Patent Description:
The present invention relates to molecular diagnosis, and more particularly, to a technology capable of determining whether an infection is present using a change in color of a reagent.

The content described in this section merely provides background information for embodiments described in this specification and does not necessarily constitute the related art.

Since coronavirus disease <NUM> (COVID-<NUM>) was first identified in Wuhan, China in December <NUM>, the number of confirmed cases and deaths worldwide has continued to increase. COVID-<NUM> was initially known as an infectious respiratory disease of unknown cause, but has been identified as a new type of coronavirus by the World Health Organization (WHO). As COVID-<NUM> spreads not only in Korea but also in Europe, the United States, etc., the WHO declared a pandemic on March <NUM>, <NUM> which is the highest risk level among the infectious disease warning levels, for COVID-<NUM> and warned of its seriousness.

As of <NUM>, for the diagnosis of COVID-<NUM> in Korea, a method of separating a virus from a sample or detecting a specific viral gene by using diagnostic test criteria is used regardless of clinical features. A genetic test used in the above is real-time reverse transcription polymerase chain reaction (RT-PCR). It is known that the real-time RT-PCR has an advantage in that it is an accurate test with close to <NUM>% sensitivity and specificity, but has a disadvantage in that it requires professional personnel to collect the sample and takes a long time to obtain a test result.

Recently, fatigue due to the prolonged COVID-<NUM> pandemic has accumulated and the daily average of new confirmed cases has rapidly increased to <NUM> to <NUM> so that a need for the introduction of "self-diagnosis kits" for COVID-<NUM> is increasing. In the United States and many European countries, as the number of confirmed cases is already on the rise again, self-diagnosis kits are being recommended to the public to use as a "prevention option.

However, the self-diagnosis kit has a disadvantage in that it is less sensitive than a genetic test method (e.g., polymerase chain reaction (PCR)), in which medical personnel or a test expert collects a sample from the nasopharynx deep in the nose. It has been reported that although performance of the self-diagnosis kit is degraded due to a difference in measurement principles, a difference in sensitivity may appear depending on a method of collecting a sample. Researchers at the University of Birmingham in UK reported in the academic journal Public Library of Science (PLOS) Biology on April <NUM> that the accuracy of the PCR test varies considerably depending on the technique used to collect the sample with a swab, with <NUM>% for skilled medical personnel and <NUM>% for the general public, and differences in sensitivity and specificity may occur due to differences in the techniques of collecting the sample with a swab.

Accordingly, there is a need for a method of determining whether an infection is present even when an amount of a sample collected is small.

Further prior art can be found in <CIT> and in <NPL>.

The present invention is directed to providing a test apparatus and a test method, which are capable of determining whether an infection is present through molecular diagnosis.

Objects of the present invention are not limited to the above-described object and other objects that are not described will be clearly understood by those skilled in the art from the following descriptions.

According to an aspect of the present invention, there is provided a test apparatus as set out in the appended set of claims.

The test apparatus may further include a heating unit configured to heat the test tube and the control tube according to a control signal output from the controller.

The first time point may be a time point adjacent to a time point at which the controller terminates the heating operation of the heating unit, and the second time point may be a time point when a preset time has elapsed since the controller terminated the heating operation of the heating unit.

The test apparatus may further include a temperature sensor configured to output a temperature value of the control tube, the test tube, or the heating unit. In this case, the second time point may be a time point when the temperature value output from the temperature sensor reaches a preset temperature value after the controller terminates heating operation of the heating unit.

The controller may determine whether the sample is infected using the following equation: <MAT>.

When the infection determination value (K) is greater than or equal to a preset reference value, the controller may determine that a result of determining whether the sample is infected is positive.

When the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, the controller may determine whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value.

When the value of the signal output from the first spectrum sensor at the second time point is greater than or equal to a preset measurement invalidity determination reference value and when the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, the controller may determine whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value.

The test apparatus may further include a communication unit configured to transmit the value of the signal output from the first spectrum sensor, the value of the signal output from the second spectrum sensor, or information on whether the sample is infected as determined by the controller.

The test apparatus may be one component of a diagnostic system including a test apparatus, and an external terminal configured to receive data transmitted from the test apparatus and display information on whether a sample is infected.

