assembly 124 retained in the base unit 102. The optical assembly 124 is positioned just below the container 122 and can be accessed through the container 122. The optical assembly 124 will be able to amplify, excite, and detect the biological sample in the sample holder. The optical assembly 124 includes a heating element for heating the biological sample to amplify it. The heating element can heat the biological sample at a constant temperature or the heating element can cycle the biological sample through different temperatures. The optical assembly 124 will then excite the biological sample with radiation, causing the biological sample to emit radiation.

The lid 120 is positioned over the container 122 to prevent radiation from escaping the housing 110 through the container 122. The lid 120 also prevents ambient light from entering the housing 110 through the container 122, which prevents the ambient light from skewing or offsetting the results of tests run in the base unit 102. The lid 120 also seals the container 122 to prevent contaminants from entering the container 122 when the base unit 102 is in use in the field. The lid 120 is movable between an open position and a closed position and can be retained in the closed position by any suitable means. In the illustrated embodiment, the lid 120 is retained in the closed position by a magnet. When the lid 120 is in the open position, a sample holder (including the tube array 108) can be inserted into and removed from the container 122. When the lid 120 is closed, the sample holder remains in the container 122, and radiation in the base unit 102 does not escape the housing 110. When the lid 120 is in the closed position, it applies pressure to the sample holder placed in the heating block in the base unit 102. This improves engagement and heat transfer between the sample holder and the heating block in the base unit 102.

The container 122 can be shaped to accommodate any sample rack, thereby allowing the base unit 102 to be designed to accommodate a wide variety of standard and conventionally designed sample racks. The tube array 108 is a standard sample rack that is widely available on the market. Cards can also be conventionally designed to serve as sample racks for use with the base unit 102. The container 122 allows the base unit 102 to be designed to accommodate a wide variety of sample rack shapes and sizes.

The base unit 102 is designed for use in the field and provides many advantages for such use. Biological materials collected in the field can be tested in the field at the time they are collected. This alleviates concerns about contamination or decomposition of the biological samples because the biological samples do not need to be transported back to the laboratory for testing. In addition, the base unit 102 allows the user to quickly react to the results of the tests run in the field. If the test is inconclusive, additional biological material can be collected and sampled immediately. In addition, if the test indicates the presence of a pathogen or toxin in the sample, the user can immediately initiate an appropriate safety plan to combat the pathogen or toxin.

The base unit 102 includes many features that make it suitable for use in the field. A handle 118 is included to facilitate transport of the device. The display 116 is integrated into the base unit 102 so that the base unit 102 can function as an all-in-one system because the base unit 102 can test biological samples, process the collected data, and display the data on the display 116. The display 116 eliminates the need to connect the base unit 102 to another machine or computer to process and display the test results. This allows users to avoid having to carry extra equipment in the field or having to wait until they return to the laboratory to read the data. The base unit 102 includes all the features needed for testing, processing, and displaying test results in a compact, all-in-one device.

3 is a block diagram of base unit 102. Base unit 102 includes display 116, power supply 130, electronics assembly 132, machine-readable code reader 134, and optical assembly 124. Optical assembly 124 includes heating block 140, light emitting diode 142, and photodetector 144.

The base unit 102 is used to analyze and obtain data from biological samples in the field. To accomplish this, the base unit 102 is equipped with a display 116, a power source 130, an electronics assembly 132, a machine-readable code reader 134, and an optical assembly 124. In the illustrated embodiment, the display 116 is a touchscreen display that serves as the primary user interface between the user and the base unit 102. The user can enter information into the display 116 to indicate which test should be run in the base unit 102 for each biological sample. In addition, the user can monitor the results of the tests run in the base unit 102 on the display 116.

Display 116 is connected to an electronics assembly 132 having interface circuitry. Information input into display 116 is transmitted to electronics assembly 132 using the interface circuitry. Electronics assembly 132 includes the hardware, firmware, and software that controls the operation of base unit 102, including a microprocessor. Electronics assembly 132 indicates which test is to be run in base unit 102 and transmits this information throughout the device. Data collected in base unit 102 during testing is also transmitted to electronics assembly 132. Electronics assembly 132 processes this data and sends it to display 116 for display. Electronics assembly 132 also stores this data for later retrieval or transfer.

The electronic assembly 132 is connected to the power supply 130 using an interface circuit. The power supply 130 includes components capable of powering the base unit 102, including a battery, a power supply board, a power switch, and a power jack that can be connected to a power supply for recharging. Power from the power supply 130 is transmitted to the electronic assembly 132 through the interface circuit, allowing the base unit 102 to operate.

The base unit 102 may further include a machine-readable code reader 134. When a sample rack containing a machine-readable code is placed in the base unit 102, the machine-readable code reader 134 can read the machine-readable code on the sample rack. The machine-readable code can also be provided separately from the sample rack. The machine-readable code can contain all parameters for the test protocol and inspection traceability information for the test to be run. Alternatively, the machine-readable code can indicate which test to be run. This is advantageous because it allows the user to insert a sample into the base unit 102, and the base unit 102 will automatically select the test protocol and start the test.

