Sample treatment kit for detecting prolactin by precipitation method

Abstract

The invention relates to the technical field of reagent detection, and discloses a sample treatment kit for detecting prolactin through a precipitation method, the sample treatment kit comprises a kit body, the upper end of the kit body is provided with a cover body, and the kit body comprises a tubular part and a hollow conical part integrally connected with the lower end of the tubular part; a plug body is arranged at an opening in the upper end of the tubular part, and an avoiding through hole through which a gun head of the pipette can conveniently penetrate is formed in the center of the plug body; a quantitative polyethylene glycol reagent is preset in the kit body, and a sealing film is arranged at the avoiding through hole. The method has the beneficial effects that the serum sample treatment time can be effectively shortened, and the treatment convenience is improved.

Description

Technical Field

[0001] The invention relates to the technical field of reagent detection, in particular to a sample processing kit for detecting prolactin using a precipitation method. Background Art

[0002] The clinical purposes of prolactin (PRL) testing involve multiple areas, such as: pituitary function assessment and pituitary disease diagnosis. Prolactin is secreted by the anterior pituitary gland, and testing its level can evaluate the hormone secretion capacity of the pituitary gland. When non-lactating women experience galactorrhea (especially bilateral milk secretion), PRL testing is required to rule out hyperprolactinemia or pituitary tumors.

[0003] However, direct prolactin testing is often subject to interference from macroprolactin (MPRL), leading to inaccurate results. Therefore, serum samples must be processed before testing. Currently, the most common method involves polyethylene glycol precipitation, where serum is mixed with an equal volume of 25% polyethylene glycol, centrifuged, and the PRL level in the supernatant is measured and the recovery rate calculated. This method is low-cost, simple to use, and suitable for routine clinical screening.

[0004] However, there are currently no dedicated test kits, and small test tubes are typically used to store polyethylene glycol and serum. To use this method, 25% polyethylene glycol must first be prepared. A certain amount of the prepared polyethylene glycol solution (usually around 400 μM) must be pipetted into the small test tube. An equal amount of serum must then be pipetted into the small test tube, and the small test tube placed in a test tube rack. The rack and all sample tubes must then be moved to a centrifuge for shaking and centrifugation to separate and precipitate macroprolactin. Finally, the serum from the upper portion of the tube must be pipetted for analysis. This entire process is cumbersome, time-consuming, and inconvenient to prepare samples. Summary of the Invention

[0005] In order to solve the above problems existing in the prior art, the present invention provides a sample processing kit for detecting prolactin by precipitation method. By using this sample processing kit, the serum sample processing time can be effectively reduced and the processing convenience can be improved.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions: A sample processing kit for detecting prolactin by a precipitation method comprises a kit body, wherein the upper end of the kit body is provided with a cover body, the kit body comprising a tubular portion and a hollow conical portion integrally connected to the lower end of the tubular portion; a plug body is provided at the upper end opening of the tubular portion, and a relief hole is provided at the center of the plug body for facilitating the passage of a pipette tip; a quantitative polyethylene glycol reagent is preset in the kit body, and a sealing membrane is provided at the relief hole.

[0007] By adopting the above technical solution: a predetermined amount of polyethylene glycol reagent (usually at a concentration of 25%) is included in the test kit, eliminating the need for manual configuration steps, avoiding concentration errors, reducing the number of pipette operations, and shortening the operation time; an avoidance through-hole is provided in the center of the plug body, and combined with a sealing membrane design, the sealing performance is good during storage, extending the shelf life; after opening the lid, serum can be directly injected into the test kit body through the sealing membrane using a pipette, which is easy to operate, has a good sealing effect on the reagents in the test kit, and reduces the risk of contamination; the tapered portion facilitates the separation of macroprolactin along the cone wall during centrifugation and its precipitation to the bottom of the test kit body.

[0008] Preferably, the avoidance through-hole is configured as a countersunk hole, the sealing film is disposed on a stepped surface of the countersunk hole, and the edge of the sealing film is provided with a tearing tab for facilitating tearing of the sealing film. If some pipette tips are thicker and it is inconvenient to directly pierce the sealing film, the sealing film can be directly torn off through the tearing tab, thus providing high versatility.

