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High-specificity procalcitonin latex turbidimetric detection kit adopting transmission-scattering integrated method

A detection kit, procalcitonin technology, applied in biological tests, measuring devices, material inspection products, etc., can solve the problems of false negatives, inconsistent test results, serious problems, etc., to meet clinical needs, test speed, and pass the test. large amount of effect

Pending Publication Date: 2022-04-08
BYRON DIAGNOSTICS SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The premise that the latex turbidimetric reagent can use the transmission-scattering integrated method: 1. For the same sample, in the transmission-scattering overlapping area (fusion area), the transmission and scattering detection results are consistent, that is, the deviation is less than 10%; 2. Due to the microspheres, the reagent formula And many other problems, not all latex turbidimetric reagents can obtain sensitivity improvement on the Hitachi transmission and scattering all-in-one machine, and reagents with unsuitable formulas may even experience a decrease in sensitivity resulting in a decrease in measurement repeatability (precision); 3. Scattering The detection of HOOK effect is more serious than that of transmission. Reagents that cannot solve the problem of HOOK effect in transmission, using the integrated method of transmission and scattering will lead to more underestimated and false negative results
[0007] For traditional turbidimetric reagents, such as PCT products from Japan JSR Company, domestic Meikang Bio, Jiuqiang Bio, etc., the sensitivity can only reach 0.5ng / ml, and the repeatability CV is less than 10%.
Moreover, for these products, there will be inconsistencies between the transmission results and the scattering results on the transmission and scattering all-in-one machine, so that the clinical needs cannot be met.
In addition, the traditional latex turbidity reagent developed based on the transmission method will have many new problems when directly applied to the integrated transmission and scattering method.
Especially in terms of sensitizer type and concentration selection, surfactant selection, raw materials or formulas that have no problem in transmission will have problems in scattering, resulting in non-specific signal values, resulting in inconsistent transmission and scattering results, and wrong results output by the instrument
For PCT detection, especially the clinically meaningful interval of 0-2ng / ml, it will lead to inconsistencies between the detection results and the Roche chemiluminescence method

Method used

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  • High-specificity procalcitonin latex turbidimetric detection kit adopting transmission-scattering integrated method
  • High-specificity procalcitonin latex turbidimetric detection kit adopting transmission-scattering integrated method
  • High-specificity procalcitonin latex turbidimetric detection kit adopting transmission-scattering integrated method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] The first reagent R1 contains components at the following concentrations:

[0099] 100mM Hepes-NaOH buffer, pH7.3

[0100] NaCl 2400mM

[0101] Polyethylene glycol 12000 3g / L

[0102] Tween-20 16ml / L

[0103] Classic adjuvant 15ml / L (sigma company)

[0104] Rabbit polyclonal antibody blocking agent 40ml / L (Scantibody HBR 26)

[0105] Preservative 0.5ml / L PC300

[0106] The corresponding R2 contains the following concentrations of components:

[0107] 50mM PBS pH7.6

[0108] Tween-20 16ml / L

[0109] 480nm carboxyl latex 2.4g / L

[0110] 350nm carboxyl latex 2.0g / L

[0111] 300nm carboxyl latex 2.0g / L

[0112] Protective agent (sucrose 30g / L, trehalose 10g / L, fructose 10g / L)

[0113] PCT rabbit polyclonal antibody 30ml / L (Chengdu Huirui Xinyuan Biology)

[0114] Preservative 0.5ml / L PC300

[0115] Among them, the carboxyl latex is subjected to secondary convergent polymerization according to 2017109869707 "A Method for Improving Antigen Excess and Linear Ran...

