WO2013070032A1

WO2013070032A1 - System for diagnosing osteoporosis and bone turnover rate and method for same

Info

Publication number: WO2013070032A1
Application number: PCT/KR2012/009487
Authority: WO
Inventors: 이상대; 김경식; 백준흠; 김은정
Original assignee: 주식회사 아이엠헬스케어
Priority date: 2011-11-09
Filing date: 2012-11-09
Publication date: 2013-05-16

Abstract

Disclosed are a system for diagnosing osteoporosis and bone turnover rate, and a method for same. The system for diagnosing osteoporosis and bone turnover rate comprises: an insertion portion into which a cartridge that has reacted with a bone marker contained in the blood or urine of a patient is inserted; a light emitting portion for irradiating light on a control line and a test line; a light receiving portion for collecting light which is reflected by the control line and the test line; and a control portion for measuring the degree of reaction on the basis of the amount of light collected by the light receiving portion and detecting the bone marker.

Description

Osteoporosis and bone turnover diagnostic system and method

The present invention relates to a system and method for diagnosing osteoporosis and bone turnover rate.

The diagnosis of osteoporosis and bone turnover rate using the conventional bone markers is mainly dependent on biochemistry, and usually takes the Enzyme-Linked Immunosorbent Assay (ELISA) method.

In other words, by applying a receptor for a known bone marker on a 96 well plate and quantifying it using a fluorescence meter using a phosphor that reacts (ex. Osteomark, NTx serum & urine), the bone marker can be quantified. The result can be obtained through various spectral analysis and calibration curve.

In the prior art, it is common to proceed at the laboratory level because the economic burden of purchasing an expensive ELISA kit and the plate once opened cannot be used again. And expensive measurement equipment for measuring the phosphor is required separately. It also takes a long time to get results.

Other diagnostic methods use DEXA, but have the biggest disadvantage of exposure to radiation, and the burden of expensive measurement cost is also great.

In general, the diagnosis using ultrasound is widely used, but since only the diagnosis of the local site is possible, the accuracy of the result is inferior. Finally, all these methods cannot diagnose the rate of bone turnover, which can only confirm the current state of the bone and cannot monitor the degree of prediction and treatment.

Accordingly, the present invention is to provide a system and method for diagnosing osteoporosis and bone turnover rate using a bone marker.

According to a feature of the invention, the osteoporosis and bone turnover diagnostic system An insertion unit into which a cartridge reacting the bone markers included in the blood and urination of the patient is inserted, a light emitting unit for irradiating light to the control line and the test line, and a light receiving unit collecting light reflected from the control line and the test line And a controller configured to detect the bone marker by measuring the reaction degree based on the amount of light collected by the light receiver.

The cartridge may include a sample port for injecting blood and urination samples collected from a patient, and a control line and a test line in which a degree of response between the antigen and the antibody is displayed.

The antigen may comprise a gold nano-particle antibody.

The bone markers may include NTX (N-terminal telopeptide), CX (CTx, C-terminal telopeptide), and OC (Osteocalcin).

The cartridge is produced for each of the bone markers, and includes a bar code or QR code containing information indicating a corresponding bone marker on one side, and the control unit is connected to an external reader that recognizes the barcode or QR code The bone marker of the cartridge may be identified through information recognized by an external reader.

In accordance with another aspect of the present invention, a method for diagnosing osteoporosis and bone turnover may include inserting a cartridge in which a bone marker and gold marker included in the blood and urination of the patient reacted, and antibody in the cartridge using optical technology. And measuring a degree of response between antigens, and detecting a bone marker for diagnosing osteoporosis and bone turnover rate based on the result of the measurement of the degree of response.

The measuring may include irradiating light to a control line and a test line showing a degree of reaction between the antigen and the antibody, collecting light reflected from the control line and the test line, and collecting the collected light amount. Based on the reaction degree may be measured.

Before the reacting step, further comprising the step of identifying from the external reader the bone markers included in the barcode or QR code included in one side of the cartridge recognized by the external reader,

The detecting may detect the identified bone marker.

According to an embodiment of the present invention, it is possible to expect a reduction in medical costs and real-time diagnosis is possible.

In addition, osteoporosis and bone turnover treatment may help in selecting a medicine, and monitoring for osteoporosis and bone turnover treatment is possible.

In addition, it is possible to use a low cost cartridge when diagnosing the bone turnover rate can be a regular inspection, it may be possible to determine the presence of disease and quantitative determination of the extent of symptoms.

