What is claimed is:
1. A method for determining a profile data set for a subject with infectious
disease or
inflammatory conditions related to infectious disease based on a sample from
the subject,
the sample providing a source of RNAs, the method comprising:
using amplification for measuring the amount of RNA corresponding to at least
2
constituents from Table 1 and
arriving at a measure of each constituent,
wherein the profile data set comprises the measure of each constituent and
wherein amplification is performed under measurement conditions that are
substantially
repeatable.
2. A method according to claim 1, wherein the subject has presumptive signs of
a
systemic infection including at least one of: elevated white blood cell count,
elevated
temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
3. A method according to claim 1, wherein the inflammatory conditions related
to
infectious disease are inflammatory conditions arising from at least one of:
blunt or
penetrating trauma, surgery, endocarditis, urinary tract infection, pneumonia,
or dental or
gynecological examinations or treatments.
4. A method for determining a profile data set according to claim 1, wherein
the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than five percent.
5. A method for determining a profile data set according to claim 1, wherein
the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than three percent.
6. A method for determining a profile data set according to claim 1, wherein
efficiencies of amplification for all constituents are substantially similar.
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7. A method for determining a profile data set according to claim 6, wherein
the
efficiency of amplification for all constituents is within two percent.
8. A method for determining a profile data set according to claim 6, wherein
the
efficiency of amplification for all constituents is less than one percent.
9. A method according to any of claims 1-8 wherein the sample is selected from
the
group consisting of blood, a blood fraction, body fluid, a population of cells
and tissue
from the subject.
10. A method of characterizing infectious disease or inflammatory conditions
related
to infectious disease in a subject, based on a sample from the subject, the
sample
providing a source of RNAs, the method comprising:
assessing a profile data set of a plurality of members, each member being a
quantitative measure of the amount of a distinct RNA constituent in a panel of
constituents selected so that measurement of the constituents enables
characterization of
the presumptive signs of a systemic infection, wherein such measure for each
constituent
is obtained under measurement conditions that are substantially repeatable.
11. A method according to claim 10, wherein the subject has presumptive signs
of a
systemic infection including at least one of: elevated white blood cell count,
elevated
temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
12. A method according to claim 10, wherein the subject has presumptive signs
of a
systemic infection that are related to inflammatory conditions arising from at
least one of:
blunt or penetrating trauma, surgery, endocarditis, urinary tract infection,
pneumonia, or
dental or gynecological examinations or treatments.
13. A method for characterizing infectious disease or inflammatory conditions
related
to infectious disease in a subject according to claim 10, wherein assessing
further
comprises:
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comparing the profile data set to a baseline profile data set for the panel,
wherein
the baseline profile data set is related to the infectious disease or
inflammatory conditions
related to infectious disease to be characterized.
14. A method for characterizing infectious disease or inflammatory conditions
related
to infectious disease in a subject according to claim 10, wherein efficiencies
of
amplification for all constituents are substantially similar.
15. A method according claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a microbial infection.
16. A method according to claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a bacterial infection.
17. A method according to claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a eukaryotic parasitic
infection.
18. A method according claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a viral infection.
19. A method according claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a fungal infection.
21. A method according claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from systemic inflammatory
response
syndrome (SIRS).
21. A method according to claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from bacteremia, viremia, or
fungemia.
22. A method according to claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from septicemia due to any class
of microbe.
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23. A method according to claim 10, wherein the infectious disease or
inflammatory
conditions related to infectious disease are with respect to a localized
tissue of the subject
and the sample is derived from a tissue of fluid of a type distinct from that
of the
localized tissue.
26. A method according to any of claims 1-9, further comprising:
storing the profile data set in a digital storage medium.
27. A method according to claim 26, wherein storing the profile data set
includes
storing it as a record in a database.
28. A method for evaluating infectious disease or inflammatory conditions
related to
infectious disease in a subject based on a first sample from the subject, the
sample
providing a source of RNAs, the method comprising:
deriving from the first sample a first profile data set, the profile data set
including
a plurality of members, each member being a quantitative measure of the amount
of a
distinct RNA constituent in a panel of constituents selected so that
measurement of the
constituents enables evaluation of the infectious disease or inflammatory
conditions
related to infectious disease wherein such measure for each constituent is
obtained under
measurement conditions that are substantially repeatable; and
producing a calibrated profile data set for the panel, wherein each member of
the
calibrated profile data set is a function of a corresponding member of the
first profile data
set and a corresponding member of a baseline profile data set for the panel,
and wherein
the baseline profile data set is related to the infectious disease or
inflammatory conditions
related to infectious disease to be evaluated,
the calibrated profile data set being a comparison between the first profile
data set
and the baseline profile data set, thereby providing evaluation of the
infectious disease or
inflammatory conditions related to infectious disease of the subject.
29. A method according to claim 28, wherein the subject has presumptive signs
of a
systemic infection including at least one of: elevated white blood cell count,
elevated
temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
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30. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are related to inflammatory
conditions arising
from at least one of: blunt or penetrating trauma, surgery, endocarditis,
urinary tract
infection, pneumonia, or dental or gynecological examinations or treatments.
31. A method according to claim 28, wherein the baseline profile data set is
derived
from one or more other samples from the same subject taken under circumstances
different from those of the first sample.
32. A method according to claim 31, wherein the circumstances are selected
from the
group consisting of (i) the time at which the first sample is taken, (ii) the
site from which
the first sample is taken, (iii) the biological condition of the subject when
the first sample
is taken.