According to an aspect of the present invention, there is provided a test method as set out in the appended set of claims.

The first time point may be a time point relatively earlier than the second time point.

The first time point and the second time point may have an interval which is greater than or equal to a preset time.

The operation (c) may include an operation of determining, by the processor, whether the sample is infected using the following equation: <MAT>.

The operation (c) may include, when the infection determination value (K) is greater than or equal to a preset reference value, an operation of determining, by the processor, that a result of determining whether the sample is infected is positive.

The operation (c) may include, when the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, an operation of determining, by the processor, whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value.

The operation (c) may include, when the value of the signal output from the first spectrum sensor at the second time point is greater than or equal to a preset measurement invalidity determination reference value, and when the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value, an operation of determining, by the processor, whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value.

The test method according to the present invention may be implemented in the form of a computer program written to cause the test apparatus to perform each of the operations of the test method on a computer and recorded on a computer-readable recording medium.

The test method according to the present invention may be implemented using a terminal including a processor configured to cause the test apparatus to perform each of the operations of the test method, and a communication unit configured to receive, from a test apparatus, a value of a signal output from the first spectrum sensor and a value of a signal output from the second spectrum sensor.

The terminal may be one component of a diagnostic system including a terminal, and a test apparatus including the first spectrum sensor and the second spectrum sensor.

Other specific details of the present invention are included in the detailed description and accompanying drawings.

Advantages and features of the present invention and methods of achieving the same will be clearly understood with reference to the accompanying drawings and embodiments described in detail below. However, the present invention is not limited to the embodiments disclosed below but may be implemented in various different forms. The embodiments are provided in order to fully describe the present embodiments and fully explain the scope of the present invention to those skilled in the art. The scope of the present invention is only defined by the appended claims.

Like reference numerals indicate like components throughout the specification and the term "and/or" includes each and all combinations of one or more referents. It should be understood that, although the terms "first," "second," etc. may be used herein to describe various components, these components are not limited by these terms. The terms are only used to distinguish one component from another component.

<FIG> is a reference diagram for helping with understanding of a diagnostic system according to the present invention.

Referring to <FIG>, a diagnostic system <NUM> according to the present invention may include a test apparatus <NUM> and an external terminal <NUM>.

The test apparatus <NUM> is an apparatus capable of performing a test on a sample collected from a respiratory system. The test apparatus <NUM> may be a molecular diagnostic apparatus or an antigen diagnostic apparatus. In this specification, as an example of the test apparatus <NUM>, an amplifier capable of performing a test on a sample using a molecular diagnostic method is provided. The molecular diagnostic method refers to a method of checking whether a disease is infected by extracting deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) from a sample (e.g., saliva, blood, etc.) of a person infected with a virus or bacteria and then amplifying the DNA or RNA using gene amplification technology. Depending on the gene amplification method, there are various methods such as polymerase chain reaction (PCR), reverse transcription polymerase chain reaction (RT-PCR), loop-mediated isothermal amplification (LAMP), and the like. In this specification, an example of the test apparatus <NUM> for determining whether an infection is present by qualitatively determining a novel coronavirus (severe acute respiratory syndrome coronavirus <NUM> (SARS-CoV-<NUM>)) gene (spike (S) gene, nucleocapsid (N) gene) using LAMP with a sample collected from the nasopharynx or nasal cavity of a patient suspected of being infected with the novel coronavirus (SARS-CoV-<NUM>) will be described. However, a target for which the test apparatus <NUM> determines whether an infection is present, or a molecular diagnosis method performed by the test apparatus <NUM> is not limited by the above example.

In order to perform a test on a sample using the test apparatus <NUM> according to the present invention, a test kit may be required. The test kit refers to a tool, a reagent, or a consumable, which is necessary for the test, and may be sealed and provided in a pouch <NUM>.

