OA16987A

OA16987A - A quality control sensor method, system and device for use with biological/environmental rapid diagnostic test devices.

Info

Publication number: OA16987A
Application number: OA1201400215
Authority: OA
Inventors: Qing Xiang; Michael Chmura; Ian FINE; Graham GREENLAND; Roman Zastawny
Original assignee: Fio Corporation
Priority date: 2011-11-20
Filing date: 2012-11-20
Publication date: 2016-02-26

Abstract

Quality control (QC) sensor methods, systems and devices are for use with biological/environmental rapid diagnostic test (RDT) devices and provide for automatic timers, reminders and RDT cassette images. Sensors are calibrated and optimized, and provide for quality control of the RDT devices. Image analysis identifies cassette and patient information, and evaluates the processing and conditions of the RDT devices, cassettes and RDTs. Results may be accessed and analyzed remotely from the RDT devices. RDT chain of custody and workflow, incubation and reading sequences are tracked. A QC score for each unique patient RDT is determined based on QC criteria.

Description

A QUALITY CONTROL SENSOR METIIOD, SYSTEM AND DEVICE FOR USE WITII BIOLOGICAL/ENVIRONMENTAL RAPID DIAGNOSTIC TEST DEVICES

FIELD OF TIIE INVENTION [0001] The présent invention relates generally to a quality control method, system and device, and more particularly to a quality control sensor method, system and device for use with biological/environmental rapid diagnostic test devices. ___

BACKGROUND OF TIIE INVENTION [0002] In the prior art, the use of rapid diagnostic tests (“RDTs”) may hâve been restricted 10 and/or limited by inadéquate, insufTicient and/or lacking quality control (“QC”).

[0003] RDTs may be sensitive to and/or affected by température, pre-analytical steps, reading errors, and/or storage problème. There may be a number of existing problème associated with RDTs, including, for example, the following:

• Température during shipping and/or storage may, from time to time, hâve been higher than an RDT’s température spécification, and/or a user of the RDT may not notice and/or pay sufficient heed to same, which may hâve led to one or more inaccurate diagnostic results.

• RDTs may need to be read at a spécifie time and/or within a spécifie time period. One or more separate timers usually may hâve been shipped together with the RDTs. In the field, however, the timers may be lost, and/or the user(s) of the RDTs may work on other

RDTs during an assay time. The assay time may not be accuratcly followed for one or more reasons, and/or it may be quite common to read an RDT too early and/or too late. Such factors may also hâve led to inaccurate diagnostic results.

• In the field, doctors and/or nurses may hâve grouped patients together for RDTs when they hâve multiple patients. Perhaps to save time, doctors and/or nurses may hâve taken one or more patients’ blood, added blood samples and/or buffers into RDTs, and/or counted time, in sequence. Previously, RDT users may hâve needed to be very careful not to mix various patients* RDTs and/or in timing each RDT correctly. However, it may f

hâve been very challenging to do so in the circumstances, perhaps due to multiple patients. And/or, • RDT reader devices may hâve been used in community healthcare centers, in villages, and/or in association with mobile healthcare facilities (e.g., such as, for example, in cars and/or tents). Providing for the continued working status and/or ongoing functionality of such devices may hâve been a big concem. Providing for the continued working status of real-time RDT monitoring devices, for example, may hâve presented huge quaiity control issues.

[0004] One or more of the above issues may hâve been related to RDT quaiity control and/or process control.

[0005] A QC sensor device, system and/or method may be required which monitors RDT expiration date and/or RDT storage (and/or shipping) température. A QC sensor device, system and/or method may be required which may automatically count RDT assay time. A QC sensor device, System and/or method may be required which may improve the throughput of RDT diagnoses.

[0006] As an aside, it is here noted that at least some portions of the présent disclosure may apply equally well to non-RDT diagnostic tests, and the présent invention and disclosures therefore will be appreciated by persons having ordinary skill in the art to extend to include and apply to such subject matter as well.

[0007] What may be needed is a QC sensor system, method and/or device which is remotely opérable by a service provider who (operating portions thereof for end users) may preferably hâve expertise in diagnostics, image processing, cellular communications, user interfaces, software development, nano- and polymer chemistry, optics, information science, industrial design, and/or database solutions. The service provider’s clinical expertise may preferably include internai medicine and/or infectious disease clinical practice and/or research, diagnostics, regulatory afTairs, and/or clinical trials.

[0008] Some Of Today’s Related Challenges [0009] The World Health Organization (“WHO”) may recommend that ail cases of presumptive malaria be confirmed with a diagnostic test, yet most fevers may not receive proper diagnosis before treatment. Health workers in malaria endemic régions may often assume that fever may be caused by malaria and/or may over-treat with anti-malaria! médication. Misdiagnosis may increase morbidity and/or mortality. Overtreatment may increase the risk of drug résistance. Valuable and/or limited health resources may thus be wasted.

[0010] While the adoption of malaria RDTs may hâve improved fever management, impact may hâve been hindered by factors such as quality issues, human error and/or variation of interprétation, some or ail of which may decrease accuracy and/or impact quality of care. The same factors may impair the real-world accuracy of non-malaria RDTs as well.

[0011] Infectious disease surveillance în developing countries may be compromised by inaccurate, incomplète and/or stale data, perhaps due to the current labour-intensive and/or errorprone manua! capture and/or transcription of diagnostic results. This may impair the abîlity of program managers to make timely, data-driven resource allocation decisions, perhaps leading to inefficient use of current resources.

[0012] Ovgrview of Some Ancillarv Devices. Systems and/or Methods [0013] Preferably, the QC sensor system, method and/or device according to the présent invention may be adapted for use with mobile digital diagnostics integrated with cloud information services, preferably empowering health workers to deliver more accurate diagnoses and/or health program managers to make evidence-based decisions.

[0014] Preferably, the QC sensor system, method and/or device according to the présent invention may be adapted for use with a smartphone-based, mobile device used by health worker at point of care. Preferably, such an ancillary device may: (a) interpret commercially availabie infectious disease RDTs to improve diagnostic accuracy through digital image analysis; (b) automatically upload real-time, encrypted and/or geo-localized data (e.g., diagnostic, démographie, survey, and/or user workflow data) to a secure database in a cloud-based network; (c) automatically download guidance directives (e.g., clinical protocole, data capture surveys, and/or alerts) from health program managers to health workers, preferably incorporating medical best practices into users’ workflow through digital aids; and/or (d) consolidate disparate mobile health programs on a single platform.

