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Urinary transferrin detection kit with wide detection range

A technology for detecting kits and transferrin, applied in the biological field, can solve the problems of increasing reagent loss cost, unsatisfactory, unadaptable, etc., and achieve the effect of maintaining low-value sensitivity, saving patient expenses, and expanding the linear range

Active Publication Date: 2018-11-06
BYRON DIAGNOSTICS SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the existing kits for detecting UTRF in urine using latex immunoturbidimetric reagents are simply unable to meet the detection of UTRF content in urine of most early glomerular nephropathy patients, and a large number of samples are diluted manually or by instruments. inspection, which not only increases the labor intensity of hospital staff but also increases the cost of reagent loss
[0005] At present, the mainstream reagents for detecting UTRF content in urine are the UTRF reagents of the imported Siemens BNII (2.2-35mg / L) system, and the UTRF reagents of the Beckman Coulter (BC) IM800 (2.0-40mg / L) system , both of which use scattering immunoturbidimetry, although the detection range is relatively wide, can reach 35-40mg / L, covering 60% of patients, but the detection limit can only reach 2.2 and 2.0mg / L
Since the results cannot be reported for samples smaller than the minimum detection limit, and the reference value of this item is 2mg / L, which makes clinical application relatively embarrassing, gray area samples cannot detect the results, weakly positive samples (UTRF content in urine is 2.0-5mg / L) measurement repeatability is poor
In addition, imported reagents are expensive, and the existing kits for detecting UTRF in urine are extremely slow, all less than 250t / h, which cannot meet the needs of large hospitals with many patients and massive samples for physical examination
[0006] Based on the existing UTRF latex turbidimetric reagent, through the pre-dilution method of the instrument to expand the detection range, the detection speed of the biochemical instrument will be reduced by 50%-70%. Compared with the existing Siemens and BC reagents, the detection speed of this method is not obvious. , and the ability of this method to expand the detection range is limited, it can only reach 50-60mg / L, and it cannot meet the requirement that the upper limit of the linear range exceeds 80mg / L
In addition, a substantial increase in the amount of antibodies can be used to broaden the linear range of reagents, but simply increasing the amount of antibodies will not only adversely affect the range of excess antigens, but also greatly increase the cost of testing. In the background, the method of greatly increasing the amount of antibody used to broaden the linear range of the reagent is obviously unable to be popularized.

Method used

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  • Urinary transferrin detection kit with wide detection range
  • Urinary transferrin detection kit with wide detection range
  • Urinary transferrin detection kit with wide detection range

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Using the method described in the patent No. 201710986970.7, that is, the secondary convergent polymerization latex transformation technology, the linear range of the first-generation UTRF reagent of the company was expanded to obtain reagent A, and the performance of the first-generation UTRF reagent and reagent A was verified.

[0036] The first generation of UTRF reagents: registration number Shanghai Machinery Note 20162400121, the linear range is 0.2-24mg / L, and the antigen excess range is 1000mg / L; the main components are:

[0037] Reagent 1: sodium chloride, the concentration is 400mM / L; polyethylene glycol PEG6000, the concentration is 1g / L; Tween-20, the concentration is 5ml / L;

[0038] Reagent 2: latex particles, 3g / L, latex particle size 297nm; UTRF antibody (product number Q0327), 10ml / L, brand Dako.

[0039] Among them, the specific steps of transforming the first-generation UTRF reagent into the latex of the second convergent polymerization are as follows:...

Embodiment 2

[0056] Verify the effect of metal additives

[0057] Using reagent A, add different concentrations of zinc acetate, copper sulfate and ferrous sulfate to reagent one of reagent A, use 2ul samples, 105ul reagent one, 35ul reagent two, at 570nm wavelength, 18-34 read points On Hitachi7180, use the same batch of UTRF standards with different concentrations to measure ΔABS, the results are shown in Table 4-6 and Figure 1-3 shown.

[0058] The impact of different concentrations of zinc acetate in table 4 on the sensitivity of the determination of different concentrations of UTRF

[0059]

[0060] The impact of different concentrations of ferrous sulfate in table 5 on the sensitivity of different concentrations of UTRF

[0061]

[0062] Table 6 The impact of different concentrations of copper sulfate on the sensitivity of different concentrations of UTRF

[0063]

[0064] from Tables 4-6 and Figure 1-3 It can be seen that adding zinc acetate, copper sulfate or ferrous...

Embodiment 3

[0067] Using conventional thinking in this field, the latex particle size is reduced within a certain range, and the linear range of the reagent is expanded.

[0068] In the reagent A of Example 1, the latex with a particle size of 297nm from Polymicrospheres company was replaced with the latex with a particle size of 200nm by Bangslab. According to the secondary convergence polymerization latex transformation technology recorded in the patent No. 201710986970.7, D 3 =0.78*200nm=156nm latex, obtains reagent B, and the main component of reagent B is:

[0069] Reagent 1: sodium chloride, the concentration is 400mM / L; polyethylene glycol PEG6000, the concentration is 1g / L; Tween-20, the concentration is 5ml / L; preservative PC-300, the concentration is 0.35ml / L;

[0070] Reagent 2: latex particles after secondary convergent polymerization, concentration is 3g / L, latex particle size D 3 156nm; UTRF antibody (product number Q0327), the concentration is 10ml / L, the brand Dako, using...

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Abstract

The invention discloses a urinary transferrin detection kit with a wide detection range. The kit comprises a reagent I and a reagent II, wherein the reagent I comprises a metallic ion additive; the metallic ion additive is a zinc salt; the zinc salt has a concentration of 6-19mM; the reagent II is a latex granule solution marked by an UTRF (Urinary Transferrin) antibody; latex granules have a particle size range of 172-200nm. The kit disclosed by the invention has an upper linear range limit greater than 80mg / L, can cover 90% or more of patients, has good repeatability near a reference value of 2mg / L, and is beneficial to gray area sample judgment; in addition, the kit disclosed by the invention can replace an imported reagent, and the expense of patients can be reduced.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a urine transferrin detection kit with a wide detection range. Background technique [0002] Transferrin (UTRF) is a negatively charged small molecule circulating protein. Under physiological conditions, both transferrin and albumin are difficult to pass through the glomerular filter membrane, but when the kidneys are diseased, transferrin and albumin can Leakage from the glomerulus, so urinary transferrin is a sensitive indicator of glomerular filter damage. The uniqueness of transferrin not only makes it have the characteristics of detecting routine renal function, but also can be more widely used in the detection of earlier and milder renal injury. [0003] The content of transferrin in the urine of normal adults is low, usually <2mg / L, but the content of transferrin in the blood of normal adults is as high as 2200-4000mg / L. When the glomerulus is slightly damaged, the transfe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558
CPCG01N33/558
Inventor 王钊
Owner BYRON DIAGNOSTICS SHANGHAI