[0009] Preferably, the stepped surface of the counterbore is provided with a micro-hole for equalizing the internal and external pressures of the reagent kit body. The upper end of the micro-hole is sealed by the sealing film. After the sealing film is removed, the micro-hole ensures internal and external pressure balance. Even if the pipette tip completely closes the avoidance hole, stable liquid addition and withdrawal can be performed, thereby ensuring the stability of liquid addition and withdrawal (preventing liquid residue or spraying due to negative pressure).

[0010] Preferably, the outer side of the lower end of the conical portion is provided with a plurality of convex pieces evenly distributed along the circumference, the lower end surfaces of the convex pieces being coplanar to form a positioning plane, and the axial end of the reagent box body is perpendicular to the positioning plane; the upper side surface of the cover body is configured as a support plane, and the center of the lower side surface of the cover body is provided with an annular boss, and the annular boss is provided with a plurality of engaging grooves that engage with the convex pieces in a one-to-one manner; when the cover body is removed and flipped over so that the annular boss faces upward, the convex pieces are snapped into the engaging grooves, so that the reagent box body can stand upright on a plane. After the cover body is flipped over, the engaging grooves cooperate with the convex pieces, so that the reagent box body can stand upright stably, even without a test tube rack, and can be positioned upright, facilitating temporary storage during transfer and preventing the cover body from being lost; during the process of adding or removing liquid with a pipette, the reagent box body stands upright on a workbench (desktop), and only requires slight support from the left hand to position it, while the pipette is operated with the right hand, eliminating the need for full left-hand gripping and positioning, making operation more convenient.

[0011] Preferably, the lower side of the cover body is provided with a connecting sleeve that is snap-fitted to the outside of the tubular portion, and a supporting protrusion is provided on the outer side of the lower end of the connecting sleeve, and the ratio of the outer diameter of the supporting protrusion to the outer diameter of the tubular portion is configured to be 1.3-1.5; when the reagent kit is placed in the test tube rack, the supporting protrusion rests on the upper edge of the test tube rack, so that the tapered portion is separated from the bottom of the test tube rack. The diameter and length of the test tube rack body of this type are relatively small, and it is inconvenient to remove it after it is placed in the test tube rack; when the test tube rack is placed in the present structure, the supporting protrusion rests on the upper edge of the test tube rack, so that it can adapt to test tube racks with a height greater than the test tube rack body and a diameter greater than the test tube rack body, which has strong adaptability and can also reduce vibration interference; because the supporting protrusion is supported on the upper end of the test tube rack, the upper part of the upper cover located above the supporting protrusion protrusion exceeds the upper end surface of the test tube rack, making it convenient to pick up the test tube rack with fingers.

[0012] Preferably, the inner diameter of the tubular portion is configured to be 7-10 mm, the total height of the reagent kit body is configured to be 35-42 mm, and the volume of the reagent kit body is configured to be 1.2-1.5 ml. By rationally configuring the dimensions of the reagent kit body, the liquid level within the reagent kit body meets certain requirements, facilitating more convenient liquid extraction with a pipette (if the liquid level is too low, the pipette must be moved to a precise position when extracting liquid, resulting in unreliable operation; if the liquid level is too high, the pipette must be inserted deeply when extracting liquid, requiring a larger pipette tip and becoming incompatible with the equipment during subsequent centrifugal shaking).

