372 results about "Test Strip (device)" patented technology

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical / reflectance testing measuring device, or a visual inspection.

An elimination-absorber monitoring system addresses diaper-monitoring problems with a unique, low cost, multi-layer disposable sensor structure that absorbs small volumes of urine, yet allows most urine volume to flow unimpeded through it, and into the diaper below. When connected with a reusable, miniature monitor / indicator unit, the sensor presents a clear and on-going change of measurement condition upon experiencing a rapid influx into the diaper of a significant volume of urine, and / or upon a significant reduction in the available absorbency of the diaper's top surface. The sensor additionally provides recessed, protected elements for similarly presenting a clear and on-going change in measurement condition upon experiencing the presence of fecal matter. Further provided is the monitor unit employing narrow, widely-spaced, fast rise-time, fast transition-time pulses for conductivity measurement and alarm activation. The monitor and sensor are interconnected and attached to a diaper by particularly effective and unique means, and the monitor is equipped with a highly intuitive and convenient control interface, as well as improved assemblies for the transmission of audible and visual alarm indications. Also described is a convenient test-strip device which, when connected to the monitor / alarm unit of the system, can selectively simulate either a soiled or unsoiled elimination-absorber / sensor for test, caregiver-training or demonstration purposes.

Abstract of Disclosure Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The subject devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. At least one fluid pathway resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space-defining configuration therein which acts as a sample fluid pooling area upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter for making analyte concentration measurements. Methods for using the devices and systems are also provided.

A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the sample chamber. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.

An elimination-absorber monitoring system addresses diaper-monitoring problems with a unique, low cost, multi-layer disposable sensor structure that absorbs small volumes of urine, yet allows most urine volume to flow unimpeded through it, and into the diaper below. When connected with a reusable, miniature monitor / indicator unit, the sensor presents a clear and on-going change of measurement condition upon experiencing a rapid influx into the diaper of a significant volume of urine, and / or upon a significant reduction in the available absorbency of the diaper's top surface. The sensor additionally provides recessed, protected elements for similarly presenting a clear and on-going change in measurement condition upon experiencing the presence of fecal matter. Further provided is the monitor unit employing narrow, widely-spaced, fast rise-time, fast transition-time pulses for conductivity measurement and alarm activation. The monitor and sensor are interconnected and attached to a diaper by particularly effective and unique means, and the monitor is equipped with a highly intuitive and convenient control interface, as well as improved assemblies for the transmission of audible and visual alarm indications. Also described is a convenient test-strip device which, when connected to the monitor / alarm unit of the system, can selectively simulate either a soiled or unsoiled elimination-absorber / sensor for test, caregiver-training or demonstration purposes.

A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber or other testing zone, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the testing zone. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.

Devices and methods for determining the concentration of an analyte in a physiological sample are provided. The subject devices are meters characterized by having an internal structure that includes a test strip selecting element having a continuously reduced cross-sectional area configured to select a single test strip at a time and means for determining the concentration of an analyte in a physiological sample applied to the selected test strip. In the subject methods for containing at least one test strip and dispensing a single test strip at a time, a meter having at least one test strip contained therein is provided. The meter is positioned with respect to the ground to cause the single test strip to move from a contained position to a dispensed position. The subject invention also includes kits for use in practicing the subject methods.

Devices for dispensing test strips and methods of using the same are provided. The subject devices are characterized by having a housing made of a cover and a base configured to retain a plurality of test strips. In certain embodiments, the height of the base is less than the height of each of the test strips, such that a portion of each of the test strips extends beyond the distal or top edge of the base. The subject devices may further be characterized as having a substantially air and moisture tight seal. In using the subject devices, a plurality of test strips stored in a subject device are provided. A single test strip is removed from the subject device by moving the test strip distal to the remaining test strips. Also provided by the subject invention are kits for use in practicing the subject methods.

A body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid.

Systems and methods are provided for determining whether a volume of biological sample is adequate to produce an accurate analyte concentration measurement. Certain such systems and methods provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.

An assay device, a fluid analyte sample separator device and methods for use of thereof for determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, such as drugs of abuse. The device is composed of a housing having separate slots therein for insertion of one or more analyte test strips, one end of which protrudes from the housing, and one or more units of a sample integrity monitoring system. The device may be used in dipstick or cassette form. An analyte sample separator for division of sample and retention of uncontaminated sample for further testing is also provided. The analyte test strips and sample integrity monitoring system are replaceable, so that the panel of analytes and of sample condition parameters tested can be customized.

