WO2015070750A1

WO2015070750A1 - Test strip card

Info

Publication number: WO2015070750A1
Application number: PCT/CN2014/090853
Authority: WO
Inventors: 马义才; 顾敏; 马灵
Original assignee: 成都领御生物技术有限公司; 马义才
Priority date: 2013-11-16
Filing date: 2014-11-11
Publication date: 2015-05-21
Also published as: CN103645313A

Abstract

A test strip card having a storage medium (13) to store a standard curve or coefficient parameter information of an object to be tested, the test strip card comprising a card case (3) and a test strip (2); a test strip insertion slot (12) is formed in the opening at one end of the card case (3); the test strip (2) is a detached insertion structure of the card case (3); the storage medium (13) is installed on the card case (3); when conducting sample testing, one end of the sample absorbing pad (4) of the test strip (2) inserted in the card case (3) extends out of the opening end of the card case (3) to dip into and absorb the sample, and an instrument having a signal detection function collects the characteristic signal of a detection band (6) of the test strip (2), and combines the standard curve or coefficient parameter of the object to be tested simultaneously read from the storage medium (13) so as to calculate and obtain the single-component or multicomponent concentration of the sample. The present invention is convenient and fast, and flexible to use, and is highly sensitive and produces objective results.

Description

Test strip card

Technical field

The invention belongs to the field of in-vitro diagnosis, and particularly relates to a detection information such as a standard curve or a coefficient parameter of a storage medium 13 for storing a test object, and an instrument capable of detecting a single component or a plurality of groups can be quickly detected by an instrument with a signal detection function. The test strip card.

Background technique

Immunochromatographic strip technology, which is mainly represented by colloidal gold strips, has been widely used in various aspects of immunoassays. The technology is simple and fast, and results are available in minutes. The inadequacies are: (1) Only qualitative detection of samples, it is difficult to achieve quantitative detection of samples, it is more difficult to achieve rapid quantitative detection of multi-component samples. (2) For samples with very low antigen or antibody content, it is difficult to judge the results with the naked eye and the detection sensitivity is low.

The use of the standard curve of the test substance to quantify the concentration of the test substance is the main method for quantifying the concentration of the sample in the current detection field. The standard curve is technically strong and the process is complicated, and it is inseparable from professional technicians. Recently developed storage media in the information field, such as RFID tags (also known as radio frequency identification tags), IC chips, magnetic codes, barcodes, etc., for information access identification is now widely used in computers, communications, electronics, commerce, transportation Control management and other fields. RFID tags, small size, large storage capacity, identification without manual intervention, is an ideal means of information access identification, but few people use it in biomedical testing.

In order to overcome the deficiencies of the prior art, the present invention provides a test information for storing a test object such as a standard curve or a coefficient parameter with a storage medium 13 (the operator does not need to make a standard curve of the test object when detecting the sample) Combined with the instrument with signal detection function, it can quickly realize the test strip card for single-component or multi-component quantitative detection of samples. The invention is used for sample detection, and has the characteristics of simple and rapid, high sensitivity and objective result.

Summary of the invention

The technical scheme of the present invention is as follows:

The test strip card of the present invention comprises a cartridge 3 and a test strip 2. The test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, and an absorbent pad 8 which are fixed to the substrate 1 in this order. The analysis membrane 7 has a detection strip 6. The detection tape 6 is one or more. One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 12 to facilitate the insertion of the test strip 2 into the cartridge 3. The test strip 2 is a separate insertion structure of the cartridge 3. At the time of sample detection, the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample. The upper casing of the cartridge 3 is provided with a detection window 10 at a position corresponding to the test strip analysis film 7. A storage medium 13 is mounted on the cartridge 3.

The marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.

The test strip 6 of the test strip 2 is coated with another specific molecule associated with detection of a certain target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The storage medium 13 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode. The storage medium 13 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the test strip batch number, the test strip validity period, the storage medium password, the clinical index reference value, and the test strip manufacturer information. Etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.

The standard curve of the sample stored in the storage medium 13 can be selected in various forms including, but not limited to, a corresponding relationship between the concentration of the sample standard series and the A _{detection zone} . The A _{detection zone is} defined as the detection zone signal strength measured by the concentration of the sample standard series.

After the water absorbing pad 8 of the test strip 2 of the present invention, a test strip reaction end point indicating label 9 can be overlapped. Correspondingly, the test strip reaction end point of the cartridge 3 indicates that the label 9 has a viewing window 11 corresponding thereto. The strip reaction end point indicating label 9 includes, but is not limited to, a pH test strip having a discoloration range of 5-9.

The marking pad 5 of the test strip 2 of the present invention is a glass fiber membrane; the analysis membrane 7 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane; The backing 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.