[0013] Preferably, a position limiting assembly for limiting the position of the pipette tip is provided within the test kit body at the junction of the tubular portion and the conical portion; the position limiting assembly includes a clasp, a baffle, and a plurality of connecting arms for connecting the clasp and the baffle, the clasp being clamped to the inner wall of the lower end of the tubular portion, and the baffle being parallel to and concentrically disposed above the clasp. In the prior art, after centrifugation, the test tube is held in the left hand and the liquid is extracted with the right hand through the pipette. During the extraction process, attention must be focused and the position of the pipette tip must be fine-tuned. If the pipette tip is inserted too deep, it is easy to aspirate macroprolactin precipitated at the bottom. If the pipette tip is inserted too shallowly, a quantitative amount of serum cannot be extracted, requiring a second extraction, which leads to inconvenience and low efficiency. The present structure uses a position limiting assembly to limit the insertion depth of the pipette tip. During extraction, the test kit body is upright on a flat surface through the cover body, and the left hand can be used for slight support. The right hand operates the pipette. When the pipette tip is blocked, the liquid can be extracted. Extraction is very convenient and accurate.

[0014] Preferably, the baffle is circular, with a ratio of the outer diameter of the baffle to the inner diameter of the tubular portion being 0.3-0.5, and three connecting arms being arranged, with the three connecting arms being evenly distributed and inclined along the circumference. The three inclined connecting arms support the baffle, and when the pipette tip contacts the baffle, the supporting arms undergo slight elastic deformation, thereby preventing damage to the pipette tip.

[0015] Preferably, the baffle is provided with a plurality of throttling micropores having a diameter smaller than the outer diameter of the pipette tip. When the pipette tip contacts the baffle, the throttling micropores prevent the pipette tip from being blocked by the baffle. Furthermore, the throttling micropores utilize the throttling principle to reduce turbulence under the baffle during pipette aspiration, thereby preventing the aspiration of bottom sediment, ensuring the purity of the supernatant, and further improving detection accuracy.

[0016] Preferably, the reagent kit body, cover, stopper, and stopper assembly are all made of polyethylene, or alternatively, polypropylene. Polyethylene and polypropylene are safe, non-toxic, stable, low-cost, suitable for centrifugal shaking, and non-reactive with polyethylene glycol reagents. Using polyethylene or polypropylene as the stopper assembly enhances the elasticity of the connecting arm and provides better protection for the pipette tip.

[0017] Therefore, the present invention has the following beneficial effects: (1) a standardized reagent box is used to replace the test tube, which reduces the cost of operation training and improves the convenience and controllability of operation; (2) the cover body is connected to the reagent box body for upright positioning, and the left hand is used to assist in achieving complete positioning, which reduces the fatigue strength of the complete left-hand grip positioning and improves the convenience and stability of adding and taking liquids with the pipette; (3) a limit component is provided to limit the position of the pipette tip during the process of taking liquids with the pipette, eliminating the operation of repeatedly adjusting the pipette tip and improving the convenience of taking liquids. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a structural diagram of Example 1.

[0019] Figure 2 for Figure 1 Axonometric drawing of .

[0020] Figure 3 for Figure 1 Cross-sectional view at AA in the middle.

[0021] Figure 4 for Figure 1 Exploded diagram.

[0022] Figure 5 for Figure 4 Another perspective of the picture.

[0023] Figure 6It is a structural diagram of the limit component.

[0024] Figure 7 This is a schematic diagram of the cover moving to the lower end position of the tapered portion after being opened.

[0025] Figure 8 for Figure 7 Schematic diagram of the snap-in fit of the middle protrusion snap-in slot.

[0026] Figure 9 Schematic diagram of the pipette adding and removing liquid.

[0027] Figure 10 This is a structural diagram of Example 2.

[0028] Figure 11 This is a schematic diagram of the state of Example 2 being placed in a test tube rack. DETAILED DESCRIPTION

[0029] In order to make the technical problems, technical solutions and beneficial technical effects to be solved by the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and multiple exemplary embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the scope of protection of the present invention.

[0030] It should be understood that, in this document, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance, nor as implicitly specifying the quantity of the technical features being referenced. A feature specified as "first" or "second" may explicitly or implicitly indicate that at least one of the features is included.