Referring to <FIG>, a swab <NUM>, a sample tube <NUM>, a test tube <NUM>, and a control tube <NUM> may be identified. The swab <NUM>, the sample tube <NUM>, the test tube <NUM>, and the control tube <NUM> may be manufactured for one-time use by one subject. Therefore, the swab <NUM>, the sample tube <NUM>, the test tube <NUM>, and the control tube <NUM> may be provided as new components for each test to perform additional and repeated tests. Further, the swab <NUM>, the sample tube <NUM>, the test tube <NUM>, and the control tube <NUM> may be manufactured in a sterile state and may be sealed in the pouch <NUM> and distributed.

The swab <NUM> is a tool (sampling tool) for a subject to collect a sample. A length and thickness of the swab <NUM> may have values suitable for collecting the sample.

The sample tube <NUM> may include a solution for nucleic acid extraction. Specifically, the solution for nucleic acid extraction may include a buffer solution, a nonionic surfactant, a kosmotropic salt, and an indicator.

In the solution for nucleic acid extraction, the buffer solution may be a Tris-buffer solution. Specifically, the buffer solution may be Tris-HCl of pH <NUM> to pH <NUM> or pH <NUM> to pH <NUM>. A concentration of the buffer solution may range from <NUM> to <NUM>.

In the solution for nucleic acid extraction, the nonionic surfactant may be a Tween-type surfactant. Specifically, the nonionic surfactant may be Tween <NUM>. A concentration of the nonionic surfactant may range from <NUM> vol% to <NUM> vol% or <NUM> vol% to <NUM> vol%.

In the solution for nucleic acid extraction, the kosmotropic salt may include at least one selected from the group consisting of ammonium sulfate, potassium chloride, and magnesium sulfate. Specifically, the kosmotropic salt may include all of the ammonium sulfate, the potassium chloride, and the magnesium sulfate. In this case, a concentration of the ammonium sulfate may range from <NUM> to <NUM> or <NUM> to <NUM>. Further, a concentration of the potassium chloride may range from <NUM> to <NUM> or <NUM> to <NUM>. Furthermore, a concentration of the magnesium sulfate may range from <NUM> to <NUM> or <NUM> to <NUM>.

In the solution for nucleic acid extraction, the indicator may include at least one selected from the group consisting of cresol red and phenol red, but the present invention is not limited thereto, and an appropriate indicator may be used according to the purpose of use.

Further, the solution for nucleic acid extraction may further include an additive such as guanidine. When the solution for nucleic acid extraction includes guanidine, a concentration of the guanidine may range from <NUM> to <NUM> or <NUM> to <NUM>.

The test tube <NUM> and the control tube <NUM> may include primers for LAMP. The primer that is contained in the test tube <NUM> and the primer that is contained in the control tube <NUM> are different primers. The primer contained in the test tube <NUM> is a primer capable of amplifying the nucleic acid of a virus that is a target for checking whether an infection is present, and the primer contained in the control tube <NUM> is a primer capable of amplifying a nucleic acid that can be collected from a general person.

Further, the test tube <NUM> and the control tube <NUM> may further include a <NUM> to <NUM> vM primer mix, a <NUM> KU/T Bst DNA polymerase, a <NUM> mU/T ribonuclease (RNase) inhibitor, <NUM> to <NUM> deoxynucleotide triphosphates (dNTPs), <NUM> vg/T bovine serum albumin (BSA), <NUM> vg/T trehalose, a <NUM> vg sample buffer, or the like.

The test apparatus <NUM> may perform a test on a sample by itself without external interference, or may communicate with the external terminal <NUM> to perform a test on a sample. The test apparatus <NUM> may have a structure of which a lid is opened or closed, and may have a space in which the test tube <NUM> and the control tube <NUM> are accommodated when the lid is opened. According to an embodiment of the present invention, the test tube <NUM> and the control tube <NUM> may have different shapes (e.g., a cylindrical shape and a quadrangular container shape) for easy distinction, and a space may be formed inside the test apparatus <NUM> to correspond to the shapes of the test tube <NUM> and the control tube <NUM>.

Meanwhile, since it is possible for the test apparatus <NUM> to perform a test on the sample using LAMP, a configuration required for LAMP may be included.

<FIG> is a schematic block diagram of a configuration of the test apparatus according to the present invention.

Referring to <FIG>, the test apparatus <NUM> according to the present invention may include a controller <NUM>, a measurement unit <NUM>, a communication unit <NUM>, a display unit <NUM>, a heating unit <NUM>, and a power supply <NUM>.

