U.S. patent application number 16/714618 was filed with the patent office on 2020-04-16 for system for collecting and displaying diagnostics from diagnostic instruments.
This patent application is currently assigned to Quidel Corporation. The applicant listed for this patent is Quidel Corporation. Invention is credited to David Dickson BOOKER, Cheryl Marie MILLER.
Application Number | 20200118692 16/714618 |
Document ID | / |
Family ID | 52988414 |
Filed Date | 2020-04-16 |
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United States Patent
Application |
20200118692 |
Kind Code |
A1 |
BOOKER; David Dickson ; et
al. |
April 16, 2020 |
SYSTEM FOR COLLECTING AND DISPLAYING DIAGNOSTICS FROM DIAGNOSTIC
INSTRUMENTS
Abstract
A system including multiple diagnostic instruments, each
diagnostic instrument including a detector that interacts with a
test assay is provided. At least one diagnostic instrument is
configured to automatically associate the test assay with multiple
values to generate a diagnostic. The diagnostic may be stored
within a memory of the diagnostic instrument, and the multiple
values may be related to one or more of: a test assay identifier, a
test assay result, a patient identifier, and a diagnostic
instrument identifier. At least one diagnostic instrument in the
system may be configured to transmit the diagnostic to a first
server for storage. The first server being configured to generate a
report based on the diagnostic from each diagnostic instrument for
display on a second server or on an end-user workstation. Methods
for use the above system are also provided.
Inventors: |
BOOKER; David Dickson;
(Albuquerque, NM) ; MILLER; Cheryl Marie;
(Evanston, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Quidel Corporation |
San Diego |
CA |
US |
|
|
Assignee: |
Quidel Corporation
|
Family ID: |
52988414 |
Appl. No.: |
16/714618 |
Filed: |
December 13, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15127379 |
Sep 19, 2016 |
10541056 |
|
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PCT/US2015/021731 |
Mar 20, 2015 |
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16714618 |
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61968160 |
Mar 20, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H 50/80 20180101;
G06F 16/951 20190101; G01N 33/48792 20130101; G16H 10/40
20180101 |
International
Class: |
G16H 50/80 20060101
G16H050/80; G01N 33/487 20060101 G01N033/487; G16H 10/40 20060101
G16H010/40; G06F 16/951 20060101 G06F016/951 |
Claims
1-23. (canceled)
24. A computer-implemented method, comprising: retrieving a data
set from a database, wherein the data set is transferred to the
database by a diagnostic instrument, and wherein the data set
comprises a diagnostic result based on a presence of a
disease-associated analyte or infectious disease agent in a sample
analyzed by the diagnostic instrument; evaluating a statistical
parameter based on the data set and on a database information
comprising a data from one or more of multiple diagnostic
instruments distributed across a geographic area; forming a report
based on the data set and the statistical parameter; and providing
the report to an end user.
25. The computer-implemented method of claim 24, wherein retrieving
the data set from a database comprises querying the database for a
newly transferred data set from one or more of the diagnostic
instruments.
26. The computer-implemented method of claim 24, wherein retrieving
a data set from a database comprises querying the database at a
pre-determined frequency, and increasing the pre-determined
frequency during an infectious disease outbreak.
27. The computer-implemented method of claim 24, wherein evaluating
a statistical parameter based on the data set comprises evaluating
a percentage proportion of positive diagnostic results based on a
location of one or more of the diagnostic instruments.
28. The computer-implemented method of claim 24, wherein forming a
report based on the data set and the statistical parameter
comprises forming a chart indicating multiple results trends for
one or more diseases, over time.
29. The computer-implemented method of claim 24, wherein providing
the report to the end user comprises providing to the end user an
interface to access the database, to browse or to query multiple
data sets stored in the database.
30. The computer-implemented method of claim 24, wherein providing
the report to the end user comprises displaying at least a portion
of the data set on a display interface of an end user device.
31. The computer-implemented method of claim 24, wherein providing
the report to the end user comprises allowing the end user to
manipulate the report on a graphic display of an end user
device.
32. The computer-implemented method of claim 24, wherein providing
the report to the end user comprises displaying the data set based
on a date when one or more diagnostic results were obtained, a type
of each of the one or more diagnostic results, and a location of
each of one or more diagnostic instruments providing the one or
more diagnostic results.
33. The computer-implemented method of claim 24, wherein providing
the report to the end user comprises selecting a regularly
scheduled frequency for sending the report to the end user.
34. A system, comprising: a data base storing a data set, wherein
the data set is transferred to the data base by a diagnostic
instrument, and wherein the data set comprises a diagnostic result
based on a presence of a disease-associated analyte or infectious
disease agent in a sample analyzed by the diagnostic instrument; a
memory storing an instruction; and a processor configured to
execute the instruction and cause the system to: retrieve the data
set from the data base; evaluate a statistical parameter based on
the data set and a database information comprising a data from one
or more of the diagnostic instruments; form a report based on the
data set and the statistical parameter; and provide the data report
to an end user.
35. The system of claim 34, wherein to retrieve the data set from a
database, the system is configured to query the database for a
newly transferred data set from one or more of the diagnostic
instruments.
36. The system of claim 34, wherein to retrieve a data set from a
database, the system is configured to query the database at a
pre-determined frequency, and to increase the pre-determined
frequency during an infectious disease outbreak.
37. The system of claim 34, wherein to evaluate a statistical
parameter based on the data set the system is configured to
evaluate a percentage proportion of positive diagnostic results
based on a location of the diagnostic instrument.
38. The system of claim 34, wherein the database is configured to
store the data set from the diagnostic instrument based on an owner
identification of the data set.
39. The system of claim 34, further configured to provide the
report to a designated end user based on an owner identification of
the data set, on a schedule selected by the designated end
user.
40. The system of claim 34, wherein to form a report based on the
data set, the system is further configured to select a
characteristic of the data set, and to provide the report to a
designated end user, wherein the characteristic is provided by the
end user.
41. The system of claim 34, wherein to form a report based on the
data set and the statistical parameter the system is configured to
combine a first portion of a first data set from a first diagnostic
instrument with a second portion of a second data set from a second
diagnostic instrument in a custom report based on an end user
request.
42. The system of claim 34, wherein to form a report based on the
data set and the statistical parameter, the system is configured to
generate a graphical representation of the data set in a display
for the end user.
43. The system of claim 34, wherein the data set comprises an owner
identification, and to provide the data report to an end user the
system is further configured to verify that the end user is one of
multiple designated users based on the owner identification.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/968,160, filed Mar. 20, 2014, which is
incorporated by reference herein.
TECHNICAL FIELD
[0002] The present disclosure is directed to networked systems for
clinical diagnostics, surveillance, data analysis and reporting to
health organizations. The systems described herein automate the
process of generating a database containing current clinical
diagnostic data and reporting clinical diagnostic results to
concerned organizations and agencies in a timely manner.
