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CN-122017232-A - Colloidal gold test strip for detecting human parathyroid hormone, kit and application thereof

CN122017232ACN 122017232 ACN122017232 ACN 122017232ACN-122017232-A

Abstract

The invention belongs to the technical field of biomedical detection, and particularly relates to a colloidal gold test strip for detecting human parathyroid hormone, a kit and application thereof. The colloidal gold test strip can be arranged according to a conventional colloidal gold test strip, and at least comprises a capture antibody and a detection antibody. The test strip can realize the instant detection of suspected parathyroid tissue in thyroid surgery, sample pretreatment is not needed, the detection result is not interfered by low-concentration PTH in blood, the operation is simple and convenient, the result is reliable, an intraoperative decision-making auxiliary tool is provided for a surgeon, the occurrence rate of parathyroid miscut and postoperative hypofunction is reduced, and the test strip has good practical application value.

Inventors

  • GENG CHONG

Assignees

  • 山东第一医科大学附属省立医院(山东省立医院)
  • 济南欧捷生物科技有限公司

Dates

Publication Date
20260512
Application Date
20260228

Claims (10)

  1. 1. A colloidal gold test strip for detecting human parathyroid hormone, which is characterized by at least comprising a capture antibody and a detection antibody; the amino acid sequences of CDR-H1, CDR-H2 and CDR-H3 of the heavy chain variable region of the capture antibody AB1 are respectively shown as SEQ ID NO.2-4, and the amino acid sequences of CDR-L1, CDR-L2 and CDR-L3 of the light chain variable region of the capture antibody AB1 are respectively shown as SEQ ID NO. 6-8; the amino acid sequences of CDR-H1, CDR-H2 and CDR-H3 of the heavy chain variable region of the detection antibody AB2 are respectively shown as SEQ ID NO.10-12, and the amino acid sequences of CDR-L1, CDR-L2 and CDR-L3 of the light chain variable region are respectively shown as SEQ ID NO. 14-16.
  2. 2. The colloidal gold test strip according to claim 1, wherein the amino acid sequence of the heavy chain variable region of the capture antibody AB1 is shown as SEQ ID NO.1, and the amino acid sequence of the light chain variable region of the capture antibody AB1 is shown as SEQ ID NO. 5.
  3. 3. The colloidal gold test strip according to claim 1, wherein the amino acid sequence of the heavy chain variable region of the detection antibody AB2 is shown in SEQ ID NO.9, and the amino acid sequence of the light chain variable region of the detection antibody AB2 is shown in SEQ ID NO. 13.
  4. 4. The colloidal gold test strip according to any one of claims 1 to 3, wherein the colloidal gold test strip comprises a bottom plate, and a sample pad, a colloidal gold binding pad, a detection pad and a water absorption pad are sequentially arranged on the bottom plate, and adjacent pads are overlapped and connected at a joint.
  5. 5. The colloidal gold test strip according to claim 4, wherein the bottom plate is a cardboard or PVC plate.
  6. 6. The colloidal gold test strip according to claim 4, wherein the sample pad is a glass fiber membrane immersed in a treatment solution, the treatment solution is a phosphate buffer solution containing 1-5% BSA and a surfactant, and the surfactant is Tween-20 with a concentration of 0.1-1%.
  7. 7. The colloidal gold test strip according to claim 4, wherein the colloidal gold binding pad uses a glass fiber membrane as a base pad, and is coated with a colloidal gold-coupled detection antibody AB2; The detection pad takes a nitrocellulose membrane as a base pad, a quality control line and a detection line are sequentially arranged on the nitrocellulose membrane, a capture antibody AB1 is coated on the detection line, and goat anti-rabbit IgG is coated on the quality control line; the water absorption pad is a water absorption plate or a water absorption cotton pad.
  8. 8. The colloidal gold test strip according to claim 4, wherein a filter is provided at the interface between the sample pad and the colloidal gold conjugate pad.
  9. 9. A kit, which is characterized in that the kit at least comprises the colloidal gold test strip for detecting human parathyroid hormone according to any one of claims 1-8, and further, the colloidal gold test strip is provided with a shell.
  10. 10. Use of a colloidal gold test strip according to any one of claims 1 to 9 or a kit according to claim 9 in any one or more of the following: (a) Detecting parathyroid hormone or preparing a product for detecting parathyroid hormone; (b) Confirming parathyroid tissue or preparing a product for confirming parathyroid tissue.