The controller <NUM> may control a process necessary for performing a test on a sample using LAMP. When the controller <NUM> can output a signal for controlling each component included in the test apparatus <NUM>, the controller <NUM> may receive the signal from each component and perform necessary processes such as calculation, storage, processing, etc..

The measurement unit <NUM> may serve to measure the test tube <NUM> and the control tube <NUM> according to a procedure for performing a test on a sample. As will be described below in more detail, depending on the presence or absence of the nucleic acid, as the nucleic acid is amplified, the colors of the solutions which are contained in the test tube <NUM> and the control tube <NUM> may be changed. The measurement unit <NUM> may measure the colors of the solutions which are contained in the test tube <NUM> and the control tube <NUM> and output the measured colors as signals to the controller <NUM>. To this end, the measurement unit <NUM> may include spectrum sensors <NUM> and <NUM> and/or light sources <NUM> and <NUM>.

The communication unit <NUM> may serve to perform data transmission and reception between the test apparatus <NUM> and the external terminal <NUM>. The communication unit <NUM> may perform wired communication and/or wireless communication, and may transmit and receive data according to a preset communication protocol. Preferably, the communication unit <NUM> may be a short range communication module for short range communication. The short range communication module may support short range communication using at least one of Bluetooth™, radio frequency identification (RFID), the Infrared Data Association (IrDA), ultra-wideband (UWB), ZigBee, near-field communication (NFC), Wi-Fi, Wi-Fi Direct, and wireless Universal Serial Bus (USB).

The display unit <NUM> may serve to display status information and operation information about the test apparatus <NUM>. For example, the display unit <NUM> may include two light-emitting diodes (LEDs) installed on an external front surface of the test apparatus <NUM>. A first LED may display a communication connection state between the test apparatus <NUM> and the external terminal <NUM>. A second LED may display a charging state and a normal operation state of the test apparatus <NUM>.

The heating unit <NUM> may serve to heat the test tube <NUM> and the control tube <NUM>. The heating unit <NUM> may be configured as a coil to receive power from the power supply <NUM> in response to a control signal of the controller <NUM> and convert the power into thermal energy. The coil may have a length and resistance sufficient to heat the test tube <NUM> and the control tube <NUM> to a preset temperature. According to an embodiment of the present invention, the heating unit <NUM> may further include a temperature sensor <NUM>. The controller <NUM> may output a signal for controlling the operation of the heating unit <NUM> according to a temperature signal output from the temperature sensor <NUM>.

The power supply <NUM> may serve to supply power required for the operation of the components included in the test apparatus <NUM> according to the present invention. To this end, the power supply <NUM> may include a power terminal <NUM> and a battery <NUM>. The battery <NUM> may be one of a primary battery and a secondary battery, and preferably, the battery <NUM> is a secondary battery. The power terminal <NUM> is an interface for connection with an external power supply source (e.g., a commercial power grid, a rechargeable battery, etc.), and, for example, the power terminal may be configured as a USB input/output terminal. The power supply <NUM> may charge the battery <NUM> with power applied through the power terminal <NUM>. In order to perform a test on a sample, the power charged in the battery <NUM> may be used, or the power may be directly received from the power terminal <NUM> and used.

The external terminal <NUM> according to the present invention may be a communication terminal capable of performing data transmission and reception, for example, a smartphone, a laptop computer, a digital broadcasting terminal, a personal digital assistant (PDA), a portable multimedia player (PMP), a navigation system, a slate personal computer (PC), a tablet PC, an Ultrabook, a wearable device (e.g., a watch-type terminal (smartwatch), a glass-type terminal (smart glass), a head mounted display (HMD)), or the like. In the external terminal <NUM> according to the present invention, an application program necessary for performing a test on a sample may be installed.

An example of a method of diagnosing whether a viral infection is present using the test apparatus <NUM> according to the present invention will be described. In this case, it is assumed that the battery included in the test apparatus <NUM> is fully charged and an application program necessary for performing a test on a sample is installed in the external terminal <NUM>.