BACKGROUND
[0003] Clinical diagnostics is a rapidly growing field of medicine
which has been greatly facilitated by the explosive increase in the
determination of pathogen structure including nucleic acid
sequences (genomic sequence data) and proteomics. Coupled to this
rapid increase in sequence knowledge has been the vast improvement
of detection techniques, specifically, immunohistochemistry for the
detection of proteins and nucleic acid amplification and detection
for the detection of nucleic acids. To fully benefit from these
improved detection methods, it is critical to automate, wherever
possible, the various diagnostic methods. Such automation reduces
the need for tedious tasks and high level personnel and reduces
introduction of human error.
[0004] As the number of clinical diagnostic tests increases as well
as the number of patients undergoing such tests, the task of
collecting and storing the resultant data has increasing importance
and difficulty. Not only do the data need to be stored for current
and later use, the data need to readily accessible and easy to
manipulate by pertinent parties.
[0005] As explained by the Centers for Disease Control and
Prevention (CDC), Electronic Laboratory Reporting (ELR) is the
automated transmission of laboratory-related data from commercial,
public health, hospital, and other labs to state and local public
health departments thorough an electronic health records (EHR)
system or a Laboratory Information Management System (LIMS). ELR
helps identify reportable conditions determined by confirmatory
testing and supports case reporting at the state or local level.
ELR is used by laboratory providers to help them meet state
reportable diseases laws mandating that providers report cases of
specified diseases to the health department. ELR supports overall
public health surveillance by helping improve the timeliness and
accuracy of case reporting and confirmation to state and local
health departments. It also supports national public health
surveillance by improving the timeliness and accuracy of notifiable
disease data voluntarily shared by states with CDC.
[0006] Accordingly, there is a great need for means by which
clinical diagnostic data can be collected, maintained and
transmitted. Of greater importance is the need for these data to
remain secure and confidential. Preferably, these tasks require
minimal human intervention and maintenance.
BRIEF SUMMARY
[0007] The foregoing examples of the related art and limitations
related therewith are intended to be illustrative and not
exclusive. Other limitations of the related art will become
apparent to those of skill in the art upon a reading of the
specification and a study of the drawings.
[0008] In one aspect, a disease surveillance system that is capable
of near real-time disease surveillance is provided. In one
embodiment, the system comprises a diagnostic instrument, a router,
and a first server that, collectively, perform and transmit results
of one or more clinical diagnostic assays. In another embodiment,
the system additionally comprises a second server. The diagnostic
instrument, in one embodiment, has a detector that interacts with a
test assay to perform a diagnostic test and software to generate a
result or a data set that can be stored within the diagnostic
instrument, for example on the instrument hard drive, and/or on a
removable storage device. The router transmits the result or the
data set from the diagnostic instrument to the first server which
houses a first database which is configured to store a plurality of
the data sets. In one embodiment, the first server is in a
geographic location that is remote from the geographic location of
the diagnostic instrument. In another embodiment the data set is
transmitted from the router to the first server via a cellular
signal or through an internet connection.
[0009] In embodiments where the system includes a second server,
the data set is then transmitted to the second server which houses
a second database which is configured to store a plurality of the
data sets. In one embodiment, the second server is in a geographic
location that is remote from the geographic location of the first
server and/or a diagnostic instrument.
[0010] In one embodiment, the second server comprises an
application which queries the first server regarding the presence
of one or more new data sets since the previous query and initiates
transfer of the one or more new data sets to the second server.
[0011] In one embodiment, the second server comprises an
application which generates a diagnostic surveillance report which
is transmitted to a customer reporting database housed on a third
server or on an end user workstation. The end user workstation may
be, for example, part of a health department disease surveillance
system. The third server may be, for example, at a geographic
location remote from the first server, the second server, and/or
the end user workstation.
[0012] In one embodiment, the diagnostic instrument performs a
diagnostic assay and generates a data set comprising a result from
the assay and diagnostic assay-associated data elements, such as a
patient identifier, a diagnostic instrument identifier, an owner of
the diagnostic instrument identifier, an identifier of the
geographic location of the diagnostic instrument, and the like. In
another embodiment, the data set is encrypted and transmitted to
the router. In another embodiment, the patient identifier data
element is masked or deleted in order to provide a de-identified
data set for compliance with regulations to de-identify the patient
associated with a single diagnostic assay or result in the data
set. In one embodiment, the identifier of the geographic location
of the diagnostic instrument is a zip code. In another embodiment,
the assay-associated data element is a zip code of the residence of
the patient and/or the location of the diagnostic instrument.
[0013] In one embodiment, the diagnostic instrument is any
apparatus which is capable of performing a clinical diagnostic test
assay, analyzing the results of the assay and converting the
results to a digital signal which can be saved to and/or
transmitted to, for example, a router, a server or a computer
system. In one embodiment, the clinical diagnostic assay is an
immunofluorescent assay. In another embodiment, the assay is an
amplification assay, using for example polymer chain reaction (PCR)
or an isothermal amplification such as helicase dependent
amplification, where for example a dye or fluorescent label is
detected.
[0014] In another aspect, a process by which a clinical diagnostic
test is performed and the results are transmitted to an end user
computer is provided.
[0015] In yet another aspect, a system for disease surveillance is
provided, where the system comprises a diagnostic instrument
comprising a detector that interacts with a diagnostic assay. The
diagnostic instrument is configured to (i) automatically associate
a diagnostic assay with multiple values to generate a data set, the
data set stored within a memory of the diagnostic instrument, the
multiple values related to one or more of: a patient identifier, a
diagnostic instrument identifier, an owner of the diagnostic
instrument identifier, and a geographic location of the diagnostic
instrument; and (ii) transmit the data set to a first server via a
router for storage at the first server. A server in the system
generates a diagnostic report based on the data set for
transmission to a database housed on a database server or on an
end-user workstation.
[0016] In one embodiment, the router comprises an application with
encrypts the data set. In another embodiment, the router receives
the data set from the diagnostic instrument and then transmits the
data set to the first server.
[0017] In another embodiment, the first server comprises a first
database which is designed to store multiple data sets generated by
the diagnostic instrument.
[0018] In still another embodiment, the end-user workstation
comprises an application which allows the end-user workstation to
query the database.
[0019] In one embodiment, the system further comprises a second
server that receives the data set transmitted by the first server,
wherein the second server comprises a second database comprised of
multiple data sets generated by the diagnostic instrument.
[0020] In yet another embodiment, the end-user workstation
comprises an application which allows the end-user to query the
second database. In another embodiment, an end-user can access the
data set on the first or the second server via an internet
browser.
[0021] In still another embodiment, the second server and/or the
first server comprise a reporting application which transmits a
diagnostic report to the end-user computer, wherein the diagnostic
report comprises a plurality of data sets, and wherein the end-user
computer comprises a database configured to receive the diagnostic
report or the end-user computer permits access to the diagnostic
report using a internet tool, such as a brower application.
[0022] In another embodiment, the system comprises multiple
diagnostic instruments.
[0023] In another aspect, a system for disease surveillance is
provided. The system comprises a) one or more diagnostic
instruments, each comprising a detector to interact with a test
assay that receives a patient sample and software to analyze and
store results detected by the detector as it interacts with the
test assay to generate a data set, wherein the data set comprises a
plurality of assay-associated data elements including at least a
diagnostic instrument owner identifier, a diagnostic instrument
identifier, and a test assay result; and b) a first server
comprising a first database which stores a first plurality of the
data sets received from the one or more diagnostic instruments,
wherein for each of the data sets, each of the first plurality of
the data sets is saved to the first database and wherein a unique
identifier is assigned to each of the first plurality of data sets
to generate a second plurality of the data sets.