The electronic assembly 132 includes a microprocessor, associated memory, and interface circuitry for interfacing with the display 116 and the optical assembly 124. Input received from the display 116 in the electronic assembly 132 can be processed in the electronic assembly 132. This information can be used to control the optical assembly 124. The optical assembly 124 performs a test on a biological sample placed in the base unit 102. Upon completion of the test, the data collected in the optical assembly 124 can be transmitted to the electronic assembly 132. The electronic assembly 132 processes this data and can send the data to the display 116 so that the user can monitor the test results. The electronic assembly 132 can also send the data to an external device using any suitable data transfer means, including wireless transmission or transmission through a USB port, microUSB port, SD card, or microSD card.

The optical assembly 124 includes a heat block 140, a light-emitting diode 142, and a photodetector 144 to perform testing on a biological sample placed in the base unit 102. The optical assembly 124 uses heat to amplify the biological sample and then excites the biological sample with radiation to detect the presence of a specific fluorescent marker. The biological sample placed in the base unit 102 is mixed with a reaction mixture containing one or more fluorescent dyes. When the biological sample is placed in the base unit 102, the heat block 140 amplifies the biological sample with heat. The heat block 140 is positioned below the container 122 in the base unit 102 so that when a sample holder containing the biological sample is placed in the base unit 102, the sample holder is positioned in the heat block 140. After the biological sample is amplified, the biological sample can be analyzed using the light-emitting diode 142 and the photodetector 144. The light-emitting diode 142 transmits radiation to the biological sample to excite it. Multiple light-emitting diodes 142 can be used in the base unit 102 to excite the biological sample at a predetermined cycle rate. In the illustrated embodiment, the plurality of light emitting diodes 142 are cycled intermittently at 1.54 kHz. In alternative embodiments, the light emitting diodes 142 may be cycled at any predetermined cycle rate. When the biological sample is excited at the predetermined cycle rate, it will emit radiation at the same predetermined cycle rate and at a wavelength corresponding to the fluorescent dye added to the biological sample. This radiation may be received by a photodetector 144. Multiple photodetectors 144 may be used in the base unit 102 to read the emitted radiation from the biological sample at different radiation wavelengths. The signals generated by the photodetectors 144 may then be sent to the electronics assembly 132 for processing and analysis, and displayed on the display 116 as data collected during the test.

The base unit 102 is advantageous because it is an integrated device. The base unit 102 includes an optical assembly 124 for performing tests on biological samples in the field. The base unit 102 also includes an electronic assembly 132 and a display 116 to specify which test is being run and to process and display the data collected during the test. The base unit 102 also includes a power supply 130 (including batteries) so that the base unit 102 can be used in the field. The base unit 102 includes every component necessary to perform tests on biological samples, and does so in a compact device that can be easily used in the field. Using the base unit 102 in the field prevents concerns about contamination or decomposition of the biological sample and allows the user to quickly react to test results in the field.

4 is a perspective view of the expansion unit 106. The expansion unit 106 includes a housing 150 (including a first housing portion 152 and a second housing portion 154), a cover 156, a container 158, and the optical assembly 124.

The expansion unit 106 is used to analyze a biological sample that has been mixed with a reaction mixture (also referred to as a biological sample and reactant mixture). The housing 150 forms the main body of the expansion unit 106. The housing 150 includes a first housing portion 152 and a second housing portion 154. The first housing portion 152 forms the base portion of the expansion unit 106, and the second housing portion 154 forms the top portion of the expansion unit 106. The expansion unit 106 also includes a cover 156.

In the illustrated embodiment, the container 158 is located on the top side of the expansion unit 106, but may be located in any suitable location in alternative embodiments. The container 158 is an opening in the housing 150 of the expansion unit 106. A sample rack containing a biological sample may be placed in the container 158 for testing. In the illustrated embodiment, the container 158 is configured to accommodate the tube array 108 (not shown in FIG. 4 ), but in alternative embodiments, the container 158 may be configured in any manner capable of accommodating a sample rack.

The housing 150 also includes a lid 156. In the illustrated embodiment, the lid 156 is located on the top side of the housing 150, but in alternative embodiments, it may be located in any suitable location. The lid 156 is included on the expansion unit 106 to seal the container 158. When a sample holder is placed in the container 158 of the expansion unit 106, it is positioned within the optical assembly 124 retained within the expansion unit 106. The optical assembly 124 is positioned just below the container 158 and is accessible through the container 158. The optical assembly 124 is capable of amplifying, exciting, and detecting biological samples in the sample holder. In the embodiment shown in FIG. 4 , the optical assembly 124 includes a heating component and a detection component. The heating component is used to heat the biological sample, causing it to amplify. The heating component can heat the biological sample at a constant temperature or it can cycle the biological sample through different temperatures. The optical assembly 124 then uses radiation to excite the biological sample, causing it to emit radiation, which can then be detected by the detection component. In alternative embodiments, the expansion unit 106 may include only a heating component or only a detection component. Additionally, the heating component may heat the biological sample at a constant temperature, the heating component may cool the biological sample at a constant temperature, or the heating component may cycle the biological sample through different temperatures.

Lid 156 is positioned over container 158 to prevent radiation from escaping housing 150 through container 158. Lid 156 also prevents ambient light from entering housing 150 through container 158, which prevents the ambient light from skewing or offsetting the results of tests run in extension unit 106. Lid 156 also seals container 158 to prevent contaminants from entering container 158 when extension unit 106 is in use in the field. Lid 156 is movable between an open position and a closed position and can be retained in the closed position by any suitable means. When lid 156 is in the open position, a sample holder (including tubing array 108) can be inserted into and removed from container 158. When lid 156 is closed, the sample holder remains in container 158, and radiation in extension unit 106 does not escape housing 150. When lid 156 is in the closed position, it applies pressure to the sample holder placed in the heating block in extension unit 106. This improves engagement and heat transfer between the sample holder and the heating block in the extension unit 106 .