In addition, it can be quickly tested and included in the real-time diagnosis area through real-time measurement, and by adding a bone marker other than NTx, CTx, OC can improve the diagnosis accuracy for bone turnover rate.

In addition, it may be applicable to the diagnosis of other diseases by utilizing a diagnostic method using a bone marker (antigen, antibody).

In addition, the convenience of using a disposable cartridge can be pursued, the use of a disposable cartridge can be maximized the productivity.

In addition, as a miniaturized and accelerated in vitro diagnostic device, it can be a competitive product in the osteoporosis and bone turnover market.

1 is a schematic diagram of a system for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.

2 is a view schematically showing a process for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.

3 is a block diagram of a osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention.

Figure 4 is an exploded side perspective view of the osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention.

5 is a schematic internal configuration of the osteoporosis and bone turn rate diagnostic apparatus according to an embodiment of the present invention.

6 is a block diagram of an optical system for diagnosing osteoporosis and bone turnover according to an embodiment of the present invention.

Figure 7 shows the measuring principle of the osteoporosis and bone turnover diagnostic according to an embodiment of the present invention.

8 is a flowchart illustrating a process for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art may easily implement the present invention. As those skilled in the art would realize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the present invention. In order to clearly describe the present invention in the drawings with reference to the accompanying drawings will be described in detail to be easily carried out by those of ordinary skill in the art with respect to the embodiments of the present invention. As those skilled in the art would realize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the present invention. In the drawings, parts irrelevant to the description are omitted in order to clearly describe the present invention, and like reference numerals designate like parts throughout the specification.

Throughout the specification, when a part is said to "include" a certain component, it means that it can further include other components, except to exclude other components unless specifically stated otherwise.

In addition, the term "... unit" described in the specification means a unit for processing at least one function or operation, which may be implemented in hardware or software or a combination of hardware and software.

Hereinafter, a system and method for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention will be described in detail.

Referring to FIG. 1, an osteoporosis and bone turnover diagnostic system includes an osteoporosis and bone turnover diagnostic apparatus 100 and a cartridge 200.

Here, the osteoporosis and bone turnover diagnostic system uses human blood and urination as specimens. And antigen-antibody reactions against gold nano-particles (Gold nano-particles) of a randomly set wavelength range.

In addition, the cartridge 200 may be manufactured separately for specific bone markers for diagnosing osteoporosis and bone turnover rate. That is, it may be separately manufactured to measure NT-terminal telopeptide (NTx), C-terminal telopeptide (CTx), and osteocalcin (OC). In this case, a barcode or QR code may be attached to one side of the cartridge 200 to include measurement marker information of the cartridge 200. In this case, the osteoporosis and bone turn rate diagnostic apparatus 100 may be connected to a reader unit (not shown) capable of reading a barcode or a QR code of the cartridge 200.

The cartridge 200 may be a lateral flow immunochromatography. And the reaction time can be different depending on the sample.

As such, osteoporosis and bone turnover diagnostic systems are lateral flow systems using antigen and antibody responses. In addition, it is an immunodiagnostic kit for detecting biochemical markers of three species, namely NTx, CTx, and OC using trace amounts of blood and urination. In addition, it is used as a point of care (POCT) diagnosis system for diseases and clinics for the purpose of early diagnosis and treatment of osteoporosis or measurement of bone turnover rate, and the risk of osteoporosis can be diagnosed along with bone density measurement.

2, the cartridge 200 is injected into the blood and urination through the collector 300, and then inserted into the osteoporosis and bone turn rate diagnostic apparatus 100. Osteoporosis and bone turnover rate diagnosis device 100 diagnoses osteoporosis and bone turnover rate by measuring the antigen antibody response of blood and urination collected by the cartridge 200 using an optical system.

3 is a configuration diagram of the osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention, showing a state equipped with a diagnostic strip.

Referring to FIG. 3, the cartridge 200 includes a control line 201 and a test line 203 for measuring the antigen-antibody response, and a sample port for injecting urine and blood. (sample port) 205. Here, the control line 201 and the test line 203 are the configuration of the diagnostic strip.

The control line 201 and the test line 203 are integrated with antibodies. In addition, the conjugate pad 209 of the diagnostic strip is integrated with gold nano-particle antibodies. The gold nado-particles react with the blood and urine injected through the sample port 205, and the degree of response is displayed on the control line 201 and the test line 203.

Referring to FIG. 4, the diagnostic strip mounted on the cartridge 200 may include a control line 201, a test line 203, a sample port 205, a sample pad 207, and a conjugate pad. 209, a membrane 211, an absorbent pad 213, and the cartridge includes a housing 215 on which the diagnostic strip is mounted.