[0024] In one embodiment, the system further comprises a second
server comprising a second database which stores a second plurality
of the data sets, and wherein the second server comprises a query
generation program configured to generate a plurality of diagnostic
information queries specific to an assay-associated data element in
the plurality of assay-associated data; and wherein the query
generation program generates a diagnostic report containing one or
more diagnostic assay-associated data elements based on the
plurality of diagnostic information queries.
[0025] In one embodiment, the system further comprises one or more
routers, wherein each of the data sets is transmitted from the one
or more diagnostic instruments to the one or more routers, and then
to the first server.
[0026] In another embodiment, the system further comprises a
workstation which stores a laboratory information system (LIS),
wherein the workstation is connected to one or more of the one or
more diagnostic instruments via a local area network.
[0027] In yet another embodiment, the plurality of diagnostic
assay-associated data elements includes a residence or zip code of
the patient or of the diagnostic instrument's location, age of the
patient, and/or gender of the patient. In still another embodiment,
the diagnostic report is generated in the form of a geographic map
based on the residence or zip code of the patient.
[0028] In another aspect, a method for generating and reporting
data sets comprising diagnostic information related to an
infectious agent is provided. The method comprises a) inputting
information regarding a clinical diagnostic assay and
identification data for a patient into a diagnostic instrument, the
diagnostic instrument comprising a detector that interacts with a
test assay; b) running, on the diagnostic instrument, the test
assay with a sample from the patient to obtain an assay test
result; c) with the diagnostic instrument, storing the assay test
result in combination with the patient identification data to
generate a data set; d) transmitting the data set from the
diagnostic instrument to a router; and e) transmitting the data set
from the router to a first server, wherein the first server
comprises a first database configured to store a plurality of the
data sets. The data set is added to a first database; and the
server or an end-user workstation or end-user server comprises an
application which queries the first server for the presence of a
new data set in the first database and initiates transfer of the
new data set, if present, to the end-user workstation or end-user
server.
[0029] In one embodiment, the method further comprises f)
transmitting the data set from the router to a second server,
wherein the second server comprises a second database configured to
store a plurality of the data sets, wherein the data set is added
to the second database, wherein the second server comprises a query
generation program configured to generate a plurality of diagnostic
information queries specific to a diagnostic instrument owner
identifier; and wherein the query generation program generates a
diagnostic report containing one or more diagnostic
assay-associated data elements based on the plurality of diagnostic
information queries.
[0030] In another embodiment, the method further comprises
encrypting the data set prior to transmitting the data set from the
diagnostic instrument to the router.
[0031] In another embodiment, the identification data for a patient
includes a patient unique identifier and wherein the data set is
processed by an application to remove the patient unique identifier
from the data set prior to transmitting the data set to the
router.
[0032] In another embodiment, the method further comprises
generating an auto-reporting data set from the first database or
the second database and transmitting the auto-reporting data set to
a health information database located on an end-user
workstation.
[0033] Additional embodiments of the present system and methods
will be apparent from the following description, drawings,
examples, and claims. As can be appreciated from the foregoing and
following description, each and every feature described herein, and
each and every combination of two or more of such features, is
included within the scope of the present disclosure provided that
the features included in such a combination are not mutually
inconsistent. In addition, any feature or combination of features
may be specifically excluded from any embodiment of the present
invention. Additional aspects and advantages of the present
invention are set forth in the following description and claims,
particularly when considered in conjunction with the accompanying
examples and drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0034] FIG. 1 is a block diagram of a system in accordance with the
present disclosure.
[0035] FIG. 2 is a block diagram of a system in accordance with the
present disclosure wherein several diagnostic instruments are
connected to a router.
[0036] FIG. 3 is a block diagram of a system in accordance with the
present disclosure wherein several diagnostic instruments are
connected to a router and an LIS.
[0037] FIGS. 4A and 4B show an embodiment of a diagnostic
instrument.
[0038] FIG. 5 shows an embodiment of an assay test strip.
[0039] FIG. 6 shows an embodiment of an interface with a database
on a server.
[0040] FIG. 7 shows an embodiment of output generated from a
database on a server.
[0041] FIGS. 8A and 8B shows an embodiment of output generated from
a database on a server.
[0042] FIG. 9 shows an embodiment of output generated from a
database on a server.
[0043] FIG. 10 is a flow diagram of the method steps to obtain,
store and report data generated by a clinical diagnostic
instrument.
DETAILED DESCRIPTION
[0044] Various aspects now will be described more fully
hereinafter. Such aspects may, however, be embodied in many
different forms and should not be construed as limited to the
embodiments set forth herein; rather, these embodiments are
provided so that this disclosure will be thorough and complete, and
will fully convey its scope to those skilled in the art.
I. Definitions
[0045] As used in this specification, the singular forms "a," "an,"
and "the" include plural referents unless the context clearly
dictates otherwise. Thus, for example, reference to a "computer"
includes a single computer as well as two or more of the same or
different computers.
[0046] As used herein, the phrase "at least one of" preceding a
series of items, with the term "and" or "or" to separate any of the
items, modifies the list as a whole, rather than each member of the
list (i.e., each item). The phrase "at least one of" does not
require selection of at least one of each item listed; rather, the
phrase allows a meaning that includes at least one of any one of
the items, and/or at least one of any combination of the items,
and/or at least one of each of the items. By way of example, the
phrases "at least one of A, B, and C" or "at least one of A, B, or
C" each refer to only A, only B, or only C; any combination of A,
B, and C; and/or at least one of each of A, B, and C.
[0047] As used herein, "data" is used generically and includes but
is not limited to information in a form suitable for processing by
a computer. Except where noted otherwise, "data" is information
(including operational and legacy) which is contained or capable of
being contained in a data source (as defined below). For example,
"data," includes but is not limited to individual patient
information such as height, weight, sex and age; diagnostic
instrument information such as owner and serial number; and
diagnostic test data such as lot number and time of testing. A
"data set" is a collection of data wherein all individual data
within a data set originated from a single diagnostic test.
[0048] As used herein, a "diagnostic instrument" is any apparatus
or device which can perform a diagnostic test on a sample obtained
from a subject, analyze the results, and convert the results to
data which is suitable for processing by a computer. A diagnostic
instrument includes but is not limited to one that reads results as
positive or negative, or one which quantifies the results to
provide a quantitative value to the results.
[0049] As used herein, "database" is used generically and includes
but is not limited to a database and/or software application which
provides and/or stores data. For example a "database" contains
information relating to a clinical diagnostic test, diagnostic
instrument, site, study, patient or any other entity related to the
clinical diagnostics industry.
II. Disease Surveillance System
[0050] The present disclosure provides methods and systems for
detecting, recording and reporting information related to the
incidence and spread of disease among a population. Also provided
are means for efficient, useful and controlled access to the
information by persons or agencies of interest.
