Device including a proteinaceous factor, a recombinant proteinaceous factor, and a nucleotide sequence encoding the proteinaceous factor

• US 20050233390A1
• Filed: 04/09/2003
• Published: 10/20/2005
• Est. Priority Date: 04/09/2003
• Status: Abandoned Application

• Current Assignee: North Carolina State University (University of North Carolina System)
• Original Assignee: North Carolina State University (University of North Carolina System)
• Inventors: Allen, John W.
• Application Number:
  US10/410,649
• Publication Number:
  US 20050233390A1
• Time in Patent Office: Days
• US Class Current: 435/7.900
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

A device that includes a proteinaceous factor is disclosed. The proteinaceous factor is encoded by the nucleotide sequence of any one of SEQ ID NO.: 1, a degenerate variant of SEQ ID NO.: 1, and a complement of SEQ ID NO.: 1. The proteinaceous factor may be a recombinant. In addition, the device may include any one of (i) Immunoglobulin G (IgG) bound non-specially to the proteinaceous factor, (ii) at least one diagnostic label bound to the proteinaceous factor, (iii) Immunoglobulin G bound non-specially to the proteinaceous factor and at least one diagnostic label bound to the proteinaceous factor, and (iv) at least one base supporting the proteinaceous factor.

Claims

1. A device including a proteinaceous factor encoded by the nucleotide sequence of any one of SEQ ID NO.:

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1.

2. The device according to claim 1 further including at least one of:

(a) Immunoglobulin G (IgG) bound non-specially to the proteinaceous factor;

(b) at least one diagnostic label bond to the proteinaceous factor;

(c) Immunoglobulin G bound non-specially to the proteinaceous factor and at least one diagnostic label to the proteinaceous factor; and

(d) at least one base supporting the proteinaceous factor.

3. The device according to claim 2 wherein the base for supporting the proteinaceous factor is an inert solid support.

4. The device according to claim 3 wherein the device is an enzyme immuno assay.

5. The device according to claim 3 wherein the inert solid support included a plurality of wells.

6. The device according to claim 3 wherein the inert solid support is any one of a polymer, a glass, a paper and combination thereof.

7. The device according to claim 6 wherein the polymer is any one of a polystyrene (PS), a polyethylene (PE) and a polypropylene (PP).

8. The device according to claim 7 wherein the polyethylene (PE) is a low density polyethylene (LDPE).

9. The device according to claim 7 wherein the polyethylene (PE) is a high-density polyethylene (HDPE).

10. The device according to claim 7 wherein the polyethylene is a polyethylene terephthalate (PET).

11. The device according to claim 10 wherein the polyethylene terephthalate (PET) is a polyethylene terephthalate glycolate (PETG).

12. The device according to claim 3 wherein the device is one of

(a) an electro-immuno blot and

(b) a dot blot.

13. The device according to claim 12 wherein the base is a cellulosic membrane.

14. The device according to claim 13 wherein the cellulosic membrane is a nitrocellulose.

15. The device according to claim 3 wherein the device is any one of

(a) an antibody isolator;

(b) an antibody purifier; and

(c) an antibody isolator and purifier.

16. The device according to claim 15 wherein the base is one of a microbead and a porous membrane.

17. The device according to claim 2 wherein said device is for detecting one of monoclonal mammalian IgG, polyclonal mammalian IgG, and monoclonal mammalian IgG and polyclonal mammalian IgG.

18. The device according to claim 17 wherein the mammalian IgG is human IgG.

19. The device according to claim 18 wherein the human IgG is any one of human IgG₁, human IgG₂, human IgG₃, human IgG₄ and combinations thereof.

20. The device according to claim 17 wherein the mammalian IgG is one of horse IgG, bovine IgG, rat IgG, swine IgG, mouse IgG, sheep IgG, goat IgG, guinea pig IgG, hamster IgG, and combinations thereof.

21. The device according to claim 2 wherein the Immunoglobulin G (IgG) bound to the proteinaceous factor is selected for its antigenic specificity.