[0015] For example, such an ancillary device may be a universal reader for existing RDTs. It may enable quality imaging of RDTs at a time of interprétation, Such a device may preferably capture an image of the RDT at the time of interprétation, preferably under controlled composition and/or lighting. The image may preferably be transmitted to a cloud-based system 5 for aggregation and/or later use. The device may also enable accurate RDT processing and/or interprétation at a point of care. It may preferably improve real-world accuracy of RDTs, preferably by facilitating workflow and/or objectively interpreting results. This automated interprétation may preferably be compatible with select malaria RDTs. Other disease targets may include HIV, Dengue, and Hepatitîs (among others). The ancillary device may also enable 10 dïgitization of patient information. Users may preferably enter patient information, responses to custom surveys, and/or results of any diagnostic test, preferably via touch screen. The ancillary devices may preferably combine this data with date, time, geo-location and/or other metainformation into a data set for transmission. The ancillary device may also enable automatic data aggregation. Data sets may preferably be transmitted to a cloud-based system, preferably in real15 time over the local mobile phone network, for use by program managers. The ancillary devices may access medical best practices. Two-way communication with such devices may preferably allow program managers to disseminate current case management guidelines and/or data capture best practices, preferably for intégration into everyday workflow. The ancillary devices may preferably host applications capable of making case management recommendations, preferably 20 based on diagnostic results and/or patient symptoms.

[0016] Still by way of example, the system, method and/or computer readable medium according to the présent invention may be adapted for use with one or more ancillary devices which may preferably possess / enable one or more of the following features: may facilitate simultaneous workflow of multiple RDTs; may hâve a simple user interface with visual eues for 25 step-by-step training and/or operation; ail content may be remotely managed through a cloudbased system by program managers; applications / updates to the device software, and/or custom surveys may be downloaded over a mobile phone network; ail diagnostic functionality needed by health worker using RDTs may be performed on-board the devices, preferably without any need for cellular communication function; hundreds of patient records may be stored on-board 30 the devices when beyond cell tower range and/or automatically transmitted when coverage may be restored; data records may be encrypted and/or securely transmitted using a secure hypertext transfer protocol (“https); an automated routine QC check may be performed regularly (e.g., daily); may be run and/or be compatible with select applications on the Android operating system offered by Google Inc. of Mountain View, California and/or on another mobile device operating system; may be battery powered, e.g., aflording about four (4) days’ operation per charge; hand crank and/or solar charging accessories may be available upon request; may afford GSM communication, e.g., EDGE, 2G and/or 3G; may include SIM card functionality; may enable geo-location via GPS; and/or may hâve a high-resolution and/or backlit LCD (e.g., a 3.75 LCD); preferably with a capacitive touch screen.

Such ancillary devices may preferably possess / enable one or more of the following may put the skill of an expert RDT technician in the hands of minimaHy-trained health may unify diagnosis and/or data; data from every clinical encounter may be captured [0017] benefits: workers;

for determining resource allocation and/or public health poücy; may alert program managers of trend development and/or enable coordinated and/or tîmely responses; health workers may upgrade their skiüs through dissémination of best practices in case management; may be compatible in a broad range of point-of-care settings, e.g., clinics, health posts, community outreach, military théâtres and/or airports; RDT images and/or aggregate clinical data may be easily used by program managers to quality control health workers and/or may help to identify those in need of remédiai training; record keeping may facilitate accountability of resource distribution and/or utilization; and/or may serves as a platform for innovative applications, e.g., therapy guidance, drug authentication, and/or continuing medical éducation.

[0018] Preferably, the QC sensor system, method and/or device according to the présent invention may also be adapted for use with a web interface accessible via any Intemet-enabled computer by an authorized health program manager. Preferably, such an interface may: (a) enable storage, retrieval, and/or analysis of data; (b) enable remote and/or real-time monitoring / management of devices, users’ workflows, quality control procedures, and/or data capture; (c) enable real-time dissémination of clinical protocols, surveys, and/or alerts to devices; (d) generate reports; (e) export / import data to / from other databases; and/or (f) enable real-time and/or two-way communication between program managers and/or health workers.

[0019] For example, such an ancillary interface may enable web-based access to a cloudbased system. It may enable data aggregation and/or storage. Preferably, data transmitted by devices in the field may be routed in real-time to a cloud-based data warehouse, preferably at least one which may employ enterprise-level data redundancy and/or off-site backup. Preferably, access may be password protected and/or no spécial IT infrastructure may be required. Such an ancillary interface may enable real-time reporting and/or analysis. Preferably, it may analyze data using customized reports (e.g., maps, statistical analyses, and/or graphs) updated regularly (e.g., every fifieen minutes) and/or search the data warehouse for up-to-the-second information. Such an interface may be enable dissémination of best practice guidelines. Preferably, it may be used to control workflow in clinics by transmittîng custom surveys, device software updates, and/or medical best practice protocols. Such an interface may also remotely oversee devices and/or users. Preferably, it may send/receive messages and/or transmit alerts to devices in the field. Preferably, it may control quality of health worker performance and/or coordinate interventions, remotely. This interface may afford interoperability with other health information Systems. Preferably, it may import and/or export data to and/or from external databases for enhanced access and/or data management. Preferably, it may leverage the latest reporting and/or analytical tools, and/or mobile health applications, e.g., drug authentication, GIS mapping, and/or SMS clinical follow up.

[0020] Still by way of example, the system, method and/or computer readable medium according to the présent invention may be adapted for use with one or more ancillary interfaces which may preferably possess / enable one or more of the following features: may be webhosted; may be accessed via an Internet browser (e.g., Internet Explorer, Safari, Firefox, and/or Chrome) on any computer; may not require any software and/or hardware installation; access may be protected through secure login; program managers may distribute accounts to authorized individuals; reports may be exported in multiple formats, e.g., .pdf, .csv, .xlsx, .docx, and/or .xml; advanced search function may enable customized query of database; may be based on more than forty (40+) search criteria; and/or data transmission and/or format may be compatible with future HL7 compliance and/or interoperability with existing databases and/or electronic medical record Systems.

