WO2019127959A1 - Rapid detection system and method involving biochemical detection, enzyme immunoassay and chemiluminescence detection - Google Patents

Abstract

A rapid detection system and method involving biochemical detection, enzyme immunoassay and chemiluminescence detection. The system comprises a detection card and a detector, and has the function of performing a plurality of different detection methods. The detection card is provided with more than one reagent cup, sample cup, normal saline cup, cleaning agent cup and washing water cup. The sample cup is a single-well cup or a double-well cup with the two holes being in communication with each other inside the cup. The double-well cup comprises an outer cup located outside the detection card and a corresponding inner cup, and the bottom of the outer cup is lower than the bottom of the inner cup. The detector comprises a control unit and data processing unit, a suction needle and a transfer unit, a detection disk rotation system, a detection unit, a needle cleaning system and a detection cup waste liquid discharging unit. When the detection disk rotation system drives the detection card to rotate at a high speed, the blood cells of the whole blood in the double-well cup can be centrifuged to the outer wall of the outer cup, and then the cells settle at the bottom of the outer cup due to a relatively large specific gravity, and the plasma accumulates in the inner cup. The system has the function of re-detecting high-value samples without consuming any additional reagent.

Description

Biochemical, enzyme-free and chemiluminescence rapid detection system and method Technical field

The invention relates to the field of medical examination, in particular to a rapid detection system and method with biochemical, enzymatic and chemiluminescence.

Background technique

The existing automatic biochemical analyzer has made great progress compared with the previous biochemical analyzer, but there are still some deficiencies in use. For example, because the sample required for instrumental testing is serum, the whole blood should be centrifuged beforehand. Before the test, the professional parameters should be set and the samples and reagents should be placed in the sample position and reagent position. The first reagent and the second reagent are different. For each item, the first reagent needs to be added to the different detection cups, then the serum is added, and then the second reagent is added, and each reagent bottle and the detection cup occupy a large space. The steps are cumbersome, the consumption of the cleaning liquid required for the detection is large, and the waste liquid generated is also large, and the instrument detection takes a long time, which brings inconvenience to the user; the large bottle of reagent is opened for a long time and the reagent for detecting the reagent is repeatedly taken, which may result in The actual component content of the reagent changes, affecting the test results. The content of some samples in clinical work is often much higher than the detection range of reagents and instrument design. When the first biochemical analyzer finds that the sample content is too high, it needs to be used again to dilute the sample and reuse the diluted sample. Adding reagents for testing requires additional consumption of reagents and samples and wastes time. The existing rapid biochemical analyzer and immunoassay analyzer mainly use dry test paper technology. Although it is convenient and fast, due to technical limitations, some items cannot be detected, and the dry test paper technology has poor accuracy. At present, biochemical detection, enzyme labeling detection or chemiluminescence detection are performed on different instruments, and there is no analyzer that can be quickly and conveniently, and has biochemical, enzymatic and chemiluminescence detection. The system can also be designed as a system device suitable for environmental, food and other applications.

Summary of the invention

OBJECT OF THE INVENTION The technical problem to be solved by the present invention is to provide a rapid detection system and method for biochemical, enzymatic and chemiluminescence in view of the deficiencies of the prior art.

In order to solve the above technical problems, the present invention provides a biochemical, enzymatic and chemiluminescence rapid detection system, including a detection card and a detector. The test card is provided with a sample cup and more than one reagent cup, each cup is independent of the other cups independently, and all reagents and samples of the test item are on the test card; the sample cup is used for placing the sample; Each reagent cup is pre-loaded with different reagents required for each item detection, and each item has a first reagent cup, each item is completed and detected in the corresponding first reagent cup; the sample cup is used for placing the sample.

In the present invention, the detection card is further provided with a second reagent cup, which is pre-installed with a second reagent required for each detection item, and the designated second reagent is transferred by the aspirating needle according to the required quantity and sequence of the detection item. Into the designated first reagent cup, after the mixing reaction, optical detection is performed.

In the present invention, the test card is further provided with a cleaning agent cup, and the cleaning agent cup is pre-installed with a cleaning agent for cleaning the inside and outside of the suction needle.

In the present invention, the test card is further provided with a water cup which is pre-filled with distilled water or physiological saline for cleaning the sample aspirating needle, diluting the sample or diluting the reaction liquid exceeding the detection result. When the instrument does not have an external cleaning water bottle, pump and pipeline, the suction needle is directly connected to the diluter. When cleaning the sample needle, first wash a certain amount of cleaning agent to the cleaning agent cup, and discharge it to the instrument waste liquid discharge position. The water is sucked from the first washing water cup to the waste liquid discharge position, and the washing water is sucked from the second washing water cup to the waste liquid discharge position; the sample needle can be used for sucking other reagents after cleaning, or according to the degree of contamination of the reagent. Set different cleaning times and whether to use different processes such as cleaning agent. When the sample needle enters the cleaning agent cup and the cleaning cup, the outside is contacted with the cleaning agent and the cleaning water to be cleaned, and the multiple contacts are better cleaned. The inside of the sample needle is effectively cleaned by inhaling the cleaning agent and the washing water and discharging. .

In the present invention, the two-hole cup is internally connected, and includes an outer cup on the outer side of the detecting card and a corresponding inner cup, the outer cup is flush with the inner cup top, and the bottom of the outer cup is lower than the bottom of the inner cup. During the detection, the detection card rotation system drives the detection card to rotate at a high speed, and the blood cells in the sample cup are centrifuged to the outer wall of the outer cup, and the cells in the blood sample are centrifuged to the outer wall of the outer cup after the centrifugation is stopped, and the inner cup and the outer cup are settled due to the large specific gravity. The upper part is plasma.