First, power of the test apparatus <NUM> may be turned on by pressing a (power) button positioned on a front surface of the test apparatus <NUM>. In addition, the test apparatus <NUM> and the external terminal <NUM> may be connected by executing the application program installed in the external terminal <NUM>.

Next, a subject may collect a sample by pushing the swab <NUM> up to the nasopharynx inside his or her nose. The swab <NUM>, which completed sample collection, may be put into the sample tube <NUM> and the sample tube <NUM> may be sufficiently shaken about <NUM> to <NUM> times, and thus the sample may be mixed in the sample tube <NUM>.

Next, a preset amount (e.g., <NUM> ul) of the sample mixed by sufficiently shaking the sample tube <NUM> may be added to the test tube <NUM> and the control tube <NUM>. The test tube <NUM> and the control tube <NUM> are mounted at their places in the test apparatus <NUM>, and the lid of the test apparatus <NUM> is closed. When the lid of the test apparatus <NUM> is closed, the test apparatus <NUM> may be driven for a preset time at a preset temperature. In this case, the remaining time among a total time may be displayed on a display screen of the external terminal <NUM>.

When the preset time has elapsed, the display screen of the external terminal <NUM> may be transitioned to a driving completion screen, and a determination result may be displayed on the display screen. In this case, the measurement unit <NUM> of the test apparatus <NUM> may output a signal for a change in color of the test tube <NUM> and the control tube <NUM>. The signal output from the measurement unit <NUM> may be stored in the memory <NUM> of the controller <NUM>.

The controller <NUM> may obtain a result of determining whether an infection is present by using data on the change in the color of the test tube <NUM> and the control tube <NUM>. Alternatively, the controller <NUM> may transmit data on the signal stored in the memory <NUM> to the external terminal <NUM> through the communication unit <NUM>. The external terminal <NUM> may obtain a result of determining whether an infection is present by using the data on the change in the color of the test tube <NUM> and the control tube <NUM> and display the result on the display screen.

<FIG> illustrates exemplary views of tubes whose color is changed.

Referring to <FIG>, it can be seen that a solution contained in a tube is yellow, and referring to <FIG>, it can be seen that a solution contained in a tube is red. Each of the test tube <NUM> and the control tube <NUM> may contain a reagent whose color is changed according to pH. In the example shown in <FIG>, the "yellow" may indicate "positive" meaning that detection target nucleic acid is contained therein, and the "red" may indicate "negative" meaning that the detection target nucleic acid is not contained therein.

<FIG> is an exemplary table for interpreting results according to colors of tubes.

Referring to the table shown in <FIG>, when a control tube is measured to be yellow, this means that a sample is well extracted and the LAMP reaction is also well performed, indicating that the measurement result is reliable. On the other hand, when the control tube is measured to be red, this means that the sample is not well extracted or the LAMP reaction is well performed, indicating that the measurement result is unreliable. In this case, the test is invalid and thus a retest may be recommended.

Meanwhile, when the control tube is measured to be yellow and the test tube is measured to be yellow, this means that coronavirus disease <NUM> (COVID-<NUM>) virus has been detected. That is, it may be determined that the subject is infected with the COVID-<NUM> virus. On the other hand, when the control tube is measured to be yellow and the test tube is measured to be red, this means that no COVID-<NUM> virus has been detected. That is, it may be determined that the subject is not infected with the COVID-<NUM> virus. It is obvious that the color may be variously changed according to the types of the reagents contained in the test tube <NUM> and the control tube <NUM>.

<FIG> illustrates an example of changes in absorbance over time of a control tube and a test tube with respect to a sample determined as negative.

Referring to <FIG>, a horizontal axis represents time (min), a left vertical axis represents absorbance, and a right vertical axis represents temperature (Temp). According to an embodiment of the present invention, each of the first and the second spectrum sensors <NUM> and <NUM> may output a signal related to an intensity of light of a specific wavelength (e.g., <NUM>). The light that is emitted from each of the first and the second light sources <NUM> and <NUM> is transmitted through the control tube <NUM> or the test tube <NUM> and measured by a corresponding one of the first and the second spectrum sensors <NUM> and <NUM>. That is, the intensity of the light, which is measured by each of the first and the second spectrum sensors <NUM> and <NUM>, is an intensity of the light that is transmitted through the control tube <NUM> or the test tube <NUM>. The intensity of the light may be converted into a current value by the first and the second spectrum sensors <NUM> and <NUM>, and an analog current value may be converted into a digital binary value, and the digital binary value may be converted into <NUM> bits. Therefore, in the example illustrated in <FIG>, a unit indicated on the left vertical axis may be understood as a value indicating a relative intensity of the light that is transmitted through the control tube <NUM> or the test tube <NUM>.