[0021] Such ancillary interfaces may preferably possess ! enable one or more of the following benefîts: may improve timely access by simultaneous authorized users from any

Intemet-enabled computer to accurate, real-time, and/or épidémiologie data from point-of-care to support program monitoring and/or évaluation, clinical practice quality control, surveillance.

and/or data-driven resource allocation decisions; may help to build and manage human capital; may help to identify and/or foster highly productive health workers; may help to provide those in need of remedia! training with appropriate materials and/or attention; may help to create and/or improve accountability and/or transparency by gaining and/or aflording access to timeîy and/or auditable records of work performed; and/or may centralize disparate health system strengthening initiatives on one platform.

[0022] One or more of the aforementioned features and/or benefits of the ancillary devices and/or interfaces may potentiaîîy be achieved and/or improved in tandem with the QC sensor system, method and/or device according to the présent invention.

[0023] It may be an object according to an aspect of one embodiment of the invention to provide a quality control (QC) method, System and/or device.

[0024] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device for use with biological ! environmenta! diagnostic test devices.

[0025] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device for use with biological / environmenta! RDT devices.

[0026] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device which provides for automatic timers, reminders and/or RDT cassette images.

[0027] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device which provides sensors calibrated and/or optimized, and/or for quality control of RDT devices.

[0028] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device which provides image analysis to identify cassette and/or patient information, and/or évaluâtes the processing and/or conditions of RDT devices, cassettes and/or RDTs.

[0029] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device which provides for QC results to be accessed and/or analyzed remotely from the RDT devices.

[0030] It may be an object according to an aspect of one embodiment of the invention to 5 provide a QC sensor method, system and/or device which tracks RDT chain of custody and/or RDT workflow, incubation and/or reading sequences.

[0031] It may be an object according to an aspect of one embodiment of the invention to provide a QC sensor method, system and/or device which provides for a QC score for each unique patient RDT to be determined based on QC criteria.

[0032] It may be an object of the invention to obviate and/or mitigate one or more of the above mentioned disadvantages and/or problème associated with the prior art, and/or to achieve one or more of the aforementioned objects of the invention.

SUMMARY OF THE INVENTION [0033] According to the invention, there is disclosed a quality control (QC) sensor method, 15 system and/or device for use with one or more biological or environmental rapid diagnostic test (RDT) devices. Each of RDT devices has a RDT cassette bed. According to the QC sensor method, system and/or device, one or more QC sensors are provided for QC of the RDT devices. One or more RDT cassettes are provided with one or more barcodes and/or radio frequency identification (RFID) chips which encode cassette information associated with the cassettes. The 20 QC sensors include a température sensor and/or the cassettes are provided with one or more color température pads. Cassette images taken of the cassettes include at least one of the color température pads. Analysis of a color change in the color température pads monitors, assesses and/or détermines one or more storage températures associated with the cassettes. The QC sensor method, system and/or device provides for a wireless and/or hard-wired connection to a 25 remote, central and/or distributed database. The QC sensors include a light sensor and/or a weight sensor associated with the cassette bed. A timer is provided as part of the RDT devices. The light sensor and/or the weight sensor détermine when one of the cassettes is placed at a predetermined position. Then, the timer automatically commences an assay time count. When the assay time count is completed, (I) a RDT resuit is automatically read from the cassettes, 30 and/or (2) an alert is presented by the RDT device as a reminder to take a cassette image of, or to rend a RDT resuit from, the cassettes. A motor is provided in association with the cassette bed. When the RDT is completed, the motor moves the cassette bed into position for a caméra of the RDT device to take a cassette image. When the cassette bed is moved into the aforesaid position, the caméra automatically takes the cassette image. Caméra parameters are recorded in association with each cassette image to détermine working conditions associated with the caméra. The caméra parameters are transmitted to the database for access or analysis remotely from the devices. The cassettes are provided with one or more visual indicia of a predetermined intensity. Intensity software is provided to regularly require an intensity analysis or cassette image of the visual indicia, and/or each RDT resuit is accompanied by the intensity analysis or cassette image of the visual indicia when transmitted to the database. The cassettes are provided with one or more colored indicia which, when the RDT is valid or proceeds validly, are of a predetermined color. Color determining software is provided to regularly require a color analysis or cassette image of the colored indicia, and/or each RDT resuit is accompanied by the color analysis or cassette image of the colored indicia when transmitted to the database. Récognition software is provided which, together with the caméra, enables détection and identification of the cassette and/or of labeling on the cassette. The QC sensor method, system and/or device tracks (a) times and/or durations of one or more workflow, incubation and/or reading sequences associated with the RDT, and/or (b) a workflow chain of custody associated with the RDT. The QC sensors include one or more optical or electric détection sensors. The QC sensor method, system and/or device provides for: (i) variation, calibration or optimization of one or more sensor parameters associated with the optical or electric détection sensors; (ii) an optical calibration method wherein fluorescence détection is performed, with multiple images being taken and/or assessed over time; (iii) optimization of the détection time based on multiple images being taken and/or assessed during one or more of the workflow and/or incubation sequences; (iv) qualitative and/or quantitative assay calibration and an associated method of labeling and/or cassette récognition; (v) a static calibration pattern to be accessible, one for each different RDT and/or type of RDT; (vi) pre-analysis ofthe RDT and/or cassette to be performed for détection of errors through images and/or pattern récognition; and/or (vii) calibration or adjustment of the optical détection sensors based on the assay type. A QC score for each unique patient RDT is determined, calculated and/or recorded, based on and/or with reference to one or more QC criteria.

[0034] According to the invention, there is also disclosed a quality control (QC) sensor method, system and/or device for use with one or more biological or environmental rapid diagnostic test (RDT) devices. Each of the RDT devices has a RDT cassette bed. According to the QC sensor method, system and/or device, one or more QC sensors are provided for QC of the RDT devices.

[0035] According to an aspect of one preferred embodiment of the invention, one or more RDT cassettes may preferably, but need not necessarily, be provided with one or more barcodes and/or radio frequency identification (RFID) chips which may preferably, but need not necessarily, encode cassette information associated with the cassettes.

[0036] According to an aspect of one preferred embodiment of the invention, the cassette information may preferably, but need not necessarily, include a lot number and/or an expiration date associated with the cassettes.

[0037] According to an aspect of one preferred embodiment of the invention, a barcode scanner may preferably, but need not necessarily, be provided and/or adapted to read said encoded cassette information of the barcodes.

[0038] According to an aspect of one preferred embodiment of the invention, a caméra may preferably, but need not necessarily, be provided and/or adapted to take cassette images. Each of the cassette images may preferably, but need not necessarily, be of a respective one of the cassettes.