In the present invention, the test card is further provided with a blank detecting cup, wherein no reagent is pre-installed, and when any one of the first reagent cups detected by the instrument absorbs the OD value of the final reaction liquid more than a preset value of 1.6 or more, the suction is performed. The sample needle automatically absorbs the physiological saline in the physiological saline cup, adds it to the blank detection cup, and absorbs part of the reaction liquid in the first reagent cup whose absorbance exceeds the set OD value, and adds it to the blank detection cup, and after dilution and mixing Retest, the dilution factor is 0.5-20 times. The instrument is again calculated based on the absorbance of the diluted reaction solution to obtain a more accurate test result, and the sample can be re-tested in the ultra-concentration range without taking up new samples and reagents.

In the invention, the detection card is provided with a specific identifier, and the detector has an identification device for automatically identifying the identifier, and the detector can automatically identify the detection card information through the specific identifier, including the type of the detection card, the detection item, whether the detection card is in the validity period, Parameter information such as sample loading amount, sample loading procedure, detection conditions, and standard curve for each test item. Specifically, the specific identifier may be a barcode, a two-dimensional code or a chip; when the detection card is placed on the rotating device, the detection card barcode is automatically rotated through the detection card reading area of the detector, or the detection card barcode is manually aligned with the detector. Read the reading area.

In the present invention, the sample cup on the test card is a single-hole cup, the sample cup is pre-loaded with a quantitative hemolytic agent, and the sample is directly diluted and hemolyzed, and the sample suction needle directly absorbs the diluted hemolyzed sample in the sample cup for detection. There is no need to centrifuge to separate plasma.

In the present invention, there is also a hemoglobin test cup on the test card, wherein the quantitative reagent is pre-loaded, and the quantitative hemolysis sample is added to the hemoglobin test cup by artificial or aspirating needle during the test, and the whole blood and the hemolytic agent are diluted, hemolyzed and mixed. Determine the hemoglobin content in the cup, and calculate the proportion and content of red blood cells and plasma in the blood sample according to the principle of positive correlation between hemoglobin and red blood cell content. Due to the different plasma content in the whole blood of different individuals, the amount of plasma obtained by separation is different. After obtaining the red blood cell and plasma content of the blood sample and the total amount of whole blood taken, and based on the total amount of the diluted solution, the full calculation can be more accurately calculated. The actual amount of each component in the plasma in the blood sample.

Calculation formula: plasma to volume ratio of whole blood = 100% - (measured hemoglobin concentration × factor K)%, wherein the unit of hemoglobin concentration is g / l, the factor K ≧ 30, other units can be calculated according to the corresponding proportion K factor.

As a result, the concentration of each component in plasma was calculated based on the amount of plasma added. The method is suitable for the analysis of biochemical, enzymatic and chemiluminescence detection results.

In the present invention, the detector includes a control and data processing unit, a sample aspirating and transferring unit, a temperature control unit, a detecting unit and a cleaning unit; the control and data processing unit controls the coordination between the units of the instrument, and processes the detected data and Calculate the test results, etc.; during the test, the sample aspirating needle will automatically absorb and distribute the sample and reagent according to the test procedure, and the reaction and detection of each item are concentrated in the first reagent cups of the test card;

The aspirating needle and the transfer unit are composed of a suction needle, a quantitative diluter, a connecting line, a valve and a motor for sucking the sample from the sample cup into the first reagent cup, and then taking the second reagent cup for quantification. a second reagent is added to the corresponding first reagent cup; the detecting unit includes a light source and a detector for performing the detection;

The aspirating needle cleaning unit comprises a sample aspirating needle, a washing water bottle, a connecting pipe, a valve, a diluter, a washing pool and a draining pump, and is used for cleaning the inside and outside of the aspirating needle. The aspirating needle cleaning unit shares the aspiration needle, the valve and the quantitative diluter with the aspiration needle and the transfer unit.

In the invention, the detector has a plurality of supporting detection cards. When different detection cards are applied, the instrument automatically recognizes the types of the detection cards, processes and detects the samples according to the preset process of each detection card, and automatically calculates and reports the detection results.

In the present invention, the first reagent cup of the partial detection card has the same structure as the sample cup, and the sample is directly added to the different first reagent cups of the same detection card for reaction and treatment, and the entire reaction process is completed in the cup. And testing, each first reagent cup completes the inspection of a project.

In the present invention, the sample aspirating sample quantitatively absorbs the sample and the reagent on the test card, and the first motor and the second motor respectively control the up and down movement of the sample needle and the horizontal movement to realize the transfer of the sample and the reagent, instead of being realized by the flow.

In the present invention, the manner of stirring and mixing includes air agitation, rolling mixing of the built-in glass ball of the detecting cup, reciprocating rotating stirring of the detecting disc or rapid turning and emergency stop.

In the present invention, the instrument is further provided with a magnetic attraction device for detecting the position of the test cup for separating the immunomagnetic beads in the cup before sucking the liquid in the test cup.

In the invention, the temperature control unit is an incubation tank or a incubation chamber, and the detection card is located in the incubation chamber, and the incubation chamber has a closed, dark and constant temperature heating device to ensure that the detection card is in a constant temperature state within 35-45 ° C when working, such as 37 ±0.5 °C.

In the present invention, when the chemiluminescence immunological test is performed, the instrument automatically turns off the illuminating light source, and when the detection is performed according to the process, the illuminating substrate in the cup is detected after the reaction is completed by the detector disposed at the upper portion of the first reagent cup. The luminous intensity is detected, and the result is calculated based on the signal obtained by the detection.

In the present invention, when the instrument detects that the absorbance OD value of the reaction liquid is greater than or equal to a predetermined value, the sample aspirate automatically absorbs the physiological saline in the physiological saline cup, and dilutes the reaction solution in the corresponding reagent cup and re-detects the dilution factor. It is 0.5-20 times. The instrument is again calculated based on the diluted absorbance to obtain a more accurate test result without re-absorbing new samples and reagents for dilution and retest.