22. The device according to claim 2 wherein the diagnostic label is one of ferritin, gold and silver.

23. The device according to claim 2 wherein the diagnostic label is a chemical conjugate of the proteinaceous factor.

24. The device according to claim 23 wherein the chemical conjugate is an enzyme conjugate.

25. The device according to claim 24 wherein the enzyme conjugate includes one of a horseradish peroxidase (HRP), an alkaline phosphatase (APAAP), a lactoperoxidase (LPO), a glucose oxidase, digoxigenin and combinations thereof.

26. The device according to claim 25 further including a chemiluminescent substrate for the enzyme conjugate.

27. The device according to claim 2 wherein the diagnostic label includes a radioactive component.

28. The device according to claim 27 wherein the radioactive component includes at least one of ³³P, ³H, ³⁵S, ¹²¹I, ¹³¹I, ³²P, ⁵⁴CR, and combination thereof.

29. A recombinant proteinaceous factor usable alone or in a device, the recombinant proteinaceous factor encoded by the nucleotide sequence of any one of SEQ ID NO.:

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1.

30. The recombinant proteinaceous factor according to claim 29 wherein a N-terminal amino acid sequence is alanine, proline, threonine, valine, proline, glutamine, alanine, proline, alanine, threonine, glycine, glutamine, glutamine, alanine, alanine, glutamic acid, valine, threonine, glutamic acid, leucine, lysine, aspartic acid, valine, lysine, phenylalanine, threonine, phenylalanine, lysine, and methionine.

31. The recombinant proteinaceous factor according to claim 29 wherein a N-terminal amino acid sequence is encoded by bases 103 through 189 of SEQ ID NO.:

1.

32. The recombinant proteinaceous factor according to claim 30 wherein an N-terminal amino acid sequence is substantially the same as the native N-terminal amino acid sequence of the proteinaceous factor.

33. The recombinant proteinaceous factor according to claim 29 wherein a computer generated translation of the nucleotide sequence is SEQ ID NO.:

2.

34. The recombinant proteinaceous factor according to claim 29 wherein a N-terminal amino acid sequence corresponds substantially to amino acids 35 through 63 of SEQ ID NO.:

2.

35. A recombinant proteinaceous factor according to claim 30 wherein the N-terminal amino acid sequence of the proteinaceous factor substantially conforms to the corresponding N-terminal amino acid sequence of the computer generated translation of the nucleotide sequence.

36. The recombinant proteinaceous factor according to claim 29 wherein the nucleotide sequence comprising a sequence at least 80% identical to SEQ ID NO.:

1.

37. The recombinant proteinaceous factor according to claim 29 wherein the nucleotide sequence comprises a sequence that encodes a polypeptide which is at least 80% identical to SEQ ID NO.:

2.

38. The recombinant proteinaceous factor according to claim 29 wherein the nucleotide sequence comprises a sequence that encodes a polypeptide having any one of the sequence of SEQ ID NO.:

2 and SEQ ID NO.;

2 with conservative amino acid substitutions.

39. The recombinant proteinaceous factor according to claim 29 wherein the nucleotide sequence comprises a sequence that encodes a polypeptide comprising any one of the amino acid sequence of SEQ ID NO.:

2 and a fragment of SEQ ID NO.;

2 at least 8 residues in length.

40. The recombinant proteinaceous factor according to claim 29 wherein the recombinant proteinaceous factor is a receptor for the Fc region of mammalian IgG.

41. The recombinant proteinaceous factor according to claim 40 wherein the mammalian IgG is human IgG.

42. The recombinant proteinaceous factor according to claim 40 wherein the human IgG includes IgG₁, IgG₂, IgG₃ and IgG₄.

43. The recombinant proteinaceous factor according to claim 40 wherein the mammalian IgG is one of horse IgG, bovine IgG, rat IgG, swine IgG, mouse IgG, sheep IgG, goat IgG, guinea pig IgG, hamster IgG, and combinations thereof.

44. The recombinant proteinaceous factor according to claim 29 having a molecular weight of about 60,000 Daltons as measured using a surface enhanced laser desorption ionization—

time of flight (SELDI-TOF) mass spectrometry.