When the test starts, the heating unit <NUM> may heat the test tube <NUM> and the control tube <NUM> in response to a control signal output from the controller. The heating starts at <NUM> minutes, <NUM> to <NUM> minutes is a section in which the temperature of the heating unit <NUM> itself is increased, <NUM> to <NUM> minutes is a heating section for amplification, and <NUM> to <NUM> minutes is a section in which the heating is stopped and cooling is performed. In <FIG>, a line represented by circular marks indicates the internal temperature of the heating unit <NUM>, a line represented by triangular marks indicates the absorbance of the control tube <NUM>, and a line represented by square marks indicates a change in absorbance of the control tube <NUM>.

In the heating section, since the temperatures of the control tube <NUM> and the test tube <NUM> themselves are increased and the color of the indicator may be changed, the absorbance may be increased. However, in the case of a negative sample, since there is no amplification in the test tube <NUM>, the absorbance may be reduced when the temperature is lowered. On the other hand, in the control tube <NUM>, even when amplification occurs and the temperature is lowered, the absorbance may be increased or maintained. That is, since the absorbance of the control tube <NUM> is greater than or equal to a preset measurement invalidity determination reference value, the test may be determined as a valid test, and since the absorbance of the test tube <NUM> is less than or equal to an infection determination reference value, a result of the test may be determined as "negative.

<FIG> illustrates an example of changes in absorbance over time of a control tube and a test tube with respect to a sample determined as positive.

Referring to <FIG>, horizontal/vertical axes and each item are the same as those in <FIG>, and thus redundant descriptions thereof will be omitted. Similarly, in a heating section of <FIG>, since the temperatures of the control tube <NUM> and the test tube <NUM> themselves are increased and the color of the indicator may be changed, the absorbance may be increased. However, in the case of a positive sample, since there is amplification in the test tube <NUM>, the absorbance may be increased or maintained even when the temperature is lowered. Further, in the control tube <NUM>, even when amplification occurs and the temperature is lowered, the absorbance may be increased or maintained. That is, since the absorbance of the control tube <NUM> is greater than or equal to a preset measurement invalidity determination reference value, the test may be determined as a valid test, and since the absorbance of the test tube <NUM> is greater than or equal to an infection determination reference value, a result of the test may be determined as "positive.

<FIG> illustrates an example of changes in absorbance over time of a control tube and a test tube with respect to a sample, which is positive but collected in insufficient quantities.

Referring to <FIG>, it can be seen that a slope of a graph of absorbance of the control tube <NUM> is lower than that in each of the examples illustrated in <FIG> and <FIG>. The example illustrated in <FIG> is an example in which, although the sample is positive, since the absorbance of the control tube <NUM> is greater than or equal to a preset measurement invalidity determination reference value, the test is determined as a valid test, and since the absorbance of the test tube <NUM> is less than or equal to an infection determination reference value, a result of the test is determined as "negative. " That is, when a change in absorbance of the test tube <NUM> over time is qualitatively determined, the example illustrated in <FIG> is the case in which, although it may be determined as positive, the result of the test is determined as negative due to the finally measured value of the absorbance. Therefore, there is a need for a method in which the controller <NUM> may determine the result of the test as positive or negative even when an amount of amplification is small.

The controller <NUM> according to the present invention may determine whether a sample is infected according to a ratio of change in absorbance of two tubes. The two tubes are the control tube <NUM> and the test tube <NUM>, and the ratio of the change refers to a change in amount of amplification in the test tube compared to a change in amount of amplification in the control tube.