The test strip 2 of the present invention is any test strip, including but not limited to a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, and a nano rare earth fluorescent complex labeling test. Strips, nano-magnetic particle labeling strips, time-resolved chromatographic strips, chemiluminescent strips.

The test strip 2 of the present invention is a disposable product. The storage medium 13 on the cartridge 3 and the cartridge 3 is a product for use in the same batch test strip 2.

When the test strip of the present invention is used for sample detection, the test strip 2 is currently inserted into the cartridge 3, and the liquid sample is immersed in the interference projection end of the test strip 2 inserted into the cartridge 3. After the sample is tested on the test strip 2, the signal with the signal detection function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.) is used to collect the characteristic signal of the test strip 2 in the test strip 2 and The sample one-component or multi-component concentration is calculated by combining the standard curve or coefficient parameter of the test object simultaneously read from the storage medium 13 by the instrument.

The sample to be tested of the test strip card of the present invention may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, Samples of hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drugs Samples such as detection.

The invention has the following beneficial effects:

(1) Rapid and quantitative detection of sample components. A storage medium 13 is mounted on the test strip card of the present invention, and the storage medium 13 stores detection information such as a standard curve or a coefficient parameter of the test object. After the sample to be tested completes the chromatographic reaction on the test strip, the characteristic signal of the test strip 6 of the test strip 2 in the strip is collected by the instrument with the signal detecting function and combined with the instrument to read from the storage medium 13 at the same time. The sample standard curve or coefficient parameter allows for rapid (in minutes) quantitative sample component concentration.

(2) When the test strip 2 in the test strip card of the invention adopts the quantum dot mark, the multi-component rapid and accurate quantitative detection of the sample can be simultaneously realized. Quantum Dots (QDs) are semiconductor nanocrystals with excellent spectral characteristics and photochemical stability developed in the 1990s. They have high fluorescence emission efficiency, wide excitation line range, narrow emission line range, and fluorescence lifetime. Long, Stokes displacement is large, the particle size is similar to biomolecules, and the surface can be multi-functional after modification. Quantum dots of different particle sizes, types and structures can produce sustained fluorescence peak spectra with different characteristic wavelengths, and the characteristic wavelength fluorescence peak spectra produced by the quantum dot mixture do not overlap. The corresponding reaction molecules of the test object are respectively labeled by using different quantum dots, and the mixture is coated on the test strip of the test strip of the present invention to react with the sample to be tested, and the specific fluorescent signal of the test strip can be measured within a few minutes. Quickly and accurately quantify sample multi-component concentrations. However, the existing test strip technology can only qualitatively detect samples, and can not achieve quantitative detection of samples, and can not achieve quantitative detection of multi-component samples.

(3) The reagents and materials in the test strip are not involved in activity inactivation and can be stored at room temperature for a long time.

DRAWINGS

Figure 1 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a test line in the inner test strip)

Figure 2 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the strip card of the present invention (the test strip adopts a test line)

Figure 3 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)

Figure 4 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of test lines)

Figure 5 is a top plan view of another preferred embodiment of the test strip of the present invention (showing a test line in the test strip)

Figure 6 is a side view showing the structure of the test strip in another embodiment of the test strip card of the present invention (the test strip adopts a test line)

Figure 7 is a top plan view of another preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)

FIG. 8 is a side view structural view of a test strip in a cartridge according to another preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of detection lines)

The serial number is as follows:

1. Underlay, 2, test strip, 3, cartridge, 4, suction pad, 5, marker pad, 6, test tape, 7, analysis membrane, 8, absorbent pad, 9, test strip reaction end indication label, 10, detection window, 11, observation window, 12, test strip slot, 13, storage medium.

detailed description

The following examples and the accompanying drawings are only intended to further illustrate the invention, and those skilled in the art should not limit the scope of the invention.

Embodiment 1

Figures 1-4 illustrate a first embodiment. Embodiment 1 is one of the preferred embodiments of the test strip card of the present invention.

In Figures 1-4, the test strip card of the preferred embodiment includes a cartridge 3 and a test strip 2. The test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, and an absorbent pad 8 which are sequentially attached to the substrate 1 by overlapping. The analysis membrane 7 has a detection strip 6. One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 12 to facilitate the insertion of the test strip 2 into the cartridge 3. The test strip 2 is a separate insertion structure of the cartridge 3. At the time of sample detection, the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample. The upper casing of the cartridge 3 is provided with a detection window 10 at a position corresponding to the test strip analysis film 7. A storage medium 13 is mounted on the cartridge 3.

The test strip 6 of the test strip 2 may be one (shown in FIGS. 1 and 2) or a plurality of strips (shown in FIGS. 3 and 4). The test strip 6 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The marking pad 5 of the test strip 2 is a glass fiber membrane; the analysis membrane 7 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a mixed membrane of nitrocellulose/cellulose acetate; the bottom of the test strip 2 The liner 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.