The container 158 can be shaped to accommodate any sample rack, thereby allowing the extension unit 106 to be designed to accommodate a wide variety of standard and conventionally designed sample racks. The tube array 108 is a standard sample rack that is widely available on the market. Cards can also be conventionally designed to serve as sample racks for use with the extension unit 106. The container 158 allows the extension unit 106 to be designed to accommodate a wide variety of sample rack shapes and sizes.

The expansion unit 106 is advantageous because it allows the user to increase the number of tests the user is running in any given situation. The expansion unit 106 can be used in a laboratory setting or in the field. The expansion unit 106 can interface with the base unit, where the base unit instructs the expansion unit 106 which tests should be performed and when the tests should be started. Once data is collected in the expansion unit 106, it can be transferred to the base unit. Before the data is transferred to the base unit, the data can be processed in the expansion unit 106 or it can be transferred to the base unit without processing. The base unit can then run the test plan to process the data.

5 is a block diagram of the expansion unit 106. The expansion unit 106 includes a power supply 160, an electronic assembly 162, and an optical assembly 124. The optical assembly 124 includes a heating block 140, a light emitting diode 142, and a photodetector 144.

The expansion unit 106 is used to analyze and obtain data from biological samples. To achieve this, the expansion unit 106 is equipped with a power supply 160, an electronic assembly 162, and an optical assembly 124. The electronic assembly 162 includes the hardware, firmware, and software that control the operation of the expansion unit 106, including a microprocessor. The electronic assembly 162 also includes a communication interface that communicates with the electronic assembly in the base unit. The communication interface can be a hardwired interface or a wireless interface. The wireless interface can communicate via Bluetooth, Wi-Fi, infrared, or any other wireless technology.

The electronics in the base unit will indicate what test is to be run in the extension unit 106 and will transmit this information to the electronics 162 in the extension unit 106. Data collected in the extension unit 106 during the test will be transmitted to the electronics 162 in the extension unit 106. The electronics 162 in the extension unit 106 will then transmit the data to the electronics in the base unit. Before the data is transmitted to the base unit, the data may be processed in the extension unit 106 or it may be transmitted to the base unit without processing. The electronics in the base unit may also process this data and send it to the display for display. The electronics in the base unit also store this data for later retrieval or transmission.

In one embodiment, the extension unit 106 can be docked to the base unit via a hardwired interface circuit. While the extension unit 106 is docked to the base unit, the base unit can provide instructions to the extension unit 106 via the hardwired interface circuit. The extension unit 106 can then be removed from the base unit and used to run a test. After the test is complete, the extension unit 106 can be docked back to the base unit via the hardwired interface circuit to transfer data collected during the test to the base unit. In a second embodiment, the extension unit 106 can receive instructions from the base unit wirelessly using a wireless interface circuit. The extension unit 106 can then be used to run a test. After the test is complete, the extension unit 106 can be docked back to the base unit via the hardwired interface circuit to transfer data collected during the test to the base unit.

The electronic assembly 162 is connected to the power supply 160 using an interface circuit. In the embodiment shown in FIG5 , the power supply 160 includes components capable of supplying power to the expansion unit 106, including a battery, a power supply board, a power switch, and a power jack that can be connected to the power supply for recharging. Power from the power supply 160 is transmitted to the electronic assembly 162 via the interface circuit, enabling the expansion unit 106 to operate. In an alternative embodiment, the expansion unit 106 can be powered by the base unit and the power supply 160 will include a power jack that can be connected to the base unit to provide power to the expansion unit 106.

Electronic assembly 162 also includes a microprocessor, associated memory, and an interface circuit for interfacing with optical assembly 124. Inputs received from the electronic assembly of the base unit in electronic assembly 162 can be processed in electronic assembly 162. This information can be used to control optical assembly 124. Optical assembly 124 performs a test of the biological sample placed in extension unit 106. When the test is completed, the data collected in optical assembly 124 can be transferred to electronic assembly 162. Electronic assembly 162 processes this data and can send the data to the electronic assembly in the base unit. The electronic assembly in the base unit can then send the data to a display so that the user can monitor the test results. Electronic assembly 162 can also send data to an external device using any suitable data transfer means (including wireless transmission or transmission through a USB port, microUSB port, SD card, or microSD card).