More specifically, the controller <NUM> may convert signals output from the first spectrum sensor <NUM> and signals output from the second spectrum sensor <NUM> at a first time point and a second time point and store the converted signals. The first time point and the second time point are preset time points, and the first time point and the second time point are different time points. However, the first spectrum sensor <NUM> and the second spectrum sensor <NUM> simultaneously output the signals at the first time point, and similarly, the first spectrum sensor <NUM> and the second spectrum sensor <NUM> simultaneously output the signals at the second time point. The first time point may be a time point relatively earlier than the second time point, and the first time point and the second time point may have an interval which is greater than or equal to a preset time.

According to an embodiment of the present invention, the first time point may be a time point adjacent to a time point at which the controller <NUM> terminates the heating operation of the heating unit <NUM>. That is, the first time point may be a time point immediately before or immediately after the controller <NUM> terminates the heating operation of the heating unit <NUM>. Further, the second time point may be a time point when a preset time has elapsed since the controller <NUM> terminated the heating operation of the heating unit <NUM>. Preferably, the second time point may be a time point sufficiently far from the time point at which the heating operation is terminated. As another example, the second time point may be a time point when a temperature value output from the temperature sensor <NUM> reaches a preset temperature value after the controller <NUM> terminates the heating operation of the heating unit <NUM>. Preferably, the preset temperature value is a value at which discoloration of the indicator is not affected by the temperature.

The controller <NUM> may calculate a difference value (hereinafter, referred to as a "control spectrum difference value") between a value of the signal output from the first spectrum sensor <NUM> at the first time point and a value of the signal output from the first spectrum sensor <NUM> at the second time point. In addition, the controller <NUM> may calculate a difference value (hereinafter, referred to as a "test spectrum difference value") between a value of the signal output from the second spectrum sensor <NUM> at the first time point and a value of the signal output from the second spectrum sensor <NUM> at the second time point. In addition, the controller <NUM> may determine whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value.

More specifically, the controller <NUM> may determine whether the sample is infected using Equation <NUM> below.

In this case, when the infection determination value K is greater than or equal to a preset reference value, the controller <NUM> may determine that a result of determining whether the sample is infected is positive. Hereinafter, Tables <NUM> and <NUM> are examples in which the result of determining whether the sample is infected is determined as negative and positive when the preset reference value is "<NUM>.

Meanwhile, when the value of the signal output from the first spectrum sensor <NUM> at the second time point is greater than or equal to a preset measurement invalidity determination reference value and when the value of the signal output from the second spectrum sensor <NUM> at the second time point is less than or equal to a preset primary infection determination reference value, the controller <NUM> according to the present invention may determine whether the sample is infected using the test spectrum difference value compared to the control spectrum difference value. In other words, when the primary determination is "negative," whether the sample is infected may be secondarily determined by supplementarily using the test spectrum difference value compared to the control spectrum difference value.

Thereafter, the communication unit <NUM> may transmit the value of the signal output from the first spectrum sensor, the value of the signal output from the second spectrum sensor, or information on whether the sample is infected as determined by the controller to the external terminal <NUM>. In this case, the external terminal <NUM> may receive the data transmitted from the test apparatus and display the information on whether the sample is infected on a display.

The embodiment in which the test apparatus <NUM> itself determines whether the sample is infected has been described. The diagnostic system <NUM> according to the present invention includes not only the test apparatus <NUM> but also the external terminal <NUM>, and thus the test apparatus <NUM> may provide measurement values and the external terminal <NUM> may determine whether the sample is infected. Hereinafter, a test method according to the present invention will be described on the premise of a computer program executed in the external terminal <NUM> to which the measurement values are provided. However, the test method described below is not necessarily limited to being performed in the external terminal <NUM> such as a smartphone, and may be performed in the test apparatus <NUM>.

The external terminal <NUM> may include a communication unit that receives the value of the signal output from the first spectrum sensor <NUM> and the value of the signal output from the second spectrum sensor <NUM> from the test apparatus <NUM>, and a processor that performs each of operations of the test method which will be described below.

<FIG> is a flowchart of a test method according to an embodiment of the present invention.

