Saliva liquefied sugar chain antigen determination kit and detection method thereof

Abstract

The invention relates to the technical field of in-vitro diagnostic reagents, and particularly relates to a saliva liquefied sugar chain antigen determination kit and a detection method thereof. The saliva liquefied sugar chain antigen detection kit comprises a reagent R1 and a reagent R2, wherein the reagent R1 includes 5-50g / L of a stabilizer and 0.05-2g / L of a preservative, and a pH value is adjusted to 2-9 by utilizing a buffer solution; and the reagent R2 includes 5-30 g / L of a surfactant, 5-30 g / L of a stabilizer, 0.1-2 g / L of an anti-human saliva liquefied sugar chain antigen antibody latex particle conjugate and 0.05-2 g / L of a preservative, and the pH value is adjusted to 2-9 by using the buffer solution. The kit is high in sensitivity, the lowest detection can reach 50.0 U / mL, alinear range is wide and can reach 50-10000 U / mL, and accurate detection of the saliva liquefied sugar chain antigen can be achieved.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic reagents, in particular to a kit for measuring salivary sugar chain antigens and a detection method thereof. Background technique [0002] Sialylated sugar chain antigen (Krebs Von Den Lungen-6, KL-6) is a transmembrane high molecular weight mucin containing a sialylated sugar chain with a molecular weight of about 200KD, which is mainly composed of 20 amino acid residues The tandem repeat sequence has a spatially structured epitope recognized by specific antibodies. KL-6 forms the covering fluid of the pulmonary bronchial epithelium at the disulfide bonds on the membrane surface of the pulmonary bronchial epithelium, and is mainly expressed in the cytoplasm and membrane of type II alveolar cells and bronchial epithelial cells. Studies have pointed out that KL-6 is not only a protein that constitutes the interstitium of lung tissue, but also serves as a highly specific marker of lung ...

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Problems solved by technology

In enzyme-linked immunosorbent assay, its detection sensitivity is high, but the operation process is slightly complicated, the measurement time is long, and there are many influencing factors, and this method is mainly used in scientific research and cannot be used in clinical diagnosis; in chemiluminescence immunoassay In the measurement, its automatic operation speed is fast and the accuracy is high, but the cost is high, the equipment is expensive, and the stability is poor, so it cannot be popularized in middle and primary hospitals and medical institutions; the immune nephelometric method can be divided into nephelometry (INA) and transmission Turbidimetric (ITA), the advantages of this type of method are fast and simple, high precision, easy to automate, suitable for simultaneous detection of large quantities of samples, and can also be used for the determination of a small number of samples and emergency samples, with strong applicability

Due to the characteristics of its light wave receiving method, the sensitivity and speed of the test results are usually better than those of the transmission turbidimetry. However, it requires a special nephelometry instrument or a special protein meter, and special matching reagents. High, not easy to promote and use in primary hospitals

Turbidimetric transmission (ITA) method is easy to operate and has strong applicability. Both ordinary automatic biochemical analyzers and spectrophotometers can be used, and it is easier to be used for routine analysis. Almost all laboratories and grassroots hospitals can carry out it. Sensitivity and precision are not ideal

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