Embodiment 2

[0133] The first reagent R1 contains components at the following concentrations:

[0134] 100mM Hepes-NaOH buffer, pH6.7

[0135] NaCl 600mM

[0136] Polyethylene glycol 12000 3g / L

[0137] Tween-20 16ml / L

[0138] Classic adjuvant 10ml / L (sigma company)

[0139] Goat polyclonal antibody blocking agent 20ml / L (Fei Peng Bio E-014)

[0140] Preservative 0.5ml / L PC300

[0141] The corresponding R2 contains the following concentrations of components:

[0142] 200mM BES-NaOH pH7.0

[0143] Tween-20 10ml / L

[0144] 480nm carboxyl latex 1.6g / L

[0145] 350nm carboxyl latex 1.2g / L

[0146] 300nm carboxyl latex 1.2g / L

[0147] Protective agent (sucrose 20g / L, trehalose 20g / L, fructose 20g / L)

[0148] PCT sheep polyclonal antibody 60mg / L (Hytest company)

[0149] Preservative 0.5ml / L PC300

[0150]Among them, the carboxyl latex latex is subjected to secondary convergent polymerization according to 2017109869707 "A Method for Improving the Antigen Excess and Linear Range o...

Embodiment 3

[0194] The first reagent R1 contains components at the following concentrations:

[0195] 100mM Hepes-NaOH buffer, pH7.0

[0196] NaCl 1500mM

[0197] Polyethylene glycol 12000 3g / L

[0198] Tween-20 16ml / L

[0199] Classic adjuvant 13ml / L (sigma company)

[0200]Rabbit polyclonal antibody blocking agent 30ml / L (Scantibody HBR26)

[0201] 1g / L sodium azide

[0202] The corresponding R2 contains the following concentrations of components:

[0203] 100mM Glycine-Tris pH7.3

[0204] Tween-20 4ml / L

[0205] 480nm carboxyl latex 2.0g / L

[0206] 350nm carboxyl latex 1.6g / L

[0207] 300nm carboxyl latex 1.6g / L

[0208] Protective agent (sucrose 10g / L, trehalose 30g / L, fructose 30g / L)

[0209] PCT rabbit polyclonal antibody 20mg / L (Chengdu Huirui Xinyuan Biology)

[0210] 1g / L sodium azide

[0211] Among them, the carboxyl latex latex is subjected to secondary convergent polymerization according to 2017109869707 "A Method for Improving the Antigen Excess and Linear Rang...

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Abstract

The invention discloses a high-specificity procalcitonin latex turbidimetric detection kit adopting a transmission-scattering integrated method, and belongs to the technical field of biological detection. The invention discloses a high-specificity procalcitonin latex turbidimetric detection kit adopting a transmission-scattering integrated method. The kit comprises a first reagent R1 and a second reagent R2, the R1 is prepared from a Hepes-NaOH buffer solution, NaCl, polyethylene glycol 12000, Tween-20, a Titer classical water-soluble adjuvant and a polyclonal antibody blocking agent; r2 comprises a buffer solution, Tween-20, carboxyl latex of 480 nm, carboxyl latex of 350 nm, carboxyl latex of 300 nm, a protective agent and a PCT polyclonal antibody. According to the invention, the linear range of the PCT detection range of 0.05-20ng / ml can be realized; the repeatability CVlt is 0.1 ng / ml; 10%; a correlation coefficient gt of a clinical sample and Rogowski; and 0.95%.

Description

technical field [0001] The invention relates to the technical field of biological detection, in particular to a high-specificity transmission-scattering integrated procalcitonin latex turbidimetric detection kit. Background technique [0002] Procalcitonin (PCT) detection is an important indicator for judging the severity of infection, distinguishing between viral and bacterial infections, and regulating the use of antibiotics. When 0.1ng / ml, the possibility of bacterial infection is ruled out, and antibiotics are not recommended; when 0.25-0.5ng / ml, bacterial infection may exist, and antibiotics can be used; when ≥0.5ng / ml, bacterial infection exists, and antibiotics are strongly required; see BRAHMSPCT standard, the relationship between sepsis and PCT: 0.5-2.0ng / ml, there may be a risk of sepsis and shock; PCT>2ng / mL indicates a high risk of severe sepsis and / or septic shock. It can be clearly seen that the PCT detection kit used as a clinical diagnosis must at least b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/74G01N33/539G01N21/82
Inventor 庞傅王钊
Owner BYRON DIAGNOSTICS SHANGHAI
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