RAPID MASS BLOOD SCREENING DEVICE AND METHOD THEREOF

Abstract

Embodiments of the present disclosure relate to a rapid mass blood screening device (100) and a method (200) of operating the same. The device (100) includes a reagent strip (102), a slot (104), a light indicator (106), a power switch (108). The reagent strip (102) is pre-coated with a chemical reagent that interacts with a target analyte in blood sample, resulting in a color change proportional to the concentration of the analyte. The slot (104) is provided to accommodate the reagent strip (102). The light indicator (106) provides a visual cue to signal the presence of the analyte based on a threshold color change on the reagent strip (102) using reflectance photometer technique. Advantageously the present invention relates to a device with absence of the display screen enabling rapid interpretation of screening results solely through the activation of the light indicator.

Specification

Description:TECHNICAL FIELD
[0001] The present disclosure generally relates to the field of medical screening devices. More particularly, the present disclosure relates to a rapid mass blood screening device and a method of operating the same.

BACKGROUND
[0002] Testing blood and urine samples for various analytes is commonly practiced and is an accurate metric for diagnosis. Testing for the analytes, however, requires skilled personnel, expensive reagents and equipment. To make testing more economical and rapid, industries have used point of care machines or strips. These screening technologies basically fall under three main types. One uses a reagent coated strip which needs to be inserted into an instrument after applying a drop of sample on it; or a reaction mixture containing defined amount of sample and reagents is directly loaded onto the instrument using a tube(cuvette), which has a readout/display. Both these require skilled manpower and regular instrument calibration. The other uses reagent coated strip that needs to be dipped in the sample and needs to be visually compared with a nomogram after it shows color depending on analyte. Even though this does not require an instrument, it needs some skill to compare and interpret the analyte concentration. The third category also uses precoated cassettes either for one or multiple analytes on which sample needs to be applied. This will show two precipitation bands if a given analyte concentration crosses a given threshold. This is currently used for pregnancy and toxicology screening and only used for immunological reactions based on antigen antibody interactions.
[0003] Currently available technologies use strips or instruments to accurately measure a given analyte at the bedside that can be helpful in health emergencies for quick decision making. The same methods also have been extended to some common analytes like glucose, lipid profiles, hemoglobin, urine analytes etc. for regular monitoring purposes at hospital or home settings. But an ideal screening tool should be simple, cost effective, rapid and an untrained person also should be able to use. Screening tools also need not accurately quantify an analyte in normal or abnormal range rather should indicate only when a given analyte is beyond the normal reference interval without accurately measuring the same.
[0004] All currently available point of care devices uses a calibrated machine or strips which can quantify analytes at all ranges. This feature not only requires skilled manpower also additional cost in manufacturing such strips machines. Also, as these need to accurately measure analytes at all concentrations, they need to undergo multipoint calibration. As they are sometimes used in clinical management, they also need to get approvals from stringent regulatory bodies on a regular basis. All these adds cost which gets transferred to the end user.
[0005] At present, such a 'go - no go' threshold principle is used only for pregnancy and toxicology testing where the appearance of two precipitation bands (based on antigen antibody interactions) decides if the sample has analyte beyond the specified range. Such a technique is not used for regular and routine analytes like glucose, hemoglobin etc which use complex chemical reactions leading to color formation.
[0006] Current machines use instruments/strips which are validated to measure analyte accurately across all ranges. This enables them to be used not only for screening but also for clinical diagnosis and management. Because of these attributes it makes them costlier as they have to go through stringent calibration, validations and approvals form regulatory bodies.
[0007] To address these limitations, the present invention provides a rapid mass blood screening device and a method of operating the same that overcomes the shortcomings of the prior art.

OBJECTS OF THE PRESENT DISCLOSURE
[0008] It is a primary object of the present disclosure to provide a rapid mass blood screening device and a method of operating the same.
[0009] It is another object of the present disclosure to develop a device with absence of the display screen enabling rapid interpretation of screening results solely through the activation of the light indicator.
[0010] It is yet another object of the present disclosure to provide a device with absence of colored nomogram for interpretation for to be used also by an untrained person/ person with color blindness.
[0011] It is yet another object of the present disclosure to provide a cost effective and rapid mass blood screening device that eliminates the cost and time required for calibration, validations, approval and interpretation.