The optical assembly 124 includes a heat block 140, a light-emitting diode 142, and a photodetector 144 to perform testing on a biological sample placed in the expansion unit 106. The optical assembly 124 uses heat to amplify the biological sample and then excites the biological sample with radiation to detect the presence of a specific fluorescent marker. The biological sample placed in the expansion unit 106 is mixed with a reaction mixture containing one or more fluorescent dyes. While the biological sample is placed in the expansion unit 106, the heat block 140 amplifies the biological sample with heat. The heat block 140 is positioned below the container 158 in the expansion unit 106 so that when a sample rack containing the biological sample is placed in the expansion unit 106, the sample rack is positioned in the heat block 140. As the biological sample is amplified, the biological sample can be analyzed using the light-emitting diode 142 and the photodetector 144. The light-emitting diode 142 transmits radiation to the biological sample to excite it. Multiple light-emitting diodes 142 can be used in the expansion unit 106 to excite the biological sample at a predetermined cycle rate. In the illustrated embodiment, the multiple light-emitting diodes 142 cycle intermittently at 1.54 kHz. In alternative embodiments, the light emitting diode 142 can cycle at any predetermined cycle rate. When the biological sample is excited at the predetermined cycle rate, it will emit radiation at the same predetermined cycle rate and at a wavelength corresponding to the fluorescent dye added to the biological sample. This radiation can be received by the photodetector 144. Multiple photodetectors 144 can be used in the extension unit 106 to read the emitted radiation from the biological sample at different radiation wavelengths. The signal generated by the photodetector 144 can then be sent to the electronics assembly 162 for transmission to the electronics assembly of the base unit. The electronics assembly of the base unit can then process and analyze the data and display the data as data collected during the test.

FIG6A is a perspective view of optical assembly 124. FIG6B is a cross-sectional view of optical assembly 124. Optical assembly 124 includes a heating portion 170 (not shown in FIG6A ), a lens portion 172 (not shown in FIG6A ), a housing portion 174, a first optical mounting portion 176, and a second optical mounting portion 178. Tube array 108 is also shown in FIG6B .

The optical assembly 124 can be positioned in both the base unit 102 and the expansion unit 106. The optical assembly 124 includes a heating portion 170 to heat the biological sample and reactant mixture in the tube array 108. A lens portion 172 is positioned in the heating portion 170 to direct radiation through the optical assembly 124. A housing portion 174 is positioned around the heating portion 170 and forms the main body of the optical assembly 124. A first optical mounting portion 176 is positioned on a first side of the housing portion 174 and a second optical mounting portion 178 is positioned on a second side of the housing portion 174. The first optical mounting portion 176 and the second optical mounting portion 178 each mount a light emitting diode to the optical assembly 124 to excite the biological sample and reactant mixture in the tube array 108. Additionally, the first optical mounting portion 176 and the second optical mounting portion 178 each mount a photodetector to the optical assembly 124 to detect signals from the biological sample and reactant mixture in the tube array 108.

7 is an exploded view of heating portion 170 of optical assembly 124. As seen in FIG6B and FIG7, heating portion 170 includes sample block 190, heating element 192, temperature sensor 194, well 196, channel 198, channel 200, channel 202, and channel 204.

The heating section 170 includes a sample block 190, which forms the main body of the heating section 170. A heating element 192 is attached to a second side of the sample block 190. In the illustrated embodiment, the heating element 192 is a flat polyimide heater, but in alternative embodiments, it may be any suitable heater. A temperature sensor 194 is positioned in the bottom of the sample block 190 to sense the temperature of the sample block 190. Additionally, in alternative embodiments, a thermal cutoff switch, such as a PEPI switch, may be placed in series with the heating element 192 using wires.

The sample block 190 includes a recessed hole 196 on the top side of the sample block 190. Each recessed hole 196 is sized to accommodate one of the tubes in the tube array 108. In the embodiment shown in Figure 7, the heating component 192 heats each of the recessed holes 196 at a constant temperature so that the modular test device 100 can be used together with an isothermal amplification chemical reaction. In an alternative embodiment, the heating component 192 can heat each recessed hole 196 at different temperatures across a gradient, or a plurality of heating components can be present so that each recessed hole is heated to a different temperature by a different heating component. This allows the user to perform basic testing to determine what temperature should be used to analyze a specific biological sample. In another alternative embodiment, the heating component 192 may include a thermal cycler capable of circulating the heating portion 170 at different temperatures so that the modular test device 100 can be used together with a non-isothermal polymerase chain reaction (PCR) chemical reaction.

Sample block 190 also includes channel 198, channel 200, channel 202, and channel 204. Channel 198 extends from a first side of sample block 190 to well 196. Channel 200 extends from a bottom side of sample block 190 to well 196. Channel 202 extends from a second side of sample block 190 to well 196. Channel 204 extends from a bottom side of sample block 190 to well 196. Channels 198, 200, 202, and 204 extend through sample block 190 to direct radiation into and out of the biological sample and reactant mixture in tubing array 108 in well 196.

8 is an exploded view of the lens portion 172 of the optical assembly 124. As seen in FIG6B and FIG8, the lens portion 172 includes a lens 210 and a lens holder 212.

The lens section 172 includes lenses 210 positioned in the sample block 190 of the heating section 170. The channels 198 in the sample block 190 are sized to accommodate the lenses 210 on a first side of the sample block 190. One lens 210 is positioned in each channel 198 of the sample block 190. The lenses 210 are held in the channels 198 by lens holders 212. The lens holders 212 have a plurality of apertures such that radiation can pass through the lens holders 212 to pass through the lenses 210.

9 is an exploded view of housing portion 174 of optical assembly 124. As seen in FIG6A-6B and FIG9, housing portion 174 includes first housing 220, second housing 222, heat shield 224, channel 226, channel 228, channel 230, channel 232, and aperture 234.

