Method of detecting circulating antibody types using dried or lyophilized cells

• US 5,759,774 A
• Filed: 09/11/1992
• Issued: 06/02/1998
• Est. Priority Date: 05/18/1988
• Status: Expired due to Fees

• Current Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Original Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Inventors: Olson, Jon A., Galle, Richard F., Williams, Christine M., Cho, Miller, Goodrich, Raymond P. Jr., Hackett, Roger W.
• Primary Examiner(s): ULM, JOHN D
• Application Number:
  US07/934,448
• Time in Patent Office: 2,090 Days
• Field of Search: 435/2, 435/7.21, 435/7.23, 435/7.24, 435/29, 435/34, 435/240.2, 435/240.27, 435/172.1, 435/172.2, 435/172.3, 435/5, 435/243, 435/23, 424/129, 424/529, 424/450, 427/533
• US Class Current: 435/2
• CPC Class Codes: A61K 35/18 Erythrocytes haemoglobin A61K38/42
• CPC Class Codes: G01N 33/5005 involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025
• CPC Class Codes: G01N 33/554 the carrier being a biological cell or cell fragment, e.g. bacteria, yeast cells
• CPC Class Codes: G01N 33/555 Red blood cell

Abstract

A method is provided for qualitatively detecting in vitro the presence or absence of selected circulating antibody types using a diagnostic kit comprising reconstituted, after lyophilization or evaporative drying, red blood cell samples or other cell or cell-like material which have antigens which are recognized and bound by the selected antibody-type to be screened. Diagnostic kits containing the lyophilized blood samples according to the present invention have improved shelf life, and may comprise lyophilized samples packaged in a variety of forms convenient for manual single-test uses or automated multiple-test uses.

Claims

1. A method of forming dry cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells or erythrocytes, bound to a solid support comprising the steps of:

(a) binding a material selected from the group consisting of cells, cell membranes, lymphocytes, platelets peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells and erythrocytes, having a profile of cytosolic or cell surface receptors capable of being recognized and bound by a ligand, to said solid support;

(b) immersing the bound material in a cryoprotective medium comprising a carbohydrate selected from the group consisting of a monosaccharide, a disaccharide and a trisaccharide and at least one biologically compatible amphipathic polymer; and

c lyophilizing said bound material and cryoprotective medium to form a lyophilized composition.

9. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said ligand is a circulating antibody.

10. A method according to claim 9 wherein said receptors comprise cell-surface antigens.

12. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said cells are selected from the group consisting of tissue samples, cultured cells, stem cells, peripheral blood cells, and cancer cells.

13. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said cells are selected from the group consisting of erythrocytes, lymphocytes, platelets, liposomes and hemosomes.

14. A method according to claims 1, 2, 3, 4, 6 or 7 wherein said cells are treated with activating agents that enhance receptor-ligand binding or increase the expression of cell receptors.

15. A method according to claim 14 wherein said activating agents are selected from the group consisting of digestive enzymes, cell growth factors, proteases, glycohydrolases, and cell maturation and differentiation factors.

16. A method according to claim 15 wherein said proteases are selected from the group consisting of bromelain, papain, trypsin, chymotrypsin, pronase, ficin and proteinase K.

23. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said cytosolic receptors are selected from the group consisting of cell enzymes and intracellular receptors.

24. A method according to claim 23 wherein said intracellular receptors comprise steroid hormone receptors.

44. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said material comprises human cells.

45. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said composition! material comprises animal cells.

46. A method as claimed in claim 45 wherein said animal cells are mammalian cells.

47. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said material comprises antibody-coated cells.

48. A method as claimed in claim 47 wherein said antibodycoated cells are antibody-coated erythrocytes.

49. A method according to claim 48 wherein said antibody is selected from the group consisting of antihuman IgG and antihuman IgM.

50. A method according to claim 47 wherein said antibody-coated cells are selected from the group consisting of non-human mammalian cells and human cells.