[0051] FIG. 1 illustrates an embodiment of a disease surveillance
system 5 which includes at least one diagnostic instrument 10, a
router 20, a first remote server 30, a second remote server 40, and
an end-user device 50. Diagnostic instrument 10 functions to read a
diagnostic test strip or device, as described in more detail below,
analyze the results, encrypt at least a portion of the results, and
transmit the results to router 20. Transmission of data from
diagnostic instrument 10 to router 20 is preferably done through a
physical connection (e.g., wire or cable), but may optionally be
done via a wireless connection. The data are transferred from
router 20 to first remote server 30 though a cellular connection.
In some embodiments, the data are transmitted from router 20 to
first remote server 30 through an internet connection (E.g.,
Ethernet or fiber optic cable). The transmission is secure via SSL
TCP/IP. An application located on second remote server 40 is
programmed to retrieve data which are temporarily stored on first
remote server 30. The application can be programmed to identify and
retrieve only data which are new, i.e., which have not previously
been retrieved by the application.
[0052] Data which were generated using diagnostic instrument 10 and
transmitted to second remote server 40 are stored on second remote
server 40 in a database which has restricted access to parties as
determined by the owner of diagnostic instrument 10. The database
on second remote server 40 is configured such that it can be
queried by a remote user to generate a reporting data set. Second
remote server 40 can also house an application programmed to
generate and send to an end user device a data report. The data
report is one which contains data according to specifications set
by the owner of the data sets generated by one or more diagnostic
instruments 10 or by a user 55 and/or administrator of end user
device such as a workstation having a browser application. End user
device 50 may include an application which can receive data which
is transmitted from second remote server 40 in the absence of a
query from end user device 40. In this embodiment, an application
on second remote server 40 is programmed to send data to end user
device 50 according to specifications (data types, frequency of
transmission) set by a user or administrator of end user device 50.
End user device 50 includes any device which is configured to run
an application which can query the data stored on second remote
server 40 or which houses a database which can receive and store
data obtained from the database on second remote server 40. An
application on remote server 40 can generate a data report and send
the data report to multiple end user devices as determined by the
owner of the data in the data report. In another embodiment, an
end-user can access the data set on the first or the second server
via an internet browser.
[0053] A disease surveillance system as described above is designed
to allow connection and management of one or of multiple diagnostic
instruments. For example, tens, hundreds, thousands, tens of
thousands or more diagnostic instruments, such as those described
below, are each connected via one or more routers to a first remote
server. Each diagnostic instrument is designed to run and analyze a
diagnostic assay, wherein little or no human interaction with the
diagnostic instrument occurs after a patient sample is introduced
to the diagnostic instrument. The diagnostic instruments may be
located anywhere within a country or within the world as long as
the router is capable of transmitting new data sets to a first
remote server.
[0054] The disease surveillance system described above and herein
can include alternative configurations. In one embodiment, as shown
in FIG. 2, a surveillance system 100 includes one or more
diagnostic instruments (E.g., 100a, 100b, 100c, 100d) which are
each connected to a hub or switch 110 by way of a wired connection
105a, 105b, 105c, 105d. The connection between each diagnostic
instrument 100a-b and hub or switch 110 can be a cable connection
or a wireless connection. A cable then connects hub or switch 110
to a single router 120 by a wire 115. Router 120 is then connected
to a first remote server 130, by way of a cellular or
cable/internet connection.
[0055] Another configuration of a networked system 135 includes a
workstation which houses a Library Information Management System
(LIMS). As shown in FIG. 3, one or more diagnostic instruments
140a, 140b, 140c within a clinical laboratory, for example, are
each connected by a wire 145a, 145b, 145c to a hub or switch 150.
Hub or switch 150 is then connected to a personal computer or
workstation 170 which can house a LIMS. Hub or switch 150 can also
be connected by a cable 162 to a router 160. Router 160 is
connected to a first remote server 180, by way of a cellular or
cable/internet connection.
[0056] The embodiments illustrated in FIGS. 2 and 3 are exemplary
embodiments which may be varied according to need. Either one or
more than one diagnostic instrument can be connected to the switch.
The apparatus shown as a switch may also be a hub. The connection
between the diagnostic instrument and the switch or hub may be a
wired connection such as an Ethernet cable. The connection between
the switch or hub and the router may be any appropriate wired
connection.
[0057] When the system is configured to include a workstation
having a Library Information System (LIS), there is a connection
between each diagnostic instrument and the workstation, and between
each diagnostic instrument and the router. In some embodiments,
there is a wire or cable connecting the router directly to the LIS
as shown in FIG. 3. In such an embodiment, there may be no direct
connection between the router and the LIS workstation (no wire
connected to the router and to the LIS workstation). FIG. 3 shows
that router 160 is connected directly to the LIS workstation. This
direct connection is optional. Router 160 is connected to a first
remote server via a cellular signal. In an alternative embodiment,
the LIS is connected to a first remote server such as first remote
server 180 in FIG. 3 via a wired internet cable such as an ethernet
cable or a fiber optic cable.
[0058] An ordinarily skilled artisan understands that a variety of
connection means can be used to connect the diagnostic instruments
to one another, to an LIS and/or to a router. In an alternative
embodiment, there is a connection between the switch or hub and the
LIS, and a connection between the switch or hub and the router. As
an example, one clinical laboratory may have eight diagnostic
instruments, each capable of performing a unique diagnostic test,
wherein all eight diagnostic instruments are connected to a single
router. A second clinical laboratory may have five diagnostic
instruments connected to a first router in one room, and seven
diagnostic instruments connected to a second router in a second
room. Each of the first and second routers connects via a cellular
signal to a first remote server, in which data and information from
all twelve diagnostic instruments in the first and second rooms are
stored. The first and second clinical laboratories may be located,
for example, in different towns, different states, or different
countries assuming compatibility of the all routers with the first
remote server. Data saved to the first remote server is then
transferred to a second remote server. One or more devices, such as
a computer, work station, or hand held device, each of which may be
located in a different town, state or country for example, is
capable of accessing the second remote server to query or browse
the data held there, based on permissions granted a user.
[0059] The system as described herein is designed to allow, in
part, automated and secure transmission of results generated by a
diagnostic instrument to a router, a first remote server, then to a
second remote server. Each result from a single diagnostic assay is
automatically associated with multiple values related to the
patient, the diagnostic instrument and the owner of the diagnostic
instrument to generate a data set which is then stored within the
memory of the diagnostic instrument. For example, a positive result
from a single diagnostic assay is saved in association with
instrument data such as an instrument identification number and
laboratory affiliation, and patient information such as patient age
and place of residence. In this way, for example, by automatically
associating each result from a single diagnostic assay with
multiple values related to the patient, the functioning of the
diagnostic instrument is improved. As an illustrative and
non-limiting example, such improvement may include less memory use
and faster processing by the diagnostic instrument. It is to be
appreciated that these example improvements are not limited to the
diagnostic instrument and may occur at other components (e.g.,
servers, routers, end-user computers etc.) associated with the
diagnostic instrument. Each data set is then transmitted to the
first remote server via a router. Before each data set is
transmitted, the data are encrypted using a program within the
diagnostic instrument. Additionally, the diagnostic instrument
administrator and/or user may program the diagnostic instrument to
generate a data set for transmission which omits or masks, for
example, the patient identification number.