SUMMARY
[0012] The present disclosure generally relates to the field of medical screening devices. More particularly, the present disclosure relates to a rapid mass blood screening device and a method of operating the same.
[0013] The primary aspect of the present invention is to design a rapid mass blood screening device. The Rapid Mass Blood Screening Device is a simple, user-friendly tool designed for high-volume, non-clinical blood analyte screening. It consists of a slot for inserting a reagent strip, a light indicator to signal analyte presence above a threshold, a reagent strip that changes color based on analyte concentration, and a power switch. Upon sample application, the strip develops a color change, which the device detects when inserted into the slot. If the analyte concentration exceeds a predefined threshold, the light indicator activates, giving a clear, binary output without complex displays or calibration. This streamlined design is accessible to untrained users, suitable for mass screening applications, and eliminates the need for color comparisons or technical interpretations, making it a cost-effective solution for industries and community health screenings.
[0014] In an aspect, a method of operating a rapid mass blood screening device is disclosed. The method includes applying blood sample to a reagent strip pre-coated with a chemical reagent. An interaction of the target analyte in the blood sample is made to react with precoated reagents on the strip, resulting in a color change proportional to the concentration of the analyte. The strip is inserted into a slot provided on the device. The presence of the analyte is detected if the analyte is at or above a pre-determined threshold level, based on a threshold color change on the reagent strip using reflectance photometer technique. A visual cue is provided to signal the presence of the analyte by a light indicator.

