Kit for detecting content of fetal red blood cells in maternal peripheral blood

Abstract

The utility model discloses a maternal peripheral blood fetal red blood cell content detection kit, which comprises a card, the card is provided with a plurality of first micro-column holes and a plurality of second micro-column holes, the first micro-column holes are filled with neutral glue, and the second micro-column holes are filled with staining fluid. The maternal peripheral blood fetal red blood cell content detection kit adopting the structure is similar to an existing gel card product, production equipment can be universally used, and mass production in the later period is easy; detection reagents and dyeing are placed in one card, so that the operation is convenient, the packaging is simple, and various packaging bottles are not needed; equipment development can be improved on the basis of an existing project hemoglobin detector, and equipment development progress is facilitated.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a kit for detecting the content of fetal red blood cells in maternal peripheral blood. Background Art

[0002] Fetomaternal hemorrhage (FMH), in addition to factors such as the fetus, mainly refers to a certain amount of fetal red blood cells entering the maternal blood circulation through the damaged placenta or intervillous space before or during maternal delivery. If the maternal and fetal blood types are incompatible, it can cause a series of clinical syndromes of hemolytic transfusion reaction between the mother and the fetus. In some cases, FMH can cause serious damage and complications to the fetus and have a serious impact on the future pregnancy of women. Due to the insidious onset of the disease, most FMH still occurs in normal pregnancies. Most of the placental barrier abnormalities that can cause FMH lack specific clinical manifestations, and most cases of fetomaternal transfusion still cannot be predicted and explained, and cannot attract enough attention like Rh maternal-fetal blood type incompatibility. At present, there is a lack of specific diagnostic criteria for this disease, and it is difficult to diagnose it early, and it is easy to cause missed diagnosis. Therefore, the early identification and diagnosis of FMH are crucial. For this disease, only by early detection, early diagnosis, and early treatment can the incidence of adverse pregnancy outcomes of perinatal infants be effectively reduced. Content of the Utility Model

[0003] The purpose of the utility model is to provide a kit for detecting the content of fetal red blood cells in maternal peripheral blood to solve the technical problem that the current fetomaternal hemorrhage syndrome lacks a specific diagnostic device, is difficult to diagnose early, and is easy to cause missed diagnosis.

[0004] To achieve the above purpose, the utility model provides a kit for detecting the content of fetal red blood cells in maternal peripheral blood, including: a card, the card is provided with a number of first micro-column holes and a number of second micro-column holes, the filling material of the first micro-column holes is neutral glue, and the filling material of the second micro-column holes is a staining solution.

[0005] Preferably, in the above-mentioned kit for detecting the content of fetal red blood cells in maternal peripheral blood, there are six first micro-column holes and six second micro-column holes, and the first micro-column holes and the second micro-column holes are arranged at intervals.

[0006] Preferably, in the above-mentioned kit for detecting the content of fetal red blood cells in maternal peripheral blood, the shape of the first micro-column holes is the same as the shape of the gel card; the second micro-column holes are cube-shaped and have light transmittance.

[0007] Preferably, in the above-mentioned kit for detecting the content of fetal red blood cells in maternal peripheral blood, it further includes a detection system supporting the kit, as follows:

[0008] A number of liquid containers. In one liquid container, the peripheral blood of the mother is prepared into a red blood cell suspension with physiological saline, and in another liquid container, an antibody corresponding to an antigen that is positive for the paternal line and negative for the maternal line is placed.

[0009] A special centrifuge for gel cards. After the above-mentioned red blood cell suspension and the antibody corresponding to the antigen that is positive for the paternal line and negative for the maternal line are mixed and incubated, they are placed in the first micro-column hole, and then centrifuged by the special centrifuge for gel cards.

[0010] A pipette, which is used to remove the supernatant in the first micro-column hole after centrifugation, and is also used to add distilled water to the material in the first micro-column hole after removing the supernatant to rupture the aggregated cells, obtaining a fetal hemoglobin solution; the pipette is also used to aspirate the dissolved fetal hemoglobin solution in the upper layer of the first micro-column hole into the second micro-column hole.

[0011] An incubator. The incubator is used to incubate the second micro-column hole containing the dissolved fetal hemoglobin solution in the upper layer of the first micro-column hole at a constant temperature.

[0012] A spectrophotometer, which measures the absorbance to calculate the content of fetal hemoglobin.