The housing portion 174 includes a first housing 220 positioned on a first side of the heating portion 170 and a second housing 222 positioned on a second side of the heating portion 170. The first housing 220 and the second housing 222 form a main body portion of the housing portion 174. A heat shield 224 is positioned between the first housing 220 and the second housing 222 on the top side of the heating portion 170.

The first housing 220 includes a channel 226 and a channel 228. The channel 226 extends from a first side of the first housing 220 to the inside of the first housing 220 adjacent to the sample block 190. Each channel 226 in the first housing 220 is aligned with one of the channels 198 in the sample block 190. The channel 228 extends from a bottom side of the first housing 220 to the inside of the first housing 220 adjacent to the sample block 190. Each channel 228 in the first housing 220 is aligned with one of the channels 200 in the sample block 190. The channels 226 and 228 extend through the first housing 220 to direct radiation into and out of the biological sample and reactant mixture in the tubing array 108 in the well 196 of the sample block 190.

The second housing 222 includes a channel 230 and a channel 232. The channel 230 extends from a second side surface of the second housing 222 to the inside of the second housing 222 adjacent to the sample block 190. Each channel 230 in the second housing 222 is aligned with one of the channels 202 in the sample block 190. The channel 232 extends from a bottom side of the second housing 222 to the inside of the second housing 222 adjacent to the sample block 190. Each channel 232 in the second housing 222 is aligned with one of the channels 204 in the sample block 190. The channels 230 and 232 extend through the second housing 222 to direct radiation into and out of the biological sample and reactant mixture in the tubing array 108 in the well 196 of the sample block 190.

Heat shield 224 is positioned above sample block 190 and held between first housing 220 and second housing 222. Orifices 234 extend from the top side to the bottom side of heat shield 224. Each orifice 234 in heat shield 224 aligns with one of recesses 196 in sample block 190. This allows tube array 108 to be positioned in recesses 196 in sample block 190 that passes through orifices 234 in heat shield 224. Heat shield 224 is positioned above sample block 190 to prevent heat from escaping the top side of sample block 190. Heat shield 224 also provides an insulating surface to protect a user from the top side of sample block 190 when sample block 190 is hot.

FIG10A is a partially exploded view of first optical mounting portion 176 of optical assembly 124. FIG10B is a partially exploded view of second optical mounting portion 178 of optical assembly 124. FIG10C is a partially exploded view of first optical mounting portion 176 and second optical mounting portion 178 of optical assembly 124. As seen in FIG6A-6B, FIG10A, and FIG10C, first optical mounting portion 176 includes housing 240, housing 242, emission filter 244, spacer 246, excitation filter 248, channel 250, channel 252, photodetector mounting plate 254, photodetector 256, spacer 258, LED mounting plate 260, LED 262, and spacer 264. As seen in Figures 6A to 6B and Figures 10B to 10C, the second optical mounting portion 178 includes a housing 270, a housing 272, an emission filter 274, a gasket 276, an excitation filter 278, a channel 280, a channel 282, a photodetector mounting plate 284, a photodetector 286, a gasket 288, an LED mounting plate 290, a LED 292 and a gasket 294.

The first optical mounting portion 176 is positioned on a first side of the housing portion 174. The first optical mounting portion 176 includes a housing 240 and a housing 242 that form the main body of the first optical mounting portion 176. The housing 240 is attached to a first side of the first housing 220 of the housing portion 174. An emission filter 244 is positioned between the housing 240 and the first housing 220 in a recess on the first side of the first housing 220. A spacer 246 is positioned between the emission filter 244 and the housing 240. The housing 242 is attached to the bottom side of the first housing 220 of the housing portion 174. An excitation filter 248 is positioned between the housing 242 and the first housing 220 in a recess on the bottom side of the first housing 220.

The housing 240 includes channels 250. Channels 250 extend from a first side surface of the housing 240 to the inside of the housing 240 adjacent to the first housing 220. Each channel 250 in the housing 240 is aligned with one of the channels 226 in the first housing 220. The housing 242 includes channels 252. Channels 252 extend from a bottom side of the housing 252 to the inside of the housing 242 adjacent to the first housing 220. Each channel 252 in the housing 242 is aligned with one of the channels 228 in the first housing 220.

A photodetector mounting board 254 is connected to a first side of housing 240. Photodetector mounting board 254 is an electronic board that includes photodetectors 256. Each photodetector 256 on photodetector mounting board 254 is positioned within one of channels 250 in housing 240. A gasket 258 is positioned between photodetector mounting board 254 and housing 240. An LED mounting board 260 is attached to the bottom side of housing 242. LED mounting board 260 is an electronic board that includes LEDs 262. Each LED 262 on LED mounting board 260 is positioned within one of channels 252 in housing 242. A gasket 264 is positioned between LED mounting board 260 and housing 242.

The second optical mounting portion 178 is positioned on a second side of the housing portion 174. The second optical mounting portion 178 includes a housing 270 and a housing 272 that form the main body of the second optical mounting portion 178. The housing 270 is attached to the second side of the second housing 222 of the housing portion 174. An emission filter 274 is positioned between the housing 270 and the second housing 222 in a recess on the second side of the second housing 222. A spacer 276 is positioned between the emission filter 274 and the housing 270. The housing 272 is attached to the bottom side of the second housing 222 of the housing portion 174. An excitation filter 278 is positioned between the housing 272 and the second housing 222 in a recess on the bottom side of the second housing 222.