51. A method according to claim 47 wherein said antibody-coated cells comprise fluorescently tagged antibodies.

52. A method according to claim 51 wherein said antibodies are derived from polyclonal antisera.

53. A method according to claim 51 wherein said antibodies are derived from hybridoma cell cultures.

54. A method according to any of claims 1, 2, 3, 4, 6 or 7 wherein said material comprises cellular membranes.

55. A method according to claim 54 wherein said membranes are mammalian cell membranes.

56. A method according to claim 55 wherein said cell membranes are selected from the group consisting of membranes prepared from erythrocytes, lymphocytes, platelets, peripheral blood cells, stem cells, cancer cells and tissue explants.

57. A method according to any of claims 1, 2, 3 or 4 wherein a plurality of separate compositions is lyophilized-or dried while attached to a solid support, thereby providing a panel of standard compositions for screening a predetermined set of antibody types.

58. A method according to claim 57 wherein said standard composition is selected from the group consisting of cell membranes, cell membrane fragments, and cell membrane ghosts.

59. A method according to claim 57 wherein said standard composition is selected from the group consisting of leukocytes, platelets, lymphocytes, and red blood cells.

60. A method according to claim 57 wherein said standard composition is selected from the group consisting of peripheral blood cells and hematopoietic stem cells.

61. A method according to claim 57 wherein said standard composition is mammalian cells.

62. A method according to claim 57 wherein said standard composition is selected from the group consisting of cancerous cultured cell lines and primary tumor cell explants.

63. A method according to claim 57 wherein said standard composition comprises cultured nerve cells.

64. A method according to claim 57 wherein said sample composition is animal antisera.

65. A method according to claim 57 wherein said sample composition comprises hybridoma cell fluid.

106. The method according to any of claims 1, 2, 3 or 4 wherein said carbohydrate is selected from the group consisting of monosaccharides, disaccharides, trisaccharides and oliggosaccharides.

2. A method for forming dry cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells or erythrocytes, bound to a solid support comprising the steps of:

(a) binding a material selected from the group consisting of cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells and erithrocytes, having a profile of cytosolic or cell surface receptors capable of being recognized and bound by a ligand, to a solid support;

(b) immersing the bound cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells or erythrocytes in a cryoprotective medium comprising a carbohydrate selected from the group consisting of a monosaccharide, a disaccharide and a trisaccharide and at least one biologically compatible amphipathic polymer; and

c evaporatively drying said bound material and cryoprotective medium to form a dried composition.

3. A method of detecting in vitro the presence or absence of a ligand in a fluid sample comprising the steps of:

(a) binding a material selected from the group consisting of cells, cell membranes, lymphocotes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells and erythrocytes having a profile of cytosolic or cell surface receptors capable of being recognized and bound by said ligand, to a solid support;

(b) immersing the bound cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes. hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells or erythrocytes in a cryoprotective medium comprising a carbohydrate selected from the group consisting of a monosaccharide, a disaccharide and a trisaccharide and at least one biologically compatible amphipathic polymer;

c lyophilizing said bound material and cryoprotective medium;

(d) reconstituting the lyophilized material;

(e) optionally, washing the reconstituted material;

(f) contacting said reconstituted material with a fluid sample containing or suspected of containing said ligand; and

(g) detecting the presence or absence of ligand bound to said receptors.

5. A method according to claim 3 or 4 wherein, prior to said reconstituting of material in step (d) the dried or lyophilized material from step (c) is stored.

8. A method according any of claim 3, 4, 6 or 7 wherein said sample is selected from the group consisting of plasma, serum, antiserum, hybridoma fluid, tissue or body fluids, cell culture fluids, whole blood, and fractions derived from tissue or body fluids, cell culture fluids, whole blood, plasma, serum, antiserum, or hybridoma fluid.

17. A method according to any of claims 3, 4, 6 or 7 wherein said ligand is a steroid hormone.

18. A method according to any of claims 3, 4, 6 or 7 wherein said ligand is a growth factor.

19. A method according to any of claims 3, 4, 6 or 7 wherein said ligand is a protein or peptide.

20. A method according to any of claims 3, 4, 6 or 7 wherein said ligand is a metabolite.

21. A method according to claim 20 wherein said metabolite is an inorganic or organic compound.

22. A method according to claim 21 wherein said inorganic or organic compounds are selected from the group consisting of trace elements, cofactors, cyclic nucleosides, toxins, pharmaceutical drugs, nucleic acids, and metabolic byproducts of toxins and pharmaceutical drugs.

33. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises erythrocytes.

34. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises platelets.

35. A method according to any of claims 3, 4, 6 or 7 wherein said composition material comprises lymphocytes.

36. A method according to any of claims 3, 4, 6 or 7 wherein said composition material comprises liposomes.

37. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises hemosomes.

38. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises peripheral blood cells.

39. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises stem cells.

40. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises cancer cells.

41. A method according to any of claims 3, 4, 6 or 7 wherein said material comprises tissue explants.

42. A method according to any of claims 3, 4, 6 or 7 wherein said sample fluid is selected from the group consisting of human plasma and serum.

43. A method according to any of claims 3, 4, 6 or 7 wherein said sample fluid is selected from the group consisting of animal plasma and serum.

66. A method according to any of claims 3,4, 6 or 7 wherein said detecting of bound ligands comprises use of an agent selected from the group consisting of secondary antibodies and antibody-conjugates.

67. A method according to claim 66 wherein said use comprises an immunoassay selected from the group consisting of indirect immunoassays and competitive immunoassays.

68. A method according to claim 67 wherein said agent is attached to a solid support.

69. A method according to claim 68 wherein said solid support is selected from the group consisting of pellets, beads, and microspheres.

70. A method according to claim 69 wherein said solid support comprises a material selected from the group consisting of natural or synthetic polymers, and glass.

71. A method according to claim 70 wherein said polymers are selected from the group consisting of agar, agar derivatives, gelatin, plastics, cellulose, and latex.

72. A method according to claim 66 wherein said secondary antibodies are selected from the group consisting of antibodies directed against IgG and antibodies directed against IgM.

73. A method according to claim 66 wherein said secondary antibodies comprise anti-human antibodies.

74. A method according to claim 66 wherein said antibody-conjugates comprise antibody-radioisotope conjugates.

75. A method according to claim 74 wherein said radioisotopes are selected from the group consisting of ¹²⁵ I, ¹³¹ I, ³ H, ¹⁴ C, and ³⁵ S.

76. A method according to claim 66 wherein said antibody conjugates comprise antibody-enzyme conjugates.

77. A method according to claim 76 wherein said antibody-enzyme conjugates are selected from the group consisting of alkaline phosphatase, horseradish peroxidase, beta-D-galactosidase, and glucose oxidase.

78. A method according to claim 66 wherein said conjugates compromise antibodies conjugated with fluorochrome dyes.

79. A method according to claim 78 wherein said fluorochrome dyes are selected from the group consisting of rhodamine, fluorescein, and phycobiliproteins.

80. A method according to any of claims 3, 4, 6 or 7 wherein said detecting of bound ligand comprises measurement of altered optical properties in the reaction solution.

81. A method according to claim 80 wherein said optical properties are selected from the group consisting of light scatter, light reflection, light transmission, and optical density.

82. A method according to any of claims, 3, 4, 6 or 7 wherein said detecting comprises immunoglobulin binding proteins.

83. A method according to claim 82 wherein said immunoglobulin-binding protein is selected from the group consisting of Protein A, Protein G, and antibodies.

84. A method according to claim 83 wherein said immunoglobulin-binding protein is selected from recombinant proteins, polyclonal antibodies, and monoclonal antibodies.

85. A method according to any of claims 3, 4, 6, or 7 wherein said ligand is selected from the group consisting of biotin or biotin-conjugated proteins and nucleic acids.

86. A method according to claims 3, 4, 6 or 7 wherein said ligand is selected from the group consisting of avidin or conjugates of avidin with enzymes, fluorescent dyes, colloidal gold particles and metals.

87. A method according to any of claims 3, 4, 6 or 7 wherein said detecting is selected from the group consisting of an enzyme-linked immunosorbent assay, radio-immunoassay, enzyme immunoassay, and competitive immunoassay.

88. A method according to any of claims 3, 4, 6, or 7 wherein said detecting comprises an agglutination assay.

89. A method according to claim 88 wherein said agglutination assay comprises agglutination of cells.

90. A method accordingto claim 88 wherein said ahhlutination assay comprises agglutination of a material selected from the group consisting of cell-like materials, beads, particles, and microspheres.