The test strip 2 is any test strip, which includes, but is not limited to, a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, a nano rare earth fluorescent complex label strip, Nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.

The test strip 2 is a disposable product. The storage medium 13 on the cartridge 3 and the cartridge 3 is matched with the same batch of test strips 2 The use of the set.

When the test strip card is used for sample detection, the test strip 2 is currently inserted into the cartridge 3, and the liquid sample is immersed in the interference projection end of the test strip 2 inserted into the cartridge 3. After the liquid sample is subjected to the test strip reaction on the test strip 2, the characteristic signal of the test strip 2 of the test strip 2 is collected by an instrument having a signal detecting function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.) and combined with the instrument. The sample one-component or multi-component concentration is calculated from the test sample standard curve or coefficient parameter simultaneously read from the test strip storage medium 13.

The sample to be tested of the test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, Samples of cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing, etc. The sample inside.

Embodiment 2

Figures 5-8 illustrate a second embodiment. Embodiment 2 is another preferred embodiment of the test strip card of the present invention.

In Figures 5-8, the strip card of the preferred embodiment includes a cartridge 3 and a strip 2. The test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, an absorbent pad 8, and a test strip reaction end indicating label 9 which are sequentially attached to the substrate 1. The analysis membrane 7 has a detection strip 6. One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 12 to facilitate the insertion of the test strip 2 into the cartridge 3. The test strip 2 is a separate insertion structure of the cartridge 3. At the time of sample detection, the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample. The upper casing of the cartridge 3 is provided with a detection window 10 at a position corresponding to the test strip analysis film 7. The upper casing of the cartridge 3 is provided with an observation window 11 at a position corresponding to the test strip end point indicating label 9. A storage medium 13 is mounted on the cartridge 3.

The test strip 6 of the test strip 2 may be one (shown in FIGS. 5 and 6) or a plurality of strips (shown in FIGS. 7 and 8). The test strip 6 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.

The strip reaction end point indicating label 9 includes, but is not limited to, a pH test strip having a discoloration range of 5-9. When the sample is tested, the test strip reaction end point label 9 on the test strip can be colored according to the pH condition of the test strip reaction, to indicate whether the test strip reactant has fully oozing through the test strip 6, indicating whether the test strip reaction is sufficient, Whether the test result is valid.

The test strip 2 is any test strip, which includes, but is not limited to, a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, a nano rare earth fluorescent complex label strip, Nano magnetic particle marking strip, Time-resolved chromatographic strips and chemiluminescent strips.

The test strip 2 is a disposable product. The storage medium 13 on the cartridge 3 and the cartridge 3 is a product for use in the same batch test strip 2.

When the test strip card is used for sample detection, the test strip 2 is currently inserted into the cartridge 3, and the liquid sample is immersed in the interference projection end of the test strip 2 inserted into the cartridge 3. The test strip reaction end indication label 9 indicates that the sample is subjected to the chromatographic reaction on the test strip 2, and the test strip card test strip is collected by an instrument having a signal detection function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.). The detection band 6 characteristic signal of 2 is combined with the standard curve or coefficient parameter of the test object simultaneously read from the test strip card storage medium 13 to calculate the single component or multi-component concentration of the sample.

It should be noted that the test strip card of the present invention may have other improvements. For example, the storage medium 13 storing the detection information such as the standard curve of the test object may be installed on the cartridge 3 of the test strip card. Directly installed on the test strip 2 in the test strip card; based on the same principle of the present invention, the test strip in the cartridge 3 can also be expanded and replaced with a biochip (including an antigen-antibody chip, a protein chip, a nucleic acid chip, a microfluidic chip), etc. Wait. Therefore, any other technical solutions formed by any equivalent replacement or equivalent transformation of the test strip of the present invention fall within the scope of protection of the present invention.

Claims

A test strip card comprising a cassette (3) and a test strip (2), the test strip (2) comprising a suction pad (4) and a marking pad (5) fixed in sequence on the underlay (1) , the analysis film (7), the water absorption pad (8), the analysis film (7) has a detection tape (6), the detection tape (6) is one or more, and the upper surface of the cartridge (3) corresponds to the test strip A detection window (10) is opened at the position of the analysis membrane (7), which is characterized by:

One end of the card box (3) and the upper box surface opening of the card box end form a test strip slot (12), and the test strip (2) is a separate plug-in structure of the card box (3), when the sample is tested, a test strip (2) inserted into the cartridge (3), one end of the suction pad (4) is over-extended to extend out of the open end of the cartridge (3) to dip the sample;

A storage medium (13) is also mounted on the cartridge (3).
The test strip of claim 1 wherein:

The marker pad (5) of the test strip (2) is coated with a single target molecule associated with a target analyte detected by a single marker, or: a target analyte coated with a marker corresponding to a different marker Detecting a mixture of related specific molecules;