According to different detection methods, the detection results are calculated differently:

A. For biochemical endpoint method, enzyme labeling method and chemiluminescence detection method, concentration of reaction solution before dilution = absorbance of diluted reaction solution × dilution factor × coefficient K1, where K1 is the relationship between absorbance and concentration of the reaction solution before dilution, K1 For any value between 0.1 and 500, the K1 value varies according to the project;

B. For biochemical rate method and two-point method detection, the concentration of the reaction solution before dilution = absorbance of the diluted reaction solution × dilution factor × K2, where K2 is the relationship between the concentration of the reaction solution before dilution and the absorbance/time value, K2 is 0.1~ There are 3000 arbitrary values, and the K2 values vary according to the project. In the rate method detection, because the time control is not accurate, the calculation results are not necessarily very accurate. Experiments show that the detection results obtained by this method are far superior to those obtained by other methods.

The invention discloses a rapid detection system and method for biochemical, enzymatic and chemiluminescence, characterized in that the sample cup of the detection card of the system is two connected double-hole cups, and a physiological saline cup is further arranged on the detection card. Biochemical testing of whole blood samples includes the following steps:

Step 1: Take quantitative whole blood into the double-well sample cup;

Step 2: Place the test card on the rotating plate of the test card of the detector, open the detection button, draw the quantitative physiological saline from the saline cup, add the double-well sample cup and mix it, and test the card rotating plate to rotate at high speed. The blood cells in the sample cup are moved to the outer cup, the blood cells in the whole blood are centrifuged to the outer wall of the outer cup, and the cells in the blood sample are centrifuged to the outer wall of the outer cup after the centrifugation is stopped, and the inner cup and the outer cup are settled due to the large specific gravity. The upper part is plasma;

Step 3: The aspirating needle draws the quantitatively diluted plasma from the inner cup and adds it to each first reagent cup. After the sample is dispensed, the instrument automatically mixes the reagent and the plasma in the first reagent cup;

Step 4: After the plasma distribution is completed, the aspirating needle is transferred to the first cleaning agent cup position, and the first cleaning agent is taken up, the suction needle is moved to the cleaning tank, the cleaning agent sucked in the suction needle is discharged, and then the diluent is taken through the diluter. The washing water is extracted from the washing water bottle, and the washing water is injected into the washing pool through the sampling needle to clean the inside and outside of the sucking needle;

Step 5: Aspirating the needle to take the second reagent of the item and adding the item to the first reagent cup, the instrument automatically mixes the liquid after adding the second reagent in the first reagent cup;

Step 6: Transfer the sample needle to the first cleaning agent cup position, suck the quantitative first cleaning agent, move the sample needle to the cleaning pool, discharge the cleaning agent inhaled in the sample needle, and then take it out from the cleaning water bottle through the diluter. Water, washing water is injected into the cleaning tank through the suction needle, and the inside and outside of the suction needle are cleaned;

Step 7: The instrument detects the liquid in the first reagent cup, and the rotating motor of the instrument drives the detection card to rotate, and pauses at a position where the sample and the reagent need to be sucked and dispensed, and the detecting unit is first in each rotation cycle. The reagent cup performs a multi-wavelength detection, and the detection result is recorded every time. Finally, the final detection result of each cup detection item is calculated based on all the detection data.

The detection data is mainly to compare the absorbance value of the original reagent of each first reagent cup, the absorbance value after the first reagent and the sample are mixed, the absorbance value finally obtained by reacting the first reagent with the sample, and the first reagent, the sample, the second reagent. The final absorbance value obtained by the reaction is compared and the detection result is calculated. In calculating the rate method and the two-point method, it is necessary to introduce a correlation between the change in absorbance and time. Since the calculation and methods of these detection results are very mature, not the technical points of the present invention, they will not be described in detail in the present invention.

The invention also discloses a biochemical, enzymatic and chemiluminescence rapid detection system and method, characterized in that the system further has a detection card for performing enzyme label detection, and the detection card sets two or more reagents for a single detection item. Cup, when testing, two or more reagents can be applied to one test item, and the first reagent cup on the test card also bears the function of the sample cup. When used, the sample is directly added to each first reagent cup of the test card; The first reagent pre-coated in the reagent cup is different, and the items to be tested are also different. The system performs the following steps when performing the enzyme label detection:

Step 1: taking quantitative samples separately into each first reagent cup of the test card, the test card sample cup and the first reagent cup have the same structure;

Step 2: Place the test card on the rotating disc of the test card of the detector, and turn on the detection button; rotate the motor to drive the detection card for more than 1 minute, and repeatedly rotate back and forth more than once to make the sample in the first reagent cup flow and the wall of the cup. Pre-coated immune (antigen or antibody) is fully contacted and bound;

Step 3: After the sample is fully combined with the immune substance coated in the first reagent cup, the detection cup waste liquid removing unit completely sucks out the liquid in the first reagent cup; the suction needle absorbs the quantitative cleaning agent and is added to the first reagent cup. The detection card is rotated back and forth several times, and the residual sample in the cup is fully washed; the detection cup cleaning needle is again extended into the bottom of the first reagent cup, and all the liquid in the first reagent cup is sucked out; the cleaning step is repeated twice or more;

Step 4: The aspirating needle is taken from the second reagent cup and the second reagent is added to the first reagent cup of the item. If the second reagent is the same, the aspirating needle does not need to be cleaned between the second and second reagents. Instead, the second reagent is continuously taken. If the second reagent is different, the needle needs to be cleaned; then the rotating motor drives the detection card to be separated for more than 1 minute, and repeatedly rotates back and forth more than once to make the liquid in the first reagent cup flow. Fully contacting and combining with the immune complex bound to the wall of the cup. When the second reagent is fully combined with the immune complex in the first reagent cup, the test cup cleaning needle extends into the bottom of the first reagent cup, and the first reagent cup is placed. The liquid is completely sucked out; the suction needle absorbs the quantitative cleaning agent and is added to the first reagent cup, and the detection card rotates back and forth several times to fully wash the residual sample in the cup; the detection cup cleaning needle re-extends into the bottom of the first reagent cup, which will be the first The liquid in the reagent cup is completely sucked out; the above steps are repeated for more than 2 times;