BRIEF DESCRIPTION OF DRAWINGS
[0015] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure, and together with the description, serve to explain the principles of the present disclosure.
[0016] FIG. 1A illustrates an exemplary front view of the rapid mass blood screening device, in accordance with an embodiment of the present disclosure.
[0017] FIG. 1B illustrates an exemplary experimental setup of the rapid mass blood screening device, in accordance with an embodiment of the present disclosure.
[0018] FIG. 2 illustrates an exemplary flowchart explaining the method of operating the rapid mass blood screening device, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION
[0019] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit, and scope of the present disclosure as defined by the appended claims.
[0020] Specific details are given in the following description to provide a thorough understanding of the embodiments. However, it will be understood by one of ordinary skill in the art that the embodiments may be practiced without these specific details. For example, circuits, systems, networks, processes, and other components may be shown as components in block diagram form in order not to obscure the embodiments in unnecessary detail. In other instances, well-known circuits, processes, algorithms, structures, and techniques may be shown without unnecessary detail to avoid obscuring the embodiments.
[0021] Also, it is noted that individual embodiments may be described as a process that is depicted as a flowchart, a flow diagram, a data flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be re-arranged. A process is terminated when its operations are completed but could have additional steps not included in a figure. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination can correspond to a return of the function to the calling function or the main function.
[0022] The present disclosure generally relates to the field of medical screening devices. More particularly, the present disclosure relates to a rapid mass blood screening device and a method of operating the same.
[0023] The present disclosure proposes to use a precoated strip on which routine chemistry analytes like glucose, urea, hemoglobin etc can be tested rapidly without quantifying. This will give the user and beep or indicator only when analyte concentration goes beyond the threshold. This can be used even by untrained/color blind person during mass screening programs.
[0024] FIG. 1A illustrates an exemplary front view of the rapid mass blood screening device, in accordance with an embodiment of the present disclosure.
[0025] FIG. 1B illustrates an exemplary experimental setup of the rapid mass blood screening device, in accordance with an embodiment of the present disclosure.
[0026] With reference to Fig. 1A, the device (100) (also herein referred as instrument) includes a reagent strip (102), a slot (104), a light indicator (106), a power switch (108). The reagent strip (102) is pre-coated with a chemical reagent that interacts with a target analyte in blood sample, resulting in a color change proportional to the concentration of the analyte. The slot (104) is provided to accommodate the reagent strip (102). The light indicator (106) provides a visual cue to signal the presence of the analyte at or above a pre-determined threshold level, based on a threshold color change on the reagent strip (102) using reflectance photometer technique, thereby eliminating the need for quantitative measurement.
[0027] In an embodiment, unlike the currently available point of care instruments, the instrument does not require any display screen and stringent multipoint calibration. There is no requirement of color comparison using a nomogram for interpretation and hence can be used by any untrained person or a person with colorblindness. As this instrument is not used for clinical diagnosis or management but only used for rapid screening, it does not have to go through stringent approval process by regulatory authorities. So, it can be put to use by any industries easily. As it eliminates all the costs mentioned for the above validations it can significantly reduce the cost of analysis especially suitable for mass screening. As shown here, this instrument uses reflectance photometer technique.
[0028] In an embodiment, the reagent coated strip can be developed using currently available technology for measuring glucose/any specific analyte. Once a sample is applied on the strip, it develops a color depending on analyte concentration. This colored strip needs to be inserted into the slot of this instrument. When light falls on to this strip, the machine is programmed to indicate by a beep or light only when the color crosses a certain threshold. Thus, this instrument will not quantify any analyte in normal or abnormal ranges, making it unique and novel. This is very much suitable for mass screening of the population. Some analytes which are regularly measured in hospital settings like - glucose, hemoglobin, cholesterol, urea, creatinine, lipid profiles etc can be measured using this method.
[0029] In an embodiment, the device includes a single LED light indicator positioned on the device's exterior to provide a clear, visual signal. This LED illuminates only when the analyte concentration on the test strip reaches or exceeds a pre-set threshold, offering a straightforward, binary readout for the user (i.e., "light on" for positive, "light off" for negative). Located on the front panel, the device has a slot to accommodate an analyte-specific reagent strip. The slot is dimensioned to fit the strip securely and ensure proper alignment. Inside the slot, an internal light source and a sensor are positioned to detect color changes on the strip that correspond to analyte levels. The strip itself has an end marked with arrows to guide the user in correct orientation when inserting the strip.
[0030] In an embodiment, the reagent strip is pre-coated with a chemical reagent that interacts with the target analyte in the blood sample, resulting in a color change proportional to the analyte's concentration. For example, in one embodiment designed for glucose screening, the reagent strip changes from yellow to green as glucose concentration increases. The strip is calibrated to react at specific analyte concentration levels, turning a specific color at the threshold point, which the device's internal sensor then detects. The device includes a single on/off power switch located on the side panel. The switch powers the device and initiates the internal sensor system. When the power switch is turned on, the device enters a standby mode, waiting for a reagent strip to be inserted. This switch can be toggled to power the device off after each use, conserving battery life or energy.