33. A method according to claim 31, wherein the one or more other samples are
taken
over an interval of time that is at least one month between the first sample
and the one or
more other samples.
34. A method according to claim 31, wherein the one or more other samples are
taken
over an interval of time that is at least twelve months between the first
sample and the
one or more samples.
35. A method according to claim 31, wherein the one or more other samples are
taken
pre-therapy intervention.
36. A method according to claim 31, wherein the one or more other samples are
taken
post-therapy intervention.
37. A method according to claim 28, wherein the first sample is derived from
blood
and the baseline profile data set is derived from tissue or body fluid of the
subject other
than blood.
38. A method according to claim 28, wherein the first sample is derived from
tissue or
body fluid of the subject and the baseline profile data set is derived from
blood.
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39. A method according to claim 31, wherein the baseline profile data set is
derived
from one or more other samples from the same subject, taken when the subject
is in a
biological condition different from that in which the subject was at the time
the first
sample was taken, with respect to at least one of age, nutritional history,
medical
condition, clinical indicator, medication, physical activity, body mass, and
environmental
exposure.
40. A method according to claim 28, wherein the baseline profile data set is
derived
from one or more other samples from one or more different subjects.
41. A method according to claim 40, wherein the one or more different subjects
have
in common with the subject at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication, physical
activity, body mass, and environmental exposure.
42. A method according to claim 41, wherein a clinical indicator has been used
to
assess infectious disease or inflammatory conditions related to infectious
disease of the
one or more different subjects, further comprising: interpreting the
calibrated profile data
set in the context of at least one other clinical indicator.
43. A method according to claim 42, wherein the at least one other clinical
indicator
is selected from the group consisting of blood chemistry, urinalysis, X-ray or
other
radiological or metabolic imaging technique, other chemical assays, and
physical
findings.
44. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a microbial infection.
45. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a bacterial infection.
46. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a eukaryotic parasitic
infection.
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47. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a viral infection.
48. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a fungal infection.
49. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from systemic inflammatory
response
syndrome (SIRS).
50. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from bacteremia, viremia, or
fungemia.
51. A method according to claim 28, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from septicemia due to any class
of microbe.
52. A method according to claim 28, wherein the function is a mathematical
function
and is other than a simple difference.
53. A method according to claim 52, wherein the function is a second function
of the
ratio of the corresponding member of first profile data set to the
corresponding member
of the baseline profile data set.
54. A method according to claim 53, wherein the function is a logarithmic
function.
55. A method according to claim 53, wherein each member of the calibrated
profile
data set has biological significance if it has a value differing by more than
an amount D,
where D= F(1.1) - F(.9), and F is the second function.
56. A method according to claim 28, wherein obtaining the first sample and
quantifying the first profile data set are performed at a first location, and
producing the
calibrated profile data set includes using a network to access a database
stored on a digital
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storage medium in a second location.
57. A method according to claim 56, further comprising updating the database
to
reflect the first profile data set quantified from the sample.
58. A method according to claim 56, wherein using a network includes accessing
a
global computer network.
59. A method according to claim 28, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
60. A method according to claim 28 wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 1
percent.
61. A method of providing an index that is indicative of infectious disease or
inflammatory conditions related to infectious disease of a subject based on a
first sample
from the subject, the first sample providing a source of RNAs, the method
comprising:
deriving from the first sample a profile data set, the profile data set
including a
plurality of members, each member being a quantitative measure of the amount
of a
distinct RNA constituent in a panel of constituents selected so that
measurement of the
constituents is indicative of the presumptive signs of a systemic infection,
the panel
including at least two of the constituents of the Gene Expression Panel of
Table 1; and
in deriving the profile data set,
achieving such measure for each constituent under measurement conditions that
are substantially repeatable; and
applying at least one measure from the profile data set to an index function
that provides
a mapping from at least one measure of the profile data set into one measure
of the
presumptive signs of a systemic infection, so as to produce an index pertinent
to the
infectious disease or inflammatory conditions related to infectious disease of
the subject.
62. A method according to claim 61, wherein the subject has presumptive signs
of a
systemic infection including at least one of: elevated white blood cell count,
elevated
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temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
63. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are related to inflammatory
conditions arising
from at least one of: blunt or penetrating trauma, surgery, endocarditis,
urinary tract
infection, pneumonia, or dental or gynecological examinations or treatments.
64. A method of providing an index according to claim 61, wherein the index
function
has 2 components including disease status, disease severity, or disease
course.
65. A method of providing an index according to claim 61, wherein the index
function
has 3 components including disease status, disease severity, or disease
course.
66. A method of providing an index according to claim 61, wherein the index
function
has 4 components including disease status, disease severity, or disease
course.
67. A method of providing an index according to claim 61, wherein the index
function
has 5 components including disease status, disease severity, or disease
course.
68. A method of providing an index according to any one of claims 61-67,
wherein
the index function is constructed as a linear sum of terms having the form:
I = .SIGMA.C i M~(i),
wherein I is the index, M i is the value of the member i of the profile data
set, C i is a
constant, and P(i) is a power to which M i is raised, the sum being formed for
all integral
values of i up to the number of members in the data set.
69. A method of providing an index according to claim 68, wherein the values C
i and
P(i) are determined using statistical techniques, such as latent class
modeling, to correlate
data, including clinical, experimentally derived, and any other data pertinent
to the
presumptive signs of a systemic infection.
