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High-accuracy detection kit for NGAL in urine

A detection kit and accuracy technology, which is applied in the field of high-accuracy urine NGAL detection kits, can solve the problems of low correlation coefficient and achieve the effect of avoiding interference and improving accuracy

Active Publication Date: 2020-09-04
BYRON DIAGNOSTICS SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the correlation coefficient is still low, and usually the correlation coefficient must be above 0.95 to be called a good correlation; moreover, there is still a deviation of about 40% between the absolute values ​​of J&W reagents and Bioporto

Method used

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  • High-accuracy detection kit for NGAL in urine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] 1. Accuracy analysis of existing kits

[0053] Use J&W and Bioporto latex turbidimetric reagent described in CN201711132885.0 to detect 26 urine clinical samples respectively, the results are shown in Table 1 and figure 1 As shown, the correlation coefficient R 2 It is 0.937, which is close to the result recorded in CN201711132885.0.

[0054] However, for some samples with NGAL above 200ng / mL, the J&W reagent will be lower than the Bioporto reagent of the latex turbidimetric method (more than 15% lower), and the higher the concentration, the lower the concentration. Many, the low level of samples above 1000ng / mL is even more serious (lower than 25%); the deviation of reagents from other domestic manufacturers even exceeds 40%; therefore, the problem of detection accuracy seriously limits the clinical application of domestic reagents.

[0055] Table 1

[0056]

[0057] 2. Analysis of factors affecting the accuracy of urine NGAL detection

[0058] According to the ...

Embodiment 2

[0110] Control group 1:

[0111] Reagent 1: pH6.8 100mM Hepes-NaOH background buffer solution, sodium chloride 23.38g / L, Tween-20 5mL / L, proclin-300 preservative 0.35mL / L, polyethylene glycol 6000 5g / L, Scantibody HBR-26 blocking agent 2.5mL / L.

[0112] Reagent 2: 50mM pH7.6 Taps-NaOH background buffer, Polymicroshperes 270nm carboxyl latex 3g / L, Dako NGAL rabbit polyclonal antibody (product number OA995, concentration 5mg / mL) 5mL / L, Tween-20 6mL / L, proclin-300 preservative 0.35mL / L, Bovstar IgG free grade bovine serum albumin 1g / L.

[0113] Reagent 2 was coupled by the conventional chemical coupling method described in Example 1 without sensitization treatment.

[0114] Experimental group 1 (add human IgG and human albumin):

[0115] Reagent 1: pH6.8 100mM Hepes-NaOH background buffer solution, sodium chloride 23.38g / L, Tween-20 5mL / L, proclin-300 preservative 0.35mL / L, polyethylene glycol 6000 5g / L, Scantibody HBR-26 blocking agent 2.5mL / L, human IgG 66.7mg / L (human immu...

Embodiment 3

[0143] Control group 2:

[0144] Reagent 1: pH7.5 100mM Hepes-NaOH background buffer solution; sodium chloride 116.88 / L, Tween-20 20mL / L, proclin-300 preservative 0.35mL / L, polyethylene glycol 6000 15g / L, Scantibody HBR -26 blocking agent 2.5mL / L.

[0145] Reagent 2: 50mM pH8.2 Taps-NaOH background buffer, Polymicroshperes 270nm carboxyl latex 3g / L, Dako NGAL rabbit polyclonal antibody (product number OA995, concentration 5mg / mL) 5mL / L, Tween-20 6mL / L, proclin-300 preservative 0.35mL / L, Bovstar IgG free grade bovine serum albumin 1g / L.

[0146] Reagent 2 was coupled by the conventional chemical coupling method described in Example 1 without sensitization treatment.

[0147] Experimental group 3 (addition of human IgG and human albumin):

[0148] Reagent 1: pH7.5 100mM Hepes-NaOH background buffer solution; sodium chloride 116.88 / L, Tween-20 20mL / L, proclin-300 preservative 0.35mL / L, polyethylene glycol 600015g / L, Scantibody HBR- 26 blocking agent 2.5mL / L, human IgG 66.7mg / ...

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Abstract

The invention discloses a high-accuracy detection kit for NGAL in urine, and belongs to the technical field of NGAL detection. The kit comprises a reagent 1 and a reagent 2, the reagent 1 is a reaction buffer solution, the reagent 2 is an NGAL antibody sensitized latex solution, and a mixture of the reagent 1 and the reagent 2 contains human albumin and human IgG. By adding the human albumin and the human IgG, the interference of the human albumin and the human IgG with different concentrations in a urine sample on an NGAL detection result can be avoided so that the detection accuracy of the NGAL in the urine is improved; in addition, in combination with sensitization treatment of the reagent 2, high detection sensitivity can be ensured while the accuracy is improved.

Description

technical field [0001] The invention relates to the technical field of NGAL detection, in particular to a high-accuracy detection kit for NGAL in urine. Background technique [0002] Neutrophil gelatinase-associated lipocalin (NGAL) is one of the most ideal markers of acute kidney injury AKI; Danish company Bioporto has discovered and produced reagents for Elisa and latex immunoturbidimetric assays to detect NGAL, and currently the world Most of the NGAL research in the world is based on the reagents of Bioporto. Bioporto authorized Abbott Abott to use its raw materials to develop NGAL detection reagents by chemiluminescence method, and obtained the registration certificate from NMPA in China. [0003] The determination of NGAL in urine has become the main method of NGAL determination due to its non-invasiveness; at present, there are a large number of NGAL detection kits and related patents in China, which claim that they can solve the problems of sensitivity, linear range...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/58
CPCG01N33/6893G01N33/585G01N2800/347G01N2333/47Y02A50/30
Inventor 王钊庞傅
Owner BYRON DIAGNOSTICS SHANGHAI
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