Step 5: The aspirating needle draws the third reagent from the third reagent cup and adds it to the first reagent cup. If the third reagent is added, the continuous suction sample is not required to be cleaned. If different, the suction needle needs to be cleaned in the middle, and the rotating motor drives the detection. The card repeatedly rotates and mixes the liquid in the first reagent cup; after the mixing, the detection card rotates for more than one week, and the instrument detecting unit detects and records the information obtained by detecting all the first reagent cups in the process;

Step 6: Part of the detection reagent cup item needs to add the fourth reagent, the suction needle sucks a certain amount of the fourth reagent from the fourth reagent cup and adds it to the first reagent cup, and the test card rotates for more than one week, and the instrument detection unit is Each of the first reagent cups is separately tested to obtain a final test result.

Step 7: The instrument automatically calculates the test results of each cup, including the test result of subtracting the background value of each cup, and the result of comparison with the reference standard.

The invention also discloses a rapid detection system and method for biochemical, enzymatic and chemiluminescence, characterized in that the detector further has a magnetic attraction device and has detection of detecting light signals on the upper part of the movement path of the first reagent cup. The device has a chemiluminescence detection function, and the first reagent cup of the detection card of the system also bears the function of the sample cup. When the system performs chemiluminescence detection, the following steps are included:

Step 1: the quantitative sample is separately added to each of the first reagent cups, and the sample cup of the test card and the first reagent cup have the same structure;

Step 2: Place the test card on the rotation plate of the test card of the tester, and turn on the test button; the test card rotates the disk to drive the test card to rotate back and forth once every time for a certain period of time, so that the mark on the magnetic beads in the first reagent cup is immunized. The substance (antigen or antibody) and the sample are in sufficient contact with the reaction;

Step 3: After the sample is fully combined with the immunomagnetic beads in the first reagent cup, the magnetic attraction device is adjacent to the outside of the first reagent cup, and the magnetic beads are attracted to the side wall of the cup, and the detection cup is inserted into the bottom of the first reagent cup. All the liquid in the first reagent cup is sucked out; the suction needle absorbs the quantitative cleaning agent and is added to the first reagent cup, the magnetic attraction device leaves the first reagent cup, the magnetic beads are suspended in the first reagent cup, and the number of round-trip rotations of the detection card is detected. Then, the residual sample in the cup is fully washed; the magnetic attraction device is close to the outside of the first reagent cup, the magnetic beads are attracted to the side wall, and the detection cup cleaning needle re-enters the bottom of the first reagent cup, and the liquid in the first reagent cup is completely sucked out. The first reagent cups of the test card are repeatedly washed twice or more according to the above steps;

Step 4: Aspirating the sample from the second reagent cup and taking the quantitative second reagent into the first reagent cup of the item, the magnetic attraction device leaves the first reagent cup, the magnetic beads are suspended in the first reagent cup, and the detection card is rotated back and forth. Mixing the liquid in the first reagent cup; when the second reagent is fully combined with the immune complex in the first reagent cup, the magnetic attraction device is adjacent to the side of the first reagent cup, attracting the magnetic beads to the side wall, and detecting the cup cleaning needle Extending into the bottom of the first reagent cup, all the liquid in the first reagent cup is sucked out; the suction needle sucks the quantitative cleaning agent and is added to the first reagent cup, the magnetic attraction device leaves the first reagent cup, and the magnetic beads are suspended in the first reagent cup. The detection card is rotated back and forth several times to fully wash the residual sample in the cup; the magnetic attraction device is close to the first reagent cup, and the magnetic beads are attracted to the side wall, and the detection cup cleaning needle again protrudes into the bottom of the first reagent cup, which will be the first The liquid in the reagent cup is completely sucked out; the first reagent cups of the test card are again washed twice or more according to the above steps. And if the second reagent added in the process is the same, the aspirating needle does not need to clean the continuous aspirating and dispensing reagent, but if the second reagent is added, the aspirating needle needs to be cleaned before the different reagents are aspirated;

Step 5: The aspirating needle draws the third reagent from the third reagent cup into the first reagent cup, and washes the unbound third reagent after the incubation period; if the third reagent is added, the needle is not cleaned. Continuously sucking the third reagent and dispensing, if the third reagent is different, the needle needs to be cleaned, and the rotating motor drives the detecting card to repeatedly rotate and mix the liquid in the first reagent cup;

Step 6: When the motor is driven, the detection card rotates at a constant speed, and the detecting device performs optical signal detection on each reagent cup to record the detection result. Before adding the luminescent substrate, the background value of each cup is detected, and after the luminescent substrate is added, the illuminating signal of each cup is detected again, and the test results of each item of the sample are calculated by comparison with the standard product.

Advantageous Effects: The invention eliminates parameter setting and reagent placement by using a detector and a special detection card, can conveniently and quickly complete the detection, and simultaneously improves the accuracy of the detection result; can complete multiple biochemical, enzyme-free and chemiluminescence project detection, and Double reagent detection can be performed and the sample blank is automatically deducted; the instrument has only one detection card rotating disk, all the required reagents and samples are loaded, and the number of cleanings required is reduced, and the cleaning is reliable, effectively reducing reagent waste and cross-contamination; The special detection card is placed on the rotating disc of the detecting card during testing, and only one needle completes the absorption and distribution of the reagent and the sample; the rotating disc of the instrument detecting card can drive the detecting card to rotate rapidly to generate centrifugal force, and automatically separate the plasma in the whole blood. The detection system of the invention can quickly complete the detection of the over-range sample without additional reagents and samples, save reagents and samples, and improve efficiency. Therefore, the biochemical, enzymatic and chemiluminescence rapid detection system and method of the invention are more convenient, more accurate, more economical and more environmentally friendly, and the system is also suitable for rapid analysis of samples in other fields such as food, environmental protection and the like.

