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Hybrid blocking agent of eliminating endogenous interference of in vitro diagnostic reagent and application thereof

A technology for blocking reagents and in vitro diagnosis, applied in the biological field, to achieve the effect of optimizing the detection system, improving the accuracy, and reducing the dose

Active Publication Date: 2019-05-31
武汉原谷生物科技有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been found through research that not all immune interference can be removed

Method used

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  • Hybrid blocking agent of eliminating endogenous interference of in vitro diagnostic reagent and application thereof
  • Hybrid blocking agent of eliminating endogenous interference of in vitro diagnostic reagent and application thereof
  • Hybrid blocking agent of eliminating endogenous interference of in vitro diagnostic reagent and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] A blocking reagent for an immune detection system, the blocking agent component includes two components of an active blocking agent and a passive blocking agent, the two are mixed and stored in a box for future use, wherein the active blocking agent The content of each component in the passive blocker is as follows:

[0039] Table 1

[0040]

[0041] As shown in the table above, the proportion of various passive blocker components to active blocker components in the mixed blocker is shown. Among them, the blocking agents of various formulations can be used alone or in combination. The scope of use of the active blocker and passive blocker of the present invention should be determined through gradient experiments. The concentration for the first use starts from a higher concentration, and after the effect is confirmed, it is gradually diluted to a lower concentration.

[0042] Take six verified endogenous interference sera and one healthy non-interference sample as ...

Embodiment 2

[0052] Selected five verified endogenous interfering sera and two non-interfering samples as research objects, and tested blocker formula 1, formula 2, formula 3, and formula 6 in the HBeAg project (double antibody sandwich method, chemiluminescence) , The blocking effect of formula 7, each blocking agent is used at a concentration of 100ug / ml, added to the marker liquid for use, and the samples are tested, the results are as follows:

[0053] Table 4 Comparison of blocking effects of different formulation blockers on the HBeAg project (chemiluminescence)

[0054]

[0055] As shown in the above table, the blocking effects of the above five blockers were evaluated on the HBeAg project in the chemiluminescent system, among which, for the five serum samples with endogenous interference, the blocker can effectively reduce the endogenous interference, The measurement result is close to the actual value. For the two serum samples without interference, the results showed that the...

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Abstract

The present invention relates to the field of biotechnology, and more particularly to a hybrid blocking agent of eliminating endogenous interference of an in vitro diagnostic reagent. The hybrid blocking agent comprises an active blocking agent and a passive blocking agent. The active blocking agent comprises the following components: 10-50 mmol / L of a first buffer solution, 150-500 mmol / L of NaCl, and 3-6 mg / ml of a monoclonal antibody or a polyclonal antibody. The passive blocking agent comprises the following components: 10-50 mmol / L of a second buffer solution 150-500 mmol / l of NaCl and 4-9 mg / mL of immune globulin. When hybrid blocking agent is used, the active blocking agent and the passive blocking agent are mixed in a certain ratio, are sterilely filtered and then directly added into a detection system so as to eliminate false results caused by various endogenous interferences without influence on a normal reaction curve; and moreover, when the active blocking agent and the passive blocking agent are added, a small amount of dose is only required, and therefore, the hybrid blocking agent of eliminating endogenous interference of the in vitro diagnostic reagent is efficientand convenient.

Description

technical field [0001] The invention relates to the field of biotechnology, more specifically, to a mixed blocking reagent for eliminating endogenous interference of in vitro diagnostic reagents and its application. Background technique [0002] With the continuous development of science and technology, immunological detection methods have been widely used in in vitro diagnostic reagents. However, any immunoassay method may be interfered with false positive or false negative results. Endogenous interference is often caused by the cross-reaction of antibodies used in the reagent with endogenous substances in patient samples. Such interference Collectively referred to as endogenous interference. The most susceptible to interference are immunoturbidimetry based on double antibody sandwich method, competitive inhibition method, lateral flow chromatography, chemiluminescence and enzyme-linked immunosorbent method, etc. In addition, IgM detection reagents will also be interfered ...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/577G01N33/573G01N33/558G01N33/531
Inventor 熊雨胜张薇周欢丁章成江月闫虎山
Owner 武汉原谷生物科技有限责任公司