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70. A method according to claim 68, further comprising providing with the
index a
normative value of the index function, determined with respect to a relevant
set of
subjects, so that the index may be interpreted in relation to the normative
value.
71. A method according to claim 70, wherein providing the normative value
includes
constructing the index function so that the normative value is approximately
1.
70. A method according to claim 71, wherein providing the normative value
includes
constructing the index function so that the normative value is approximately 0
and
deviations in the index function from 0 are expressed in standard deviation
units.
72. A method according to claim 71, wherein the relevant set of subjects has
in
common a property that is at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication, physical
activity, body mass, and environmental exposure.
73. A method according to claim 72, wherein the relevant set of subjects has
in
common a property that is at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication, physical
activity, body mass, and environmental exposure.
74. A method according to claim 68, wherein a clinical indicator has been used
to
assess the infectious disease or inflammatory conditions related to infectious
disease of
the relevant set of subjects, further comprising: interpreting the calibrated
profile data set
in the context of at least one other clinical indicator
75. A method according to claim 74, wherein the at least one other clinical
indicator
is selected from the group consisting of blood chemistry, urinalysis, X-ray or
other
radiological or metabolic imaging technique, other chemical assays, and
physical
findings.
76. A method according to claim 61, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
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77. A method of providing an index according to claim 61 wherein the
quantitative
measure is determined by amplification, and the measurement conditions are
such that
efficiencies of amplification for all constituents differ by less than
approximately 1
percent.
78. A method for of providing an index according to claim 61, wherein the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than five percent.
79. A method for determining a profile data set according to claim 61, wherein
the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than three percent.
80. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease being evaluated are with respect to a
localized
tissue of the subject and the first sample is derived from tissue or fluid of
a type distinct
from that of the localized tissue.
81. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a microbial infection.
82. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a bacterial infection.
83. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a eukaryotic parasitic
infection.
84. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a viral infection.
85. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a fungal infection.
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86. A method according to claim 61, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from systemic inflammatory
response
syndrome (SIRS).
87. A method of providing an index according to claim 61, further comprising:
deriving from at least one other sample at least one other profile data set,
the at
least one other profile data set including a plurality of members, each being
a quantitative
measure of the amount of a distinct RNA constituent in a panel of constituents
selected so
that measurement of the constituents is indicative of the presumptive signs of
a systemic
infection,
wherein the at least one other sample is from the same subject, taken under
circumstances different from those of the first sample with respect to at
least one of time,
nutritional history, medical condition, clinical indicator, medication,
physical activity,
body mass, and environmental exposure; and
applying at least one measure from the at least one other profile data set to
an
index function that provides a mapping from the at least one measure of the at
least one
other profile data set into one measure of the infectious disease or
inflammatory
conditions related to infectious disease under different circumstances, so as
to produce at
least one other index pertinent to the infectious disease or inflammatory
conditions
related to infectious disease of the subject under circumstances different
from those of the
first sample.
88. A method according to claim 87, wherein the relevant set of subjects has
in
common a property that is at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication, physical
activity, body mass, and environmental exposure.
89. A method according to claim 88, wherein the relevant set of subjects has
in
common a property that is at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication, physical
activity, body mass, and environmental exposure.
90. A method of providing an index according to claim 87, wherein the index
function
has 2 components including disease status, disease severity, or disease
course.
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91. A method of providing an index according to claim 87, wherein the index
function
has 3 components including disease status, disease severity, or disease
course.
92. A method of providing an index according to claim 87, wherein the index
function
has 4 components including disease status, disease severity, or disease
course.
93. A method of providing an index according to claim 87, wherein the index
function
has 5 components including disease status, disease severity, or disease
course.
94. A method of providing an index according to any one of claims 87-93,
wherein
the index function is constructed as a linear sum of terms having the form:
I = .SIGMA.C i M~(i),
wherein I is the index, M i is the value of the member i of the profile data
set, C i is a
constant, and P(i) is a power to which M i is raised, the sum being formed for
all integral
values of i up to the number of members in the data set.
95. A method of providing an index according to claim 94, wherein the values C
i and
P(i) are determined using statistical techniques, such as latent class
modeling, to correlate
data, including clinical, experimentally derived, and any other data pertinent
to the
presumptive signs of a systemic infection.
96. A method according to claim 87, further comprising providing with the at
least
one other index a normative value of the index function, determined with
respect to a
relevant set of subjects, so that the at least one other index may be
interpreted in relation
to the normative value.
97. A method according to claim 96, wherein providing the normative value
includes
constructing the index function so that the normative value is approximately
1.
98. A method according to claim 97, wherein providing the normative value
includes
constructing the index function so that the normative value is approximately 0
and
deviations in the index function from 0 are expressed in standard deviation
units.
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99. A method according to claim 94, wherein a clinical indicator has been used
to
assess infectious disease or inflammatory conditions related to infectious
disease of the
relevant set of subjects, further comprising: interpreting the calibrated
profile data set in
the context of at least one other clinical indicator.
100. A method according to claim 139, wherein the at least one other clinical
indicator
is selected from the group consisting of blood chemistry, urinalysis, X-ray or
other
radiological or metabolic imaging technique, other chemical assays, and
physical
findings.
101. A method according to claim 87, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
102. A method of providing an index according to claim 87 wherein the
quantitative
measure is determined by amplification, and the measurement conditions are
such that
efficiencies of amplification for all constituents differ by less than
approximately 1
percent.