45. The recombinant proteinaceous factor according to claim 29 wherein the proteinaceous factor is the product of incorporation of the nucleotide sequence of any one of SEQ ID NO.:

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1 in a plasmid vector, transforming the plasmid vector into a host cell and expressing the proteinaceous factor from the host cell.

46. The recombinant proteinaceous factor according to claim 29 wherein the sequence is the nucleotide sequence in E. coli host cells of NRRL Deposit No.:

B-30634.

47. The recombinant proteinaceous factor according to claim 29 wherein an isolated nucleotide sequence in ATCC Deposit No. 55195 is at least 90% identical to an isolated nucleotide sequence in NRRL Deposit No.:

B-30634 and the percent identity is calculated using FASTDB with the parameters set such that percentage of identity is calculated over the full length of the reference nucleotide sequence.

48. The recombinant proteinaceous factor according to claim 47 wherein gaps in homology of up to 5% of the total number of nucleic acids in the reference nucleotide sequence are allowed.

49. The recombinant proteinaceous factor according to claim 47 wherein the isolated nucleotide sequence in ATCC Deposit No. 55195 is at least 95% identical to the isolated nucleotide sequence in NRRL Deposit No.:

B-30634.

50. A device including:

(a) a recombinant proteinaceous factor encoded by the nucleotide sequence of any one of SEQ ID NO.;

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1; and

(b) at least one of;

(i) Immunoglobulin G (IgG) bound non-specially to the proteinaceous factor;

(ii) at least one diagnostic label bond to the proteinaceous factor;

(iii) Immunoglobulin G bound non-specially to the proteinaceous factor and at least one diagnostic label to the proteinaceous factor; and

(iv) at least one base supporting the proteinaceous factor.

51. The device according to claim 50 wherein the base for supporting the proteinaceous factor is an inert solid support.

52. The device according to claim 51 wherein the device is an enzyme immuno assay.

53. The device according to claim 51 wherein the inert solid support includes a plurality of wells.

54. The device according to claim 51 wherein the inert solid support is any one of a polymer, a glass, a paper and combination thereof.

55. The device according to claim 54 wherein the polymer is any one of a polystyrene (PS), a polyethylene (PE) and a polypropylene (PP).

56. The device according to claim 55 wherein the polyethylene (PE) is a low density polyethylene (LDPE).

57. The device according to claim 55 wherein the polyethylene (PE) is a high-density polyethylene (HDPE).

58. The device according to claim 55 wherein the polyethylene is a polyethylene terephthalate (PET).

59. The device according to claim 58 wherein the polyethylene terephthalate (PET) is a polyethylene terephthalate glycolate (PETG).

60. The device according to claim 51 wherein the device is one of

(a) an electro-immuno blot and

(b) a dot blot.

61. The device according to claim 60 wherein the base is a cellulosic membrane.

62. The device according to claim 61 wherein the cellulosic membrane is a nitrocellulose.

63. The device according to claim 51 wherein the device is any one of

(a) an antibody isolator;

(b) an antibody purifier; and

(c) an antibody isolator and purifier.

64. The device according to claim 63 wherein the base is one of a microbead and a porous membrane.

65. The device according to claim 50 wherein said device is for detecting one of monoclonal mammalian IgG, polyclonal mammalian IgG, and monoclonal mammalian IgG and polyclonal mammalian IgG.

66. The device according to claim 65 wherein the mammalian IgG is human IgG.

67. The device according to claim 66 wherein the human IgG is any one of human IgG₁, human IgG₂, human IgG₃, human IgG₄ and combinations thereof.

68. The device according to claim 65 wherein the mammalian IgG is one of horse IgG, bovine IgG, rat IgG, swine IgG, mouse IgG, sheep IgG, goat IgG, guinea pig IgG, hamster IgG, and combinations thereof.

69. The device according to claim 50 wherein the Immunoglobulin G (IgG) bound to the proteinaceous factor is selected for its antigenic specificity.

