Method for the rapid diagnosis of targets in human body fluids using undiluted samples
First Claim
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1. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:
- (a) non-invasively collecting a body fluid sample with a swab member;
(b) directly contacting said swab member with a sample application zone on a lateral flow chromatographic test strip;
wherein the sample is not diluted before contact between the swab member and the sample application zone on the lateral flow chromatographic test strip; and
wherein at least a part of said body fluid sample is released directly into said sample application zone due to said swab member contacting said sample application zone;
wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one binding partner for the target;
(c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone on the lateral flow chromatographic test strip; and
(d) analyzing the sample.
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Abstract
More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.
74 Citations
27 Claims
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1. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:
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(a) non-invasively collecting a body fluid sample with a swab member; (b) directly contacting said swab member with a sample application zone on a lateral flow chromatographic test strip; wherein the sample is not diluted before contact between the swab member and the sample application zone on the lateral flow chromatographic test strip; and wherein at least a part of said body fluid sample is released directly into said sample application zone due to said swab member contacting said sample application zone; wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one binding partner for the target; (c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone on the lateral flow chromatographic test strip; and (d) analyzing the sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:
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a) non-invasively collecting a body fluid sample with a swab member; b) directly contacting said swab member and said sample on said swab member with a sample application zone on a lateral flow chromatographic test strip, wherein dilution of the sample does not occur before direct contact between the swab member and the sample and the sample application zone on the lateral flow chromatographic test strip; c) applying an elution medium to an absorbent pad on said lateral flow chromatographic test strip to transfer said sample to a detection zone on the chromatographic test strip; and d) analyzing the sample; wherein the lateral flow chromatographic test strip further comprises a conjugate zone located at least partially within the sample application zone, wherein said conjugate zone comprises at least one labeled binding partner that is able to migrate with the elution medium wherein, when the analyte is present, the labeled binding partner complexes with the analyte and then migrates to the detection zone. - View Dependent Claims (22, 23, 24)
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25. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:
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a) non-invasively collecting a body fluid sample with a swab member; b) directly contacting said swab member with a sample application zone on a lateral flow chromatographic test strip, wherein at least a part of said body fluid sample is released directly into said sample application zone due to said swab member contacting said sample application zone; and wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one labeled binding partner for the target; and c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone on the lateral flow chromatographic test strip; wherein the sample is not diluted prior to steps b) and c); and d) analyzing the sample.
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26. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:
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a) non-invasively collecting a body fluid sample with a swab member; b) directly contacting said swab member and said sample on said swab member with a sample application zone on a lateral flow chromatographic test strip; and wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one labeled binding partner for the target; c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone; wherein the sample is not diluted prior to steps b) and c); and d) analyzing the sample.
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27. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:
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a) non-invasively collecting a body fluid sample with a swab member; b) directly contacting said swab member and said sample on said swab member with a sample application zone on a lateral flow chromatographic test strip, wherein dilution of the sample does not occur before direct contact between the swab member and the sample and the sample application zone on the lateral flow chromatographic test strip; c) applying an elution medium to an absorbent pad on said lateral flow chromatographic test strip to transfer said sample to a detection zone on the chromatographic test strip; and d) analyzing the sample; wherein the lateral flow chromatographic test strip further comprises a conjugate zone located within the sample application zone, wherein the conjugate zone comprises at least one labeled binding partner that is able to migrate with the elution medium, and wherein, when the analyte is present, the labeled binding partner complexes with the analyte and then migrates to the detection zone.
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Specification