Referring to <FIG>, in operation S <NUM>, a processor may calculate a difference value (hereinafter, referred to as a "control spectrum difference value") between a value of a signal output from a first spectrum sensor that outputs a signal related to a wavelength of light emitted from a first light source and transmitted through a control tube at a preset first time point, and a value of a signal output from the first spectrum sensor at a preset second time point different from the first time point. The first time point may be a time point relatively earlier than the second time point. Further, the first time point and the second time point may have an interval which is greater than or equal to a preset time.

Next, in operation S200, the processor may calculate a difference value (hereinafter, referred to as a "test spectrum difference value") between a value of a signal output from a second spectrum sensor that outputs a signal related to a wavelength of light emitted from a second light source and transmitted through a test tube at the first time point, and a value of a signal output from the second spectrum sensor at the second time point.

Next, in operation S300, the processor may determine whether a sample is infected using the test spectrum difference value compared to the control spectrum difference value. In operation S300, the processor may determine whether the sample is infected using Equation <NUM> described above. In addition, when the infection determination value K is greater than or equal to the preset reference value, the processor may determine that a result of determining whether the sample is infected is positive.

Meanwhile, operation S300 may be performed when the value of the signal output from the first spectrum sensor at the second time point is greater than or equal to a preset measurement invalidity determination reference value and when the value of the signal output from the second spectrum sensor at the second time point is less than or equal to a preset primary infection determination reference value.

The controller <NUM> may include a processor, an application-specific integrated circuit (ASIC), another chipset, a logic circuit, a register, a communication modem, a data processing device, and the like, which are known in the art in order to execute calculations and various control logics. Further, when the above-described control logic is implemented in software, the controller may be implemented as a set of program modules. In this case, the program modules may be stored in a memory and may be performed by the processor.

The computer program may include code coded in a computer language such as C/C++, C#, JAVA, Python, or machine language that a processor (i.e., a central processing processor (CPU)) of the computer may read through a device interface of the computer in order for the computer to read the program and execute the methods implemented as a program. The code may include functional code related to a function defining functions necessary to execute the above methods and the like and include execution procedure related control code necessary for the processor of the computer to execute the functions according to a predetermined procedure. Further, the code may further include memory reference-related code for referencing a location (address) of an internal or external memory of the computer where there is additional information or media necessary for the processor of the computer to execute the functions. Further, when the processor of the computer needs to communicate with any other computer or server in a remote location in order to execute the functions, the code may further include communication-related code for how to communicate with any other remote computer or server using the communication module of the computer and what information or media to transmit or receive during communication.

The storage medium is not a medium that stores data for a short moment, such as a register, a cache, a memory, etc., but a medium that stores data semi-permanently and may be read by a device. Specifically, examples of the storage medium include a read only memory (ROM), a random access memory (RAM), a compact disc read only memory (CD-ROM), a magnetic tape, a floppy disk, an optical data storage device, and the like, but the present invention is not limited thereto. That is, the program may be stored in various recording media on various servers accessible by the computer or in various recording media on the computer of the user. Further, the media may be distributed to computer systems connected by a network, and computer-readable code may be stored in a distributed manner.

According to one aspect of the present invention, even when an amount of sample collected is small, it is possible to determine whether an infection is present.

According to another aspect of the present invention, even when an amount of amplification is small due to an external environment, it is possible to determine whether an infection is present.

Effects of the present invention are not limited to the above-described effects and other effects that are not described will be clearly understood by those skilled in the art from the above detailed descriptions.

Claim 1:
A test apparatus (<NUM>) comprising:
a first spectral sensor (<NUM>) configured to output a signal related to a wavelength of light emitted from a first light source and transmitted through a control tube (<NUM>);
a second spectral sensor (<NUM>) configured to output a signal related to the at least one wavelength of light emitted from a second light source and transmitted through a test tube (<NUM>); and
a controller (<NUM>) configured to determine whether a sample is infected using a test spectral difference value between a value of a signal output from the second spectral sensor (<NUM>) at a preset first time point and a value of a signal output from the second spectral sensor (<NUM>) at a preset second time point different from the first time point compared to a control spectral difference value between a value of a signal output from the first spectral sensor (<NUM>) at the first time point and a value of a signal output from the first spectral sensor (<NUM>) at the second time point.