103. A method for of providing an index according to claim 87, wherein the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than five percent.
104. A method for determining a profile data set according to claim 87,
wherein the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than three percent.
105. A method according to claim 87, wherein the infectious disease or
inflammatory
conditions related to infectious disease being evaluated are with respect to a
localized
tissue of the subject and the first sample is derived from tissue or fluid of
a type distinct
from that of the localized tissue.
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106. A method according to claim 87, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a microbial infection and
the panel of
constituents includes at least two constituents of Table 1.
107. A method according to claim 87, wherein the infectious disease or
inflammatory
conditions related to infectious disease are from a bacterial infection and
the panel of
constituents includes at least two constituents of Table 1.
108. A method according to claim 87, wherein the is a eukaryotic parasitic
infection
and the panel of constituents includes at least two constituents of Table 1.
109. A method according to claim 87, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a viral infection and the panel of
constituents
includes at least two constituents of Table 1.
110. A method according to claim 87, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a fungal infection and the panel
of constituents
includes at least two constituents of Table X.
111. A method according to claim 87, wherein the infectious disease or
inflammatory
conditions related to infectious disease is systemic inflammatory response
syndrome
(SIRS) and the panel of constituents includes at least two constituents of
Table X.
presumptive signs of a systemic infection.
112. A method for evaluating infectious disease or inflammatory conditions
related to
infectious disease of a subject based on a first sample from the subject, the
first sample
providing a source of RNAs, the method comprising:
deriving from the first sample a first profile data set, the first profile
data set
including a plurality of members, each member being a quantitative measure of
the
amount of a distinct RNA constituent in a panel of constituents selected so
that
measurement of the constituents enables evaluation of the infectious disease
or
inflammatory conditions related to infectious disease wherein such measure for
each
constituent is obtained under measurement conditions that are substantially
repeatable;
and
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producing a calibrated profile data set for the panel, wherein each member of
the
calibrated profile data set is a function of a corresponding member of the
first profile data
set and a corresponding member of a baseline profile data set for the panel,
wherein each
member of the baseline profile data set is a normative measure determined with
respect to
a relevant set of subjects of the amount of one of the constituents in the
panel and the
baseline profile data set is related to the infectious disease or inflammatory
conditions
related to infectious disease to be evaluated,
the calibrated profile data set being a comparison between the first profile
data set
and the baseline profile data set, thereby providing evaluation of the
infectious disease or
inflammatory conditions related to infectious disease of the subject.
113. A method according to claim 112, wherein the subject has presumptive
signs of a
systemic infection including at least one of: elevated white blood cell count,
elevated
temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
114. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease are related to inflammatory
conditions arising
from at least one of blunt or penetrating trauma, surgery, endocarditis,
urinary tract
infection, pneumonia, or dental or gynecological examinations or treatments.
113. A method according to claim 112, wherein the relevant set of subjects is
a set of
healthy subjects.
114. A method according to claim 112, wherein the relevant set of subjects has
in
common a property that is at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication, physical
activity, body mass, and environmental exposure.
115. A method according to claim 114, wherein a clinical indicator has been
used to
assess infectious disease or inflammatory conditions related to infectious
disease of the
relevant set of subjects, further comprising: interpreting the calibrated
profile data set in
the context of at least one other clinical indicator.
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116. A method according to claim 115, wherein the at least one other clinical
indicator
is selected from the group consisting of blood chemistry, urinalysis, X-ray or
other
radiological or metabolic imaging technique, other chemical assays, and
physical
findings.
117. A method according to claim 112, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
118. A method according to claim 112, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 1
percent.
119. A method according to claim 112, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
five percent.
120. A method according to claim 112, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
three percent.
121. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease being evaluated is with respect to a
localized
tissue of the subject and the first sample is derived from tissue or fluid of
a type distinct
from that of the localized tissue.
122. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a microbial infection.
123. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a bacterial infection.
124. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a eukaryotic parasitic infection.
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125. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a viral infection.
126 A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a fungal infection.
127. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is systemic inflammatory response
syndrome
(SIRS).
128. A method according to any one of claims 112, wherein the infectious
disease or
inflammatory conditions related to infectious disease is bacteremia, viremia,
or fungemia.
129. A method according to claim 112, wherein the infectious disease or
inflammatory
conditions related to infectious disease is septicemia due to any class of
microbe.
130. A method according to claim 112, further comprising:
storing the profile data set in a digital storage medium.
131. A method according to claim 130, wherein storing the profile data set
includes
storing it as a record in a database.
132. A method according to claim 112, wherein the baseline profile data set is
derived
from one or more other samples from the same subject taken under circumstances
different from those of the first sample.
133. A method according to claim 132, wherein the one or more other samples
are
taken pre-therapy intervention.
134. A method according to claim 132, wherein the one or more other samples
are
taken post-therapy intervention.
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135. A method according to claim 132, wherein the one or more other samples
are
taken over an interval of time that is at least one month between an initial
sample and the
sample.
136. A method according to claim 132, wherein the one or more other samples
are
taken over an interval of time that is at least twelve months between an
initial sample and
the sample.
137. A method according to claim 112, wherein the first sample is derived from
blood
and the baseline profile data set is derived from tissue or body fluid of the
subject other
than blood.
