Systems and methods for sample use maximization

Abstract

The present invention provides systems, devices, and methods for point-of-care and / or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

Description

CROSS-REFERENCE[0001]This application claims priority to U.S. Provisional Patent Application Ser. No. 61 / 435,250, filed Jan. 21, 2011, which application is entirely incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]The discovery of a vast number of disease biomarkers, new therapies and the establishment of miniaturized medical systems have opened up new avenues for the prediction, diagnosis and monitoring of treatment of diseases in a point-of-care or other distributed test settings. Point-of-care systems can rapidly deliver test results to medical personnel, other medical professionals and patients. Early diagnosis of a disease or disease progression and monitoring of therapy are often critical for treatment of deadly conditions such as certain cancers and infectious diseases.[0003]Diagnosis and treatment of diseases can take advantage of multiplexed biomarker measurements, which provide additional knowledge of the condition of a patient. For example, when monitorin...

AI Technical Summary

Benefits of technology

[0013]The present invention addresses the aforementioned needs and provides related advantages.

Problems solved by technology

In a Point-of-Care (POC) device, the number of assays that can be performed in parallel is often limited by the size of the device and the volume of the sample to be analyzed.

A shortcoming of many multiplexed POC assay devices is the high cost of manufacturing the components of the device.

If the device is disposable, the cost of the components can make the manufacturing of a POC device impractical.

Further, for multiplexed POC devices that incorporate all of the necessary reagents onboard of the device, if any one of those reagents exhibit instability, an entire manufactured lot of devices may have to be discarded even if all the other reagents are still usable.

When a customer is interested in customizing a POC device to a particular set of analytes, manufacturers of multiplexed POC assay systems are often confronted with the need to mix and match the assays and reagents of the device.

A multiplexed POC assay suitable to each customer can be very expensive, difficult to calibrate, and difficult to maintain quality control.

Blood cells have to be separated from plasma (or serum) prior to most types of analysis since the presence of cells would compromise the assay chemistries.

Larger volume samples (say up to 200 uL) usually cannot be taken by fingerstick methods without repeated, inconvenient (“milking”) of fingers.

It is usually very difficult to perform more than a single assay using small blood sample with 20 uL or less.

This is especially so when the blood sample has to be filtered to remove cells and the recovery of usable plasma from such small volumes is inefficient.

Samples as large as 200 uL can be efficiently separated by automated POC systems (Abaxis, Biosite etc.) but this cannot be done routinely unless a technician is available to draw the sample.

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