METHOD AND DEVICE FOR DETECTING THE PRESENCE OF A SINGLE TARGET NUCLEIC ACID IN A SAMPLE

1 . A microfluidic device comprising:

a first sample chamber; and

a first sample portion, said first sample portion being positioned in said first sample chamber, whereby if said first sample portion contains at least a single molecule of a target nucleic acid, said first sample portion would attain a detectable concentration of said target nucleic acid within a portion of said first sample chamber after a single round of amplification.

2 . A microfluidic device as recited in claim 1 , wherein if said first sample portion contains at least a single molecule of said target nucleic acid, said first sample portion would attain a detectable concentration of said target nucleic acid within a portion of said first sample chamber after a single amplification step.

3 . A microfluidic device as recited in claim 1 , wherein said first sample chamber further comprises constituents for enabling amplification of a target nucleic acid.

4 . A microfluidic device as recited in claim 1 , wherein said single round of amplification comprises at least one thermocycle step.

5 . A microfluidic device as recited in claim 1 , wherein said single round of amplification comprises at least one homogeneous amplification step.

6 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume of about 1 picoliter or less.

7 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume in the range of from about 1 picoliter to about 1 microliter.

8 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume of about 10 picoliters or less.

9 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume of about 100 picoliters.

10 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume of about 1 nanoliter.

11 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume of 10 nanoliters or less.

12 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has a volume of about 10 nanoliters.

13 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has at least one dimension of 2 mm or less.

14 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has at least one dimension of 1 mm or less.

15 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has at least one dimension of 100 microns or less.

16 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has at least one dimension of 20 microns or less.

17 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has at least one dimension of a few microns or less.

18 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume of about 1 picoliter or less.

19 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume in the range of from about 1 picoliter to about 1 microliter.

20 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume of about 10 picoliters or less.

21 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume which is nanoliter-sized.

22 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume of about 1 nanoliter or less.

23 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume of about 10 nanoliters or less.

24 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume of about 100 nanoliters or less.

25 . A microfluidic device as recited in claim 1 , wherein said first sample portion has a volume of about 1 microliter or less.

26 . A microfluidic device as recited in claim 1 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 2 mm or less.

27 . A microfluidic device as recited in claim 1 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 1 mm or less.

28 . A microfluidic device as recited in claim 1 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 500 microns or less.

29 . A microfluidic device as recited in claim 1 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 100 microns or less.

30 . A microfluidic device as recited in claim 1 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 20 microns or less.

31 . A microfluidic device as recited in claim 1 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by a few microns or less.

32 . A microfluidic device as recited in claim 1 , wherein said first sample chamber contains at least one amplification targeting reagent.

33 . A microfluidic device as recited in claim 1 , wherein said microfluidic device comprises a plurality of sample chambers.

34 . A microfluidic device as recited in claim 33 , wherein at least said first sample chamber contains at least a first amplification targeting reagent, and at least a second sample chamber contains at least a second amplification targeting reagent, said first amplification targeting reagent differing from said second amplification targeting reagent.

35 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume of about 1 picoliter or less.

36 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume in the range of from about 1 picoliter to about 1 microliter.

37 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume of about 10 picoliters or less.

38 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume of about 100 picoliters.

39 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume of about 1 nanoliter.

40 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume of 10 nanoliters or less.

41 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers has a volume of about 10 nanoliters.

42 . A microfluidic device as recited in claim 33 , wherein each of said sample chambers contains at least one amplification targeting reagent.

43 . A microfluidic device as recited in claim 1 wherein said microfluidic device comprises from about 10,000 to over 100,000 sample chambers.

44 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has at least one dimension of 500 microns or less.

45 . A microfluidic device as recited in claim 44 , wherein said first sample chamber has at least one dimension of 100 microns or less.

46 . A microfluidic device as recited in claim 1 , wherein said first sample chamber has opposing barriers separated by 500 microns or less.

47 . A microfluidic device as recited in claim 46 , wherein said first sample chamber has opposing barriers separated by 100 microns or less.

48 . A microfluidic device as recited in claim 1 , wherein said microfluidic device further comprises at least one cured displacing fluid which seals said first sample portion within said first sample chamber.

49 . A microfluidic device as recited in claim 1 , wherein said microfluidic device further comprises at least one cured adhesive which seals said first sample portion within said first sample chamber.

50 . A microfluidic device as recited in claim 1 , wherein said microfluidic device further comprises a sealing device adjacent to said first sample chamber.

51 . A microfluidic device as recited in claim 50 , wherein said sealing device is selected from the group consisting of microscope slide coverslips, tapes, films, silicon films, silicon devices, and devices comprising an array of reactants.

52 . A microfluidic device as recited in claim 1 , wherein said first sample chamber comprises a first microcapillary device.