DRAWINGS

Figure 1 is a schematic view of the overall structure of the present invention.

2-1 is a schematic structural view of a test card according to the present invention, wherein the sample cup is divided into an inner side cup and an outer side cup, and the sample cup is located in the inner circumference of the detecting card;

2-2 is a schematic structural view of a test card according to the present invention, wherein the sample cup is divided into an inner side cup and an outer side cup, and the sample cup is located on the outer circumference of the detecting card;

2-3 is a schematic structural view of a test card according to the present invention, wherein the sample cup is a single-hole cup;

3-1 is a schematic diagram of a scattered light detecting device, FIG. 3-2 is a schematic diagram of a transmitted light detecting device, and FIG. 3-3 is a schematic diagram of a combined detecting device of transmitted light and scattered light;

Figure 4 is a schematic view showing the structure of the sample cup as a double cup;

Figure 5-1 test cup waste liquid removal unit, wherein the magnetic attraction device N is away from the detection cup; Figure 5-2 detects the cup waste liquid removal unit, wherein the magnetic attraction device N is close to the detection cup;

Figure 6 is a schematic view showing the structure of the instrument incubation chamber.

Detailed ways

The invention will be further described with reference to the drawings and specific embodiments.

Example 1:

As shown in FIG. 1 , FIG. 2 and FIG. 4 , in the embodiment, the instrument is provided with a cleaning water bottle, a sample needle and a transfer unit working principle: the detection card is placed in the detection card position of the detector, and the reagent cup is placed in the annular incubation tank. In the 14th, the blood collection tube 11 is extended under the aspiration needle 12, and the detection key is opened; the first valve 18 is opened, the second valve 19 is closed, the diluter 20 is pulled down, the blood sample is sucked into the diluter, and the first motor 16 and the second motor 17 are Control the suction needle to move up and down, left and right to the top of the sample cup 1, push up the diluter, and add the sample to the sample cup; the sample needle is transferred to the first cleaning cup 6 to absorb the quantitative cleaning agent, and then the suction needle moves. To the cleaning tank, discharge the cleaning agent sucked in the sampling needle; then the sampling needle 12 moves to the top of the physiological saline cup 4, and the suction needle absorbs the quantitative physiological saline and is added to the sample cup, and the suction needle is repeatedly sucked several times to ensure the dilution of the sample. Mixing; the sampling needle draws the quantitative dilution sample from the sample cup, adds it to the first reagent cup 10 of each item of the test card, and mixes it by suction with the suction needle; in each sample distribution and with the first reagent cup After the reagent is mixed, the aspirating needle is transferred. The first cleaning agent cup is 6 positions, and the quantitative cleaning agent is sucked, and then the sampling needle moves to the cleaning pool to discharge the cleaning agent sucked in the sampling needle; then the first valve 18 is closed, the second valve 19 is opened, and the diluter 20 is pulled down. The washing water in the washing water bottle 21 enters the diluter 20, after which the first valve 18 is opened, the second valve 19 is closed, the diluter 20 is pushed up, and the washing water is sprayed from the dilifier 20 to the aspirating needle 12 into the washing pool. The inside and outside of the needle are simultaneously cleaned, and after the internal and external cleaning of the needle is completed, the first pump 13 that has been turned off starts to work, and the cleaning liquid in the cleaning pool is discharged; then the diluter again sprays the washing water into the cleaning tank, and The inside and outside of the needle are simultaneously cleaned, and after the internal and external cleaning of the needle is completed, the first pump 13 that is turned off is operated again, and the washing water in the washing pool is discharged into the waste liquid collector;

The sample needle enters one of the second reagent cups 8 of the item, and the second reagent of the item is added to the first reagent cup 10 corresponding to the item; the second sample is added to the first reagent cup after each suction of the sample needle, and the first The liquid in the reagent cup is absorbed and mixed. After completion, the sample needle moves to the first cleaning agent cup 6 to absorb the quantitative cleaning agent, and then moves to the cleaning pool to drain, and simultaneously cleans the needle inside and outside; some items take the second After the reagent is mixed and mixed, the aspirating needle needs to be moved to the second cleaning agent cup 7, and the quantitative cleaning agent is sucked from the second cleaning agent cup, moved to the cleaning tank to be drained, and the inside and outside of the needle are cleaned; the needle is diluted by the inside. The washing water is sucked to clean the inside of the needle. After the internal cleaning of the needle is completed, the drain pump is closed, the diluter sucks the washing water to the washing pool to clean the outer wall of the needle, and the drain pump discharges the washing water in the washing pool into the waste collector. ;

The first reagent cup is detected before and after the sample is added, and is also detected after the second reagent is added, and each item is tested according to the test item, and the detection result is recorded.

Example 2:

In this embodiment, the difference from Embodiment 1 is that the sample is sucked and added to the first first reagent cup, and after the sample is detected, the sample is taken up and then added to the second first reagent cup. Mix and test.

Example 3:

As shown in FIG. 3-1 to FIG. 3-3, in the embodiment, the optical detecting device 22 is disposed above each cup of the detecting card for performing chemiluminescence detection on the reagent background and the reagent sample mixture in the first reagent cup; The light source 24 and the optical detecting device 23 are disposed on both sides of the groove wall matched with the cups of the detecting card, and are used for detecting the transmitted light of the reagent background, the reagent and the sample mixture in the first reagent cup.