[0013] Therefore, the detection kit for the content of fetal red blood cells in the peripheral blood of the mother with the above structure of the present utility model is similar to the existing gel card products, and the production equipment can be universal, and it is easy to mass-produce later; the detection reagent and the stain are placed on one card, which is convenient for operation and has a simple packaging, without the need for multiple packaging bottles; the equipment development can be improved on the basis of the existing hemoglobin detector project, which is convenient for the progress of equipment development.

[0014] Next, through the drawings and embodiments, the technical solutions of the present utility model will be further described in detail. Description of the Drawings

[0015] Figure 1 It is a schematic structural diagram of the detection kit for the content of fetal red blood cells in the peripheral blood of the mother of the present utility model;

[0016] Figure 2 It is a schematic diagram of the detection system supporting the detection kit for the content of fetal red blood cells in the peripheral blood of the mother of the present utility model. Detailed Embodiments

[0017] The technical solutions of the present utility model will be further described below through the drawings and embodiments.

[0018] Unless otherwise defined, the technical terms or scientific terms used in this utility model shall have the ordinary meanings understood by those with ordinary skills in the field to which this utility model belongs. The "first", "second" and similar words used in this utility model do not denote any order, quantity or importance, but are only used to distinguish different components. Words such as "comprising" or "including" mean that the elements or objects appearing before this word cover the elements or objects listed after this word and their equivalents, without excluding other elements or objects. Words such as "connected" or "linked" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Upper", "lower", "left", "right", etc. are only used to indicate relative position relationships. When the absolute position of the object being described changes, the relative position relationship may also change accordingly.

[0019] This utility model provides a kit for detecting the content of fetal red blood cells in maternal peripheral blood, including: a card, the card is provided with a number of first micro-column holes 1 and a number of second micro-column holes 2, the filling material of the first micro-column hole 1 is neutral glue, and the filling material of the second micro-column hole 2 is staining solution.

[0020] To further optimize the above technical solution, there are six first micro-column holes 1 and second micro-column holes 2, and the first micro-column holes 1 and the second micro-column holes 2 are arranged at intervals.

[0021] Specifically, the card adopts a mode similar to the existing 6-hole micro-column gel card, so that the sample addition and sealing equipment can be universal after the product is launched on the market, and the existing gel card sample addition equipment can be utilized; mold the card according to the product characteristics, place the neutral gel and staining solution for separation into the blank gel card, and seal the film;

[0022] To further optimize the above technical solution, the shape of the first micro-column hole 1 is the same as the shape of the gel card; the second micro-column hole 2 is in the shape of a cube and has light transmittance.

[0023] It should be noted that the card is composed of 6 micro-column holes. The shapes of 1, 3, and 5 are the same as the existing gel card, and 2, 4, and 6 are in the shape of a cube with good light transmittance, which is convenient for direct absorbance detection; the filling materials of holes 1, 3, and 5 are neutral glue, and the filling materials of holes 2, 4, and 6 are staining solution; 3 person-portions per card;

[0024] To further optimize the above technical solution, it also includes a detection system supporting the kit, as follows:

[0025] A number of liquid containers 3, in one liquid container 3, the maternal peripheral blood is prepared into a red blood cell suspension with physiological saline, and another liquid container 3 is used to hold the antibody corresponding to the antigen that is paternal positive and maternal negative;

[0026] The dedicated centrifuge 4 for gel cards, after mixing and incubating the above-mentioned red blood cell suspension with the antibody corresponding to the antigen that is positive in the paternal line and negative in the maternal line, is placed in the first micro-column hole 1, and then centrifuged by the dedicated centrifuge 4 for gel cards;

[0027] The pipette 5 is used to remove the supernatant in the first micro-column hole 1 after centrifugation, and to add distilled water to the material with the supernatant removed in the first micro-column hole 1 to rupture the agglutinated cells, obtaining a fetal hemoglobin solution; the pipette 5 is also used to aspirate the dissolved fetal hemoglobin solution in the upper layer of the first micro-column hole 1 into the second micro-column hole 2;

[0028] The constant temperature incubator 6 is used to perform constant temperature incubation on the second micro-column hole 2 containing the dissolved fetal hemoglobin solution in the upper layer of the first micro-column hole 1;

[0029] The spectrophotometer 7 measures the absorbance, thereby calculating the content of fetal hemoglobin.

[0030] Specifically, the above-mentioned dedicated centrifuge 4 for gel cards, pipette 5, constant temperature incubator 6, and spectrophotometer 7 are all prior arts.