138. A method according to claim 112, wherein the first sample is derived from
tissue
or body fluid of the subject and the baseline profile data set is derived from
blood.
139. A method for evaluating infectious disease or inflammatory conditions
related to
infectious disease of a subject based on a first sample from the subject and a
second
sample from a defined population of indicator cells, the samples providing a
source of
RNAs, the method comprising:
applying the first sample or a portion thereof to the defined population of
indicator cells;
deriving from the second sample a first profile data set, the first profile
data set
including a plurality of members, each member being a quantitative measure of
the
amount of a distinct RNA or protein constituent in a panel of constituents
selected so that
measurement of the constituents enables measurement of the presumptive signs
of a
systemic infection, wherein such measure for each constituent is obtained
under
measurement conditions that are substantially repeatable; and
producing a calibrated profile data set for the panel, wherein each member of
the
calibrated profile data set is a function of a corresponding member of the
first profile data
set and a corresponding member of a baseline profile data set for the panel,
wherein each
member of the baseline data set is a normative measure determined with respect
to a
relevant set of subjects of the amount of one of the constituents in the panel
and wherein
the baseline profile data set is related to the infectious disease or
inflammatory conditions
related to infectious disease to be evaluated,
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the calibrated profile data set being a comparison between the first profile
data set
and the baseline profile data set, thereby providing evaluation of the
infectious disease or
inflammatory conditions related to infectious disease of the subject.
140. A method according to claim 139, wherein the subject has presumptive
signs of a
systemic infection including at least one of: elevated white blood cell count,
elevated
temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
141. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease are related to inflammatory
conditions arising
from at least one of: blunt or penetrating trauma, surgery, endocarditis,
urinary tract
infection, pneumonia, or dental or gynecological examinations or treatments.
142. A method according to claim 139, wherein the relevant set of subjects is
a set of
healthy subjects.
143. A method according to claim 139, wherein the relevant set of subjects has
in
common a property that is at least one of age group, gender, ethnicity,
geographic
location, nutritional history, medical condition, clinical indicator,
medication,
physical activity, body mass, and environmental exposure.
144. A method according to claim 143, wherein a clinical indicator has been
used to
assess infectious disease or inflammatory conditions related to infectious
disease of the
relevant set of subjects, further comprising: interpreting the calibrated
profile data set in
the context of at least one other clinical indicator.
145. A method according to claim 144, wherein the at least one other clinical
indicator
is selected from the group consisting of blood chemistry, urinalysis, X-ray or
other
radiological or metabolic imaging technique, other chemical assays, and
physical
findings.
146. A method according to claim 139, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
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amplification for all constituents differ by less than approximately 2
percent.
147. A method according to claim 139, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 1
percent.
148. A method according to claim 139, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
five percent.
149. A method according to claim 139, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
three percent.
150. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease being evaluated is with respect to a
localized
tissue of the subject and the first sample is derived from tissue or fluid of
a type distinct
from that of the localized tissue.
151. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a microbial infection.
152. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a bacterial infection.
153. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a eukaryotic parasitic infection.
154. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a viral infection.
155. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a fungal infection.
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156. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is systemic inflammatory response
syndrome
(SIRS).
157. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is bacteremia, viremia, or fungemia.
158. A method according to claim 139, wherein the infectious disease or
inflammatory
conditions related to infectious disease is septicemia due to any class of
microbe.
159. A method according to claim 139, further comprising:
storing the profile data set in a digital storage medium.
160. A method according to claim 139, wherein storing the profile data set
includes
storing it as a record in a database.
161. A method according to claim 139, wherein the baseline profile data set is
derived
from one or more other samples from the same subject taken under circumstances
different from those of the first sample.
162. A method according to claim 161, wherein the one or more other samples
are
taken pre-therapy intervention.
163. A method according to claim 161, wherein the one or more other samples
are
taken post-therapy intervention.
164. A method according to claim 161, wherein the one or more other samples
are
taken over an interval of time that is at least one month between an initial
sample and the
sample.
165. A method according to claim 161, wherein the one or more other samples
are
taken over an interval of time that is at least twelve months between an
initial sample and
the sample.
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166. A method according to claim 139, wherein the first sample is derived from
blood
and the baseline profile data set is derived from tissue or body fluid of the
subject other
than blood.
167. A method according to claim 139, wherein the first sample is derived from
tissue
or body fluid of the subject and the baseline profile data set is derived from
blood.
168. A method for evaluating infectious disease or inflammatory conditions
related to
infectious disease of a target population of cells affected by a first agent,
based on a
sample from the target population of cells to which the first agent has been
administered,
the sample providing a source of RNAs, the method comprising:
deriving from the sample a first profile data set, the first profile data set
including
a plurality of members, each member being a quantitative measure of the amount
of a
distinct RNA constituent in a panel of constituents selected so that
measurement of the
constituents enables evaluation of the infectious disease or inflammatory
conditions
related to infectious disease affected by the first agent, wherein such
measure for each
constituent is obtained under measurement conditions that are substantially
repeatable;
and
producing a calibrated profile data set for the panel, wherein each member of
the
calibrated profile data set is a function of a corresponding member of the
first profile data
set and a corresponding member of a baseline profile data set for the panel,
wherein each
member of the baseline data set is a normative measure determined with respect
to a
relevant set of target populations of cells of the amount of one of the
constituents in the
panel, and wherein the baseline profile data set is related to the infectious
disease or
inflammatory conditions related to infectious disease to be evaluated
the calibrated profile data set being a comparison between the first profile
data set
and the baseline profile data set, thereby providing an evaluation of the
infectious disease
or inflammatory conditions related to infectious disease of the target
population of cells
affected by the first agent.