[0031] The present disclosure does not quantify analyte and does not have any readout or display. Also, this disclosure does not require any colored nomograms for interpretation thus enabling it to be used by any untrained person or a person with color blindness. This disclosure uses the well-known and fully validated principle of reflectance photometry which is the backbone of majority of currently available instruments. An additional mechanism is added which enables it to indicate either by a beep or light only when analyte concentration is above a specified threshold. Thus, unlike the current instruments it will indicate only when the analyte concentration crosses a threshold without quantifying it. This makes it an ideal agent for rapid, cost-effective mass screening programs.
[0032] FIG. 2 illustrates an exemplary flowchart explaining the method of operating the rapid mass blood screening device, in accordance with an embodiment of the present disclosure.
[0033] With reference to Fig. 2, at step 202, applying (202) blood sample to a reagent strip (102) pre-coated with a chemical reagent.
[0034] At step 204, interacting (204) of a target analyte in the blood sample with precoated reagents on the strip (102), resulting in a color change proportional to the concentration of the analyte.
[0035] At step 206, inserting (206) the strip (102) into a slot (104) provided on the device (100).
[0036] At step 208, detecting (208) presence of the analyte if the analyte is at or above a pre-determined threshold level, based on a threshold color change on the reagent strip (102) using reflectance photometer technique.
[0037] At step 210, providing (210) a visual cue to signal the presence of the analyte by a light indicator (106).
[0038] In an implementation of an embodiment, a drop of blood is applied to the designated sample area on the reagent strip. After a short reaction time (e.g., 10 seconds), the color on the strip changes in accordance with the analyte's concentration in the sample. This color change on the reagent strip serves as the primary indicator of the analyte level. After the blood sample has reacted with the strip, the user inserts the strip into the slot on the device, aligning it according to the arrows printed on the strip. The slot guides the strip to an exact position for optimal interaction with the internal light and sensor. The sensor may be optional in this device. Once the strip is inserted, the device's internal photometric sensor evaluates the color on the strip. If the color intensity corresponds to an analyte concentration above the preset threshold, the light indicator on the device illuminates, providing an immediate, easily interpretable indication that the analyte level has exceeded the threshold. The device functions as a binary analyzer, displaying only a "yes" or "no" outcome via the light indicator. A lit LED indicates that the analyte concentration on the strip has crossed the threshold (positive), while an unlit LED signifies that the concentration is below the threshold (negative). This feature simplifies the interpretation process, enabling untrained personnel to understand results without needing numerical readouts or complex interpretation.
[0039] Unlike the current methods, the proposed device will not quantify analyte as we need not know the exact quantity when it falls within normal range. The device does not have a display/readout which requires an educated /skilled person to interpret. The device does not require a colored nomogram for interpretation so that an untrained person/ person with color blindness also can use. The device does not does not require multipoint calibration. The device cannot be used for diagnosis or management hence it does not have to go through stringent validations and approvals. The device is highly cost effective and rapid as it eliminates the cost and time required for calibration, validations, approval and interpretation. The device is very ideal for mass screening. The device is highly scalable.
[0040] The device can be stationed at industrial or workplace checkpoints where employees or visitors need to undergo rapid health screening. Its simplicity and binary light output allow personnel to operate the device quickly without specialized training, making it ideal for workplaces aiming to implement health monitoring protocols.
[0041] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are comprised to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
, Claims:1. A rapid mass blood screening device (100) comprising:
a reagent strip (102) pre-coated with a chemical reagent that interacts with a target analyte in blood sample, resulting in a color change proportional to the concentration of the analyte;
a slot (104) to accommodate the reagent strip (102);
a light indicator (106) that provides a visual cue to signal the presence of the analyte at or above a pre-determined threshold level, based on a threshold color change on the reagent strip (102) using reflectance photometer technique, thereby eliminating the need for quantitative measurement.
2. The device (100) as claimed in claim 1, wherein the device (100) is programmed to indicate either by a beep through a sound unit or light through the light indicator (106) only when the color crosses a certain threshold.
3. The device (100) as claimed in claim 1, wherein the analytes to be measured are selected from glucose, hemoglobin, cholesterol, urea, creatinine, lipid profiles and any combination thereof.
4. The device (100) as claimed in claim 1, wherein the device (100) provides a binary result without a display screen.
5. The device (100) as claimed in claim 4, wherein the absence of the display screen enables rapid interpretation of screening results solely through the activation of the light indicator (106).
6. The device (100) as claimed in claim 1, wherein the device (100) further includes a power switch (108) to initiate the readiness of the device (100) for testing and automatically powers down to conserve energy after a defined inactivity period.
7. The device (100) as claimed in claim 1, wherein the device (100) is specifically configured to perform high-volume blood screenings by providing quick, clear light indications of analyte presence without requiring complex interpretation or extended setup.
8. A method (200) of operating a rapid mass blood screening device (100), the method comprising the steps:
applying (202) blood sample to a reagent strip (102) pre-coated with a chemical reagent;
interacting (204) of a target analyte in the blood sample with precoated reagents on the strip (102), resulting in a color change proportional to the concentration of the analyte;
inserting (206) the strip (102) into a slot (104) provided on the device (100);
detecting (208) presence of the analyte if the analyte is at or above a pre-determined threshold level, based on a threshold color change on the reagent strip (102) using reflectance photometer technique; and
providing (210) a visual cue to signal the presence of the analyte by a light indicator (106).

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