The housing 270 includes a channel 280. The channel 280 extends from the second side surface of the housing 270 to the inside of the housing 270 of the adjacent second housing 222. Each channel 280 in the housing 270 is aligned with one of the channels 230 in the second housing 222. The housing 272 includes a channel 282. The channel 282 extends from the bottom side of the housing 282 to the inside of the housing 282 of the adjacent second housing 222. Each channel 282 in the housing 272 is aligned with one of the channels 232 in the second housing 222.

A photodetector mounting plate 284 is connected to a first side of housing 270. Photodetector mounting plate 284 is an electronic board that includes photodetectors 286. Each photodetector 286 on photodetector mounting plate 284 is positioned within one of channels 280 in housing 270. A gasket 288 is positioned between photodetector mounting plate 284 and housing 270. An LED mounting plate 290 is attached to the bottom side of housing 272. LED mounting plate 290 is an electronic board that includes LEDs 292. Each LED 292 on LED mounting plate 290 is positioned within one of channels 282 in housing 272. A gasket 294 is positioned between LED mounting plate 290 and housing 272.

As shown in Figure 6A to Figure 10C, optical assembly 124 can excite emission light from the biological sample and the reactant mixture in the tubing array 108 positioned in optical assembly 124 and detect the emitted light. Light emitting diode 262 is a dual-color light emitting diode that can emit radiation under two different wavelengths. In the embodiment shown, light emitting diode 262 is a blue and amber dual-color light emitting diode to excite fluorescein amino ester (FAM) fluorescent dye and 6-carboxyl-X-rhodamine (ROX) fluorescent dye respectively. In addition, light emitting diode 262 emits radiation under a predetermined cycle rate of 1.54kHz. The radiation from light emitting diode 262 can pass through channel 252, excitation filter 248, channel 228 and channel 200, enter the biological sample and the reactant mixture in the tubing array 108 held in recessed hole 196. Excitation filter 248 is a dual-bandpass excitation filter that can pass any one of the wavelengths emitted by light emitting diode 262. The excitation filter 248 is a single filter that extends across the entire length of the tubing array 108, and thus, the excitation filter 248 extends between adjacent channels 228 in the first housing 220. Radiation from the light emitting diode 262 can excite a fluorescent dye in the biological sample and reactant mixture. This excitation of the fluorescent dye will emit a signal from the biological sample and reactant mixture, and the emitted light can pass through the channel 198, the channel 226, the emission filter 244, and the channel 250, and be detected by the photodetector 256. In the illustrated embodiment, the emission filter 244 is a dual-bandpass emission filter. The emission filter 244 is a single filter that extends across the entire length of the tubing array 108, and thus, the emission filter 244 extends between adjacent channels 226 in the first housing 220.

The light-emitting diode 292 is a light-emitting diode that can emit radiation in a single wavelength spectrum. In the illustrated embodiment, the light-emitting diode 292 is a green light-emitting diode to excite the 6-carboxy-X-hexachlorofluorescein (HEX) fluorescent dye. In addition, the light-emitting diode 292 emits radiation at a predetermined cycle rate of 1.54 kHz. The radiation from the light-emitting diode 292 can pass through the channel 282, the excitation filter 278, the channel 232, and the channel 204, and enter the biological sample and reactant mixture in the tubing array 108 held in the recess 196. The excitation filter 278 is a single bandpass filter that can pass the wavelength emitted by the light-emitting diode 292. The excitation filter 278 is a single filter that extends across the entire length of the tubing array 108, and thus the excitation filter 278 extends between adjacent channels 232 in the second housing 222. The radiation from the light-emitting diode 292 can excite the fluorescent dye in the biological sample and reactant mixture. This excitation of the fluorescent dye will emit a signal from the biological sample and the reactant mixture, and the emitted light can pass through the channel 202, the channel 230, the emission filter 274, and the channel 280, and be detected by the photodetector 286. In the embodiment shown, the emission filter 274 is a single bandpass filter. The emission filter 274 is a single filter that extends across the entire length of the tube array 108, and thus the emission filter 274 extends between adjacent channels 230 in the second housing 222.

In an alternative embodiment, LED 292 may be a dual-color LED that emits radiation at two different wavelengths. Additionally, excitation filter 278 may be a dual-bandpass filter that passes all wavelengths emitted by LED 292, and emission filter 274 may also be a dual-bandpass filter. This would enable modular testing device 100 to test four different fluorescent dyes that may be mixed with a biological sample and a reagent mixture.

Light emitting diode 262 and light emitting diode 292 are with the form emission radiation of the light that circulates under 1.54kHz predetermined rate.This makes the emitted light from biological sample and reactant mixture be in identical predetermined rate.Therefore, photodetector 256 and photodetector 286 also receive emitted light from biological sample and reactant mixture at the speed of 1.54kHz.The electronic circuit that is connected to photodetector 256 and photodetector 286 is designed to filter out all other frequencies except 1.54kHz electronically.This will offset any ambient light that can interfere with test accuracy or other radiation sources in modular test device 100.

Having a single filter for emission filter 244, excitation filter 248, emission filter 274, and excitation filter 278 simplifies the design of modular test device 100. This simplified design makes modular test device 100 more suitable for use in the field. If one of emission filter 244, excitation filter 248, emission filter 274, or excitation filter 278 must be replaced, it is easy to replace the entire filter set rather than many different individual filters. In addition, using one filter for each of emission filter 244, excitation filter 248, emission filter 274, or excitation filter 278 reduces the cost of modular test device 100.

