Test carrier and method for the analytical determination of a component of a body fluid
First Claim
1. Test carrier assembly for the analytical determination of a component of a body fluid, comprising a base layer and at least two planar test layers which, in the initial state of the assembly, before the determination is carried out, are separate from one another but can be contacted by external manipulation, wherein a first test layer and a second test layer are arranged on the base layer essentially next to one another but separated by a gap, and a capillary-active material contact element is movable between two positions, an initial position and a contacting position, with the initial position being located so that the contact element does not contact at least one of the test layers, and the contacting position being such that upon the application of external pressure the contact element assumes the contacting position to bridge the gap and contacts both test layers to permit liquid exchange thereinbetween.
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Accused Products
Abstract
The present invention provides a test carrier (1) for the analytical determination of a component of a body fluid with a base layer (2) and at least two planar test layers which, in the initial state of the test carrier, before carrying out the determination, are separate from one another but can be brought into contact with one another by external manipulation, wherein a first test layer (8) and a second test layer (10) are arranged on the base layer essentially next to one another but separated in the initial state by a gap, a contact element (11, 17, 18, 20) being provided which consists of a capillary-active material which is so dimensioned that it can bridge the gap (12) and which is so mounted and arranged that, in a first position, it cannot contact at least one of the test layers (8, 10) but, by external pressure, it can be brought into a second position in which it contacts both test layers in such a manner that a liquid exchange between the test layers is possible.
68 Citations
21 Claims
- 1. Test carrier assembly for the analytical determination of a component of a body fluid, comprising a base layer and at least two planar test layers which, in the initial state of the assembly, before the determination is carried out, are separate from one another but can be contacted by external manipulation, wherein a first test layer and a second test layer are arranged on the base layer essentially next to one another but separated by a gap, and a capillary-active material contact element is movable between two positions, an initial position and a contacting position, with the initial position being located so that the contact element does not contact at least one of the test layers, and the contacting position being such that upon the application of external pressure the contact element assumes the contacting position to bridge the gap and contacts both test layers to permit liquid exchange thereinbetween.
- 10. Test carrier assembly for the analytical determination of a component of a body fluid, comprising a base layer, at least two test layer means for performing steps of the analytical determination on the body fluid, with at least one of said test layer means performing a step which leads to a detectable signal which can be evaluated for the analytical determination of said component, wherein a first test layer means and a second layer means are located on the base layer proximate each other but separated by a gap, and contact element means located initially so that the contact element means does not contact at leas one of the first and second test layer means, and movable from the initial location to a second location by the application of external pressure to bridge the gap and to contact both of the first and second test layer means, said contact element means for transferring liquid by capillary action from one of the first and second test layer means to the other when in the second location.
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21. A method for the analytical determination of a component of a body fluid, said method comprising forming in a first test layer of a test carrier an unbound complex of said component and a first agent complexable therewith which is present in excess in the first test layer by applying a predetermined amount of said body fluid to the first test layer and maintaining the component and the first agent under complexing conditions for a predetermined time,
thereafter applying external pressure to a capillary-active contact element to cause the first test layer and a second test layer to both be contacted by the contact element to cause liquid exchange between the first and second test layers, and binding excess first agent to said second test layer by complexing said first agent with a second agent which is complexable therewith and is bound to said second test layer, and thereafter, after a predetermined time, producing a detectable signal which can be evaluated for the analytical determination of the component by causing a reaction between the unbound complex and a reactant to produce said detectable signal by contacting the second test layer with a third test layer which contains said reactant to cause liquid exchange from the second test layer to the third test layer, and thereafter evaluating the detectable signal to determine said component.
Specification