Disclosed, in one aspect, is an assay result reading device for reading the result of an assay performed using a test strip, the device comprising: a light source or sources, said light source / s emitting light incident upon at least two, spatially separated zones of the test strip; and a photodetector which detects light emanating from each of the two said zones; in a further aspect is disclosed an assay result reading device for reading the result of an assay performed using a test strip, the device comprising: at least one light source incident upon a zone of the test strip; and at least two photodetectors both of which are able to detect some of the light emanating from the zone of the test strip illuminated by the light source.

Diagnostic products having multiple test strips within a unitary diagnostic test device, or test icon, are described herein. In the preferred embodiments of the diagnostic test device of this invention, a fluid sample distribution system is provided wherein a sample collection and distribution port is provided in the housing for receipt of a biologic fluid sample and the channeling of such sample onto a sample receiving web. The sample receiving web, which is located within the test device, is in fluid communication with an array of test strips, and is configured to deliver an aliquot of biologic fluid sample to the test site of each such test strip at essentially the same rate. In the preferred embodiments of this invention, the sample receiving web comprises at least one base segment and at least one branched segment. Each of the base and branched segments can be formed or cut from a common sheet of material or from separate sheet material and thereafter placed in contiguous relationship one another. The relative placement of the sample receiving web within the test device is coincident with a portion of each test strip and designed to effect the balanced distribution and delivery of an aliquot of the biologic fluid sample to the test site of each of the test strips within the test device.

The present invention provides a method of measuring an analyte, such a glucose in a fluid sample, such as whole blood, by a reflectance reading device. The method includes making periodic intermediate calculations of analyte level and dynamically ascertaining when an analytical reaction has reached an end point. Once stable, the process stops making periodic calculations and reports the final, actual glucose concentration. According to an exemplary embodiment, the method is performed by a reflectance photometer using an analytical test strip containing reagents that react with an analyte of interest in the test fluid. The end point is determined by calculating an intermediate analyte level of the testing element at predetermined intervals and calculating a ratio value corresponding to the (n)th measurement to an (n-5)th measurement. When two consecutive ratio values are less than or equal to a predetermined value, the end point is deemed reached and the final analyte level ascertained.

Systems, methods and devices are provided for invasive reduced-pain blood sampling and testing, the devices including, a horizontally-disposed finger support element configured to support the finger thereupon, a finger holding element adapted, in a closed position, to radially grip the finger on said support element near to a tip thereof and configured to force blood into said tip, a lancet housing element disposed vertically underneath the finger support element for piercing the finger tip with a lancet while said finger tip is gripped by said finger holding element and supported by said finger support element; and a test strip conveying element adapted to be received by the finger support element after retraction of the lancet housing element thereby bringing a test strip into direct contact with a predetermined volume of blood from said finger support element thereby effecting a blood test.

The invention belongs to the field of bio-medical instruments, and in particular relates to a system and a method for quantitative detection of test strips on the basis of continuous fluorescent-substance markers. The system comprises a continuous fluorescent-substance marker test strip, a test strip frame, a lighting system, an imaging system, a fluorescent image receiver, a signal amplifier, an analog / digital converter, a data processing-controlling system, an output display device, a printer, a keyboard and an IC card matched with the test strip. The data processing-controlling system reads parameters of the IC card and then controls the test strip frame to move so as to ensure that the light emitted by the lighting system is reflected via a dichroic mirror and then automatically scans the test strip; acquired characteristic wavelength reflection fluorescence is transmitted to the data processing-controlling system for optical density identification and concentration calculation via the fluorescent image receiver, the signal amplifier and the analog / digital converter; and the output display device displays results. The invention can quickly and accurately realize the quantitative or qualitative detection of single-component and multi-component samples. The system has the characteristics of high detection sensitivity, objective results, flexible use and the like.