91. A method according to claim 90 wherein said cells, beads, particles, or microspheres are treated with immunoglobulin-binding proteins.

92. A method acceding to claim 91 wherein said immunoglobulin-binding proteins are selected from the group consisting of Protein A, Protein G, and antibodies.

93. A method according to any of claims, 3, 4, 6 or 7 wherein said detecting comprises red cell adherence of antibody coated indicator red blood cells.

94. A method according to claim 89 wherein said cells comprise red blood cells.

95. A method according to claim 94 wherein said red blood cells comprise antibody-coated red blood cells.

98. A method according to any of claims 3, 4, 6, or 7 wherein said detecting comprises use of antibodysensitized red blood cells.

99. A method according to any of claims 3, 4, 6 or 7 wherein said detecting comprises a cytotoxicity reaction.

100. A method according to any claims 3, 4, 6 or 7 where said detecting comprises a chemiluminescence reaction.

101. A method according to any of claims 3, 4, 6 or 7 wherein said detecting step is automated.

102. A method according to claim 100 wherein said detecting comprises mechanical pipetting of fluid samples, liquid reaction reagents, and/or secondary antibody solutions.

103. A method according to claim 101 wherein the ligand-receptor complex comprises fluorochrome dyes and said detecting comprises use of an incident light beam to excite said fluorochrome dyes.

104. A method according to claim 103 wherein said detecting comprises use of a device selected from the group consisting of an optical device, a prism device and a photomultiplier device.

105. A method according to claim 101 wherein said detecting comprises use of bound antibodies to detect cell agglutination.

112. A panel according to claim 67 wherein said chemical crosslinking reagent is selected from the group consisting of aldehydes, maleimides, succinimides and carbodiimides.

113. A panel according to claim 112 wherein said aldehyde comprises glutaraldehyde.

115. A panel according to claim 113 wherein said organic dye carries a net electric charge.

119. A panel according to claim 17 wherein said antibodies are selected from the group consisting of anti-red cell antibodies, antiplatelet antibodies, antileukocyte antibodies, and antilymphocyte antibodies.

4. A method of detecting in vitro the presence or absence of a ligand in a fluid sample comprising the steps of:

(a) binding a material selected from the group consisting of cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells and erythrocytes, having a profile of cytosolic or cell surface receptors capable of being recognized and bound by said ligand to a solid support;

(b) immersing the bound material in a cryoprotective medium comprising a carbohydrate selected from the group consisting of a monosaccharide, a disaccharide and a trisaccharide and at least one biologically compatible amphipathic polymer;

c evaporatively drying said bound material and cryoprotective medium;

(d) reconstituting the dried material;

(e) optionally, washing the reconstituted material;

(f) contacting said reconstituted material with a fluid sample containing or suspected of containing said ligand; and

(g) detecting the presence or absence of ligand bound to said receptors.

6. A method of detecting in vitro the presence or absence of a ligand in a sample fluid comprising the steps of

(a) reconstituting a lyophilized composition, said composition comprising a material selected from the group consisting of cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells and erythrocytes lyophilized or dried in the presence of a cryoprotectant comprising a monosaccharide, a disaccharide or a trisaccharide and at least one biologically compatible amphipathic polymer and known to have a profile of cytosolic or cell surface receptors which are recognized and bound by said ligand;

(b) optionally, washing the reconstituted composition from step (a);

c contacting said reconstituted composition with said sample; and

(d) detecting the presence or absence of ligand bound to said receptors.

11. A method according to claim 6 wherein a plurality of separate compositions is reconstituted;

optionally washed, and each is separately mixed with a sample selected from the group consisting of plasma and serum, thereby providing a panel of standard compositions for screenings a predetermined set of ligands.

25. A method according to claim 6 or 7 wherein said lyophilized or dried composition further comprises an enhancer for enhancing a desired ligand-receptor reaction.