[0060] A diagnostic instrument, such as that which is depicted in
FIG. 1 (10) and FIG. 2 (100a-d, 130 and 170), which may be used in
any of the networked systems described herein includes any which
can at least: 1) accept data input by an operator or user via a
user interface such as a keyboard, a key pad, or a barcode reader;
2) accept a test strip which carries out a diagnostic test in the
presence of a sample; 3) a detector such as an optical reader which
generates and detects a light signal in the presence of the test
strip, and converts the optical data into digital data that can be
stored on a memory device and analyzed; 4) a processor with
software which can process the digital data to generate a result;
and 4) an output mechanism which can send data and/or results
generated though use and analysis of the test strip to an external
storage device or server. Such diagnostic instruments are well
known in the art and each is designed to analyze a specific
chemical assay which has been designed to detect the presence of a
disease-associated analyte or infectious disease agent. In the
present disclosure, the diagnostic instrument does not require
operator activity from the time the test strip has been introduced
into the instrument until the time the data are accessed by the
operator or other user.
[0061] An exemplary embodiment of a diagnostic instrument for use
with the herein described networked surveillance system is
disclosed in detail in U.S. Patent Pub. No. 2013/0230845, the
contents of which are incorporated herein by reference in their
entirety.
[0062] An embodiment of an apparatus capable of detecting a signal
produced by a test device is illustrated in FIGS. 4A-4B. Diagnostic
instrument 300 includes a housing 312 that encloses an optics
system, electronics software, and other components of the
diagnostic instrument. A front side 314 of the diagnostic
instrument includes a user interface 316 that may include, for
example, a key pad 318 and a display screen 320. The key pad
includes numeric keys for entry of numeric values, which can also
be labeled with letters of the alphabet, a decimal point key, a
back space key, and other keys that are desired by end users. As
part of the key pad or as separate keys positioned elsewhere on the
diagnostic instrument, the device may include keys to print test
results, to advance printer paper, to open or close a drawer in the
device, directional arrow keys and soft or select keys for a user
to interact and instruct the apparatus. Visible on display screen
320 to a user will be information such as test results, error
messages, instructions, calibration information, troubleshooting
information, user information, and the like.
[0063] An embodiment of the rear panel of diagnostic instrument 300
is shown in FIG. 4B and can include port to receive a source of AC
power 322 and an on/off toggle switch 324, which in this embodiment
is a soft key to activate the software. The diagnostic instrument
additionally provides ports, on the rear panel or elsewhere on the
apparatus, to connect optional components and/or to interface with
external instruments. For example, the diagnostic instrument may
include a PS2 connector, for example, to interface with an external
barcode reader; a port, such as an RJ-45 port (e.g., FIG. 4B port
330), to connect to a local area network or Ethernet; a removable
memory card port or slot; and/or a USB port. In a preferred
embodiment, the diagnostic instrument includes a slot or port 326
for insertion of a removable non-volatile flash memory card, such
as an SD card, and the diagnostic instrument is capable of read and
write operations to and from the SD card, to, for example, store
all scan data from each test strip, or to update system
software.
[0064] The diagnostic instrument is equipped with ports for
attachment to optional external devices, and in one embodiment the
diagnostic instrument is connected to an external bar code scanner.
The bar code scanner interfaces with the apparatus via a suitable
data port provided on the diagnostic instrument. Externally
attached devices ease transfer of data into and from the apparatus,
and can eliminate user keyboard input, permitting accurate data
input into the apparatus regarding a test to be analyzed or patient
or sample information. In one embodiment, a barcode scanner
external is attachable via PS-2 port on the apparatus and is
capable of reading a linear or 1D bar code.
[0065] Hardware components of diagnostic device 300 further include
an inter IC Bus (also known as the I2C-Bus, this component
facilitates communication between electronic components), serial
interface bus (SPI Bus), batteries, electronics, optional internal
barcode reader and SD card.
[0066] Diagnostic instrument 300 is able to run diagnostic tests,
as well as quality control (QC) tests and calibration assays.
[0067] The systems described herein are useful for the
transmission, recording and reporting of data generated using a
variety of diagnostic instruments. A diagnostic instrument useful
in the presently described systems is any instrument which is
capable of reading the results of an analytical assay, whether the
results of the assay are simply positive or negative or are
measured on a more quantitative scale. Examples of such diagnostic
instruments include but are not limited to instruments which
perform immunoassays and PCR. The diagnostic instrument may be any
instrument which can read results of a test strip containing a
patient or control sample and provide an automated determination of
whether the test strip rendered a positive or negative result. In
one embodiment, the diagnostic instrument is one which provides a
qualitative test result, such as a number on a scale of 1 to 10 or
1 to 100. The diagnostic instrument is one which can convert the
assay test results to a digital signal which can be transmitted
via, e.g., the internet, a wireless signal, a cellular signal,
etc.
[0068] In one embodiment, the diagnostic instrument is designed for
use with a lateral flow test strip and the diagnostic instrument
implements a lateral flow reader function. An exemplary lateral
flow immunoassay test strip is described in U.S. Patent Pub. No.
2013/0230844 (see, for example, paragraphs [0078-0085] and FIGS.
8-10, the contents of which are incorporated herein by reference in
their entirety). With reference to FIG. 5, an embodiment of a test
strip for interaction with the diagnostic instrument is
illustrated. The test strip is exemplified in the drawings below by
a lateral flow test immunoassay, however it will be appreciated
that a lateral flow immunoassay is exemplary of test strips
suitable for interaction with the apparatus. Test strip 400 is
comprised of, in sequence, a sample pad 402, a label pad 404, one
or more lines indicated collectively at 406 and selected from a
test line, a control line and a reference line, and an absorbent
pad 408. In one embodiment, a support member 410 is provided, and
each or some of the sample pad, label pad, lines and absorbent pad
are disposed on the support member. The test strip comprises a
region between the downstream edge of the most downstream
analyte-specific test line, which in the embodiment shown in FIG. 5
is test line for binding to an influenza antigen (e.g., a test line
that comprises anti-flu A antibodies), and the upstream edge of the
absorbent pad 408 is a procedural control zone, denoted PCZ in FIG.
5.
[0069] In one embodiment, the test strip is enclosed in a housing,
sometimes referred to as a cassette. A bar code label can be
affixed to the housing and positions for interaction with an
internal bar code scanner positioned within the diagnostic
instrument. In one embodiment, the bar code label is a 2D bar code,
encoding information, for example, regarding the assay test strip,
such as the pathogen/analyte the test strip is designed to detect
(e.g., Flu A/B, Strep A, RSV, etc.) which informs the diagnostic
instrument what protocol in memory to initiate for scanning the
test strip; a unique test serial number so that the diagnostic
instrument will not read same test strip twice. In one embodiment,
the information contained in the bar code does not include
information related to the patient or the sample type, and is
limited to information about the test strip.
