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CN-121995048-A - Kit for rapidly and efficiently diagnosing lung cancer meninges metastasis

CN121995048ACN 121995048 ACN121995048 ACN 121995048ACN-121995048-A

Abstract

The invention discloses a kit for rapidly and efficiently diagnosing lung cancer meninges metastasis, which relates to the technical field of medical equipment and has the technical scheme that the kit is a disposable plastic shell, four independent chromatographic channels are arranged in parallel in the kit, and the four independent chromatographic channels are Complement component C channels, frizzled-9 channels, intereukin-1 receptor accessory protein channels and Alpha-1-antichymotrypsin channels respectively. The kit can be used for simultaneously detecting 4 markers, and can be used for diagnosing lung cancer meninges metastasis, so that the dosage of cerebrospinal fluid can be reduced, the diagnosis sensitivity can be improved, the detection time can be shortened, the sampling times can be reduced, subjective judgment errors can be reduced, and the consistency and repeatability of diagnosis can be improved by setting an objective interpretation threshold and an automatic analysis module.

Inventors

  • ZENG ZHIMIN
  • LIU CHENYI
  • HUANG WENQIAN
  • Xiong le
  • LIU ANWEN
  • HE YANQING

Assignees

  • 南昌大学第二附属医院

Dates

Publication Date
20260508
Application Date
20260120

Claims (5)

  1. 1. A kit for rapidly and efficiently diagnosing lung cancer meninges metastasis is characterized in that the kit is a disposable plastic shell, four independent chromatographic channels are arranged in parallel and correspond to each other: ① Complement component C7 channels; ② Frizzled-9 channel; ③ An Interlukin-1 receptor accessory protein channel; ④ Alpha-1-antichymotrypsin channel.
  2. 2. The kit for rapidly and efficiently diagnosing lung cancer meningeal metastasis according to claim 1, wherein the kit has dimensions of 120 mm times longer and 25 times wider and mm times higher and 8 times higher and mm.
  3. 3. The kit for rapidly and efficiently diagnosing lung cancer meningeal metastasis according to claim 1, wherein the four independent chromatographic channels are sequentially arranged from bottom to top: a. sample pad, pre-loading blocking protein and release-promoting gold-labeled antibody microsphere; b. The gold-labeled binding pad is 40 nm colloidal gold-labeled corresponding monoclonal antibody, and the freeze-drying concentration is 15 mug/cm < 2 >; c. NC film: -T line coating the corresponding capture antibody at a concentration of 300pg/mL; line C, sheep anti-mouse IgG 1 mg/mL; d. the water absorption pad is more than or equal to 300 mm long, and ensures continuous chromatography in 15 min; e. The quantitative window is that 45 mm multiplied by 2mm reading windows are arranged at the positions of the shell corresponding to the T/C line, and the concentration value can be obtained by directly carrying out naked eye colorimetry or inserting a mobile phone colorimetry APP.
  4. 4. The kit for rapid and efficient diagnosis of lung cancer meningeal metastasis according to claim 3, wherein the monoclonal antibody comprises Complement component C7-mAb1、Frizzled-9-mAb1、Interleukin-1 receptor accessory protein-mAb1、Alpha-1-antichymotrypsin-mAb1.
  5. 5. A kit for rapid and efficient diagnosis of lung cancer meningeal metastasis according to claim 3, wherein the capture antibody includes, but is not limited to Complement component C-mAb 2.

Description

Kit for rapidly and efficiently diagnosing lung cancer meninges metastasis Technical Field The invention relates to the technical field of medical equipment, in particular to a kit for rapidly and efficiently diagnosing lung cancer meningeal metastasis. Background Lung cancer meningeal metastasis is a common and very poor prognosis complication in advanced lung cancer, and early identification and timely intervention are critical for patient treatment and prolongation of survival. However, the prior diagnostic techniques have some limitations. Diagnostic methods such as cytological examination, imaging examination, and liquid biopsy are commonly used in the prior art. Among them, cytological examination of cerebrospinal fluid belongs to the gold standard in the prior art for diagnosing lung cancer meningeal metastasis. However, it still has the following disadvantages: 1. The cerebrospinal fluid sample demand is large, and the conventional collection is more than or equal to 10 mL; 2. the detection sensitivity is low, the first positive rate is only 45-67%, the detection sensitivity is less than 90% even if the detection is carried out for a plurality of times (more than or equal to 3 times), and the diagnosis time is delayed; 3. The detection period is long, the time from sample collection to report sending is usually 24-72 hours, and the requirement of rapid clinical decision cannot be met; 4. Repeated sampling is needed for a plurality of times, so that the pain of a patient is increased, and the risks of complications such as infection, low craniocerebral pressure and the like are also increased; 5. the method has high dependence on the experience of operators, strong subjectivity of cell morphology interpretation and easy missed diagnosis and early or low load transfer. Disclosure of Invention The invention aims to provide a kit for rapidly and efficiently diagnosing lung cancer meninges metastasis, which can reduce the dosage of cerebrospinal fluid, improve the diagnosis sensitivity, shorten the detection time, reduce the sampling times, reduce the subjective judgment error by setting an objective judgment threshold and an automatic analysis module, and improve the consistency and repeatability of diagnosis. The technical aim of the invention is realized by the following technical scheme that the kit for rapidly and efficiently diagnosing lung cancer meninges metastasis is a disposable plastic shell, and four independent chromatographic channels are arranged in parallel and correspond to each other: ① Complement component C7 channels; ② Frizzled-9 channel; ③ An Interlukin-1 receptor accessory protein channel; ④ Alpha-1-antichymotrypsin channel. The invention is further arranged that the kit has dimensions of 120 mm x 25 x mm x 8 x mm. The invention is further provided with the four independent chromatographic channels which are sequentially arranged from bottom to top: a. sample pad, pre-loading blocking protein and release-promoting gold-labeled antibody microsphere; b. The gold-labeled binding pad is 40 nm colloidal gold-labeled corresponding monoclonal antibody, and the freeze-drying concentration is 15 mug/cm < 2 >; c. NC film: -T line coating the corresponding capture antibody at a concentration of 300pg/mL; line C, sheep anti-mouse IgG 1 mg/mL; d. the water absorption pad is more than or equal to 300 mm long, and ensures continuous chromatography in 15 min; e. The quantitative window is that 45 mm multiplied by 2mm reading windows are arranged at the positions of the shell corresponding to the T/C line, and the concentration value can be obtained by directly carrying out naked eye colorimetry or inserting a mobile phone colorimetry APP. The invention further provides that the monoclonal antibodies comprise Complement component C7-mAb1、Frizzled-9-mAb1、Interleukin-1 receptor accessory protein-mAb1、Alpha-1-antichymotrypsin-mAb1. The invention further provides that the capture antibodies include, but are not limited to Complement component C a 7-mAb2. In summary, the invention has the following beneficial effects: The invention can detect 4 lung cancer related protein markers simultaneously by only about 50 mu L of cerebrospinal fluid, the cerebrospinal fluid demand is only 0.5% of that of the traditional method, the 'one drop' level diagnosis is successfully realized, the problem that the traditional method needs a large amount of sampling is thoroughly solved, and the invention is especially suitable for patients with craniocerebral depression, children, weak body or difficult sampling for many times. The sensitivity of the lung cancer meninges metastasis detection is greatly improved by a multi-marker combined mode, namely, the primary positive rate can be improved to be more than or equal to 90% by 4-marker parallel detection and high-sensitivity immunochromatography, the total of three cerebrospinal fluid cytology is approximate or exceeds, the false negative rate is obviously reduced, the diag