Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Patent
1997-10-03
2000-11-14
Housel, James C.
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
422 56, 422 57, 422 61, 422 69, 422100, 422103, 422 70, 422 73, 436169, 436170, 436525, 436805, 436806, G01N 2100
Patent
active
061465895
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to an analytical device, specifically an integrated one step amplified assay system which is particularly useful for sensitive rapid test diagnostic devices; as well as to assay methods and to kits for use in assays.
One step rapid test systems are being increasingly used in a very wide range of applications, for example in clinical immunoassays such as those used in testing for pregnancy, sexually transmitted diseases, food testing, bacteriological infections, allergen detection, veterinary testing, environmental control, toxins, biological agents, etc. In many other cases, however, the signals from current rapid tests are not sensitive enough to provide a qualitative or quantitative result, especially when the concentration of the substance to be detected is already extremely low in the sample, as for example in detection of HIV antibodies in saliva or blood, other viral infections or low levels of bacteria in urine or faeces which indicate the onset of a particular disease.
Preferably a one-step assay uses a simple, inexpensive, disposable device that requires little or no skill to operate. The application of sample to the device is carried out as a single step, and preferably no subsequent washes or fluid changes are required. The result is presented as a visible signal which is easily read and requires no instrumentation in order to do so.
Such rapid test devices generally include particles such as coloured latex, carbon or gold, and it is these particles which are responsible for generating the final signal. A well known example of such devices are pregnancy testing kits where levels of the hormone .beta.HCG in urine are tested. In these devices, gold or latex conjugated to antibodies for .beta.HCG is responsible for generating a visible signal.
Examples of known devices of this type are shown in EP-B-176799 and EP-B-291194.
In order to generate directly a visible signal, it is important that the particles responsible for generating the signal are of a certain size. In the case of gold particles, these should exceed 10 nm, and are preferably greater than 40 nm in size in order to ensure that a clear visible signal is produced. However, there are limits to the sensitivity of these rapid one step tests which restricts their usefulness.
There is a requirement for rapid diagnostic tests which are ever more sensitive in order to detect analytes which are in very low quantities. Non-invasive sampling is frequently preferred although the concentrations of analytes in saliva are typically one hundred times lower than those found in blood.
The present invention provides a rapid detection device which is highly sensitive.
According to the present invention there is provided an assay device for detecting the presence of an analyte in a sample, wherein a visible signal indicative of the presence or absence of said analyte is produced at a detection site on a support, characterised in that The device is a strip device having a single channel said signal is generated or enhanced by means of a signal enhancement reaction between a first binding reagent which is labelled and a label developing means, which first binding reagent and label developing means are arranged to be delivered to the detection site in a single assay step but in a sequential manner such that the first binding reagent arrives at the detection site ahead of the label developing means.
In particular, the invention provides an assay device comprising through the porous element under the influence of a liquid into a detection zone, and comprises an invisible label; in a manner which is complementary to that of the first binding reagent or which competes with said analyte for binding to said first binding reagent and is immobilised within said detection site, and into said detection site after said first binding reagent, said label developing means being able to render the invisible label visible. The assay device just-described is a strip device having a single channel and the first binding reagent and the labelled deve
REFERENCES:
patent: 5198193 (1993-03-01), Bunce et al.
British Biocell International Limited
Housel James C.
Russert Jennifer L.
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