[0039] According to an aspect of one preferred embodiment of the invention, decoding software may preferably, but need not necessarily, be provided to décodé the cassette information from the barcodes and/or the RFID chips.

[0040] According to an aspect of one preferred embodiment of the invention, one or more cassettes may preferably, but need not necessarily, be provided with one or more color température pads. Cassette images taken of the cassettes may preferably, but need not necessarily, include at least one of the color température pads. Analysis of a color change in the color température pads may preferably, but need not necessarily, monitor, assess and/or détermine one or more storage températures associated with the cassettes.

[0041] According to an aspect of one preferred embodiment of the invention, the QC sensor method, system and/or device may preferably, but need not necessarily, provide for a wireless and/or hard-wired connection to a remote, central and/or distributed database.

[0042] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include a température sensor.

[0043] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include a light sensor associated with the cassette bed and/or the cassettes.

[0044] According to an aspect of one preferred embodiment of the invention, preferably when the light sensor may détermine one of the cassettes to hâve been placed at a predetermined position and/or over the light sensor, and/or preferably when one of the cassettes may affect illumination reaching the light sensor, a timer may preferably but need not necessarily automatically commence an assay time count. Preferably, but not necessarily, when the assay time count may be completed, (ï) a RDT resuit may preferably, but need not necessarily, be automatically read from the cassettes, and/or (ii) an alert may preferably, but need not necessarily, be presented by the RDT device, preferably as a reminder to take a cassette image of, and/or to read, a RDT resuit from the cassettes.

[0045] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include a weight sensor associated with, and/or under, the cassette bed and/or the cassettes.

[0046] According to an aspect of one preferred embodiment of the invention, preferably when the weight sensor may détermine one of the cassettes to be bearing on the weight sensor, a timer may preferably but need not necessarily automatically commence an assay time count. Preferably, but not necessarily, when the assay time count may be completed, (i) a RDT resuit may preferably, but need not necessarily, be automatically read from the cassettes, and/or (ii) an alert may preferably, but need not necessarily, be presented by the RDT device, preferably as a reminder to take a cassette image of, and/or to read, a RDT resuit from the cassettes.

[0047] According to an aspect of one preferred embodiment of the invention, a motor may preferably, but need not necessarily, be provided in association with the cassette bed. Preferably but not necessarily when the RDT is completed, the motor may move the cassette bed into position, preferably for a caméra of the RDT device to take a cassette image. Preferably but not necessarily when the cassette bed may be moved into the aforesaid position, the caméra may preferably, but need not necessarily, automatically take the cassette image.

[0048] According to an aspect of one preferred embodiment of the invention, the cassette bed may preferably, but need not necessarily, be a round plate. The motor may preferably, but need not necessarily, rotate the round plate into the aforesaid position.

[0049] According to an aspect of one preferred embodiment of the invention, caméra parameters may preferably, but need not necessarily, be recorded in association with each cassette image, preferably to détermine working conditions associated with the caméra and/or one or more optical détection sensors.

[0050] According to an aspect of one preferred embodiment of the invention, the caméra parameters may preferably, but need not necessarily, include an exposure time and/or an optoelectro gain associated with the caméra and/or with the optical détection sensors.

[0051] According to an aspect of one preferred embodiment of the invention, the caméra parameters may preferably, but need not necessarily, be transmitted to the database for access and/or analysis remotely from the devices.

[0052] According to an aspect of one preferred embodiment of the invention, the cassettes may preferably, but need not necessarily, be provided with one or more visual indicia of a predetermined intensity. Intensity software may preferably, but need not necessarily, be provided to regularly require an intensity analysis and/or cassette image of the visual indicia. Each RDT resuit may preferably, but need not necessarily, be accompanied by the intensity analysis and/or cassette image of the visual indicia when transmitted to the database.

[0053] According to an aspect of one preferred embodiment of the invention, the cassettes may preferably, but need not necessarily, be provided with one or more colored indicia which, preferably when the RDT is valid and/or proceeds validly, are of a predetermined color. Color determining software may preferably, but need not necessarily, be provided to regularly require a color analysis and/or cassette image of the colored indicia. Each RDT resuit may preferably, but need not necessarily, be accompanied by the color analysis and/or cassette image of the colored indicia when transmitted to the database.

[0054] According to an aspect of one preferred embodiment of the invention, the color analysis and/or cassette image of the colored indicia may preferably, but need not necessarily, be performed at the beginning, middle, and/or end of the RDT.

[0055] According to an aspect of one preferred embodiment of the invention, récognition software may preferably, but need not necessarily, be provided which, preferably together with the caméra, may enable détection and/or identification of the cassette and/or of labeling on the cassette.

[0056] According to an aspect of one preferred embodiment of the invention, the caméra and/or the récognition software may preferably, but need not necessarily, together provide for optical character and/or hand-writing récognition of patient identification indicia provided on the cassette.

[0057] According to an aspect of one preferred embodiment of the invention, the QC sensor method, system and/or device may preferably, but need not necessarily, track one or more times and/or durations of one or more workflow, incubation and/or reading sequences associated with the RDT.

[0058] According to an aspect of one preferred embodiment of the invention, the QC sensor method, system and/or device may preferably, but need not necessarily, track a workflow chain of custody associated with the RDT.

[0059] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include one or more optical or electric détection sensors. The QC sensor method, system and/or device may preferably, but need not necessarily, provide for variation, calibration and/or optimizatîon of one or more sensor parameters associated with the optical or electric détection sensors.

[0060] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include one or more optical détection sensors. The QC sensor method, system and/or device may preferably, but need not necessarily, provide for an optical calibration method wherein fluorescence détection may preferably be performed, preferably but not necessarily with multiple images being taken and/or assessed over time.

[0061] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include one or more optical détection sensors. The QC sensor method, system and/or device may preferably, but need not necessarily, provide for optimization of détection time, preferably based on multiple images which may preferably, but need not necessarily, be taken and/or assessed, preferably during one or more of the workflow and/or incubation sequences.

[0062] According to an aspect of one preferred embodiment of the invention, the QC sensor method, system and/or device may preferably, but need not necessarily, provide for qualitative and/or quantitative assay calibration and/or an associated method of labeling and/or cassette récognition.

[0063] According to an aspect of one preferred embodiment of the invention, the QC sensor method, system and/or device may preferably, but need not necessarily, provide for a static calibration pattern to be accessible, preferably but not necessarily one for each different RDT and/or type of RDT.