11 is a flow chart illustrating steps for operating the modular test apparatus 100. The flow chart includes steps 300 to 316.

Step 300 comprises preparing the biological sample and the reactant mixture for testing.The reactant mixture can contain the master mixture needed for the desired test, for detecting the desired analyte in the modular testing device 100, including fluorescent dyes or labels such as FAM or ROX. Once the user obtains the biological sample, the biological sample can then be mixed with the reactants to form the biological sample and reactant mixture. More specifically, the biological sample is first mixed with the reaction buffer. Next, a part of the biological sample and the reaction buffer mixture is transported to a sample rack containing the dry master mixture. This forms the biological sample and reactant mixture for testing. The biological sample and the reaction mixture can be tested in the sample rack containing the dry master mixture or transported to another sample rack for testing.

In step 302, both the base unit and the expansion unit 106 are turned on. In step 304, a test protocol is selected in the base unit. This can be accomplished by screening a code with a machine-readable code reader 154. The code will contain information about which test protocol to run and what parameters should be used. The test protocol can also be selected on the base unit's display, and the parameters can be entered into the base unit. Step 306 includes transferring the selected test protocol from the base unit to the expansion unit 106. The expansion unit 106 can then begin heating to the desired temperature for the selected test protocol. While preheating the expansion unit 106, it can communicate with the base unit. The base unit will visually and audibly notify the user that the expansion unit 106 is ready for testing. In step 308, the user opens the lid 156 of the expansion unit 106 and places a sample rack containing a biological sample and a reagent mixture into the heating assembly 170 in the expansion unit 106.

In step 310, the user uses the user interface on the display of the base unit to start the excitation and detection program for the desired test. The base unit then communicates with the extension unit 106 to indicate that the extension unit 106 can start the test. The optical assembly 124 in the extension unit 106 then starts the excitation and detection program. Step 312 includes collecting data from the biological sample and reactant mixture in the extension unit 106 during the excitation and detection program. Step 314 includes transferring the data from the extension unit 106 to the base unit. The data is sent from the optical assembly 124 to the electronic assembly 162 in the extension unit 106. Before the data is transferred to the base unit, the data can be processed by the electronic assembly 162 in the extension unit 106. The electronic assembly 162 in the extension unit 106 then transfers the data to the electronic assembly in the base unit. Step 316 includes processing the data in the base unit. The processed data can then be displayed to the user in the base unit.

Steps 312, 314, and 316 can be performed in real time as data is collected from the biological sample and reagent mixture in the expansion unit 106. The electronics and display in the base unit can also record the data received from the expansion unit 106 and monitor the data for threshold activity. Once the test is complete, the display signals the user a positive, negative, or indeterminate result. The electronics in the base unit can also store the acquired data for retrieval or transmission.

The above steps 300 to 316 apply to both the base unit 102 and the base unit 104. If the base unit 102 is used, additional tests can be performed in the base unit 102 while the test is being performed in the extension unit 106. When the lids 120 of the extension unit 106 and the base unit 102 are opened, the base unit 102 can be preheated simultaneously so that the sample rack containing the biological sample and the reagent mixture can be placed in the heating assembly 10 of the base unit 102. In addition, when the extension unit 106 and the data are collected in the base unit 102, the base unit 102 can simultaneously start the excitation and detection procedures for the desired test. The base unit 102 can display the data collected in the base unit 102 and the extension unit 106 on the display 116.

Although the present invention has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for various elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present invention without departing from the basic scope of the invention. Therefore, it is intended that the present invention not be limited to the specific embodiment or embodiments disclosed, but that the invention encompass all embodiments falling within the scope of the appended claims.

Claims (18)