Example 4:

As shown in FIG. 4 and FIG. 6 , in the embodiment, the sample cups are connected, but the outer side 2 is low on the inner side and the inner side is 3; when the test is performed, the sample is added into the sample cup, and then the test card 5 is mounted on the test card fixing plate, and the fourth motor 15 can be Drive the detection disc rotation system to rotate, and drive the detection card on it to rotate; when the detection sample is whole blood needs to separate plasma, before the detection, the motor drives the turntable and the detection card rotates at high speed, and the blood cells in the sample cup move to the outside and sink to the outside. The lower part of the cup is separated from the plasma by centrifugation, and the plasma is mainly distributed in the inner part of the sample cup; after the plasma separation is completed, the instrument uses the separated plasma inside the sample cup for detection. During sample dispensing, reagent dispensing, and testing, the aspiration and dispensing of the aspirating needle is coordinated with the rotation of the test card. During the test, the motor rotates at a constant speed and pauses at the position where the reagent is aspirated and dispensed.

Example 5:

As shown in Figure 2-3, the sample cup of the test card is a single hole, and no reagent or diluent is added beforehand, and serum, plasma or whole blood is directly detected;

Example 6

As shown in Figure 2-3, the sample cup of the test card is a single hole. The reagent with hemolysis function and dilution function is pre-loaded in advance. When using, a quantitative whole blood sample is directly added into the sample cup. After the sample is added, a hemolysis sample is formed. After mixing, test it.

Example 7

5-1 to 5-2, the difference between the embodiment and the embodiment 1 is that the detector of the embodiment further includes a detecting cup waste liquid removing unit, including the second pump 30, the connecting pipeline, and the fifth motor. 26 and the detection cup cleaning needle 27; when detecting the enzyme immunization item and the chemiluminescence item, after each reaction is completed, the detection cup cleaning needle 27 automatically detects the waste liquid in the first reagent cup under the control of the fifth motor 26, and passes the The second pump 30 is discharged to the waste collector 29.

Example 8

In this embodiment, the detection card is further provided with a third reagent cup, pre-loaded with a color developer or a luminescent substrate, and respectively, after the reaction of the enzyme immunochemistry and the chemiluminescence project is completed, a third reagent is added to the first reagent cup, and then The first reagent cup liquid is tested.

Example 9

As shown in FIGS. 5-1 to 5-2, the detector of the present embodiment is provided with a magnetic attraction device 31 at a corresponding position of the detection cup cleaning needle 27, and when the third motor 25 controls the magnetic attraction device 31 to approach the first reagent cup 10, The immunomagnetic beads 28 are attracted to the side wall of the first reagent cup, after which the fifth motor 26 controls the detection cup cleaning needle 27 to move downward, sucks the first reagent cup to detect the waste liquid, and is discharged to the waste liquid collector 29 through the second pump 30. The immunomagnetic beads in the first reagent cup are separated; then the fifth motor 26 controls the detection cup cleaning needle 27 to move upward, and the third motor 25 controls the magnetic attraction device 31 to leave the first reagent cup.

When detecting the chemiluminescence item, the instrument automatically turns off the illuminating light source, and detects the illuminating intensity of the luminescent substrate after the first reagent cup is finished.

Example 10:

As shown in Fig. 6, the entire test card is disposed in the incubation chamber 32. The test card is provided with a first reagent cup 10, a second reagent cup 8, a cleaning agent cup 6, and a washing water cup 9, and the heating device 33 controls the temperature in the incubation chamber to be kept constant.

Example 11

In the embodiment, the test card further has a hemoglobin test cup, wherein the quantitative hemolytic agent is pre-installed, and the quantitative whole blood sample is added to the hemoglobin test cup by artificial or aspirating needle during the detection, and the whole blood and the hemolytic agent are diluted, hemolyzed and mixed. The hemoglobin content in the cup is determined, and the proportion and content of red blood cells and plasma in the blood sample are estimated according to the principle that hemoglobin is positively correlated with the red blood cell content. Due to the different plasma content in the whole blood of different individuals, the amount of plasma obtained by separation is different. After obtaining the red blood cell and plasma content of the blood sample and the total amount of whole blood taken, and based on the total amount of the diluted solution, the full calculation can be more accurately calculated. The actual amount of each component in the plasma in the blood sample. Calculation formula: plasma to volume ratio of whole blood = 100% - (measured hemoglobin concentration × factor K)%, wherein the unit of hemoglobin concentration is g / l, the factor K ≧ 30, other units can be calculated according to the corresponding proportion K factor.

All test results were based on the amount of plasma added to calculate the concentration of various components in plasma. The method is suitable for the analysis of biochemical, enzymatic and chemiluminescence detection results.

Claims (10)

1. The invention relates to a rapid detection system and method for biochemical, enzymatic and chemiluminescence, characterized in that the detection system comprises a special detection card and a special dedicated detector; the test card is provided with a sample cup and more than one reagent cup, each cup Independently and incompatible with other cups, all reagents and samples of the test item are on the test card; the sample cup is used for placing samples; the reagent cups are pre-loaded with different reagents for each item detection, each item Each has a first reagent cup, and each item is reacted and detected in the corresponding first reagent cup.
2. The method and method for rapid detection of biochemical, enzymatic and chemiluminescence according to claim 1, wherein the detection card is further provided with a second reagent cup, and the first required for each detection item is pre-installed. The second reagent is used to transfer the designated second reagent to the designated first reagent cup according to the required amount and sequence of the test item by the aspirating needle, and is detected after being mixed and reacted.
3. A rapid detection system and method for biochemical, enzymatic and chemiluminescence according to claim 1, wherein the detection card is further provided with a cleaning agent cup, and the cleaning agent cup is pre-filled with a cleaning agent for the suction needle Cleaning inside and outside.
4. The method and method for rapid detection of biochemical, enzymatic and chemiluminescence according to claim 1, wherein the sample cup is an internally connected double-hole cup, comprising an outer cup located outside the detecting card and corresponding The inner cup, the outer cup is flush with the top of the inner cup, and the bottom of the outer cup is lower than the bottom of the inner cup; before the detection, the rotation card of the detection card drives the detection card to rotate at a high speed, the blood cells in the sample cup are centrifuged to the outer wall of the outer cup, and the blood sample is stopped after centrifugation. The cells centrifuged to the outer wall of the outer cup are deposited on the bottom of the outer cup due to the large specific gravity, and the inner side cup and the upper part of the outer cup are plasma.
5. The method and method for rapid detection of biochemical, enzymatic and chemiluminescence according to claim 1, wherein the detector comprises a control and data processing unit, a sample aspirating and transferring unit, a temperature control unit, and a detection The unit and the cleaning unit; the control and data processing unit controls the coordination between the units of the instrument, processes the detection data and calculates the detection result; during the detection process, the sample aspirating needle will automatically absorb and distribute the sample and reagent according to the test procedure;