[0031] Example 1: Figures 1-9 A sample processing kit for detecting prolactin by the precipitation method is shown, comprising a kit body 1, a cover 2 being provided at the upper end of the kit body 1, the kit body 1 comprising a tubular portion 10, and a hollow conical portion 11 integrally connected to the lower end of the tubular portion 10; a plug 3 being provided at the upper end opening of the tubular portion 10, a through hole 30 being provided at the center of the plug 3 for facilitating the passage of a pipette tip; a quantitative polyethylene glycol reagent 5 being preset in the kit body 1, and a sealing membrane 4 being provided at the through hole 30.

[0032] The avoidance through-hole 30 is configured as a countersunk hole 300. The sealing film 4 is disposed on a stepped surface of the countersunk hole 300. The edge of the sealing film 4 is provided with a tear tab 40 for facilitating tearing of the sealing film 4. The stepped surface of the countersunk hole 300 is provided with a diversion microhole 31 for balancing the internal and external pressures of the reagent container body 1. The upper end of the diversion microhole is sealed by the sealing film 4.

[0033] The outer side of the lower end of the conical portion 11 is provided with a number of circumferentially evenly distributed protrusions 12. The lower end surfaces of the protrusions 12 are coplanar, forming a positioning plane 120. The axial end of the reagent box body 1 is perpendicular to the positioning plane 120. The upper side of the cover 2 is configured as a support plane 200. An annular boss 20 is provided at the center of the lower side of the cover 2. The annular boss 20 is provided with a number of snap-in grooves 21 that correspond one-to-one with the protrusions 12. When the cover 2 is removed and flipped so that the annular boss 20 faces upward, the protrusions 12 snap into the snap-in grooves 21, allowing the reagent box body 1 to stand upright on a flat surface. In some embodiments, the diameter of the support plane 200 is set to 1.5 times the outer diameter of the tubular portion to enhance support stability.

[0034] In some embodiments, the inner diameter of the tubular portion 10 is configured to be 7-10 mm, the total height of the reagent box body 1 is configured to be 35-42 mm, and the volume of the reagent box body 1 is configured to be 1.2-1.5 ml. In this embodiment, the inner diameter of the tubular portion is configured to be 8 mm, the total height of the reagent box body 1 is configured to be 40 mm, and the volume of the reagent box body 1 is configured to be 1.5 ml.

[0035] like Figure 3 and Figure 6 As shown, a limiting assembly 6 for limiting the position of the pipette tip is provided at the junction of the tubular portion 10 and the conical portion 11 in the reagent box body 1; the limiting assembly 6 includes a clamping ring 60, a baffle 61, and a plurality of connecting arms 62 for connecting the clamping ring 60 and the baffle 61. The clamping ring 60 is clamped on the inner wall of the lower end of the tubular portion 10, and the baffle 61 is parallel to the upper side of the clamping ring 60 and is concentric with the clamping ring 60; the baffle 61 is configured to be circular, and the ratio of the outer diameter of the baffle 61 to the inner diameter of the tubular portion 10 is configured to be 0.3-0.5. There are three connecting arms 62, and the three connecting arms 62 are evenly distributed along the circumferential direction. The baffle 61 is provided with a plurality of throttling microholes 610 with a diameter smaller than the outer diameter of the pipette tip. As shown Figure 7 As shown, after the pipette tip 7 is inserted into the reagent box body, it is blocked by the blocking piece. At this time, liquid can be directly taken out, eliminating the need to observe and fine-tune the position of the pipette tip.

[0036] The reagent box body 1, the cover 2, the stopper 3, and the limiting assembly 6 are all made of polyethylene material, or the reagent box body 1, the cover 2, the stopper 3, and the limiting assembly 6 are all made of polypropylene material. In some embodiments, in order to better shield the reagent from light, the reagent box body 1, the cover 2, the stopper 3, and the limiting assembly 6 are all made of opaque polypropylene material. Since the limiting assembly is provided, the position of the pipette tip does not need to be observed, so opaque polypropylene material can be used. In the prior art, in order to facilitate accurate observation of the position of the pipette tip, a transparent or translucent test tube or container must be used.

