Rapid immunity chromatography detection of mouth cavity fluid

An immunochromatographic detection and fluid technology, applied in measurement devices, biological tests, analytical materials, etc., can solve the problems of inconvenient re-detection and low sensitivity, and achieve low manufacturing process complexity, low complexity, and cost reduction. Effect

Active Publication Date: 2009-07-29
BEIJING MARR BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It should be noted, however, that collection of oral mucosal exudate typically reduces the IgG-rich exudate available on the oral tissue surface up to one hour after the initial collection, which would allow subsequent collections to use "one-stop sample collection." Re-testing is inconvenient with a "device / detection combination" because the test subject has to wait until the exudate level is higher, otherwise the risk may be less sensitive with the sample (R. Mink, unpublished data)

Method used

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  • Rapid immunity chromatography detection of mouth cavity fluid
  • Rapid immunity chromatography detection of mouth cavity fluid
  • Rapid immunity chromatography detection of mouth cavity fluid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Embodiment 1: the production of immunochromatographic detection test strip

[0109] In this embodiment, a test strip for rapid HIV-1 / 2 oral fluid antibody detection is provided, wherein glass fiber material is used as the matrix of the sample pad, polyester material is used as the matrix of the conjugate pad, and nitrocellulose is used The plain film serves as the substrate for the test and control pads.

[0110] A 1 inch piece of S&S S-33 fiberglass material was soaked with blocking buffer consisting of: 40% normal chicken serum (heat inactivated), 0.25M potassium bicarbonate, 0.05M dipotassium hydrogen phosphate, 0.1% Tween 80, 100mM potassium stannate and 0.2% urea hydrogen peroxide, the pH of which is between 8.2 and 8.5, dried in a low humidity room at room temperature (15-30°C) for 8 hours, and then dried in a drying container at 50°C overnight and store dry.

[0111] Conjugate pads were prepared from polyester films by streaking protein A gold conjugate acros...

Embodiment 2

[0115] Example 2: Rapid Immunochromatographic Detection of Oral Fluid

[0116] Provide the rapid immunochromatographic detection of oral fluid using the test strip of the present invention, such as Picture 1-1 to Picture 1-1 5. First, mix the sample buffer (0.15M NaCl buffered at pH 7.2 + / - 0.2 potassium phosphate, 0.1% Triton X-100, 15% heat-inactivated chicken serum, 30 μg / ml Avidin, 0.2% Tween 80, 0.2% Tetronic T-904 and 0.0285% (active ingredient) ProClin 950). Remove the cap from the bottle ( Picture 1-1 ) and fill the dropper with buffer to the mark line ( Figure 1-2 ). Dispense the entire contents of the dropper into the test tube ( figure 1 -3). Then remove one of the clean swabs provided with the pack. Grab the swab handle. Avoid touching the fabric end of the swab. Next, apply moderate pressure and gently swab the fabric end of the swab back and forth across the upper gum line. Start at one corner of the mouth and wipe gently and slowly until reachi...

Embodiment 3

[0118] Embodiment 3: Determine the sensitivity, specificity and accuracy of the kit

[0119] Sensitivity, specificity and accuracy of oral fluid detection were determined in this example. An external validation trial of oral fluid HIV lateral testing at the Thai Red Cross Anonymous HIV Clinic in Bangkok, Thailand, started April 2004 and completed June 2004. Voluntary HIV antibody testing and counseling were conducted among 986 subjects who visited an anonymous HIV clinic of the Thai Red Cross Society and were not currently receiving retroviral treatment. Sequential detection of subjects was used for this study and the results were not known in advance. In addition, 37 subjects known to be positive and receiving antiretroviral therapy (ARV) also received voluntary HIV antibody testing and counseling. Subjects were given the opportunity to voluntarily agree to provide additional samples for testing by these assays.

[0120] The reference method used in the anonymous HIV cli...

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Abstract

The present invention relates to an oral fluid rapid immunochromatography test. More particularly, the present invention relates to an oral fluid collection swab separate from a lateral flow immunochromatography strip for detecting an analyte in oral fluid, consisting essentially of a sample pad, a conjugate pad, a test zone and control zone pad made of at least one matrix material, wherein the conjugate pad lies downstream of the sample pad, and is striped with a conjugate; the test and control zone pad lies downstream of the conjugate pad, wherein the test zone is immobilized with an specific binding reagent that specifically binding to the target analyte; and the control zone, downstream of the test zone, is immobilized with a second capture reagent. The invention also relates to a method for manufacturing the strip, a lateral flow immunochromatography method for detecting an analyte in oral fluid by using the strip, and kits containing the strip.

Description

technical field [0001] The invention relates to rapid immunochromatographic detection of oral fluid. More specifically, the present invention relates to lateral flow immunochromatographic test strips for detecting analytes in oral fluids, methods for collecting oral fluid samples, methods for producing said test strips, detection of analytes in oral fluids by using the test strips A lateral flow immunochromatographic method for an analyte, and a kit containing the test strip. Background technique [0002] Many analytical methods have been developed for the qualitative or quantitative detection of various analytes in biological tissues and fluids. Most current diagnostic tests use blood, urine, stool, biopsy or oral fluids. Collecting oral fluid saliva and / or oral mucosal exudate for detection involves relatively few invasions of privacy compared to other substances, is relatively safe, and can be done relatively easily and quickly. [0003] To date, much effort has been d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/52
CPCG01N33/558G01N33/54388
Inventor 约翰·迈克尔·恩尼斯保罗·罗伯特·史密斯罗纳德·威廉·明克詹姆斯·理查德·乔治托比·德沃拉赫·戈特弗里德格伦·迈克尔·福德
Owner BEIJING MARR BIO PHARMA
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