[0064] According to an aspect of one preferred embodiment of the invention, the QC sensor method, system and/or device may preferably, but need not necessarily, provide for pre-analysis of the RDT and/or cassettes to be performed, preferably for détection of errors and preferably through images and/or pattem récognition.

[0065] According to an aspect of one preferred embodiment of the invention, the errors which may preferably, but need not necessarily, be détectable include: user errors; manufacturing defects; blood in the buffer well; blood volume issues; already used diagnostic tests; and/or improper alignment ofcontrol and/or test lines.

[0066] According to an aspect of one preferred embodiment of the invention, the QC sensors may preferably, but need not necessarily, include one or more optical détection sensors. The QC sensor method, system and/or device may preferably, but need not necessarily, provide for calibration and/or adjustment of the optical détection sensors, preferably based on the assay type.

[0067] According to an aspect of one preferred embodiment of the invention, a QC score for each unique patient diagnostic test may preferably, but need not necessarily, be determined, calculated and/or recorded, preferably based on and/or with reference to one or more QC criteria.

[0068] According to an aspect of one preferred embodiment of the invention, the QC score may preferably, but need not necessarily, be recorded in a database for review and/or comparison, and/or to détermine whether the QC score is within acceptable QC score parameters.

[0069] Other advantages, features and characteristics of the présent invention, as well as methods of operation and functions of the related éléments of the system, method, and device 10 and the combination of steps, parts and économies of manufacture, will become more apparent upon considération of the following detailed description and the appended claims with reference to the accompanying drawings, the latter of which are briefly described hereinbelow.

BRI EF DESCRIPTION OF THE DRAWING(S) [0070] The novel features which are believed to be characteristic of the system, method, and 15 device according to the présent invention, as to the structure, organization, use, and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawing(s) in which presently preferred embodiments of the invention will now be illustrated by way of examplc. It is expressly understood, however, that the drawing(s) are for the purpose of illustration and description only, and are not intended as a définition of the limits 20 ofthe invention. In the accompanying drawingfs):

[0071] Figure 1 is a schematic drawing of printed lines of a predetermined intensity provided, according to the invention, on a QC cassette attached to a RDT device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0072] Preferred embodiments of the quality control (“QC”) sensor System, method, and 25 device according to the invention are altemateiy herein referred to, collectively and/or individually, as the QC system, method and/or device (or simply as the system, method and/or device). Référencés to one or more of lhe QC sensor system, method and/or device may, if and as appropriate, be understood by persons having ordinary skill in the art to apply, mutafis mu tan dis, to the others.

. 16 [0073] As aforesaid, the QC sensor system, method and device according to the invention are preferably for use with one or more bîological and/or envîronmental rapid diagnostic test (“RDT”) devices. Each of the RDT devices has a RDT cassette bed. According to the invention, QC sensors are provided for QC of the RDT devices.

[0074] RDT cassettes are preferably provided with barcodes and/or radio frequency identification (“RFID”) chips which preferably encode cassette information associated wilh lhe cassettes. The cassette information preferably includes a lot number and an expiration date associated with the cassettes. A barcode scanner is preferably provided and adapted to read the encoded cassette information of the barcodes. A caméra is preferably provided and adapted to take cassette images. Each of the cassette images is preferably of a respective one of the cassettes. Decoding software is preferably provided to décodé the cassette information from the barcodes and/or the RFID chips.

[0075] Cassettes are preferably provided with color température pads. Cassette images taken ofthe cassettes preferably include at least one ofthe color température pads. Analysis of a color change in the color température pads preferably monitors, assesses and/or détermines storage températures associated with the cassettes.

[0076] The QC sensor method, system and/or device preferably provides for a wireless and/or hard-wired connection to a remote, central and/or distributed database.

[0077] The QC sensors preferably include a température sensor, a light sensor associated with the cassette bed (and lhe cassettes), and a weight sensor under or associated with lhe cassette bed (and the cassettes).

[0078] When the light sensor détermines a cassette to hâve been placed at a predetermined position (or over the light sensor) -- and in some embodiments, simply, if the cassette is determined to hâve affected any illumination reaching the light sensor — a provided timer preferably automatically commences an assay time count.

[0079] In some embodiments, when the weight sensor détermines a cassette to be bearing on the weight sensor, the timer preferably automatically commences the assay time count.

[0080] Preferably, when the assay time count is completed, a RDT resuit is automatically read from the cassettes. In some embodiments, an alert might additionally or instead be presented by the RDT device as a reminder for the user to take a cassette image of, or to read, the RDT resuit from the cassette.

[0081] In some embodiments, a motor is preferably provided in association with the cassette bed. When the RDT is completed, the motor moves the cassette bed into position for a caméra of the RDT device to take a cassette image. Preferably, when the cassette bed is moved into position, the caméra automatically takes the cassette image. The cassette bed may, for example, be a round plate and the motor may rotate it (e.g., at a substantially constant speed) into position.

[0082] Caméra parameters are preferably recorded in association with each cassette image to détermine the working conditions associated with the caméra (or optical détection sensors). Références herein to a caméra may be considered, if and as appropriate, to also extend more generally to optical détection sensors (altemately, “optical sensors), and vice versa. The caméra parameters preferably include an exposure time and/or an opto-electro gain associated with the caméra. The caméra parameters are transmitted to the database for access and analysis remotely from the devices.

[0083] The cassettes are provided with visual indicia of a predetermined intensity. Intensity software is provided to regularly require a cassette image and an intensity analysis of the visual indicia. Additionally or instead, the cassettes are provided with colored indicia which are of a predetermined color when the RDT is valid and proceeds validly. Color determining software is provided to regularly require a cassette image and color analysis of the colored indicia. (The cassette image and color analysis of the colored indicia is preferably performed at the beginning, middle, and/or end of the RDT.) Each RDT resuit is accompanied by the cassette image, and by the intensity and/or color analyses, when transmitted to the database.

[0084] Récognition software is provided which, together with the caméra, enables détection and identification of the cassette and labeling thereon. The caméra and the récognition software together provide for optical character and hand-writing récognition of patient identification indicia provided on the cassette.

[0085] The QC sensor method, system and device track the times and durations of the workflow, incubation and reading sequences — as well as the workflow chain of custody — associated with the RDT.