70. The device according to claim 50 wherein the diagnostic label is one of ferritin, gold and silver.

71. The device according to claim 50 wherein the diagnostic label is a chemical conjugate of the proteinaceous factor.

72. The device according to claim 71 wherein the chemical conjugate is an enzyme conjugate.

73. The device according to claim 72 wherein the enzyme conjugate includes one of a horseradish peroxidase (HRP), an alkaline phosphatase (APAAP), a lactoperoxidase (LPO), a glucose oxidase, digoxigenin and combinations thereof.

74. The device according to claim 73 further including a chemiluminescent substrate for the enzyme conjugate.

75. The device according to claim 50 wherein the diagnostic label includes a radioactive component.

76. The device according to claim 75 wherein the radioactive component includes at least one of ³³P, ³H, ³⁵S, ¹²¹I, ¹³¹I, ³²P, ⁵⁴CR, and combination thereof.

77. The device according to claim 50 wherein a N-terminal amino acid sequence is alanine, proline, threonine, valine, proline, glutamine, alanine, proline, alanine, threonine, glycine, glutamine, glutamine, alanine, alanine, glutamic acid, valine, threonine, glutamic acid, leucine, lysine, aspartic acid, valine, lysine, phenylalanine, threonine, phenylalanine, lysine, and methionine.

78. The device according to claim 50 wherein a N-terminal amino acid sequence is encoded by bases 103 through 189 of SEQ ID NO.:

1.

79. The device according to claim 78 wherein a native N-terminal amino acid sequence is substantially the same as a N-terminal amino acid sequence of the recombinant proteinaceous factor.

80. The device according to claim 50 wherein a computer generated translation of the nucleotide sequence is SEQ ID NO.:

2.

81. The device according to claim 50 wherein a N-terminal amino acid sequence corresponds substantially to amino acids 35 through 63 of SEQ ID NO.:

2.

82. The device according to claim 77 wherein the N-terminal amino acid sequence of the proteinaceous factor substantially conforms to the corresponding N-terminal amino acid sequence of the computer generated translation of the nucleotide sequence.

83. The device according to claim 50 wherein the nucleotide sequence comprising a sequence at least 80% identical to SEQ ID NO.:

1.

84. The device according to claim 50 wherein the nucleotide sequence comprises a sequence that encodes a polypeptide the amino acid sequence of which is at least 80% identical to SEQ ID NO.:

2.

85. The device according to claim 50 wherein the nucleotide sequence comprises a sequence comprising that encodes a polypeptide having any one of the sequence of SEQ ID NO.:

2 and SEQ ID NO.;

2 with conservative amino acid substitutions.

86. The device according to claim 50 wherein the nucleotide sequence comprises a sequence that encodes a polypeptide comprising any one of the amino acid sequence of SEQ ID NO.:

2 and a fragment of SEQ ID NO.;

2 at least 8 residues in length.

87. The device according to claim 50 wherein the proteinaceous factor is a receptor for the F_C region of mammalian IgG.

88. The device according to claim 87 wherein the mammalian IgG is human IgG.

89. The device according to claim 88 wherein the human IgG includes IgG₁, IgG₂, IgG₃ and IgG₄.

90. The device according to claim 87 wherein the mammalian IgG is one of horse IgG, bovine IgG, rat IgG, swine IgG, mouse IgG, sheep IgG, goat IgG, guinea pig IgG, hamster IgG, and combinations thereof.

91. The device according to claim 50 having a molecular weight of about 96,000 Daltons as measured using a non-denaturing gel.

92. The device according to claim 50 wherein the proteinaceous factor is the product of incorporation of the nucleotide sequence of any one of SEQ ID NO.:

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1 in a plasmid vector, translating the plasmid vector into a host cell and expressing the proteinaceous factor from the host cell.

93. The device according to claim 50 wherein the sequence is the nucleotide sequence in competent E. coli host cells of NRRL Deposit No.:

B-30634.

