MOLECULAR DIAGNOSTICS AMPLIFICATION SYSTEM AND METHODS
First Claim
1. A single-use nucleic acid amplification device for producing an amplicon, comprising:
- a housing; and
an amplification chamber, comprising;
an ingress with a first reversible seal;
an egress with a second reversible seal;
a sealable sample entry orifice; and
a first wall forming a portion of the amplification chamber,wherein the first wall comprises a thermally conductive material and includes a first surface and an second surface,wherein the second surface includes a heating circuit and a temperature sensor,wherein the sample entry orifice permits a sample of nucleic acid to enter the amplification chamber,wherein the ingress is connected to a first conduit along with a pump and a reservoir, andwherein the egress is connected to a second conduit permitting egress of the amplicon from the amplification chamber.
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Accused Products
Abstract
The present invention relates to automated devices and methods for the amplification of segments of nucleic acid in a convenient and portable manner. A single-use nucleic acid amplification device for producing an amplicon includes a housing and an amplification chamber. The chamber includes an ingress with a first reversible seal, an egress with a second reversible seal, a sealable sample entry orifice, and a first wall forming a portion of the chamber. The first wall includes a thermally conductive material and includes an interior surface and an exterior surface. The exterior surface includes a heating circuit and a temperature sensor. The sample entry orifice permits a sample of nucleic acid to enter the amplification chamber. The ingress is connected to a first conduit along with a pneumatic pump and a fluid pouch. The egress is connected to a second conduit permitting egress of the amplicon from the amplification chamber.
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Citations
39 Claims
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1. A single-use nucleic acid amplification device for producing an amplicon, comprising:
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a housing; and an amplification chamber, comprising; an ingress with a first reversible seal; an egress with a second reversible seal; a sealable sample entry orifice; and a first wall forming a portion of the amplification chamber, wherein the first wall comprises a thermally conductive material and includes a first surface and an second surface, wherein the second surface includes a heating circuit and a temperature sensor, wherein the sample entry orifice permits a sample of nucleic acid to enter the amplification chamber, wherein the ingress is connected to a first conduit along with a pump and a reservoir, and wherein the egress is connected to a second conduit permitting egress of the amplicon from the amplification chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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38. A method of nucleic acid amplification for producing an amplicon in a single-use device, comprising the steps of:
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a.) introducing a nucleic acid sample into an amplification chamber through a sample entry orifice; b.) sealing the orifice; c.) transferring a fluid from a reservoir through a reversibly sealable ingress to the amplification chamber; d.) sealing the ingress and an egress of the amplification chamber; e.) mixing the fluid with the sample to form a mixture comprising nucleic acid, a buffer, a polymerase and one or more primers; f.) cycling the temperature of the amplification chamber between first and second temperatures for a predetermined time and for a predetermined number of cycles to form an amplicon; g.) opening the ingress and egress of the chamber; and h.) applying a pneumatic force to the ingress to move the amplicon from the chamber through the egress.
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39. A method of nucleic acid amplification for producing an amplicon in a single-use device, comprising the steps of:
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a.) introducing a nucleic acid sample into an amplification chamber through a sample entry orifice; b.) sealing the orifice; c.) transferring a fluid from a reservoir through a reversibly sealable ingress to the amplification chamber; d.) sealing the ingress and an egress of the chamber; e.) mixing the fluid with the sample to form a mixture comprising nucleic acid, a buffer, a polymerase and one or more primers; f.) increasing the temperature of the chamber to an isothermal amplification temperature for a predetermined time to form an amplicon; g.) opening the ingress and the egress of the amplification chamber; and h.) applying a pneumatic force to the ingress to move the amplicon from the chamber through the egress.
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Specification