[0086] The QC sensors preferably include optical and electric détection sensors. Preferably, the QC sensor method, system and device provide for:

(a) variation, calibration and optimization of sensor parameters associated with the optical and electric détection sensors;

(b) an optical calibration method wherein fluorescence détection is performed, with multiple images being taken and assessed over time;

(c) optimization of the détection time based on multiple images being taken and assessed during the workflow and incubation sequences;

(d) qualitative and quantitative assay calibration and an associated method of Iabeling and cassette récognition;

(e) a static calibration pattem to be accessible, one for each different RDT and type of RDT;

(f) pre-analysis of the RDT and cassette to be performed for détection of errors through images and pattem récognition; and (g) calibration and adjustment of the optical détection sensors based on the assay type.

[0087] According to subparagraph (f) of the preceding paragraph, the errors which may be detected include (among others): user errors; manufacturing defects; blood in the buffer well; blood volume issues; aiready used diagnostic tests; and improper alignment of control and test lines.

[0088] A QC score for each unique patient diagnostic test is preferably determined, calculated and recorded, based on and with reference to QC criteria. The QC score is recorded in the database for review and comparison, and to détermine whether the QC score is within acceptable QC score parameters.

[0089] OC Sensor Method [0090] Persons skilled in the art will appreciate that aithough some of the components, relations, functionalities and applications of the QC sensor system and device are not specifïcally referenced or described in conjunction with the QC sensor method, they may be used or adapted for use in association therewith. The QC sensor method is suitable for use with the QC sensor system and device described herein, but it îs not so limited.

[0091] Computer Readable Medium [0092] According to the invention, a computer readable medium (e.g., CD-ROM, DVDROM, flash USB stick, RAM, ROM, and/or other computer memory device) may also be provided which includes exécutable instructions physically stored thereon. According to the invention, the exécutable instructions are such that, upon execution, they preferably encode processors to perform the QC sensor method (according to the invention).

Further Description [0093] Preferably, according to the invention:

(a) RDT cassettes are taped with a barcode and/or RFID chip which contains information conceming the manufacture of the cassette, such as, for example, lot number and/or expiration date.

(b) According to the device, system and/or method of the présent invention, a barcode scanner is provided. Preferably, the barcode scanner is adapted to read barcode information.

In another embodiment according to the device, system and/or method of the présent invention, a caméra is provided. Preferably, the caméra is able to take an image of the entire RDT cassette.

(c) According to the device, system and/or method of the présent invention, software is preferably provided to décodé barcode information.

(d) Each of the RDT cassettes is taped with a color température pad when manufactured. According to the device, system and/or method of the présent invention, an image taken of the entire cassette preferably includes the color température pad, and/or analysis of the pad’s color change is performed, preferably to monitor and/or assess the cassette storage température.

(e) According to the présent invention, the device is wirelessly connected and/or hard-wired to a remote, centra! and/or distributed database.

(f) The device is provided with a température sensor.

(g) The device is provided with a light sensor under the cassette. Preferably, after the RDT cassette is placed on an assigned location (e.g., after sample blood and/or a buffer may be added), the light sensor signais the device, the device automatically counts the assay time, and/or the device automatically reads the RDT diagnostic resuit when the time is out.

According to one embodiment of the invention, the device îs optionally provided with a weight sensor under the cassette. Preferably, after the RDT is placed on an assigned location, the weight sensor signais the device (e.g., after the sample blood and/or buffer may be added), and/or the device automatically counts the assay time and/or reads the diagnostic resuit when the time is out.

(h) According to the présent invention, the device is provided with a reader and/or a cassette bed. Preferably, the cassette bed is hard-wired and/or built into the reader. The cassette bed preferably contains several RDT-shaped indents. Each indent position preferably has a light sensor (and/or a weight sensor) and/or a timer. Preferably, after a RDT is placed on a bed and/or when the sample and/or buffer is added, the timer automatically starts.

Preferably, after a rcmaïning assay time reaches zéro, a speaker (provided according to the présent invention) beeps to remind one or more users of the device to take a RDT image.

In addition and/or instead, the device is equipped with a motor according to the présent invention. According to this embodiment of the invention, the RDT bed preferably is a 20 round plate. Preferably, the motor rotâtes the round RDT bed at a spécifie speed.

Preferably, after the assay time is out, the cassette is in a proper position for the caméra to take a RDT image.

(i) According to the invention, the device is provided with an ability to record caméra parameters when taking a RDT picture. These parameters preferably include, for 25 example, (but are not limited to) exposure time and/or opto-electro gain of one or more associated optica! sensors. Preferably, according to the invention, the device sends these parameters to the remote / central database. Preferably, if the device is not functional or working properly, these parameters may change. A database manager is preferably able to remotely détermine the working condition of each of the devices. For point-of-care devices, it may be crucial to enable real-time monitoring of such devices’ working conditions.

The device is attached to a QC cassette. Several printed Unes are provided on the QC cassette. See Figure 1 for example. These printed lines preferably hâve a constant and/or spécifie intensity value. Preferably, the device software regularly requests users to test QC cassette intensity, and/or the QC cassette data is attached to every test resuit and/or sent to the database.

(k) According to one aspect of the présent invention, pre-printed lines are provided on the cassette in a first color which, as a QC mechanism, change to a pre-determined second color if the test is valid and/or proceeds validly. Preferably, the sensor, device, system and/or method according to the invention provides for the color of the lines to be read at the beginning, middle and end of the test to see if it is valid.

(l) The sensor, device, system and/or method according to one aspect of the invention provides for détection of labeling on the cassette, as well as cassette détection and identification. Preferably, the sensor, device, system and/or method according to one aspect of the invention provides for hand-writing détection including, for example, patient name and/or patient ID, etc.

(m) According to one aspect of the invention, the sensor, device, system and/or method provides for time tracking of various workflow sequences (e.g., incubation sequences, reading sequences) associated with the RDT.

(n) The sensor, device, system and/or method according to one aspect of the invention provides and/or records the workflow chain of custody associated with the patient RDT.

(o) According to one aspect of the invention, the sensor, device, system and/or method provides for and/or enables variation, calibration and/or optimîzation of one or more of the optical and/or electric détection sensor parameters.

The sensor, device, system and/or method according to one aspect of the invention provides for an associated optical calibration method. For example, according to one aspect of the invention, the optical calibration method preferably provides for fluorescence détection to be performed over time and/or at various different times (e.g., with multiple pictures / video being taken and/or assessed based on time).