   The aspirating needle and the transfer unit are composed of a suction needle, a quantitative diluter, a connecting line, a valve and a motor for sucking the sample from the sample cup into the first reagent cup, and then taking the second reagent cup for quantification. a second reagent is added to the corresponding first reagent cup; the detecting unit includes a light source and a detector for performing the detection;

   The aspirating needle cleaning unit comprises a sample aspirating needle, a washing water bottle, a connecting pipe, a valve, a diluter, a washing pool and a draining pump, and is used for cleaning the inside and outside of the aspirating needle, wherein the aspirating needle cleaning unit and the aspirating needle and The transfer unit shares the aspiration needle, valve and dose diluter.
6. The biochemical, enzymatic and chemiluminescence detecting system and method according to claim 1 or 4, wherein when the instrument detects the OD value of the reaction liquid absorbance greater than or equal to a preset value of 1.6 or more, the sampling needle is automatically Drain the distilled water in the water cup, dilute the reaction solution in the corresponding first reagent cup and re-test, the dilution factor is 0.5-20 times; the instrument calculates again according to the re-meased absorbance after dilution to obtain more accurate test results without re-absorption New samples and reagents are diluted for retesting.
7. The biochemical, enzymatic and chemiluminescence rapid detection system according to claim 1, 4 or 5, wherein the sample cup of the system detection card is two connected double-hole cups, and the detection card is further provided. There is a saline cup, the following steps are included in the biochemical test of whole blood samples:

   Step 1: Take quantitative whole blood into the double-well sample cup;

   Step 2: Place the test card on the rotating plate of the test card of the detector, open the detection button, draw the quantitative physiological saline from the saline cup, add the double-well sample cup and mix it, and test the card rotating plate to rotate at high speed. The blood cells in the sample cup are moved to the outer cup, the blood cells in the whole blood are centrifuged to the outer wall of the outer cup, and the cells in the blood sample are centrifuged to the outer wall of the outer cup after the centrifugation is stopped, and the inner cup and the outer cup are settled due to the large specific gravity. The upper part is plasma;

   Step 3: The aspirating needle draws the quantitatively diluted plasma from the inner cup and adds it to each first reagent cup. After the sample is dispensed, the instrument automatically mixes the reagent and the plasma in the first reagent cup;

   Step 4: After the plasma distribution is completed, the aspirating needle is transferred to the first cleaning agent cup position, and the first cleaning agent is taken up, the suction needle is moved to the cleaning tank, the cleaning agent sucked in the suction needle is discharged, and then the diluent is taken through the diluter. The washing water is extracted from the washing water bottle, and the washing water is injected into the washing pool through the sampling needle to clean the inside and outside of the sucking needle;

   Step 5: Aspirating the needle to take the second reagent of the item and adding the item to the first reagent cup, the instrument automatically mixes the liquid after adding the second reagent in the first reagent cup;

   Step 6: Transfer the sample needle to the first cleaning agent cup position, suck the quantitative first cleaning agent, move the sample needle to the cleaning pool, discharge the cleaning agent inhaled in the suction needle, and then take it out from the cleaning water bottle through the diluter. Water, washing water is injected into the cleaning tank through the suction needle, and the inside and outside of the suction needle are cleaned;

   Step 7: The instrument detects the liquid in the first reagent cup, and the rotating motor of the instrument drives the detection card to rotate, and pauses at a position where the sample and the reagent need to be sucked and dispensed, and the detecting unit is first in each rotation cycle. The reagent cup performs a multi-wavelength detection, and the detection result is recorded every time. Finally, the final detection result of each cup detection item is calculated based on all the detection data.
8. The invention relates to a biochemical, enzymatic and chemiluminescence rapid detection system, which is characterized in that the system further has a detection card for performing enzyme label detection, and the detection card sets two or more reagent cups for a single detection item, and one test can be used for one The test item uses two or more reagents, and the first reagent cup on the test card also functions as a sample cup. When used, the sample is directly added to each first reagent cup of the test card; each first reagent cup is pre-coated. The first reagent is different, and the detected items are also different. The system performs the following steps when performing the enzyme label detection:

   Step 1: taking quantitative samples separately into each first reagent cup of the test card, the test card sample cup and the first reagent cup have the same structure;

   Step 2: Place the test card on the rotating disc of the test card of the detector, and turn on the detection button; rotate the motor to drive the detection card for more than 1 minute, and repeatedly rotate back and forth more than once to make the sample in the first reagent cup flow and the wall of the cup. Pre-coated immune (antigen or antibody) is fully contacted and bound;

   Step 3: After the sample is fully combined with the immune substance coated in the first reagent cup, the detection cup waste liquid removing unit completely sucks out the liquid in the first reagent cup; the suction needle absorbs the quantitative cleaning agent and is added to the first reagent cup. The detection card is rotated back and forth several times, and the residual sample in the cup is fully washed; the detection cup cleaning needle is again extended into the bottom of the first reagent cup, and all the liquid in the first reagent cup is sucked out; the cleaning step is repeated twice or more;

