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Method for detecting whether liquid adding amount of immunoturbidimetric reagent is abnormal or not

An immunoturbidimetric and detection method technology, applied in the field of biochemical detection, which can solve the problems of reporting wrong test results, abnormal amount of added reagents, misdiagnosis, etc.

Pending Publication Date: 2022-06-24
SINOCARE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the process of fully automatic, semi-automatic and manual testing, due to the occasional failure of the sampling module of the automated instrument, human error, or the existence of bubbles / high viscosity in the reagent, the amount of added reagent will be abnormal (lower or higher than the target amount), which will lead to Reporting erroneous test results can lead to clinical misdiagnosis, which can ultimately have serious consequences for patients
[0005] However, at present, there is no systematic solution for the latex immunoturbidimetric detection methodology and the method for judging the abnormal amount of added reagents.

Method used

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  • Method for detecting whether liquid adding amount of immunoturbidimetric reagent is abnormal or not
  • Method for detecting whether liquid adding amount of immunoturbidimetric reagent is abnormal or not
  • Method for detecting whether liquid adding amount of immunoturbidimetric reagent is abnormal or not

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 measurement results:

[0050] ①The target item to be tested: β2 microglobulin;

[0051] ②Experimental material: The sample to be tested is a fresh human urine sample;

[0052] ③Reagent1: 4-hydroxyethylpiperazine ethanesulfonic acid buffer 50mM~500mM, Reagent 1 is prefilled in the colorimetric chamber;

[0053] ④Reagent2: 4-hydroxyethylpiperazine ethanesulfonic acid buffer 50mM~500mM; β2 microglobulin antibody coating latex 0.1%~0.5%; trehalose 1%~10%;

[0054] ⑤ Absorbance judgment threshold: 0.558~0.682;

[0055] ⑥Testing process: Pre-fill 240μl of Reagent 1 in the reaction chamber, transfer 60μl of Reagent 2 to the aforementioned reaction chamber with the reagent / sample needle during the test, mix well and read the absorbance A0. Compare A0 with the set threshold range of the project, if it is higher than 0.682, it indicates that Reagent2 is over-added, and if it is lower than 0.558, it indicates that Reagent 2 is under-added. Reagent / sample needle Trans...

Embodiment 2

[0059] ① Target items to be tested: C-reactive protein;

[0060] ②Experimental materials: The samples to be tested are fresh human serum samples;

[0061] ③Reagent1: 4-Hydroxyethylpiperazine ethanesulfonic acid buffer 50mM~500mM, NaCl 150Mm~500mM; Reagent 1 is prefilled in the colorimetric chamber;

[0062] ④Reagent2: 4-hydroxyethylpiperazine ethanesulfonic acid buffer 50mM~500mM; C-reactive protein antibody coating latex 0.1%~0.5%; sucrose 1%~10%;

[0063] ⑤ Absorbance judgment threshold: 0.836~0.924;

[0064] ⑥Testing process: Pre-fill 150μl Reagent 1 in the reaction chamber, transfer 150μl Reagent 2 to the aforementioned reaction chamber with the reagent / sample needle during the test, mix well and read the absorbance A0. Compare A0 with the set threshold range of the project, if it is higher than 0.924, it indicates that Reagent 2 is over-added, and if it is lower than 0.836, it indicates that Reagent 2 is under-added. Reagent / sample needle Transfer 3 μl of the serum sam...

Embodiment 3

[0068] ①The target item to be tested: myoglobin;

[0069] ②Experimental materials: The samples to be tested are fresh human serum samples;

[0070] ③Reagent1: 4-hydroxyethylpiperazine ethanesulfonic acid buffer 50mM~500mM, NaCl150Mm~500mM, polyethylene glycol 6000 1.0%~5.0%; Reagent 1 is prefilled in the colorimetric chamber;

[0071] ④Reagent2: 4-hydroxyethylpiperazine ethanesulfonic acid buffer 50mM~500mM; myoglobin antibody coating latex 0.1%~0.5%; sucrose 1%~10%;

[0072] ⑤ Absorbance judgment threshold: 0.931~1.029;

[0073] ⑥ Detection process: Pre-fill 180 μl of Reagent 1 in the reaction chamber, transfer 60 μl of Reagent 2 to the aforementioned reaction chamber with the reagent / sample needle during the test, mix well and read the absorbance A0. Compare A0 with the set threshold range of the project, if it is higher than 1.029, it indicates that Reagent 2 is over-added, and if it is lower than 0.931, it indicates that Reagent 2 is under-added. Reagent / sample needle T...

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Abstract

The invention relates to the technical field of biochemical detection, in particular to a method for detecting whether the liquid adding amount of an immunoturbidimetric reagent is abnormal or not. According to the method for detecting whether the liquid adding amount of the immunoturbidimetric reagent is abnormal or not, the absorbance A0 is detected before a sample is added, the absorbance A0 is compared with a standard value measured under the standard sample adding amount, and whether the sample adding amount is normal or not is judged. Experiments show that the method provided by the invention is accurate and reliable, and can effectively reduce the risk of misinformation of results during detection.

Description

technical field [0001] The invention relates to the technical field of biochemical detection, in particular to a method for detecting whether the addition amount of an immunoturbidimetric reagent is abnormal. Background technique [0002] In vitro diagnostics involving blood tests are usually performed using latex immunoturbidimetry. Typically, detection reagents typically include R1 reagents and R2 reagents. Wherein, the R1 reagent (also referred to as Reagent 1) contains the buffer required to realize the reaction of the target detection reagent to be detected. The R2 reagent (also referred to as Reagent 2) contains the main components of the target concentration determination reagent to be tested and the necessary reaction components of the target detection reagent to be tested. The main component of the reagent for determining the concentration of the target to be detected is latex particles coated with the antibody or antigen of the target to be detected. [0003] Ac...

Claims

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Application Information

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IPC IPC(8): G01N21/31G01N21/82G01N33/543
CPCG01N21/31G01N21/82G01N33/54313
Inventor 罗继全汪长海李宗祥周倩戴斌
Owner SINOCARE
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