[0070] As described above, the presently disclosed systems are
designed for efficient recordation, storage, retrieval and
reporting of diagnostic data with minimal human interaction
required. In one embodiment, a user must provide a sample and apply
the sample to, for example, a test strip. Once the test strip with
sample is placed within the diagnostic instrument and information
regarding the patient and test strip is input into the instrument,
no further user activity is required before the diagnostic test
results are saved within the database on the second remote server
or reported to an end user.
[0071] To initiate a scan of a test device, the diagnostic
instrument is powered-on if needed and a toggle switch to initiate
the diagnostic instrument software is activated. Prior to inserting
the test strip with sample into the diagnostic instrument, using
the optional external bar code reader, information about the user,
the sample, the patient, etc. can be scanned into the diagnostic
device memory. A "start test" button on the diagnostic instrument
or on the touch screen is pressed to start a measurement of a test
strip. The diagnostic instrument automatically opens the drawer in
the apparatus to receive the test device on which a sample has been
dispensed. The test device with loaded sample is inserted into the
drawer of the diagnostic device and the drawer is closed.
[0072] Closure of the drawer initiates a sequence of events,
comprised of the following. The internal bar code reader scans the
bar code on the test device and receives information regarding the
assay type (e.g., influenza A/B, Strep A, RSV, etc.), the serial
number and the expiration date of the test device, optical cut-off
information for the assay type, and any other information included
on the bar code secured to the test device. It will be appreciated
that the internal bar code reader is an optional feature, as the
information on the bar code label can be entered into the apparatus
by a user using the key pad or via an external bar code
scanner.
[0073] At any time after the diagnostic instrument has been
powered, an operator may enter information not obtained from the
barcode on the test strip. For example, an operator can enter an
identification number (operator ID), using either a keypad on the
diagnostic instrument, or using a barcode reader. The device
instrument operator can then enter patient information regarding
the patient from whom a sample was obtained and is to be tested
using the diagnostic instrument. Patient information may be
entered, for example, by using a barcode reader which is
functionally connected to the diagnostic instrument or the patient
information may be manually entered by the operator using a keypad
located on the diagnostic instrument.
[0074] After optionally entering a device instrument operator ID,
the operator enters information regarding the test strip such as an
assay name and type, a kit lot number, a cassette number and/or lot
number, and an analyte name. After ensuring all necessary and
relevant information is entered into the diagnostic instrument, the
test strip with patient sample is placed into the diagnostic
instrument according to manufacturer instructions and the assay is
initiated. The diagnostic instrument analyzes the results of the
assay and is capable of making a quantitative and/or qualitative
measurement of the results. For example, a diagnostic instrument
may assign a value of positive or negative to the presence or
absence, respectively, of a line which is detectable at a specified
wavelength measured by the diagnostic instrument. The results can
then be saved in the memory of the device and/or on a temporary
storage device such as a removable SD disk. The results are saved
such that they remain linked with the information described above
regarding the diagnostic instrument, the organization and facility,
the operator and the patient.
[0075] Based on the test assay type discerned from the information
on the bar code label or otherwise provided to the diagnostic
device processor, the diagnostic device initiates an algorithm
stored in the diagnostic device's memory for the assay for which
the test device is designed, and/or based on user-defined selection
of criteria.
[0076] The optics system in the diagnostic instrument can be an
assembly of mechanical, electronic and optical components which
serves to send light in the excitation wavelength range of the
compound or analyte to be measured. The emitted light is measured
by a detector, and a fluorescence value is displayed on the
instrument. Light sources include xenon lamps, high pressure
mercury vapor lamps, xenon-mercury arc lamps, lasers, and LED's. In
one embodiment, the optics system of the diagnostic instrument
illuminates the test strip with specific excitation with an
ultraviolet light-emitting diode (UV LED) and then collects,
processes and transforms the resulting europium fluorescence signal
using a photodiode to an electronic signal that is converted by an
analog-to-digital converter into useable analytical data.
[0077] In one embodiment, a calibration cassette is available for
ensuring that the diagnostic instrument is properly reading and
analyzing the results generated through use of the test strip as
described above. An exemplary calibration cassette is described in
U.S. Patent Pub. No. 2013/0230844 (see, for example, paragraphs
[0068-0073], the contents of which are incorporated herein by
reference in their entirety). Operation of an exemplary diagnostic
instrument as described herein is described in greater detail in
U.S. Patent Pub. No. 2013/0230844 (for example, see the section
titled, "Operation of Apparatus," paragraphs [0088-0098], the
contents of which are incorporated herein by reference in their
entirety).
[0078] Each time a test strip is analyzed by a diagnostic
instrument, a quality control assay can be run by the diagnostic
instrument, or a calibration cassette can be analyzed. Again, the
results of the quality control assay and/or calibration assay are
saved to the hard drive of the instrument or to a removable memory
device. After completion of the assay and results analysis within
the diagnostic instrument, an application located on the diagnostic
instrument initiates a program which results in the transmission of
the information to a router. When a diagnostic strip is used to
analyze a patient sample, a program associates the assay results
with the patient and instrument information (see Table 1 below) and
generates a unique data set. The information is stored in the
instrument and, if present, an external drive such as an SD
disk.
[0079] The diagnostic instrument is associated with and/or
generates information regarding the diagnostic instrument,
including one or more of the fields shown below in Table 1. Each
piece of information is associated with a data tag for storage in a
database.
TABLE-US-00001 TABLE 1 Data Type Example Data Tag (Field)
Diagnostic instrument Diagnostic instrument serial number
Instrument Type Registration Date Time Zone Firmware Revision
Router Type Router ID Facility Information Facility Name Facility
Address Facility City Facility Zip Code Facility County Facility
State Facility Country Organization Name Site ID Contact Name
Contact E-mail Contact Phone Date and Time of Storage Operator ID
Test Strip Information Order Number Assay Name (Indication) Kit Lot
Number Cassette Number Cassette Lot Number Assay Type (Assay
Number) Analyte name Result Type Patient Information Patient ID
Patient Age Patient Gender Patient Demographics Patient Status
Results Information Result Type (diagnostic, QC, Calibration) LOINC
Code (Logical Observation Identifiers Names and Codes) SNOMED Code
Test Result Transmission Date and Time Test Flag (Final or
Resent)
[0080] Each diagnostic instrument used to run a diagnostic test is
provided with a unique serial number at the time of manufacture. An
"instrument type" identifier is also associated with each
diagnostic instrument. When a diagnostic instrument is installed
for use in a laboratory, it can be assigned a registration date,
time zone, and firmware revision number. At the time of
installation of a diagnostic instrument, the facility name and
address can be stored in the memory of the diagnostic instrument as
well as the name of the organization which owns or controls the
diagnostic instrument. The name and contact information for an
administrator or supervisor, for example, may also be saved within
the memory of the diagnostic instrument. In one embodiment, the
information is saved to a hard drive within the instrument. In
another embodiment, the information is alternatively saved, or
additionally saved to a temporary disk such as an SD disk/card or
USB data storage device. The diagnostic instrument memory is also
programmed to be customized with respect to the type of information
which may be saved in association with a single diagnostic test. In
other words, the owner of the instrument can program the diagnostic
device to accept or require additional information which is then
saved as a record to an owner-defined field.