1. A modular testing device, comprising: Base unit: An extension unit, which communicates with the base unit, wherein the extension unit includes: case; A container, and a sample rack containing a mixture of biological samples and reactants, can be placed inside the container; and An optical component positioned within the housing, wherein the optical component is configured to amplify and detect signals from the biological sample and reactant mixture, wherein data collected in the optical component is transmitted to the base unit, and wherein the optical component in the expansion unit comprises: A heating element for heating the biological sample and reactant mixture in the sample holder; A plurality of light-emitting diodes (LEDs) for exciting the biological sample and reactant mixture in the sample holder, wherein the plurality of LEDs are positioned on a first side of an excitation filter extending across the optical assembly and the sample holder is positioned on a second side of the excitation filter; and A plurality of photodetectors for detecting signals from the biological sample and reactant mixture in the sample holder, wherein the plurality of photodetectors are positioned on a first side of an emission filter extending across the optical assembly and the sample holder is positioned on a second side of the emission filter. 2. The modular testing device according to claim 1, wherein the expansion unit and the base unit are connected and communicate via hardwired connection. 3. The modular testing device according to claim 1, wherein the expansion unit and the base unit communicate wirelessly. 4. The modular testing device according to claim 1, wherein the modular testing device includes a plurality of expansion units, each of which communicates directly with the base unit. 5. The modular testing device according to claim 1, wherein the modular testing device includes a plurality of expansion units, wherein a first expansion unit communicates directly with the base unit, and other expansion units communicate with the base unit through the first expansion unit. 6. The modular testing device according to claim 1, wherein the base unit comprises: The housing has an integrated touchscreen display; A container, and a sample rack containing a mixture of biological samples and reactants, can be placed inside the container; and An optical component positioned within the housing, wherein the optical component is configured to amplify and detect signals from the biological sample and the reagent mixture; and Electronic components configured to receive data from the optical components and transmit the data for display on the touchscreen display; and A power source, located within the housing, is used to supply power to the base unit. 7. The modular testing apparatus of claim 6, wherein the optical components of the base unit include an excitation filter extending across the optical components and an emission filter extending across the optical components. 8. The modular testing apparatus according to claim 1, wherein the base unit is a computer selected from the group consisting of desktop computers, laptop computers, tablet computers, mobile phones, smartwatches and embedded PCs. 9. The modular testing apparatus according to claim 1, wherein the expansion unit further comprises: Electronic components configured to receive data from the optical components and transmit the data to the base unit; and A power source, located within the housing, is used to supply power to the expansion unit. 10. A modular testing device, comprising: Base unit, the base unit comprising: The housing has an integrated touchscreen display; A container, and a sample rack containing a mixture of biological samples and reactants, can be placed inside the container; and An optical component positioned within the housing, wherein the optical component is configured to amplify and detect signals from the biological sample and the reagent mixture; and An extension unit, which communicates with the base unit, wherein the extension unit includes: case; A container, and a sample rack containing a mixture of biological samples and reactants, can be placed inside the container; and An optical component positioned within the housing, wherein the optical component is configured to amplify and detect signals from the biological sample and reactant mixture, and wherein the optical component in the expansion unit comprises: A heating element for heating the biological sample and reactant mixture in the sample holder; A plurality of light-emitting diodes (LEDs) for exciting the biological sample and reactant mixture in the sample holder, wherein the plurality of LEDs are positioned on a first side of an excitation filter extending across the optical assembly and the sample holder is positioned on a second side of the excitation filter; and A plurality of photodetectors for detecting signals from the biological sample and reactant mixture in the sample holder, wherein the plurality of photodetectors are positioned on a first side of an emission filter extending across the optical assembly and the sample holder is positioned on a second side of the emission filter. 11. The modular testing apparatus according to claim 10, wherein the base unit further comprises: An integrated handle for allowing transport of the base unit; The lid above the container is movable between an open position and a closed position; An electronic component configured to receive data from the optical component and transmit the data for display on the touchscreen display, and configured to receive data from the extension unit and transmit the data for display on the touchscreen display; A power source, located within the housing, is used to supply power to the base unit; and A machine-readable code reader, housed within the housing, for reading machine-readable code. 12. The modular testing apparatus of claim 10, wherein the optical components in the base unit comprise: A heating element for heating the biological sample and reactant mixture in the sample holder; A plurality of light-emitting diodes (LEDs) for exciting the biological sample and reactant mixture in the sample holder, wherein the plurality of LEDs are positioned on a first side of an excitation filter extending across the optical assembly and the sample holder is positioned on a second side of the excitation filter; and A plurality of photodetectors for detecting signals from the biological sample and reactant mixture in the sample holder, wherein the plurality of photodetectors are positioned on a first side of an emission filter extending across the optical assembly and the sample holder is positioned on a second side of the emission filter. 13. The modular testing apparatus according to claim 10, wherein the expansion unit further comprises: Electronic components configured to receive data from the optical components and transmit the data to the base unit; and A power source, located within the housing, is used to supply power to the expansion unit. 14. A method for analyzing a mixture of biological samples and reactants in a modular testing apparatus, the method comprising: Prepare a mixture of biological sample and reactant for testing, and place the mixture of biological sample and reactant in a sample holder; The sample holder is placed in a container within an expansion unit, wherein the expansion unit comprises: shell; and An optical component positioned within the housing, wherein the optical component is configured to amplify and detect signals from the biological sample and reactant mixture, and wherein the optical component in the expansion unit comprises: A heating element for heating the biological sample and reactant mixture in the sample holder; A plurality of light-emitting diodes (LEDs) for exciting the biological sample and reactant mixture in the sample holder, wherein the plurality of LEDs are positioned on a first side of an excitation filter extending across the optical assembly and the sample holder is positioned on a second side of the excitation filter; and Multiple photodetectors for detecting signals from the biological sample and reactant mixture in the sample holder, wherein the multiple photodetectors are positioned on a first side of an emission filter extending across the optical assembly and the sample holder is positioned on a second side of the emission filter; Initiate the excitation and detection test procedure to analyze the biological sample and reactant mixture in the extended unit; Data is collected from the biological sample and reactant mixture in the extended unit; and The data is transmitted from the expansion unit to the base unit. 15. The method of claim 14, wherein transmitting the data from the expansion unit to the base unit comprises transmitting the data between the expansion unit and the base unit via a hardwired connection. 16. The method of claim 14, wherein transmitting the data from the extension unit to the base unit comprises transmitting the data between the extension unit and the base unit via a wireless connection. 17. The method of claim 14, further comprising: The data is processed in the extended unit; The data is processed in the base unit; and The data is displayed on the screen of the base unit. 18. The method of claim 14, further comprising: Open the base unit and the expansion unit; Select a test plan from the base unit; The selected test plan is transferred from the base unit to the expansion unit; and The expansion unit is preheated according to the selected test plan.