Modem medical and wellness practices increasingly make use of self-administered tests and self-collection of test specimens. For example, a patient obtains a blood specimen, typically by pricking his or her finger, and allows the blood to wick onto a blood spot card. After the card has dried, the user then sends the blood spot card to a medical testing facility for testing.
The blood collection cards known in the art are suitable for use in the collection of whole blood specimens or plasma or serum for laboratory analysis, However, such collection devices have been unsatisfactory in the testing of bodily fluids when both cellular and fluid components are used.
For instance, diabetes treatment protocol indicates quantitative measurement of a patient's glucose in serum or plasma and glycated hemoglobin (A1c) in red blood cells. Whole blood collection device will provide hemoglobin result, but not glucose, while plasma/serum collection device will provide glucose, but not hemoglobin.
In addition, sample stability must be preserved through quick drying of the specimen collected to maximize the ability to analyze the sample in the testing facility or laboratory. Sample stability is adversely affected by the submission of a specimen that has not fully dried before being forwarded to a testing facility.
Another problem with certain heretofore devised blood collection devices is that a user of the device occasionally will inadvertently cause hemolysis of the blood specimen. In particular, certain blood collection devices are disclosed in U.S. patent application Ser. No. 10/706,321, filed Nov. 23, 2003; U.S. application Ser. No. 10/421,086, filed Apr. 23, 2003; and Provisional Application Ser. No. 60/374,629, filed Apr. 23, 2002. In accordance with the teachings of the foregoing applications, the specimen collection device includes an aperture by which a user may fluidically transfer blood from the user's finger to a blood collector. It has been observed that, although such specimen collection devices are useful in conjunction with the inventions disclosed and claimed in the foregoing patent applications, in some instances users of the device will press their finger onto the collector, thereby undesirably causing hemolysis of the sample. It is deemed desirable to provide a specimen collection device that mitigates against the foregoing.
Therefore, the invention seeks in preferred embodiments to present a device that provides for the collection, separation, and transport of bodily and other fluids, that is easy to use in both a medical and self-collection environment, and that will provide the testing facility or laboratory with a sufficient sample properly dried and ready for testing. In highly preferred embodiments, the invention seeks to provide a device that allows for the separation of blood cells from a fluid component of blood, and in which a user's finger or other body portion does not directly contact the fluid collector during collection of the device.
USPTO Backgrounds
USPTO Backgrounds