169. A method according to claim 168, wherein the target population of cells
has
presumptive signs of a systemic infection including at least one of: elevated
white blood
cell count, elevated temperature, elevated heart rate, and elevated or reduced
blood
pressure, relative to medical standards.
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170. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease are related to inflammatory
conditions arising
from at least one of: blunt or penetrating trauma, surgery, endocarditis,
urinary tract
infection, pneumonia, or dental or gynecological examinations or treatments.
171. A method according to claim 168, wherein the relevant set of target
populations of
cells is a set of healthy target populations of cells.
172. A method according to claim 168, wherein the relevant set of target
populations of
cells has in common a property that is at least one of age group, gender,
ethnicity,
geographic location, nutritional history, medical condition, clinical
indicator,
medication, physical activity, body mass, and environmental exposure.
173. A method according to claim 172, wherein a clinical indicator has been
used to
assess infectious disease or inflammatory conditions related to infectious
disease of the
relevant set of target populations of cells, further comprising: interpreting
the calibrated
profile data set in the context of at least one other clinical indicator.
174. A method according to claim 173, wherein the at least one other clinical
indicator
is selected from the group consisting of blood chemistry, urinalysis, X-ray or
other
radiological or metabolic imaging technique, other chemical assays, and
physical
findings.
175. A method according to claim 168, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
176. A method according to claim 168, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 1
percent.
177. A method according to claim 168, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
five percent.
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178. A method according to claim 168, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
three percent.
179. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease being evaluated is with respect to a
localized
tissue of the subject and the first sample is derived from tissue or fluid of
a type distinct
from that of the localized tissue.
180. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a microbial infection.
181. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a bacterial infection.
182. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a eukaryotic parasitic infection.
183. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a viral infection.
184. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a fungal infection.
185. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is systemic inflammatory response
syndrome
(SIRS).
186. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is bacteremia, viremia, or
fungemia...
187. A method according to claim 168, wherein the infectious disease or
inflammatory
conditions related to infectious disease is septicemia due to any class of
microbe.
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188. A method according to claim 168, further comprising:
storing the profile data set in a digital storage medium.
189. A method according to claim 188, wherein storing the profile data set
includes
storing it as a record in a database.
190. A method according to claim 168, wherein the first sample is derived from
blood
and the baseline profile data set is derived from tissue or body fluid of the
subject other
than blood.
191. A method according to claim 168, wherein the first sample is derived from
tissue
or body fluid of the subject and the baseline profile data set is derived from
blood.
192. A method according to claim 168, wherein the baseline profile data set is
derived
from one or more other samples from the same subject taken under circumstances
different from those of the first sample.
193. A method according to claim 192, wherein the one or more other samples
are
taken pre-therapy intervention.
194. A method according to claim 192, wherein the one or more other samples
are
taken post-therapy intervention.
195. A method according to claim 192, wherein the one or more other samples
are
taken over an interval of time that is at least one month between an initial
sample and the
sample.
196. A method for evaluating infectious disease or inflammatory conditions
related to
infectious disease of a target population of cells affected by a first agent
in relation to the
infectious disease or inflammatory conditions related to infectious disease of
the target
population of cells affected by a second agent, based on a first sample from
the target
population cells to which the first agent has been administered and a second
sample from
the target population of cells to which the second agent has been
administered, the
samples providing a source of RNAs, the method comprising:
deriving from the first sample a first profile data set and from the second
sample a
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second profile data set, the first and second profile data sets each including
a plurality of
members, each member being a quantitative measure of the amount of a distinct
RNA
constituent in a panel of constituents selected so that measurement of the
constituents
enables evaluation of the infectious disease or inflammatory conditions
related to
infectious disease affected by the first agent in relation to the second
agent, wherein such
measure for each constituent is obtained under measurement conditions that are
substantially repeatable; and
producing a first calibrated profile data set and a second calibrated profile
data set
for the panel, wherein (i) each member of the first calibrated profile data
set is a function
of a corresponding member of the first profile data set and a corresponding
member of a
baseline profile data set for the panel, and (ii) each member of the second
calibrated
profile data set is a function of a corresponding member of the second profile
data set and
a corresponding member of the baseline profile data set, wherein each member
of the
baseline data set is a normative measure, determined with respect to a
relevant set of
subjects, of the amount of one of the constituents in the panel, and wherein
the baseline
profile data set is related to the infectious disease or inflammatory
conditions related to
infectious disease to be evaluated,
the first and second calibrated profile data sets being a comparison between
the
first profile data set and the baseline profile set and a comparison between
the second
profile data set and the baseline profile data set, thereby providing an
evaluation of the
infectious disease or inflammatory conditions related to infectious disease of
the target
population of cells affected by the first agent in relation to the infectious
disease or
inflammatory conditions related to infectious disease of the target population
of cells
affected by the second agent.
197. A method according to claim 196, wherein the target population of cells
has
presumptive signs of a systemic infection including at least one of: elevated
white blood
cell count, elevated temperature, elevated heart rate, and elevated or reduced
blood
pressure, relative to medical standards.