26. A method according to claim 25 wherein said enhancer comprises a polymer.

27. A method according to claim 26 wherein said polymer comprises polyethylene glycol.

28. A method according to claim 25 wherein said enhancer comprises a protein.

29. A method according to claim 28 wherein said protein comprises bovine serum albumin.

30. A method according to claim 28 wherein said protein comprises an enzyme.

31. A method according to claim 30 wherein said enzyme is a protease or glycohydrolase.

32. A method according to claim 25 wherein said enhancer imparts to said composition, when reconstituted, a pH of about 7.2 or lower.

7. A method of detecting in vitro the presence or absence of a ligand in a sample fluid comprising the steps of:

(a) reconstituting a dried composition, said composition comprising a material selected from the group consisting of cells, cell membranes, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghosts, cultured mammalian cells, stroma, hybridoma cells and erythrocytes lyophilized or dried in the presence of a cryoprotectant comprising a monosaccharide, a disaccharide or a trisaccharide and at least one biologically compatible amphipathic polymer and known to have a profile of cytosolic or cell surface receptors which are recognized and bound by said ligand;

(b) optionally, washing the reconstituted composition from step (a);

c contacting said reconstituted composition with said sample; and

(d) detecting the presence or absence of ligand bound to said receptors.

96. A method according to claim 96 wherein said antibody-enzyme conjugates compromise enzyme-metal conjugates.

97. A method according to claim 96 wherein said enzyme-metal conjugates comprise colloidal gold and iron conjugates.

138. A panel according to claim 97 wherein said proteolytic enzymes are selected from the group consisting of bromelain, papain, trypsin, chymotrypsin, pronase, ficin and proteinase K.

107. A diagnostic panel comprising a plurality of compartments or sectors, each containing a different lyophilized material selected from the group consisting of cell, cell membrane, lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghost, cultured mammalian cells, stroma, hybridoma cells or erythrocytes, lyophilized or dried in the presence of a cryoprotectant comprising a monosaccharide, disaccharide or trisaccharide and at least one biologically compatible amphipathic polymer, and known to have one or more antigens which are recognized and bound by a selected antibody type.

108. A panel according to claim 107 wherein each of said standard compositions is attached to said solid support through a chemical crosslinking reagent.

109. A panel according to claim 108 wherein said chemical crosslinking reagent comprises a bifunctional crosslinking reagent.

110. A panel according to claim 109 wherein said bifunctional crosslinking reagent comprises a spacer of variable length between the reactive chemical group.

111. A panel according to claim 108 wherein said chemical crosslinking reagent comprises a 20 photoactivated crosslinking reagent.

114. A panel according to claim 109 wherein each of said standard compositions is attached to said solid support through an organic dye.

116. A panel according to claim 107 wherein each of said standard composition is attached to said support through antibodies.

117. A panel according to claim 116 wherein said antibodies comprise antibodies which recognize and bind to cell surface antigens.

118. A panel according to claim 117 wherein said antibodies comprise antibodies against mammalian cells.

120. A panel according to claim 116 wherein said antibodies are selected from the group consisting of polyclonal antibodies and monoclonal antibodies.

121. A panel according to claim 107 wherein said standard compositions are attached to said solid support through lectins.

122. A panel according to claim 107 wherein said wherein said solid support comprises a polymer.

123. A panel according to claim 122 wherein said polymer comprises a benzene nucleus.

124. A panel according to claim 122 wherein said polymer comprises a polymer diazonium salt.

125. A panel according to claim 107 wherein said solid support comprises a plastic microplate.

126. A panel according to claim 125 wherein said microplate comprises polystyrene.

127. A panel according to claim 125 wherein said microplate comprises a diazonium salt of polystyrene.

128. A panel according to claim 108 wherein said crosslinking reagent comprises a diazoamino bond.

129. A panel according to claim 107 wherein said solid support is selected from the group consisting of glass, diazobenzylcellulose, nitrocellulose, cellulose, agar, nylon, polyvinylchloride, latex, polystyrene and polypropylene.

130. A panel according to claim 107 wherein said standard composition occupy discreet areas on a solid dipstick support.

131. A panel according to claim 107 wherein said standard composition is attached to a permeable pad.

132. A panel according to claim 107 wherein said standard composition is attached to a solid support selected from the group consisting of pellets, microspheres, and beads.

133. A panel according to claim 131 wherein said permeable pad is embedded with additional enhancing, sensitizing, or detection reagents.