[0031] Since the prerequisite for detection is to know the antigen types on the surfaces of the father's and mother's red blood cells, this part of the content belongs to blood type identification and can be carried out using existing ABO blood type typing cards and RH blood type antigen detection cards;

[0032] The detection principle of the kit in this application is: by combining the specific agglutination reaction of antigen and antibody and the micro-column gel separation technology, adding the antibody corresponding to the antigen that is positive in the paternal line and negative in the maternal line to the peripheral blood of the mother, enabling the antibody to agglutinate fetal red blood cells but not maternal red blood cells, and then through the micro-column gel separation technology, the fetal red blood cells that have agglutinated with the antibody stay on the surface of the gel, while the maternal red blood cells that have not agglutinated with the antibody sink to the bottom of the gel, thereby separating the fetal red blood cells from the red blood cells in the peripheral blood of the mother, and then measuring the content of fetal red blood cells in the peripheral blood, and further judging the severity of fetal-maternal blood transfusion and evaluating the degree of damage to the placental barrier function of the pregnant woman.

[0033] The operation steps when the kit in this application is used for detection are:

[0034] 1) Prepare a 1% red blood cell suspension from the peripheral blood of the mother with physiological saline;

[0035] 2) Add 10 microliters of the antibody corresponding to the antigen that is positive in the paternal line and negative in the maternal line and mix well;

[0036] 3) Add 100 microliters of the mixed red blood cell suspension to the neutral gel and centrifuge for 5 minutes using the dedicated centrifuge for gel cards;

[0037] 4) Use the pipette to aspirate the supernatant;

[0038] 5) Add 50 μL of distilled water to the neutral gel card hole, and rinse it several times with a pipette to rupture the aggregated cells;

[0039] 6) Aspirate the cell solution dissolved in the upper layer of the neutral gel into the staining solution hole, and place it in a constant temperature incubator (37 °C) for 3 - 5 minutes;

[0040] 7) Measure the absorbance, calculate the content of fetal hemoglobin, and further estimate the amount of fetal - maternal transfusion;

[0041] Therefore, the detection kit for the content of fetal red blood cells in maternal peripheral blood with the above - mentioned structure of the present utility model is similar to the existing gel card products, and the production equipment can be universal, and it is easy to mass - produce in the later stage; the detection reagent and the stain are placed on one card, which is convenient to operate and the packaging is simple, without the need for multiple packaging bottles; the equipment development can be improved on the basis of the existing hemoglobin detector project, which is convenient for the progress of equipment development.

[0042] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present utility model and are not intended to limit them. Although the present utility model has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions of the present utility model or make equivalent replacements, and these modifications or equivalent replacements do not make the modified technical solutions deviate from the spirit and scope of the technical solutions of the present utility model.

Claims

1. A kit for detecting the content of fetal red blood cells in maternal peripheral blood, characterized in that: include: The card is provided with a plurality of first micro-column holes and a plurality of second micro-column holes, the first micro-column holes are filled with neutral glue, and the second micro-column holes are filled with dyeing liquid.

2. The kit for detecting the content of fetal red blood cells in maternal peripheral blood according to claim 1, characterized in that: There are six first micro-column holes and six second micro-column holes, and the first micro-column holes and the second micro-column holes are arranged at intervals.

3. The kit for detecting the content of fetal red blood cells in maternal peripheral blood according to claim 2, characterized in that: The shape of the first microcolumn hole is consistent with the shape of the gel card; the second microcolumn hole is a cube shape and is light-transmissive.

4. The kit for detecting the content of fetal red blood cells in maternal peripheral blood according to claim 3, characterized in that: Also included is a detection system that is compatible with the kit, as follows: Several liquid containers, one of which is used to prepare maternal peripheral blood into a red blood cell suspension with physiological saline, and another liquid container is used to hold antibodies corresponding to paternally positive and maternally negative antigens; The red blood cell suspension and the antibody corresponding to the paternally positive and maternally negative antigen are mixed and incubated in a special centrifuge for gel cards, and then placed in the first microcolumn well, and then centrifuged in a special centrifuge for gel cards; The pipette is used to remove the supernatant in the first microcolumn well after centrifugation, and to add distilled water to the material in the first microcolumn well from which the supernatant has been removed so as to break the agglutinated cells and obtain a fetal hemoglobin solution; the pipette is also used to absorb the fetal hemoglobin solution dissolved in the upper layer of the first microcolumn well into the second microcolumn well; A constant temperature incubator, the constant temperature incubator is used to incubate the second micro column well containing the fetal hemoglobin solution dissolved in the upper layer of the first micro column well at a constant temperature; Spectrophotometer measures the spectrophotometry and calculates the fetal hemoglobin content.

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