Disclosed is a CMOS image sensor-based on quantum dot marking test strip quantitative detection system, which comprises a quantum dot marking test strip, a test strip frame, a scanning system, a CMOS image sensor, a data-processing device, an output display device, a printer, a keyboard and an IC card matched with the test strip. After reading the IC card parameters, the data-processing device controls the test strip to move, so that the scanning system can automatically scan a detection band and a quality control band of the test strip; the collected signals are transmitted to the data-processing device through the CMOS image sensor, so that the optical density of the detection band and the quality control band can be identified and processed with concentration computing and technical analysis; and the test results are transmitted to the output display device and displayed. The invention can accurately achieve one-component and multi-component quantitative, semi-quantitative or qualitative detection of samples and can dynamically monitor the immunochromatographic reaction process. The system has high sensitivity, objective result and flexible operation.

A multilayer test strip and method of using the test strip for determining concentration of HDL cholesterol in a whole blood sample. The inventive test strip includes a two-stage blood separation mechanism, including a first glass fiber matrix which separates most of the blood cells and an adjacent, second matrix preferably also containing glass fibers that separates the remainder of the blood cells. The second layer also precipates and retains non-HDL cholesterol, thereby providing plasma that is substantially free of red blood cells and substantially free of non-HDL cholesterol to a reaction layer. Precipitation and retention on non-HDLs takes place by a vertical or dead-end filtration in a single layer. The reaction layer produces a color, the intensity of which is proportional to the concentration of HDL cholesterol in the blood sample which is applied to the test strip. Advantageously, the inventive test strip is a vertical flow device, which can be made more compact and operates more efficiently than a lateral flow device.

An extraction method and apparatus is provided for obtaining quick, safe and highly sensitive testing of any of a variety of body fluids including saliva, blood, urine or other fluids for drugs of abuse or other analytes. The apparatus includes a latchable extraction wand for obtaining body fluid samples from a subject which is adapted to maximize the portion of the body fluid sample that will go into a graduated bottle containing a buffer solution, and a testing device wherein the sample will be received and into which test strips can be inserted to determine levels of drugs of abuse or other analyte in the sample. In one of the methods of the invention, energy is imparted to the sample and buffer solution, such as by shaking, and this facilitates the reduction of sample viscosity, such as by promoting the breakdown of mucins when the sample is saliva.

A fluid sampling system is disclosed comprising a fluid drawing device, a fluid sampling device, and an analysis device. The fluid drawing device can be used to draw bodily fluid into a sample port of an IV tube. The fluid sampling device can be used to access the sample port to obtain a fluid sample. The fluid sampling device can include a test strip housing for receiving a test strip therein. Extending from an end of the test strip housing is a blunt canula that can be inserted into the sample port to obtain the fluid sample and communicate the fluid sample to the test strip. The test strip housing is configured to allow the second end of the test strip to be received within an analysis device to facilitate analysis of the fluid sample.

The invention is an electronically processed single-step test device for detecting the presence of a preselected analyte in a fluid. The device includes a hollow rectangular outer casing, disposed within co-joined upper and lower sections of the casing are assay material, an electronic processing system, and a LCD display. The LCD display is observable through a viewing window. The assay material is a sorptive material including a fluid sample application region in the form of a sample wick in fluid communication with a test strip. The test strip includes an analyte capture region adjacent to a light shield. The electronic processing system includes red and green LEDs which are alternately pulsed or energized over predetermined periods of time to determine if fluid test results show a marker or markers in the capture region indicative of the presence of a preselected analyte in the fluid. If so, Yes+ is displayed on the LCD. If not, No− is displayed on the LCD.

A health monitoring and diagnostic device (LIFESTREAM cholesterol meter) configured as a self-contained testing and diagnostic unit in a clam-shell type case. One side of the case includes a spring-loaded finger stick and a compartment for carrying one or more packages of disposable items including a test strip, a needle for the finger stick, and an alcohol swipe. The other half of the case includes a test strip reader, a key pad, and a liquid crystal display. The meter reads a test strip carrying a droplet of blood and receives additional diagnostic information from the patient, such as age, gender, weight, and family history of heart disease. Within minutes, the meter displays test results, including total cholesterol levels. The meter also displays additional diagnostic results, such as the patient's “cardiac age,” recommended weight loss, and a cardiac risk assessment. The meter also works in connection with a network-based comprehensive health analysis and reporting system. The meter writes patient data to a smartcard. This patient data typically includes patient identification information, the test results, the diagnostic information, and the diagnostic results. A computer station reads the smartcard and establishes a network connection with a health report server over the Internet. The computer then downloads the patient data to the health report server, which prepares a comprehensive health report. Within minutes, this report is transmitted back to the computer station, where it is printed out and delivered to the patient.