Here, the control line 201 and the test line 203 is formed on the membrane 211. The sample pad 207 is positioned below the sample port 205. The sample pad 207 and the membrane 211 sandwich the conjugate pad 209. An absorbent pad 213 is attached to the rear end of the membrane 211.

FIG. 5 is a schematic internal configuration diagram of an osteoporosis and bone turnover diagnosis device according to an embodiment of the present invention, FIG. 6 is an optical system diagram of an osteoporosis and bone turnover diagnosis device according to an embodiment of the present invention, and FIG. The measuring principle of the osteoporosis and bone turn rate diagnostic apparatus according to the embodiment is shown.

First, referring to FIG. 5, the osteoporosis and bone turn rate diagnostic apparatus 100 includes an insertion unit 101, a light emitting unit 103, a light receiving unit 105, a control unit 107, a liquid crystal display (LCD) 109, a power supply. And a supply unit 111, a battery 113, and a commercial power input unit 115.

The insertion unit 101 provides a space in which the cartridge 200 can be inserted so that the cartridge 200 is inserted and fixed.

In this case, the insertion unit 101 may be implemented as a configuration means for mounting a sensor (not shown) that determines whether the cartridge 200 is inserted, and automatically transfers the cartridge 200 to the measurement point.

The osteoporosis and bone turnover rate diagnosis device 100 includes a light emitting unit 103 and a light receiving unit 105 to perform diagnosis of osteoporosis and bone turnover rate using urination and blood using an optical system.

Here, the optical system may be configured as an active optical system for auto focus imaging in designing an optical system for optical scanning.

The light emitter 103 irradiates light to the control line 201 and the test line 203 of the cartridge 200. The light emitting unit 103 may be a green laser diode (LD).

The light receiver 105 collects light reflected from the control line 201 and the test line 203. The light receiving unit 105 may be a photo diode IC (PDIC) to which an amplification circuit is applied.

In this case, the light emitting unit 103 and the light receiving unit 105 may use a specific wavelength band, for example, gold nano-particles of 532 nm.

The optical system structure of the osteoporosis and bone turnover rate analyzer 100 is shown in FIG. That is, the light emitting unit 103, the light receiving unit 105, and three lenses 117 are included.

Here, the first lens 117-1 is positioned at the lower end of the light emitting unit 103 to transmit the light irradiated toward the cartridge 200. The second lens 117-2 and the third lens 117-3 are positioned at the lower end of the light receiving unit 105 to transmit the reflected light.

The optical system principle of the osteoporosis and bone turn rate diagnostic apparatus 100 is as shown in FIG. That is, the light irradiated by the laser diode (LD) 103 is reflected by the control line 201 and the test line 203 of the cartridge 200 and collected by the photodiode IC (PDIC) 105.

Referring back to FIG. 5, the controller 107 measures the amount of light collected by the light receiving unit 105 or the photodiode IC (PDIC) 105 and compares the result of the osteoporosis and bone turnover rate measurement with an LCD. 109).

Here, the LCD 109 may be implemented as a user interface (UI) designed in consideration of the convenience of the user (medical agent and medical inspector).

The controller 107 measures the antigen-antibody reaction result for the gold nanoparticles based on the amount of light. The degree of antigen antibody response in the control line 201 may be measured by a predetermined time unit to determine the antigen antibody reaction in the cartridge 200 and the test line measurement may be performed. In this case, the test line may be measured and corrected based on the control line 201 to obtain a result value.

The power supply 111 supplies power to the controller 107 and is connected to the battery 113 and the commercial power input 115 to receive power and provide the power to the controller 107.

In the present invention, it is possible to verify the accuracy of the diagnostic apparatus through clinical trials, and the accumulated clinical data can be used for further studies.

Based on the configuration described so far, the following describes the measurement process of the osteoporosis and bone turnover diagnostic system sequentially.

Referring to FIG. 8, the cartridge 200 injecting blood and urination of the patient is inserted into the insertion unit 101 of the osteoporosis and bone turnover rate analyzer 100 (S101).

An external reader (not shown) connected to the osteoporosis and bone turn rate diagnosis apparatus 100 reads a barcode or QR code printed on the surface of the cartridge 200 (S103).

In this case, the barcode or QR code includes information indicating whether the measurement indicator of the cartridge 200 is NTx, CTx, or OC. Therefore, the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 confirms the measurement marker based on the information read through step S103 (S105).