[0081] The diagnostic instrument can assign each assay a unique
identifier (e.g., primary key) and thereby associate each assay
(unique identifier) with some or all of the patient information as
well as with some or all of the facility and diagnostic instrument
identifier information. Importantly, by associating each diagnostic
assay with this information to form a data set, the data set can be
made accessible to only designated users, such that only owners of
individual data sets or users designated by the owners will have
access to data sets which include the owner identification.
[0082] In preferred embodiments, the diagnostic instrument includes
a program which is able to encrypt the test results, the user
information, the patient information and/or the instrument
information. The diagnostic instrument also includes a program
which can de-identify the patient. In other words, the patient name
and identifier number can be masked or deleted from each data set.
Other patient information, such as age, can also be deleted or
masked if desired. In one embodiment, patient age is replaced with
an age range. For example, patients that are older than 80 years
are assigned an age of ">80", or patients that are between the
age of 50 and 60 years are assigned an age value of "50-60."
[0083] A diagnostic instrument used according to the methods
described herein comprises a port to which a network cable may be
connected. The network cable provides a wired connection between
the diagnostic instrument and a router. Alternatively, a cable is
used to connect the diagnostic instrument to a hub or switch which
then allows a wired connection to both a router and a workstation
which has a Laboratory Information Management System installed. Use
of a hub or switch also allows one to connect multiple diagnostic
devices to a single router (See, for example, FIGS. 2 and 3).
[0084] Once the assay results are obtained within diagnostic
instrument x, the results are saved to to the hard drive of the
diagnostic instrument and/or to an external drive such an external
hard drive, SD card or a flash drive.
[0085] As depicted in FIG. 1, the networked surveillance system
includes a router 20 which receives a data set from a diagnostic
instrument 10 each time a diagnostic assay is run and analyzed by
diagnostic instrument 10, and then transmits this data set through
a router 20 to a first remote server 30. Router 20 can receive data
from the diagnostic instrument via a secure SSL TCP/IP connection.
In preferred embodiments, the information is transmitted from
diagnostic instrument 10 through a cable such as an Ethernet cable
or fiber optic cable. In alternative embodiments, the information
is transferred from the diagnostic instrument to the router by a
wireless connection.
[0086] A router as used in the presently described system includes
at least one or two Ethernet ports. A first Ethernet port is used
to provide a connection to a diagnostic instrument. The connection
between the router and the instrument may be direct, through a hub
or switch, or through other indirect means. A second Ethernet port
can be used to provide internet connectivity, for example, though a
cellular modem a LAN.
[0087] The router is able to communicate with a first remote server
via a cellular signal or via an internet (wired) connection. If for
any reason the connection with the first remote server is
interrupted, the router can buffer the encrypted data and send it
to the first remote server when the connection is restored. The
router includes configurable routing and switching capability. The
router has worldwide cellular wireless compatibility (currently
certified in at least 57 countries).
[0088] Data and test results generated by one or more diagnostic
instruments as described herein to produce a data set are first
transmitted to a router and then transmitted from the router to a
first server where it is stored at least temporarily in a folder or
other similar directory on the first server. In one embodiment, the
first server is in a location remote from the one or more
diagnostic instruments, however it will be appreciated that the
first server need to be remote for functionality of the system. The
system described herein is in the context of a system with a first
remote server yet it is to be understood that that it is merely
exemplary. This first remote server stores each of a plurality of
data sets received from every diagnostic instrument to which the
server has a connection via a router. The data sets are obtained
via one or more routers as described above. Accordingly, the
results and associated information are transmitted from the router
to the first remote server each time (or on a regularly scheduled
frequency such as once or twice per day, or more often if an
infectious outbreak is occurring) a diagnostic test is performed
and analyzed by a diagnostic instrument. In an alternative
embodiment, one or more data sets are saved to a diagnostic
instrument, and an application located within the diagnostic
instruments runs on a schedule to initiate the transmission of the
one or more data sets to the first server at a specified time(s)
during each day.
[0089] The data sets which are transferred to the first (remote)
server by numerous routers are stored in a secure directory to
which only a designated authorized user has access. In one
embodiment, the data sets are stored temporarily on the first
remote server, i.e., the data sets are stored on the first remote
server for at least 1 hour, but less than 24 hours, 48 hours, 72
hours, 1 week or 1 month. The data sets can be stored in a simple
folder within a directory on the remote server. The data sets
transmitted to the first remote server can be organized, for
example, based on the owner of the diagnostic instrument, then by
individual diagnostic instrument. The data sets of a particular
owner can be segregated from data sets of different owners.
[0090] Data sets stored in the first remote server are subsequently
transferred to an end user database server 40, to an end user work
station 50 and/or to a second remote server (FIG. 1) to facilitate
access by an end user 55. The continuing description is in the
context of the system comprising an optional second remote server,
however it will be appreciated that functionality of the system is
achieved in the absence of the second remote server in favor of a
direct communication between an end-user database server or
end-user work station. The second remote server (or end-user
database server or end-user work station) houses a software
application which instructs the second remote server (or first
server in the absence of a second server) to connect to the first
remote server and to survey all data stored within the first
database located on the first remote server and to identify any
data which have not been previously transferred to the second
remote server. Any and all new data are then transferred to a
database housed on the second remote server. A cyclic redundancy
check (CRC) is performed on the data saved to the second remote
server. Access to these data is restricted to users which have been
specified by an administrator of the second remote server, in one
embodiment. In another embodiment, only the owner of a plurality of
data sets can access the data sets. An administrator of the data
base on the second remote server is able to access data sets
belonging to all owners of all data sets.
[0091] All data sets which are transferred to the second remote
server are stored within a second database housed on the second
remote server. When individual data sets are saved to the database
housed on the second remote server, an application on the second
remote server runs which assigns to each data set a SNOMED
identifier and a LOINC identifier, which thereby become associated
with the data set.
[0092] The database located on the second remote server is designed
to be secure and accessable only by a database administrator(s) and
by users which have been granted access to the database. The second
remote server can house multiple database instances. In one
embodiment, a database on the second remote server receives and
stores data sets belonging only to a single owner. In another
embodiment, there are multiple second remote servers, each
containing a database to store results received from diagnostic
instruments via routers as described above.
[0093] In another embodiment the database on the second remote
server is a flat-file database in which each diagnostic test result
is stored in association with one or more of the parameters (also
referred to herein as assay-associated data elements or values)
listed in Table 1. In another embodiment, the database on the
second remote server is a relational database.
[0094] The second remote server has both a reporting application
and a query application. The reporting application will generate
reports containing individual data sets belonging to one or more
owners of the data sets, then send the reports to a designated end
user apparatus. The query application provides in part an interface
through which an end-user having access to the database can browse
or query the data sets which are stored in the database on the
second remote server.