Description

Colloidal gold test strip for detecting human parathyroid hormone, kit and application thereof Technical Field The invention belongs to the technical field of biomedical detection, and particularly relates to a colloidal gold test strip for detecting human parathyroid hormone, a kit and application thereof. Background The disclosure of this background section is only intended to increase the understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art already known to those of ordinary skill in the art. Parathyroid gland is endocrine gland on the back side of thyroid gland, mainly secretes parathyroid hormone (PTH), regulates and controls the calcium and phosphorus metabolic steady state in vivo, has small volume and color similar to surrounding tissues, and the position of lower gland is not fixed, thus being easy to be miscut in thyroid operation. Parathyroid miscut or injury can lead to PTH deficiency, causes transient or permanent hypocalcemia, is manifested by perioral/hand-foot numbness, spastic tics and even arrhythmia, has no effective treatment means at present, and is one of the main causes of disputes in thyroid surgery. The existing clinic parathyroid gland identification method is an intraoperative frozen pathological examination, the method takes more than 30 minutes, the operation time is prolonged, parathyroid gland tissues are easy to deactivate when being stored in vitro at normal temperature, and the tissue loss caused by the inspection and delivery also reduces the success rate of autograft. Clinical incidence of transient hypoparathyroidism is 5.6% to 57.1% and permanent is 0% to 12.8%, so there is a need to develop a rapid, accurate, tissue loss-free intraoperative parathyroid identification technique. However, the inventor finds that the conventional immunochromatography test paper can realize rapid detection of biomarkers, but the test paper for parathyroid tissue detection in operation still has the defects that the conventional test paper cannot directly treat tissue disruption liquid, needs pretreatment steps such as centrifugation, dilution or premixing with a specific buffer solution, is complex in operation and inconvenient to implement in operation, the antibody is difficult to be interfered by low-concentration PTH in blood, the specificity and the sensitivity are difficult to be compatible, a quality control system for rapid detection in the adaptation operation is lacked, and the reliability of a detection result is insufficient. Disclosure of Invention Aiming at the problems existing in the prior art, the invention provides a colloidal gold test strip for directly detecting human parathyroid tissue exudates, a kit and application thereof. In particular, the invention actually provides a colloidal gold test strip for rapidly confirming human parathyroid in operation, which realizes the instant detection of suspected parathyroid tissue in thyroid operation without sample pretreatment, has the advantages of simple and convenient operation and reliable result, provides a decision-making auxiliary tool in operation for a surgeon, and reduces the false parathyroid cutting rate and the incidence rate of postoperative hypofunction. Based on the above results, the present invention has been completed. Specifically, the invention relates to the following technical scheme: In a first aspect of the present invention, there is provided a colloidal gold test strip for detecting human parathyroid hormone, the colloidal gold test strip being configurable according to a conventional colloidal gold test strip, the colloidal gold test strip comprising at least a capture antibody and a detection antibody; the amino acid sequences of CDR-H1, CDR-H2 and CDR-H3 of the heavy chain variable region of the capture antibody AB1 are respectively shown as SEQ ID NO.2-4, and the amino acid sequences of CDR-L1, CDR-L2 and CDR-L3 of the light chain variable region of the capture antibody AB1 are respectively shown as SEQ ID NO. 6-8; The amino acid sequences of CDR-H1, CDR-H2 and CDR-H3 of the heavy chain variable region of the detection antibody AB2 are respectively shown as SEQ ID NO.10-12, and the amino acid sequences of CDR-L1, CDR-L2 and CDR-L3 of the light chain variable region of the detection antibody AB2 are respectively shown as SEQ ID NO. 14-16; Specifically, the capture antibody AB1 has an amino acid sequence of a heavy chain variable region as shown in SEQ ID NO.1 or has at least 80% homology with SEQ ID NO.1, more preferably has at least 90% homology, most preferably has at least 95% homology, such as at least 96%, 97%, 98%, 99% homology; The capture antibody AB1 has an amino acid sequence of the light chain variable region as shown in SEQ ID NO.5, or has at least 80% homology with SEQ ID NO.5, more preferably at least 90% homology, most preferably at least 95% homology, such