   Step 4: The aspirating needle is taken from the second reagent cup and the second reagent is added to the first reagent cup of the item. If the second reagent is the same, the aspirating needle does not need to be cleaned between the second and second reagents. Instead, the second reagent is continuously taken. If the second reagent is different, the needle needs to be cleaned; then the rotating motor drives the detection card to be separated for more than 1 minute, and repeatedly rotates back and forth more than once to make the liquid in the first reagent cup flow. Fully contacting and combining with the immune complex bound to the wall of the cup. When the second reagent is fully combined with the immune complex in the first reagent cup, the test cup cleaning needle extends into the bottom of the first reagent cup, and the first reagent cup is placed. The liquid is completely sucked out; the suction needle absorbs the quantitative cleaning agent and is added to the first reagent cup, and the detection card rotates back and forth several times to fully wash the residual sample in the cup; the detection cup cleaning needle re-extends into the bottom of the first reagent cup, which will be the first The liquid in the reagent cup is completely sucked out; the above steps are repeated for more than 2 times;

   Step 5: The aspirating needle draws the third reagent from the third reagent cup and adds it to the first reagent cup. If the third reagent is added, the continuous suction sample is not required to be cleaned. If different, the suction needle needs to be cleaned in the middle, and the rotating motor drives the detection. The card repeatedly rotates and mixes the liquid in the first reagent cup; after the mixing, the detection card rotates for more than one week, and the instrument detecting unit detects and records the information obtained by detecting all the first reagent cups in the process;

   Step 6: Part of the detection reagent cup item needs to add the fourth reagent, the suction needle sucks a certain amount of the fourth reagent from the fourth reagent cup and adds it to the first reagent cup, and the test card rotates for more than one week, and the instrument detection unit is Each first reagent cup is separately tested to obtain a final detection result;

   Step 7: The instrument automatically calculates the test results of each cup, including the test result of subtracting the background value of each cup, and the result of comparison with the reference standard.
9. A biochemical, enzymatic and chemiluminescence rapid detection system according to claim 1, 7 or 8, wherein the detector further has a magnetic attraction device and has a detection on the upper portion of the first reagent cup movement track. The detector of the optical signal has a chemiluminescence detection function, and the first reagent cup of the detection card of the system also bears the function of the sample cup, and the following steps are performed when the system performs chemiluminescence detection:

   Step 1: the quantitative sample is separately added to each of the first reagent cups, and the sample cup of the test card and the first reagent cup have the same structure;

   Step 2: Place the test card on the rotation plate of the test card of the tester, and turn on the test button; the test card rotates the disk to drive the test card to rotate back and forth once every time for a certain period of time, so that the mark on the magnetic beads in the first reagent cup is immunized. The substance (antigen or antibody) and the sample are in sufficient contact with the reaction;

   Step 3: After the sample is fully combined with the immunomagnetic beads in the first reagent cup, the magnetic attraction device is adjacent to the outside of the first reagent cup, and the magnetic beads are attracted to the side wall of the cup, and the detection cup is inserted into the bottom of the first reagent cup. All the liquid in the first reagent cup is sucked out; the suction needle absorbs the quantitative cleaning agent and is added to the first reagent cup, the magnetic attraction device leaves the first reagent cup, the magnetic beads are suspended in the first reagent cup, and the number of round-trip rotations of the detection card is detected. Then, the residual sample in the cup is fully washed; the magnetic attraction device is close to the outside of the first reagent cup, the magnetic beads are attracted to the side wall, and the detection cup cleaning needle re-enters the bottom of the first reagent cup, and the liquid in the first reagent cup is completely sucked out. The first reagent cups of the test card are repeatedly washed twice or more according to the above steps;

   Step 4: Aspirating the sample from the second reagent cup and taking the quantitative second reagent into the first reagent cup of the item, the magnetic attraction device leaves the first reagent cup, the magnetic beads are suspended in the first reagent cup, and the detection card is rotated back and forth. Mixing the liquid in the first reagent cup; when the second reagent is fully combined with the immune complex in the first reagent cup, the magnetic attraction device is adjacent to the side of the first reagent cup, attracting the magnetic beads to the side wall, and detecting the cup cleaning needle Extending into the bottom of the first reagent cup, all the liquid in the first reagent cup is sucked out; the suction needle sucks the quantitative cleaning agent and is added to the first reagent cup, the magnetic attraction device leaves the first reagent cup, and the magnetic beads are suspended in the first reagent cup. The detection card is rotated back and forth several times to fully wash the residual sample in the cup; the magnetic attraction device is close to the first reagent cup, and the magnetic beads are attracted to the side wall, and the detection cup cleaning needle again protrudes into the bottom of the first reagent cup, which will be the first The liquid in the reagent cup is completely sucked out; the first reagent cups of the test card are repeatedly washed twice or more according to the above steps; if the second reagent added in the process is the same, the sucking needle does not need to be cleaned. Aspiration and dispensing a reagent, the second reagent was added but if it is necessary for different sample aspirating needle cleaned before suction of different reagents;

   Step 5: The aspirating needle draws the third reagent from the third reagent cup into the first reagent cup, and washes the unbound third reagent after the incubation period; if the third reagent is added, the needle is not cleaned. Continuously sucking the third reagent and dispensing, if the third reagent is different, the needle needs to be cleaned, and the rotating motor drives the detecting card to repeatedly rotate and mix the liquid in the first reagent cup;

   Step 6: When the motor is driven, the detection card rotates at a constant speed. The detecting device performs optical signal detection on each reagent cup and records the detection result. Before adding the luminescent substrate, the background value of each cup is detected, and the luminescent substrate is added and detected again. The illuminating signal of each cup is calculated by comparing with the standard product.
10. A rapid detection system and method for biochemical, enzymatic and chemiluminescence according to claim 1, 7, 8 or 9, wherein a hemoglobin detection cup is additionally provided on the detection card, wherein the quantitative reagent is pre-loaded, and the artificial time is detected. Or aspirating a needle to add a quantitative whole blood sample to the hemoglobin test cup. After the whole blood and the hemolytic agent are diluted, hemolyzed and mixed, the apparatus measures the hemoglobin content in the cup, and based on the principle that the hemoglobin and the red blood cell content are positively correlated, the blood sample is estimated. The ratio and content of red blood cells and plasma.

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