[0037] Example 2: Figure 10 and Figure 11 The lower side of the cover 2 is provided with a connecting sleeve 22 that snaps onto the outside of the tubular portion 10. A supporting collar 23 is provided on the outer side of the lower end of the connecting sleeve 22. The ratio of the outer diameter of the supporting collar 23 to the outer diameter of the tubular portion 10 is configured to be 1.3-1.5. When the reagent kit is placed in the test tube rack, the supporting collar 23 rests on the upper edge of the test tube rack 8, separating the tapered portion 11 from the bottom of the test tube rack. The remaining structure is the same or equivalent to that of the embodiment.

[0038] In this embodiment, the reagent kit has a wider range of test tube rack options. When the reagent kit is loaded into the test tube rack, it rests on the upper edge of the test tube rack 8 through the support protrusion 23, thereby being able to adapt to test tube racks with a height greater than the reagent kit body and a diameter greater than the reagent kit body, and having strong adaptability. After each reagent kit is loaded into the test tube rack, its axis can remain in a vertical state (in the prior art, after the test tube is placed in the test tube rack, it needs to lean against one side of the test tube rack, and its axis is tilted, and it will rotate and shake around the hole of the test tube rack during rotation), thereby making the transfer process more stable and reducing vibration interference. Moreover, because the support protrusion is supported at the upper end of the test tube rack, the upper cover is located above the support protrusion and exceeds the upper end surface of the test tube rack, making it easier to pick up the reagent kit with fingers. The lower end of the reagent kit does not contact the bottom of the test tube rack, thereby preventing residual liquid in the test tube rack from contaminating the bottom of the reagent kit.

[0039] In conjunction with the accompanying drawings, the principle of the present invention is as follows: the reagent kit is preset with 400 μm of polyethylene glycol reagent at a concentration of 25%. Different volumes of polyethylene glycol reagent can be preset according to needs and marked on the label of the reagent kit to meet different needs. In this embodiment, 400 μm is used as an example. When using, take a reagent kit, open the cover and snap the protrusion into the snap-in groove on the cover (such as Figure 9 As shown), the test kit can be placed freely on a flat surface and supported by the left hand. Use the right hand to operate the pipette to take 400μm of the serum to be tested. The pipette tip pierces the sealing film and injects the serum into the test kit body (if the pipette tip model is different and cannot pierce the sealing film, tear off the sealing film by tearing the ear). Remove the cover, cover it, put it into a test tube rack or a special tray, transfer it to a shaking or centrifugal device for processing, take out the centrifuged test kit after processing, open the cover and put it into the bottom of the conical part (as shown). Figure 9 As shown, the pipette tip 7 is inserted into the reagent box until contact between the pipette tip and the baffle 61 is blocked. Liquid can then be aspirated to remove the supernatant after the removal of macroprolactin. The entire operation is more convenient and labor-saving, eliminating the need to prepare polyethylene glycol, remove and add polyethylene glycol, and eliminate the need to fully grasp and position the left hand. The pipette tip also eliminates the need to adjust the position of the pipette tip. Furthermore, the reagent box body is sealed by the lid throughout the entire transfer process, reducing the risk of contamination.

[0040] In the description of the present invention, it should be understood that the directions or positional relationships indicated by up, down, left, right, inner end, outer end, one end, the other end, etc. are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the purpose of more clearly describing the technical solution of the present invention, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific orientation, and cannot be understood as a limitation of the present invention.

[0041] Although specific embodiments of the present invention are described in detail herein, they are provided for illustrative purposes only and should not be considered to limit the scope of the present invention. Various substitutions, changes, and modifications may be conceived without departing from the spirit and scope of the present invention.

Claims

1. A sample processing kit for detecting prolactin by precipitation method, comprising a kit body (1), characterized in that: The upper end of the reagent box body (1) is provided with a cover body (2), and the reagent box body (1) comprises a tubular portion (10) and a hollow conical portion (11) integrally connected to the lower end of the tubular portion (10); A plug body (3) is provided at the upper opening of the tubular portion (10), and a through hole (30) is provided at the center of the plug body (3) for facilitating the passage of a pipette tip; A quantitative amount of polyethylene glycol reagent (5) is preset in the reagent kit body (1), and a sealing film (4) is provided at the avoidance through hole (30).

