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Test strip for semi-quantitative detection of microalbuminuria

A technology for urine microalbumin and semi-quantitative detection, which is applied in biological testing, material testing, etc., to achieve the effects of simple operation, convenient use and wide detection range

Inactive Publication Date: 2012-10-03
蓝十字生物药业(北京)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] At present, the combination of immunocompetitive inhibition method and colloidal gold detection technology for semi-quantitative detection of human urinary microalbumin, and colloidal gold test strips with the characteristics of high efficiency, sensitivity, specificity, convenience, and wide detection range are rarely reported.

Method used

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  • Test strip for semi-quantitative detection of microalbuminuria
  • Test strip for semi-quantitative detection of microalbuminuria
  • Test strip for semi-quantitative detection of microalbuminuria

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0060] Experimental example 1. the preparation method of test strip of the present invention

[0061] Biologically active raw materials: anti-human albumin monoclonal antibody, rabbit IgG, anti-rabbit IgG polyclonal antibody and human albumin are all imported from Canada Artron BioResearch Inc.

[0062] Reagents: bovine serum albumin (BSA) and casein were purchased from Sigma.

[0063] Nitrocellulose membrane: Sartorius, Germany

[0064] The test strip preparation procedure is as follows

[0065] Step 1. Prepare coating solution

[0066] Dilute anti-rabbit IgG polyclonal antibody and human albumin with 20mM PBS, prepare anti-rabbit IgG polyclonal antibody to 2mg / ml, and human albumin to 0.3mg / ml, respectively for the C and T lines on the nitrocellulose membrane Covered.

[0067] Step 2. Coating of reagents

[0068] Anti-rabbit IgG polyclonal antibody and human albumin coated on nitrocellulose membrane:

[0069] Coat human albumin and anti-rabbit IgG polyclonal antibody o...

Embodiment 2

[0088] Embodiment 2. Using method and methodological comparative experiment

[0089] How to use this product:

[0090] Take the urine to be tested and drop it on the sample fiber pad of the horizontal test strip, or immerse the part of the mucus end of the test strip below the MAX line in the urine for about 5 seconds, take it out and place it horizontally, and interpret the result within 5 minutes.

[0091] Comparison 1: Product Comparison

[0092] The product of Example 1 of the present invention is fast, accurate, specific, and convenient compared with the prior art products for detecting urine microalbumin, and there is no need for necessary instrument cleaning and maintenance before and after detecting urine microalbumin work, and does not require professionals in the field to operate.

[0093] Control product: Roche Diagnostic Products (Shanghai) Co., Ltd. Microalbumin Assay Kit (Immunoturbidimetric Method) State Food and Drug Administration (Jin) Zi 2011 No. 2402465 ...

Embodiment 3

[0106] Compared with the invention patent with the application number of 200810305085.9 in Example 1 of the present invention, a semi-quantitative detection of urine microalbumin colloidal selenium test paper can not only be judged whether it is a normal level, but also can determine the concentration exceeding the normal level. Wide range.

[0107] The comparative data are shown in Table 3:

[0108]

[0109]

[0110] Result analysis: the colloidal gold test paper can semi-quantitatively detect the specific values ​​of 20mg / L, 50mg / L, 100mg / L, and >100mg / L, while the colloidal selenium test paper can only judge whether it is a normal level (<20mg / L) , or an abnormal level (≥20mg / L), it should actually be listed as a qualitative product, and it cannot be called a semi-quantitative test strip.

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Abstract

The invention discloses a test strip for semi-quantitative detection of microalbuminuria, belonging to medical test consumables. The test strip is characterized in that the test strip for semi-quantitative detection of microalbuminuria is a colloidal gold test strip. An anti-human albumin antibody and rabbit IgG with acolloidal gold label is enveloped on a gold label fiber pad; anti-rabbit IgG antibody is enveloped on a quality control line C, and human albumin is enveloped on a detection line T. The test strip is simple, sensitive and accurate, can be used for semi-quantitative detection of microalbuminuria in human urine and suitable for detection of early renal injury patients.

Description

[0001] technology field, [0002] The invention belongs to the field of biological detection and relates to a medical detection consumable, in particular to a test strip for semi-quantitative detection of urinary microalbumin. Background technique [0003] Urinary microalbuminuria (Microalbuminuria, MAU) refers to the albumin content in urine exceeds the reference range of healthy people, but this small change cannot be detected by conventional methods. Urinary microalbuminuria is the presence of tiny amounts of albumin in the urine. Albumin is a normal protein in the blood, but only very small amounts are present in the urine under physiological conditions. Microalbuminuria reflects abnormal protein leakage from the kidneys. Microalbuminuria is a sign of early kidney damage in diabetic nephropathy, hypertensive nephropathy, etc. Urinary microalbumin caused by any disease is due to the damage of the intrinsic cells of the kidney due to different initial causes, which change...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
Inventor 聂丽芳孙茜
Owner 蓝十字生物药业(北京)有限公司
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