198. A method according to claim 196, wherein the target population of cells
has
presumptive signs of a systemic infection that are related to inflammatory
conditions
arising from at least one of: blunt or penetrating trauma, surgery,
endocarditis, urinary
tract infection, pneumonia, or dental or gynecological examinations or
treatments.
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199. A method according to claim 196, wherein the first agent is a first drug
and the
second agent is a second drug.
200. A method according to claim 196, wherein the first agent is a drug and
the second
agent is a complex mixture.
201. A method according to claim 196, wherein the first agent is a drug and
the second
agent is a nutriceutical.
202. A method according to claim 196, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
203. A method according to claim 196, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 1
percent.
204. A method according to claim 196, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
five percent.
205. A method according to claim 196, wherein the measurement conditions that
are
substantially repeatable are within a degree of repeatability of better than
three percent.
206. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease being evaluated is with respect to a
localized
tissue of the subject and the first sample is derived from tissue or fluid of
a type distinct
from that of the localized tissue.
207. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a microbial infection.
208. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a bacterial infection.
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209. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a eukaryotic parasitic infection.
210. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a viral infection.
211. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is a fungal infection.
212. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is systemic inflammatory response
syndrome
(SIRS).
213. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is bacteremia, viremia, or fungemia.
214. A method according to claim 196, wherein the infectious disease or
inflammatory
conditions related to infectious disease is septicemia due to any class of
microbe.
215. A method according to claim 196, further comprising:
storing the first and second profile data sets in a digital storage medium.
216. A method according to claim 196, wherein storing the first and second
profile data
sets includes storing each data set as a record in a database.
217. A method according to claim 196, wherein the baseline profile data set is
derived
from one or more other samples from the same subject taken under circumstances
different from those of the first sample.
218. A method according to claim 196, wherein the baseline profile data set is
derived
from one or more other samples from the same subject taken under circumstances
different from those of the second sample.
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219. A method according to claim 196, wherein the first sample is derived from
blood
and the baseline profile data set is derived from tissue or body fluid of the
subject other
than blood.
220. A method according to claim 196, wherein the first sample is derived from
tissue
or body fluid of the subject and the baseline profile data set is derived from
blood.
221. A method of providing an index that is indicative of an inflammatory
condition of
a subject with presumptive signs of a systemic infection, based on a first
sample from the
subject, the first sample providing a source of RNAs, the method comprising:
deriving from the first sample a profile data set, the profile data set
including a
plurality of members, each member being a quantitative measure of the amount
of a
distinct RNA constituent in a panel of constituents selected so that
measurement of the
constituents is indicative of the inflammatory condition, the panel including
at least two
of the constituents of the Gene Expression Panel of Table 1; and
in deriving the profile data set,
achieving such measure for each constituent under measurement conditions that
are substantially repeatable;
applying at least one measure from the profile data set to an index function
that
provides a mapping from at least one measure of the profile data set into at
least one
measure of the inflammatory condition, so as to produce an index pertinent to
the
inflammatory condition of the sample;
wherein the index function uses data from a baseline profile data set for the
panel,
each member of the baseline data set being a normative measure, determined
with respect
to a relevant set of subjects, of the amount of one of the constituents in the
panel, wherein
the baseline data set is related to the inflammatory condition to be
evaluated.
222. A method according to claim 221, wherein the subject has presumptive
signs of a
systemic infection including at least one of: elevated white blood cell count,
elevated
temperature, elevated heart rate, and elevated or reduced blood pressure,
relative to
medical standards.
223. A method according to claim 221, wherein the presumptive signs of a
systemic
infection are related to inflammatory conditions arising from at least one of:
blunt or
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penetrating trauma, surgery, endocarditis, urinary tract infection, pneumonia,
or dental or
gynecological examinations or treatments.
224. A method of providing an index according to claim 221, wherein the index
function has 2 components including disease status, disease severity, or
disease course.
225. A method of providing an index according to claim 221, wherein the index
function has 3 components including disease status, disease severity, or
disease course.
226. A method of providing an index according to claim 221, wherein the index
function has 4 components including disease status, disease severity, or
disease course.
227. A method of providing an index according to claim 221, wherein the index
function has 5 components including disease status, disease severity, or
disease course.
228. A method of providing an index according to any one of claims 221-227,
wherein
the index function is constructed as a linear sum of terms having the form:
<IMG>
wherein I is the index, M; is the value of the member i of the profile data
set, C i is a
constant, and P(i) is a power to which M i is raised, the sum being formed for
all integral
values of i up to the number of members in the data set.
229. A method of providing an index according to claim 228, wherein the values
C i
and P(i) are determined using statistical techniques, such as latent class
modeling, to
correlate data, including clinical, experimentally derived, and any other data
pertinent to
the presumptive signs of a systemic infection.
230. A method according to claim 221, further comprising providing with the
index a
normative value of the index function, determined with respect to a relevant
set of
subjects, so that the index may be interpreted in relation to the normative
value.
231. A method according to claim 221, wherein the quantitative measure is
determined
by amplification, and the measurement conditions are such that efficiencies of
amplification for all constituents differ by less than approximately 2
percent.
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232. A method of providing an index according to claim 221 wherein the
quantitative
measure is determined by amplification, and the measurement conditions are
such that
efficiencies of amplification for all constituents differ by less than
approximately 1
percent.
234. A method for of providing an index according to claim 221, wherein the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than five percent.
235. A method for determining a profile data set according to claim 221,
wherein the
measurement conditions that are substantially repeatable are within a degree
of
repeatability of better than three percent.