The test strip (6) of the test strip (2) is coated with another specific molecule associated with detection of a certain target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
A test strip according to claim 1, characterized in that the storage medium (13) on the cartridge (3) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
The test strip according to claim 1, characterized in that the storage medium (13) stores the same batch test strip (2) the sample standard curve or coefficient parameter for the quantitative sample concentration, and the test strip batch number , test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the object identification information, detector information, sample name, sample number, date of detection, and test result information.
The test strip according to claim 4, characterized in that the standard curve of the object stored in the storage medium (13) has various forms to be selected, which includes the concentration of the sample standard and the A detection. Corresponding relationship curve between the bands ; the A detection band is defined as the detection band signal intensity measured by the concentration of the sample standard series.
The test strip of claim 1 wherein:

The marking pad (5) of the test strip (2) is a glass fiber membrane, and the analysis membrane (7) of the test strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane. ;

The underlayer (1) of the test strip (2) is a polyester or plastic plate;

The cartridge (3) is made of polyester, plastic, or a hard paper material.
The test strip according to claim 1, wherein the test strip (2) is any test strip comprising a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, and an upconversion. Phosphorescent labeling strip, nano rare earth fluorescent complex labeling strip, nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.
The test strip according to claim 1, wherein said test strip (2) is a disposable product, said cartridge (3) and said storage medium (13) on said cartridge (3) Used for the same batch test strip (2).
The test strip according to claim 1, wherein the test strip (2) is currently inserted into the cartridge when the sample is detected. (3) Inside, the interference protruding end of the test strip (2) inserted into the cartridge (3) is immersed and sucked, and after the sample is reacted on the test strip (2), the signal detection function is performed. The instrument collects the test strip in the strip (2) and detects the characteristic signal of the strip (6) and combines the standard curve or coefficient parameter of the sample simultaneously read from the storage medium (13) to calculate the sample component or Multi-component concentration.
A test strip according to claim 1, wherein the absorbent pad (8) of the test strip (2) is further overlapped with a test strip reaction end indicating label (9); and the cartridge ( 3) The test strip reaction end indication label (9) has an observation window (11) corresponding thereto.
The test strip according to claim 10, wherein said test strip reaction end point indicator (9) comprises a pH test strip having a discoloration range of 5-9.
A test strip according to claim 10, wherein:

The marker pad (5) of the test strip (2) is coated with a single target molecule associated with a target analyte detected by a single marker, or: a target analyte coated with a marker corresponding to a different marker Detecting a mixture of related specific molecules;

The test strip (6) of the test strip (2) is coated with another specific molecule associated with detection of a certain target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
A test strip according to claim 10, characterized in that the storage medium (13) on the cartridge (3) comprises an RFID tag, an IC chip, a magnetic code, or a barcode.
The test strip according to claim 10, characterized in that the storage medium (13) stores the same batch test strip (2) the sample standard curve or coefficient parameter for the quantitative sample concentration, and the test strip batch number , test strip validity period, storage medium password, clinical index reference value, test strip manufacturer information, and can read the object identification information, detector information, sample name, sample number, date of detection, and test result information.
The test strip according to claim 14, characterized in that the standard curve of the test object stored in the storage medium (13) has various forms to be selected, which includes the concentration of the test object standard series and the A test. Corresponding relationship curve between the bands ; the A detection band is defined as the detection band signal intensity measured by the concentration of the sample standard series.
A test strip according to claim 10, wherein:

The marking pad (5) of the test strip (2) is a glass fiber membrane, and the analysis membrane (7) of the test strip (2) is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane. ;

The underlayer (1) of the test strip (2) is a polyester or plastic plate;

The cartridge (3) is made of polyester, plastic, or a hard paper material.
The test strip according to claim 10, wherein the test strip (2) is any test strip comprising a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, and an upconversion. Phosphorescent labeling strip, nano rare earth fluorescent complex labeling strip, nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.
The test strip according to claim 10, wherein said test strip (2) is a disposable product, said cartridge (3) and said storage medium (13) on said cartridge (3) Used for the same batch test strip (2).
The test strip according to claim 10, wherein when the sample is detected, the test strip (2) is currently inserted into the card. In the box (3), the interference projection end of the test strip (2) inserted into the cartridge (3) is immersed to suck the sample, and the test strip reaction end indication label (9) indicates that the sample is completed on the test strip (2). After the test strip reaction, the test strip (2) of the test strip (6) is collected by the instrument with the signal detection function, and the standard curve of the test object simultaneously read from the storage medium (13) is combined with the instrument. Or the coefficient parameter is calculated to obtain the single component or multi-component concentration of the sample.
A test strip according to claim 1 or 10, wherein the sample to be tested is from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous Samples, including clinical samples including infectious diseases, hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, Samples for biologics testing, veterinary testing, and drug testing.