According to one aspect of the invention, the sensor, device, system and/or method provides for optimization of the détection time. For example, according to one aspect of the invention, the détection time is preferably optimized based on multiple pictures and/or video being taken and/or assessed during one or more of the workflow sequences (e.g., according to one aspect of the invention, preferably including during the incubation sequence).

(p) The sensor, device, system and/or method according to one aspect of the invention provides for qualitative assay calibration and/or quantitative assay calibration. For example, according to one aspect of the invention, the qualitative assay calibration and/or the quantitative assay calibration preferably involves and/or is associated with a method based on labeling and/or cassette récognition.

(q) According to one aspect of the invention, the sensor, device, system and/or method provides a static calibration pattern. For example, according to one aspect of the invention, a static calibration pattern is preferably provided and/or made available, one for each different test and/or type of test.

(r) The sensor, device, system and/or method according to one aspect of the invention provides for pre-analytical steps to be performed for error détection through images and/or pattern récognition. For example, according to one aspect of the invention, the eirors so détectable preferably include user errors, manufacturing defects, blood in the buffer well, blood volume issues, already used RDTs, and/or improper alignment of control and test line (etc).

(s) According to one aspect of the invention, the sensor, device, system and/or method provides for calibration and/or adjustment of the optical sensor based on the assay type. And/or, (t) The sensor, device, system and/or method according to one aspect of the invention provides, détermines, calculâtes and/or records a QC score per unique patient RDT. The QC score is preferably determined and/or calculated, according to one aspect of the invention, in dépendent relation based upon one or more of the other éléments and/or features of the présent invention which are described herein, and/or with reference to other QC criteria. According to one aspect of the invention, the QC score is preferably recorded in a database for review, comparison against other QC scores, and/or to ascertain whether and/or the extent to which the QC score mîght be within or outside of acceptable parameters.

[0094] Preferably, ail of the aforementioned, depicted and various structures, configurations, relationshîps, processes, utilities and the like may be, but are not necessarily, incorporated into and/or achieved by one or more aspects of the invention. Any one or more of the aforementioned structures, configurations, relationshîps, processes, utilities and the like may be implemented in and/or by one or more aspects of the invention, on their own, and/or without reference, regard or likewise implémentation of any of the other aforementioned structures, configurations, relationshîps, processes, utilities and the like, in various permutations and combinations, as will be readily apparent to those skilled in the art, without departing from the pith, marrow, and spirît ofthe disclosed invention.

[0095] This concludes the description of presently preferred embodiments of the invention. The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the invention to the précisé form disclosed. Other modifications, variations and alterations are possible in light of the above teaching and will be apparent to those skilled in the art, and may be used in the design and manufacture of other embodiments according to the présent invention without departing from the spirît and scope of the invention. It is intended the scope of the invention be limited not by this description but only by any daims forming a part of this application, and/or the daims of any application claiming priority from this application, and/or any patent issuing thereon.

Claims

WHAT IS CLAIMED IS:

Claims

1. A quality control (QC) method, system and/or device for use with one or more biological or environmental rapid diagnostic test (RDT) devices, each having a RDT cassette bed;

5 wherein according to the QC sensor method, system and/or device one or more QC sensors are provided for QC of the RDT devices.
2. A method, system and/or device according to claim 1, wherein one or more RDT cassettes are provided with one or more barcodes and/or radio frequency identification (RFID) chips which encode cassette information associated with the cassettes; optionally,

10 wherein said cassette information comprises a lot number and/or an expiration date associated with the cassettes; optionally, wherein a barcode scanner is provided and adapted to read said encoded cassette information of the barcodes.
3. A method, system and/or device according to claim 1 or 2, wherein a caméra is provided

15 and adapted to take cassette images, each of a respective one of the cassettes.
4. A method, system and/or device according to any one of claims 1 to 3, wherein decoding software is provided to décodé the cassette information from the barcodes and/or the RFID chips.
5. A method, system and/or device according to any one of claims I to 4, wherein one or

20 more cassettes are provided with one or more color température pads, wherein cassette images taken of the cassettes include at least one of the color température pads, and wherein analysis of a color change in the color température pads monitors, assesses and/or détermines one or more storage températures associated with the cassettes.
6. A method, system and/or device according to any one of claims 1 to 5, which provides

25 for a wireless and/or hard-wired connection to a remote, central and/or distributed database.
7. A method, system and/or device according to any one of claims 1 to 5, wherein the QC sensors comprise a température sensor, and/or, i À wherein the QC sensors comprise a light sensor associated with the cassette bed and/or the cassettes; optionally, wherein when the light sensor détermines one of the cassettes is placed at a predetermined position and/or over the light sensor, and/or when one of the cassettes affects illumination reaching the light sensor, a timer automatically commences an assay time count, and/or when the assay time count is completed, (i) a RDT resuit is automatically read from the cassettes, and/or (ii) an alert is presented by the RDT device as a reminder to take a cassette image of, and/or to read, a RDT resuit from the cassettes.
8. A method, system and/or device according to any one of claims 1 to 7, wherein the QC sensors comprise a weight sensor associated with, and/or under, the cassette bed and/or the cassettes; optionally, wherein when the weight sensor détermines one of the cassettes is bearing on the weight sensor, a timer automatically commences an assay time count, and/or when the assay time count is completed, (i) a RDT resuit is automatically read from the cassettes, and/or (ii) an alert is presented by the RDT device as a reminder to take a cassette image of, and/or to read, a RDT resuit from the cassettes.
9. A method, system and/or device according to any one of claims 1 to 8, wherein a motor is provided in association with the cassette bed; wherein when the RDT is completed, the motor moves the cassette bed into position for a caméra of the RDT device to take a cassette image; and wherein when the cassette bed is moved into said position, the caméra automatically takes the cassette image; optionally, wherein the cassette bed is a round plate, and wherein the motor rotâtes the round plate into said position.
10. A method, System and/or device according to any one of claims 1 to 9, wherein caméra parameters:

are recorded in association with each cassette image to détermine working conditions associated with the caméra; optionally, wherein the caméra parameters comprise an exposure time and/or an opto-electro gain associated with the caméra and/or one or more associated optical sensors; and/or, are transmitted to a remote, central and/or distributed database for access and/or analysis remotely from the devices.
11. A method, system and/or device according to any one of ciaims 1 to 10, wherein the cassettes are provided with one or more visual indicia of a predetermined intensity; wherein intensity software is provided to regularly require an intensity analysis or cassette image of the visual indicia, and/or wherein each RDT resuit is accompanied by the intensity analysis or cassette image of the visual indicia when transmitted to a central, remote and/or distributed database.
12. A method, system and/or device according to any one of ciaims I to II, wherein the cassettes are provided with one or more colored indicia which, when the RDT is valid or proceeds validly, are of a predetermined color; wherein color determining software is provided to regularly require a color analysis or cassette image of the colored indicia, and/or wherein each RDT resuit is accompanied by the color analysis or cassette image of the colored indicia when transmitted to a remote, central and/or distributed database; optionally, wherein the color analysis and/or cassette image of the colored indicia is performed at the beginning, middle, and/or end of the RDT.
13. A method, system and/or device according to any one of ciaims 1 to 12, wherein récognition software is provided which, together with the caméra, enables détection and identification of the cassette and/or of labeting on the cassette; optionally, wherein the caméra and the récognition software together provide for optical character and/or hand-writing récognition of patient identification indicia provided on the cassette.
14. A method, system and/or device according to any one of ciaims 1 to 13, which tracks:

one or more times and/or durations of one or more workflow, incubation and/or reading sequences associated with the RDT; and/or, a workflow chain of custody associated with the RDT.
15. A method, system and/or device according to any one of ciaims 1 to 14, wherein the QC sensors inciude:

one or more optical or electric détection sensors; and which provides for variation, calibration and/or optimization of one or more sensor parameters associated with the optical or electric détection sensors; and/or, one or more optical détection sensors; and which provides for an optical calibration 5 method wherein fluorescence détection is performed, with multiple images being taken and/or assessed over time.
16. A method, system and/or device according to any one of claims 1 to 15, wherein the QC sensors include one or more optical détection sensors; which provides for optimization of détection time based on multiple images being taken and/or assessed during one or more

10 of the workflow and/or incubation sequences.
17. A method, system and/or device according to any one of claims I to 16, which provides for:

qualitative and/or quantitative assay calibration and an associated method of labeling and/or cassette récognition; and/or,

15 a static calibration pattern to be accessible, one for each different RDT and/or type of

RDT.
18. A method, system and/or device according to any one of claims 1 to 17, which provides for pre-analysis of the RDT and/or cassettes to be performed for détection of errors through images and/or pattern récognition; optionally, wherein the errors which are

20 détectable include: user errors; manufacturing defects; blood in the buffer well; blood volume issues; already used diagnostic tests; and/or improper alignment of control and/or test lines.
19. A method, system and/or device according to any one of claims I to 18, wherein the QC sensors include one or more optical détection sensors; which provides for calibration

25 and/or adjustment of the optical détection sensors based on the assay type.
20. A method, system and/or device according to any one of claims 1 to 19, wherein a QC score:

for each unique patient diagnostic test is determined, calculated and/or recorded, based on and/or with reference to one or more QC criteria; and/or, is recorded in a database for review and/or comparison, and/or to détermine whether the

QC score is within acceptable QC score parameters.
21. A quality control (QC) method, system and/or device according to any one of claims 1 to 20, for use with one or more biological or environmental rapid diagnostic test (RDT) devices, each having a RDT cassette bed; wherein according to the QC sensor method, system and/or device one or more QC sensors are provided for QC of the RDT devices; and:

(a) wherein one or more RDT cassettes are provided with one or more barcodes and/or radio frequency identification (RFID) chips which encode cassette information associated with the cassettes;

(b) wherein the QC sensors include a température sensor and/or the cassettes are provided with one or more color température pads, wherein cassette images taken of the cassettes include at least one of the color température pads, and wherein analysis of a color change in the color température pads monitors, assesses and/or détermines one or more storage températures associated with the cassettes;

(c) which provides for a wireless and/or hard-wired connection to a remote, central and/or distributed database;

(d) wherein the QC sensors include a light sensor and/or a weight sensor associated with the cassette bed; wherein a timer is provided as part of the RDT devices; wherein the light sensor and/or the weight sensor détermine when one of the cassettes is piaced at a predetermined position, and then the timer automatically commences an assay time count; and wherein when the assay time count is completed, (i) a RDT resuit is automatically read from the cassettes, and/or (ii) an alert is presented by the RDT device as a reminder to take a cassette image of, or to read a RDT resuit from, the cassettes;

(e) wherein a motor is provided in association with the cassette bed; wherein when the RDT is completed, the motor moves the cassette bed into position for a caméra of the RDT device to take a cassette image; and wherein when the cassette bed is moved into said position, the caméra automatically takes the cassette image;

(f) wherein caméra parameters are recorded in association with each cassette image to détermine working conditions associated with the caméra; and wherein the caméra parameters are transmitted to the database for access or analysis remotely from the devices;

(g) wherein the cassettes are provided with one or more visual indicia of a predetermined intensity; wherein intensity software is provided to regularly require an intensity analysis or cassette image of the visual indicia, and/or wherein each RDT resuit is accompanied by the intensity analysis or cassette image of the visual indicia when transmitted to the database;

(h) wherein the cassettes are provided with one or more colored indicia which, when the RDT is valid or proceeds validly, are ofa predetermined color; wherein color determining software is provided to regularly require a color analysis or cassette image of the colored indicia, and/or wherein each RDT resuit is accompanied by the color analysis or cassette image of the colored indicia when transmitted to the database;

(i) wherein récognition software is provided which, together with the caméra, enables détection and identification of the cassette and/or of labeling on the cassette;

(j) which tracks (i) times and/or durations of one or more workflow, incubation and/or reading sequences associated with the RDT, and/or (ii) a workflow chain of custody associated with the RDT;

(k) wherein the QC sensors include one or more optical or electric détection sensors;

(l) which provides for: (i) variation, calibration or optimization of one or more sensor parameters associated with the optical or electric détection sensors; (ii) an optical calibration method wherein fluorescence détection is performed, with multiple images being taken and/or assessed over time; (iii) optimization of the détection time based on multiple images being taken and/or assessed during one or more of the workflow and/or incubation sequences; (îv) qualitative and/or quantitative assay calibration and an associated method of labeling and/or cassette récognition; (v) a static calibration pattem to be accessible, one for each different RDT and/or type of RDT; (vi) pre-analysis of the RDT and/or cassette to be 5 performed for détection of errors through images and/or pattem récognition;

and/or (vii) calibration or adjustment of the optical détection sensors based on the assay type; and (m) wherein a QC score for each unique patient RDT is determined, calculated and/or recorded, based on and/or with reference to one or more QC criteria.