236. A method according to claim 221, wherein the inflammatory condition being
evaluated is with respect to a localized tissue of the subject and the first
sample is derived
from tissue or fluid of a type distinct from that of the localized tissue.
237. A method according to claim 221, wherein the inflammatory condition is a
microbial infection.
238. A method according to claim 221, wherein the inflammatory condition is a
bacterial infection.
239. A method according to claim 221, wherein the inflammatory condition is a
eukaryotic parasitic infection.
240. A method according to claim 221, wherein the inflammatory condition is a
viral
infection.
241. A method according to claim 221, wherein the inflammatory condition is a
fungal
infection.
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242. A method according to claim 221, wherein the inflammatory condition is
systemic
inflammatory response syndrome (SIRS).
243. A method of providing an index according to claim 221, further
comprising:
deriving from at least one other sample at least one other profile data set,
the at
least one other profile data set including a plurality of members, each being
a quantitative
measure of the amount of a distinct RNA constituent in a panel of constituents
selected so
that measurement of the constituents is indicative of the inflammatory
condition,
wherein the at least one other sample is from the same subject, taken under
circumstances different from those of the first sample with respect to at
least one of time,
nutritional history, medical condition, clinical indicator, medication,
physical activity,
body mass, and environmental exposure; and
applying at least one measure from the at least one other profile data set to
an
index function that provides a mapping from the at least one measure of the at
least one
other profile data set into at least one measure of the inflammatory condition
under
different circumstances, so as to produce at least one other index pertinent
to the
inflammatory condition of the subject under circumstances different from those
of the
first sample.
244. A method of using an index to direct therapy intervention in a subject
with
infectious disease or inflammatory conditions related to infectious disease,
the method
comprising:
providing an index according to any of claims 61, 87, 221 or 243;
comparing the index to a normative value of the index, determined with respect
to
a relevant set of subjects to obtain a difference;
using the difference between the index and the normative value for the index
to
direct therapy intervention.
245. A method of using an index to direct therapy intervention according to
claim 244,
wherein the therapy intervention is microbe-specific therapy.
246. A method of using an index to direct therapy intervention according to
claim 244,
wherein the therapy intervention is bacteria-specific therapy.
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247. A method of using an index to direct therapy intervention according to
claim 244,
wherein the therapy intervention is fungus-specific therapy.
248. A method of using an index to direct therapy intervention according to
claim 244,
wherein the therapy intervention is virus-specific therapy.
249. A method of using an index to direct therapy intervention according to
claim 244,
wherein the therapy intervention is eukaryotic parasite-specific therapy.
250. A method of using an index to direct therapy intervention according to
claim 244,
wherein the therapeutic intervention is toward the host immune system.
251. A method for differentiating a type of pathogen within a class of
pathogens of
interest in a subject with infectious disease or inflammatory conditions
related to
infectious disease, based on at least one sample from the subject, the sample
providing a
source of RNA, the method comprising:
determining at least one profile data set according to claim 1 for the
subject;
comparing the profile data set to at least one baseline profile data set,
determined
with respect to at least one relevant set of samples within the class of
pathogens of
interest to obtain a difference;
using the difference to differentiate the type of pathogen in the at least one
profile
data set for the subject from the class of pathogen in the at least one
baseline profile data
set.
252. A method for differentiating the type of pathogen within a class of
pathogens
according to claim 251 wherein the class of pathogens is microbial.
253. A method for differentiating the type of pathogen within a class of
pathogens
according to claim 252 wherein the class of pathogens is bacterial.
254. A method for differentiating the type of pathogen within the class of
bacteria
pathogens according to claim 253 wherein the difference is used to
differentiate a
Gram(+) bacterial pathogen from a Gram(-) bacterial pathogen.
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255. A method for differentiating the type of pathogen within a class of
pathogens
according to claim 252 wherein the class of pathogens is fungal.
256. A method for differentiating the type of pathogen within the class of
fungal
pathogens according to claim 255 wherein the difference is used to
differentiate an acute
Candida pathogen from a chronic Candida pathogen.
257. A method for differentiating the type of pathogen within a class of
pathogens
according to claim 252 wherein the class of pathogens is viral.
258. A method for differentiating the type of pathogen within the class of
viral
pathogens according to claim 257 wherein the difference is used to
differentiate a DNA
viral pathogen from an RNA viral pathogen.
259. A method for differentiating the type of pathogen within the class of
viral
pathogens according to claim 257 wherein the difference is used to
differentiate a
rhinovirus pathogen from an influenza pathogen.
260. A method for differentiating the type of pathogen within a class of
pathogens
according to claim 252 wherein the class of pathogens is eukaryotic parasites.
261. A method for differentiating the type of pathogen within the class of
eukaryotic
parasite pathogens according to claim 260 wherein the difference is used to
differentiate a
plasmodium. parasite pathogen from a trypanosomal pathogen.
262. A method of using an index for differentiating a type of pathogen within
a class of
pathogens of interest in a subject with infectious disease or inflammatory
conditions
related to infectious disease, based on at least one sample from the subject,
the method
comprising:
providing at least one index according to any of claims 61, 87, 221 or 243 for
the
subject;
comparing the at least one index to at least one normative value of the index,
determined with respect to at least one relevant set of subjects to obtain at
least one
difference;
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using the at least one difference between the at least one index and the at
least one
normative value for the index to differentiate the type of pathogen from the
class of
pathogen.
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