[0095] The reporting application, e.g., a scheduled agent, is
programmed to generate reports based on characteristics which have
been selected by the end user, such name of the clinical laboratory
that ran the diagnostic test, patient age, patient gender, and
patient residence. The scheduled agent can be programmed to
generate a report on a pre-determined and/or periodic basis. For
example, the scheduled agent may transmit a report containing all
new data sets owned by a specified owner at 08H00 UTC (coordinated
universal time) each day. Other options for the timing of the
transmission of a report include, but are not limited to, manually
transmitting a report at any time on any day by an administrator or
transmitting a report at a regular interval other than a 24-hour
interval, such as every 12 hours. This flexibility of report
transmission scheduling may be important, for example, during times
of a pandemic or other recognized health-related crisis.
Alternatively, or additionally, a user affiliated with a specified
owner may send a request for a report generation of all new data at
any time. The generated report can contain a plurality of clinical
diagnostic results and the associated data for each diagnostic
result. The information contained in a generated report can be
determined by the end-receiver of the information. For example, a
state health department may have a database designed to receive
such a generated report. Accordingly, a report generated on the
second remote server for transmission to this state health agency
will contain information and will be formatted in such a way as to
comply with the requirements of that state health department.
[0096] The report generated by the reporting application can have a
variety of formats, including but not limited to a simple text
file, a CSV file, or a PDF document. The information generated by
the reporting application may be pasted into the body of an e-mail
and e-mailed to the end-receiver of the information, or a file
containing the information (e.g., text document, CSV file, PDF
document) may be attached to the e-mail. In one embodiment, a file
generated by the reporting application is uploaded (e.g. via an ftp
client) to a server owned by the end-receiver of the report. In an
alternative embodiment, the report generated by the reporting
application may be of a format which can be received by an
end-receiver database, and an application housed on the
end-receiver server can transfer data within the report into a
database located on the end-receiver server, such that individual
data are assigned to the correct fields within the database.
[0097] The second remote server also houses a query application
which can present a user interface for an end-user to design a
report for generation. In this embodiment, the second remote server
stores script programs which can be executed by a remote user. A
remote user accesses and queries the second database from a remote
workstation. In one embodiment, the remote workstation includes a
web browser application which can access and interact with the
second database located on the second remote server. The second
remote server includes script programs which are executed by an end
user operating a remote workstation. For example, a computer or
workstation may include a web browser through which an end user
remotely accesses and queries the database on the second remote
server.
[0098] An end-user who has been granted access to the database on
the second remote server will be able to query the database only
for data sets owned by the owner with whom the end user is
associated. In one embodiment, an end user having access to data
sets associated with one or more diagnostic devices within the
disease surveillance system is able to query the second database
which contains all of the data sets generated and owned by the
owner with whom the end user is affiliated. Through this interface
and associated scripts housed on the second remote server, the end
user can produce alternative data sets, generate custom reports,
and/or generate graphical representations of the data sets. FIG. 6
shows an exemplary (artist's rendering) of an interface generated
for access to the database on the second remote server (or on the
first server if no second server is present). The interface can
display data sets based on, for example, the time the clinical
diagnostic assay was performed, the type of diagnostic assay which
was run, the type of result, the name of the organization, the
serial number of the diagnostic instrument, and/or the facility in
which the diagnostic instrument(s) was located, including for
example, county, state, country, zip code of the facility or
diagnostic instrument. The data sets may be initially displayed in
rows and columns. In such a display, the end user can manipulate
the order in which the columns and rows are displayed. Each
clinical diagnostic assay result may be selected to see details of
the result including the LOINC and SNOMED codes, the patient
information, information regarding the diagnostic assay kit used,
information regarding the testing site, and information regarding
the diagnostic instrument and owner.
[0099] Further, the queried data may be displayed as a chart. For
example, the data may be charted by run date (FIG. 7), diagnostic
assay, result, result trend, percent positive, or test volumes by
type (patient, quality control or calibration). Each chart display
may also be manipulated to show results by days, weeks, months or
years. When charting the data to show patient result trends, the
chart may be further manipulated to show results for a single
clinical diagnostic assay type (see FIGS. 8A-8B).
[0100] In a particular embodiment, the end user can query the
database to generate a map of the geographical locations of each
test result (e.g., location within a city, state or country) as
shown in FIG. 9, which is an artist's rendering of a map of a
portion of North America, showing Canada, the U.S. and a portion of
Mexico. An end-user can query the database to present data from the
dataset in graphical form according to state or province, according
to zip code in which the test facility, instrument and/or patient
sample was tested, the country, etc. Pins, such as pin 490, provide
a visual indicator of a test result for easy viewing by an end
user. Pins or color indicators can be used to indicate percent
positive and the number of tests performed in locations by country,
state, county, zip code, etc.
[0101] FIG. 10 is a flowchart illustrating one embodiment wherein
of the disease surveillance system (500) described herein. A
patient sample is applied to a test strip or other clinical
diagnostic assay device and placed into a diagnostic instrument
(505) by an operator such as a healthcare technician or clinical
assistant. Information regarding the diagnostic assay device, the
diagnostic instrument, the owner of the diagnostic instrument, the
patient or subject from whom the sample came is input into the
diagnostic instrument (510). The diagnostic assay is performed by
the diagnostic instrument (515), the results of the assay are
detected and analyzed (520) and saved to the memory of the
diagnostic instrument (525), wherein each diagnostic assay result
is associated with the information input at 510 to form a data set.
The data set are encrypted by an encryption application within the
diagnostic instrument (530). In one embodiment, the patient is
de-identified. An application within the diagnostic instrument is
then triggered to transfer the data set to a router (535) and the
router connects to the first remote server. If the router cannot
connect to the remote server, the data set is saved in the router
buffer until a connection to the first remote server is made. The
data set is then transferred and saved to a database or directory
on the first remote server and the data set is filed based on the
owner and then by the diagnostic instrument serial number (540). On
a periodic basis, the second remote server connects to the first
remote server and runs an application which queries the appropriate
directory on the first remote server to identify new data sets
(data sets which have not previously been transferred to the second
remote server (545). The new data sets are transmitted to the
second remote server and saved to a database housed on the second
remote server. The second remote server can have an application
which is programmed to generate a report which contains data sets
for a defined time period (e.g., the previous 24 hours). This
report generally includes data sets associated with a single owner.
The report is then sent to an end user designated by the owner of
the data sets within the generated report (550). The database
located on the second remote server is accessible by designated end
users who may access only data sets owned by owners with whom the
owners are affiliated. These end users can access the database on
the second remote server through the internet using, for example, a
web browser. The end user has access to an interface which allows
the end user to query the database using forms and to generate
custom reports (555).
[0102] It will be appreciated that the description of the servers
as a first "remote" server or as a second "remote" server is
exemplary, as in one embodiment the first and/or second server may
be remote (e.g., in a different geographic location) from the
diagnostic instrument or from other components of the system,
however one or both servers can be in the same location in some
situations.
[0103] While a number of exemplary aspects and embodiments have
been discussed above, those of skill in the art will recognize
certain modifications, permutations, additions and sub-combinations
thereof. It is therefore intended that the following appended
claims and claims hereafter introduced are interpreted to include
all such modifications, permutations, additions and
sub-combinations as are within their true spirit and scope.
* * * * *