2. The sample processing kit for detecting prolactin by precipitation method according to claim 1, characterized in that: The avoidance through hole (30) is configured as a countersunk hole (300), the sealing film (4) is arranged on a stepped surface of the countersunk hole (300), and the edge of the sealing film (4) is provided with a tearing ear (40) for facilitating tearing of the sealing film (4).

3. The sample processing kit for detecting prolactin by precipitation method according to claim 2, characterized in that: A guide micropore (31) for balancing the internal and external air pressure of the reagent box body (1) is provided on the stepped surface of the sink hole (300), and the upper end of the guide micropore is sealed by the sealing film (4).

4. A sample processing kit for detecting prolactin by precipitation method according to claim 1, 2 or 3, characterized in that: The outer side of the lower end of the conical portion (11) is provided with a plurality of convex pieces (12) uniformly distributed along the circumferential direction, the lower end surfaces of the convex pieces (12) are coplanar to form a positioning plane (120), and the axial end of the reagent box body (1) is perpendicular to the positioning plane (120); The upper side of the cover body (2) is configured as a support plane (200), and an annular boss (20) is provided at the center of the lower side of the cover body (2). The annular boss (20) is provided with a plurality of engaging grooves (21) that engage with the convex pieces (12) in a one-to-one corresponding manner. When the cover (2) is removed and turned over so that the annular boss (20) faces upward, the protrusion (12) is snapped into the snap-fit groove (21), so that the reagent box body (1) can stand upright on a plane.

5. The sample processing kit for detecting prolactin by precipitation method according to claim 1, characterized in that: The lower side of the cover body (2) is provided with a connecting sleeve (22) that is clamped on the outside of the tubular portion (10), and the outer side of the lower end of the connecting sleeve (22) is provided with a supporting convex ring (23), and the ratio of the outer diameter of the supporting convex ring (23) to the outer diameter of the tubular portion (10) is configured to be 1.3-1.5; When the reagent kit is placed in the test tube rack, the supporting protrusion (23) rests on the upper edge of the test tube rack, so that the tapered portion (11) is separated from the bottom of the test tube rack.

6. The sample processing kit for detecting prolactin by precipitation method according to claim 1, characterized in that: The inner diameter of the tubular portion (10) is configured to be 7-10 mm, the total height of the reagent box body (1) is configured to be 35-42 mm, and the volume of the reagent box body (1) is configured to be 1.2-1.5 ml.

7. A sample processing kit for detecting prolactin by precipitation method according to claim 1, 5 or 6, characterized in that: A limiting component (6) for limiting the position of the pipette tip is provided at the junction of the tubular portion (10) and the conical portion (11) in the reagent kit body (1); The limiting assembly (6) comprises a snap ring (60), a baffle (61), and a plurality of connecting arms (62) for connecting the snap ring (60) and the baffle (61). The snap ring (60) is clamped on the inner wall of the lower end of the tubular portion (10), and the baffle (61) is distributed parallel to the upper side of the snap ring (60) and concentrically with the snap ring (60).

8. The sample processing kit for detecting prolactin by precipitation method according to claim 7, characterized in that: The baffle (61) is configured to be circular, and the ratio of the outer diameter of the baffle (61) to the inner diameter of the tubular portion (10) is configured to be 0.3-0.

5. The number of the connecting arms (62) is configured to be three, and the three connecting arms (62) are evenly distributed along the circumferential direction.

9. The sample processing kit for detecting prolactin by precipitation method according to claim 8, characterized in that: The baffle (61) is provided with a plurality of throttling micro-holes (610) having a diameter smaller than the outer diameter of the pipette tip.

10. The sample processing kit for detecting prolactin by precipitation method according to claim 7, characterized in that: The reagent box body (1), the cover body (2), the stopper body (3), and the limiting component (6) are all made of polyethylene material, or the reagent box body (1), the cover body (2), the stopper body (3), and the limiting component (6) are all made of polypropylene material.

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