53 . A microfluidic device as recited in claim 52 , wherein said microfluidic device comprises a plurality of microcapillary devices.

54 . A microfluidic device comprising:

a first sample chamber; and

at least one amplification targeting reagent positioned in said first sample chamber,

whereby if a sample portion which comprises at least a single molecule of a target nucleic acid is positioned in said first sample chamber, said first sample portion would attain a detectable concentration of said target nucleic acid within a portion of said first sample chamber after a single round of amplification.

55 . A microfluidic device as recited in claim 54 , wherein if said first sample portion contains at least a single molecule of said target nucleic acid, said first sample portion would attain a detectable concentration of said target nucleic acid within a portion of said first sample chamber after a single amplification step.

56 . A microfluidic device as recited in claim 54 , wherein said first sample chamber further comprises constituents for enabling amplification of a target nucleic acid.

57 . A microfluidic device as recited in claim 54 , wherein said single round of amplification comprises at least one thermocycle step.

58 . A microfluidic device as recited in claim 54 , wherein said single round of amplification comprises at least one homogeneous amplification step.

59 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume of about 1 picoliter or less.

60 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume in the range of from about 1 picoliter to about 1 microliter.

61 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume of about 10 picoliters or less.

62 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume of about 100 picoliters.

63 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume of about 1 nanoliter.

64 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume of 10 nanoliters or less.

65 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has a volume of about 10 nanoliters.

66 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has at least one dimension of 2 mm or less.

67 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has at least one dimension of 1 mm or less.

68 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has at least one dimension of 100 microns or less.

69 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has at least one dimension of 20 microns or less.

70 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has at least one dimension of a few microns or less.

71 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has at least one dimension of 500 microns or less.

72 . A microfluidic device as recited in claim 71 , wherein said first sample chamber has at least one dimension of 100 microns or less.

73 . A microfluidic device as recited in claim 54 , wherein said first sample chamber has opposing barriers separated by 500 microns or less.

74 . A microfluidic device as recited in claim 73 , wherein said first sample chamber has opposing barriers separated by 100 microns or less.

75 . A microfluidic device as recited in claim 54 , wherein said microfluidic device comprises a plurality of sample chambers.

76 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume of about 1 picoliter or less.

77 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume in the range of from about 1 picoliter to about 1 microliter.

78 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume of about 10 picoliters or less.

79 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume of about 100 picoliters.

80 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume of about 1 nanoliter.

81 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume of 10 nanoliters or less.

82 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers has a volume of about 10 nanoliters.

83 . A microfluidic device as recited in claim 75 , wherein each of said sample chambers contains at least one amplification targeting reagent.

84 . A microfluidic device as recited in claim 75 , wherein at least said first sample chamber contains at least a first amplification targeting reagent, and at least a second sample chamber contains at least a second amplification targeting reagent, said first amplification targeting reagent differing from said second amplification targeting reagent.

85 . A microfluidic device as recited in claim 84 , wherein said first sample chamber further contains at least a first sample portion.

86 . A microfluidic device as recited in claim 54 , wherein said first sample chamber further contains at least a first sample portion.

87 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume of about 1 picoliter or less.

88 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume in the range of from about 1 picoliter to about 1 microliter.

89 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume of about 10 picoliters or less.

90 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume which is nanoliter-sized.

91 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume of about 1 nanoliter or less.

92 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume of about 10 nanoliters or less.

93 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume of about 100 nanoliters or less.

94 . A microfluidic device as recited in claim 86 , wherein said first sample portion has a volume of about 1 microliter or less.

95 . A microfluidic device as recited in claim 86 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 2 mm or less.

96 . A microfluidic device as recited in claim 86 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 1 mm or less.

97 . A microfluidic device as recited in claim 86 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 500 microns or less.

98 . A microfluidic device as recited in claim 86 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 100 microns or less.

99 . A microfluidic device as recited in claim 86 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by about 20 microns or less.

100 . A microfluidic device as recited in claim 86 , wherein said first sample portion is confined in at least one dimension by opposing barriers separated by a few microns or less.

101 . A microfluidic device as recited in claim 86 , wherein said microfluidic device further comprises at least one cured displacing fluid which seals said first sample portion within said first sample chamber.

102 . A microfluidic device as recited in claim 86 , wherein said microfluidic device further comprises at least one cured adhesive which seals said first sample portion within said first sample chamber.

103 . A microfluidic device as recited in claim 54 wherein said microfluidic device comprises from about 10,000 to over 100,000 sample chambers.

104 . A microfluidic device as recited in claim 54 , wherein said first sample chamber comprises a first microcapillary device.

105 . A microfluidic device as recited in claim 104 , wherein said microfluidic device comprises a plurality of microcapillary devices.