Thereafter, the osteoporosis and bone turn rate diagnostic apparatus 100 is in a standby state until the reaction in the cartridge 200 is made (S107). In other words, the blood injected into the sample port 205 of the cartridge 200 and the antigen contained in the urine are in a waiting state to react with the antibodies accumulated in the control line 201 and the test line 203.

The optical system of the osteoporosis and bone turn rate diagnostic apparatus 100 measures the control line 201 (S109) to determine whether the chemical reaction is completed (S111).

That is, the light emitting unit 103 of the osteoporosis and bone turnover rate diagnosis apparatus 100 determines the completion of the chemical reaction by measuring the amount of light reflected from the control line 201. For example, three minutes after the cartridge 200 is inserted, the control line 201 is measured to determine whether the chemical reaction is completed.

At this time, if the chemical reaction is not completed, starting from step S107.

On the other hand, when the chemical reaction is completed, the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 measures and corrects the test line 203 based on the result measured in the control line 201 to obtain a result value.

Specifically, the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 first measures the amount of light reflected from the control line 201 and compares it with a predefined threshold value. Based on the comparison result, the controller 107 measures the antigen-antibody reaction result for the gold nanoparticles (S113). For example, the numerical values of NTx, CTx, and OC may be mapped and stored for each threshold of light quantity.

Thereafter, the control unit 107 of the osteoporosis and bone turnover rate diagnosis apparatus 100 may measure the antigen-antibody reaction result by measuring and correcting the amount of light reflected from the test line 203 based on the value measured in the control line. At this time, the reaction time can be confirmed by the test line 203 and repeated measurement is also possible.

When the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 completes the measurement, the insertion unit 101 protrudes the cartridge 200 (S115).

The control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 determines whether the new cartridge 200 is inserted into the insertion unit 101 (S117). In other words, it is determined whether there is an additional measurement.

At this time, if there is an additional measurement, it starts again from step S101.

On the other hand, if there is no additional measurement, the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 outputs the measurement result of the degree of antigen antibody response of the control line and the test line through the display unit 109 (S119).

The embodiments of the present invention described above are not only implemented through the apparatus and the method, but may be implemented through a program for realizing a function corresponding to the configuration of the embodiments of the present invention or a recording medium on which the program is recorded.

Although the embodiments of the present invention have been described in detail above, the scope of the present invention is not limited thereto, and various modifications and improvements of those skilled in the art using the basic concepts of the present invention defined in the following claims are also provided. It belongs to the scope of rights.

Claims

Inserts into which the cartridge to react the bone markers contained in the blood and urination of the patient is inserted,

A light emitting unit for irradiating light to the control line and the test line,

A light receiving unit collecting light reflected from the control line and the test line, and

Osteoporosis and bone turnover diagnostic system comprising a control unit for detecting the bone markers by measuring the degree of response based on the amount of light collected by the light receiver.
The method of claim 1,

The cartridge,

A sample port for injecting blood and urination samples collected from the patient, and

Osteoporosis and bone turnover diagnostic system comprising a control line and a test line showing the degree of response between the antigen and the antibody.
The method of claim 2,

The antibody,

Osteoporosis and bone turnover diagnostic system comprising gold nano-particle antibodies.
The method of claim 3,

The bone marker,

Osteoporosis and bone turnover diagnostic system, including NTX (N-terminal telopeptide), C-X (CTx, C-terminal telopeptide), OC (OC, Osteocalcin).
The method of claim 4, wherein

The cartridge,

Each of the bone markers is produced, and includes a bar code or a QR code containing information indicating the corresponding bone markers on one side,

The control unit,

Osteoporosis and bone turnover diagnostic system connected to the external reader for recognizing the barcode or the QR code to identify the bone markers of the cartridge through the information recognized by the external reader.
Inserting a cartridge in which the bone markers included in the blood and urination of the patient and the markers including gold reacted;

Measuring the degree of reaction between the antibody and antigen in the cartridge using optical technology, and

Osteoporosis and bone turnover diagnostic method comprising the step of detecting a bone marker for diagnosing osteoporosis or bone turnover rate based on the measurement result of the degree of response.
The method of claim 6,

The measuring step,

Irradiating light to a control line and a test line showing a degree of reaction between the antigen and the antibody,

Collecting light reflected from the control line and the test line, and

Osteoporosis and bone turnover diagnostic method comprising the step of measuring the degree of response based on the amount of light collected.
The method of claim 7, wherein

Before the reacting step,

Identifying a bone marker included in a barcode or a QR code included in one side of the cartridge recognized by the external reader from an external reader,

The detecting step,

Osteoporosis and bone turnover diagnostic method for detecting the identified bone markers.