134. A panel according to claim 107 wherein said material is subjected to treatments to enhance the binding of known antibody types.

135. A panel according to claim 134 wherein said material is subjected to said treatments prior to attachment to a solid support and lyophilization.

136. A panel according to claim 134 wherein said material is subjected to said treatments after attachment to a solid support, lyophilization, and rehydration.

137. A panel according to claim 134 wherein said treatments comprise exposure to an agent selected from the group consisting of proteolytic enzymes, detergents, chemical fixatives, low ionic strength saline, high ionic strength saline, and high molecular weight polymer solutions.

139. A panel as in claim 107 wherein said material comprises antigens of the ABO blood antigen group.

140. A panel as in claim 107 wherein said material comprises antigens of the Rh-hr blood antigen system.

141. A panel as in claim 107 wherein said material comprises antigens of the M, N, S and PI blood antigen systems.

142. A panel as in claim 107 wherein said material antigens of the Duffy (Fy) and Kidd (Jk) blood antigen systems.

143. A panel as in claim 107 wherein said material comprises antigens of the Kell (K) and Cellano (k) blood antigen systems.

144. A panel as in claim 140 wherein said Rh-hr antigens are selected from the croup consisting of D, C, E, c, and e.

145. A panel as in claim 107 wherein said material is selected from the group consisting of HLA antigens and platelet-specific antigens.

146. A panel as in any one of claims 107, 139, 140 or 144 wherein said material comprises a control standard panel for manual or automated antibody detection assays.

147. A control panel as in claim 146 wherein said automated assay comprises use of a deceive selected from the group consisting of an automated pipetting lens or an optical lens.

148. A control panel as in claim 146 wherein said control cells are selected from the group consisting of the ABO blood groups and Rh-hr blood antigen systems.

149. A control panel as in claim 148 wherein said Rh-hr antigens are selected rom the group consisting of D, C, E, c, and e.

150. A control panel as in claim 147 wherein said control cells comprise the HLA antigen system.

151. A control panel as in claim 147 wherein said cells comprise platelet-specific antigens.

153. A kit according to claim 151 further comprising an enhancer for enhancing a desired antibody-antigen reaction.

154. A kit according to claim 150 wherein said enhancer comprises a polymer.

155. A kit according to claim 154 wherein said polymer comprises polyethylene glycol.

156. A kit according to claim 153 wherein said enhancer comprises a protein.

157. A kit according to claim 156 wherein said protein is bovine serum albumin.

158. A kit according to claim 153 wherein said enhancer imparts to said material, when reconstituted, a pH of about 7.2 or lower.

160. A kit according to claim 151 wherein said compartments comprise microplate wells capable of being scored for agglutination.

161. A kit according to claim 151 wherein said compartments comprise chips etched with microliter or submicroliter volume wells, capable of being scored for agglutination.

152. A diagnostic kit for detecting in vitro the presence or absence of a predetermined circulating antibody-type in a plasma or serum sample, said kit comprising a panel of a plurality of compartments, each of said compartments containing a different lyophilized material selected from the group consisting of cells lymphocytes, platelets, peripheral blood cells, stem cells, liposomes, hemosomes, cell membrane ghost, cultured mammalian cells, stroma, hybridoma cells or erythrocytes, lyophilized or dried in the presence of a cryoprotectant comprising a monosaccharide, disaccharide or trisaccharide and at least one biologically compatible amphipathic polymer and wherein each lyophilized material is characterized by one or more antigens which are recognized and bound by a predetermined antibody-type.

159. A kit according to claim 152 wherein said material is selected from the group consisting of.erythrocytes, lymphocytes, platelets, lyposomes and hemosomes.

162. A kit according to claim 152 wherein said lyophilized material is selected from the group consisting of beads, pellets and droplets, and said compartments comprise blister packs accommodating said material.

163. A kit according to claim 152 wherein said material comprises cell membranes.

164. A kit according to claim 163 wherein said cell membranes are mammalian cell membranes.

165. A kit according to claim 164 wherein said cell membranes are selected from the group consisting of cell membranes prepared from erythrocytes, lymphocytes, platelets, peripheral blood cells and stem cells.