94. The device according to claim 50 wherein an isolated nucleotide sequence in ATCC Deposit No. 55195 is at least 90% identical to an isolated nucleotide sequence in NRRL Deposit No.:

B-30634 and the percent identity is calculated using FASTDB with the parameters set such that percentage of identity is calculated over the full length of the reference nucleotide.

95. The device according to claim 94 wherein gaps in homology of up to 5% of the total number of nucleic acids in the reference nucleotide sequence are allowed.

96. The device according to claim 94 wherein the isolated nucleotide sequence in ATCC Deposit No. 55195 is at least 95% identical to the isolated nucleotide sequence in NRRL Deposit No.:

B-30634.

97. An isolated DNA the nucleotide sequence of which consists of SEQ ID NO.:

1.

98. An isolated nucleic acid comprising the nucleotide sequence of SEQ ID NO.:

1, or a degenerate variant of SEQ ID NO.;

1.

106. An expression vector comprising the nucleic acid of claim 98 operably linked to an expression control sequence.

107. A cultured cell comprising the vector of claim 106.

108. A cultured cell comprising the nucleic acid of claim 98, operably linked to an expression control sequence.

109. A cultured cell transfected with the vector of claim 106, or a progeny of the cell, wherein the cell expresses the proteinaceous factor.

110. A method of producing a proteinaceous factor, the method comprising culturing the cell of claim 108 under conditions permitting expression of the proteinaceous factor.

111. A method of producing a proteinaceous factor, the method comprising culturing the cell of claim 110 under conditions permitting expression under the control of the expression control sequence, and purifying the proteinaceous factor from the cell or the medium of the cell.

99. An isolated nucleic acid comprising a sequence that encodes a proteinaceous factor with the amino acid sequence of SEQ ID NO.:

2.

100. An isolated nucleic acid comprising a sequence that hybridizes under highly stringent conditions to a hybridization probe, the nucleotide sequence of which consists of SEQ ID NO.:

1, or the complement of SEQ ID NO.;

1.

101. An isolated nucleic acid comprising a sequence at least 80% identical to SEQ ID NO.:

1.

102. An isolated nucleic acid comprising a sequence that encodes a proteinaceous factor, the amino acid sequence of which is at least 80% identical to SEQ ID NO.:

2.

103. An isolated nucleic acid comprising a sequence that encodes a proteinaceous factor having the sequence of SEQ ID NO.:

2, or SEQ ID NO.;

2 with conservative amino acid substitutions.

104. An isolated nucleic acid comprising a sequence that encodes a polypeptide comprising the amino acid sequence of SEQ ID NO.:

2, or of a fragment of SEQ ID NO.;

2 at least 8 residues in length.

105. A DNA the sequence of which comprises SEQ ID NO.:

1 operably linked to a heterologous coding sequence.

112. A single-stranded nucleic acid that hybridizes under highly stringent conditions to a nucleic acid having the sequence of SEQ ID NO.:

1.

113. An isolated nucleic acid comprising at least 10 consecutive nucleotides of the complement of SEQ ID NO.:

1.

114. A purified proteinaceous factor, the amino acid sequence of which consists of SEQ ID NO.:

2.

115. A method for making a device, the method comprising providing a proteinaceous factor encoded by the nucleotide sequence of any one of SEQ ID NO.:

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1.

116. A method for making a recombinant proteinaceous factor usable alone or in a device, the method comprising transforming a vector including any one of SEQ ID NO.:

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1 into a host to express the recombinant proteinaceous factor encoded thereby.

117. A method for making a device, the method comprising:

(a) providing a recombinant proteinaceous factor encoded by the nucleotide sequence of any one of SEQ ID NO.;

1, a degenerate variant of SEQ ID NO.;

1, and a complement of SEQ ID NO.;

1; and

(b) performing at least one of;

(i) binding at least one substrate of the proteinaceous factor to the proteinaceous factor;

(ii) binding at least one chemical conjugate of the proteinaceous factor to the proteinaceous factor,

(iii) binding at least one substrate of the proteinaceous factor and at least one chemical conjugate of the proteinaceous factor bond to the proteinaceous factor, and

(iv) providing at least one base to support the proteinaceous factor.