Bodily Fluid Sample Collection and Transport

• US 20140342371A1
• Filed: 07/29/2014
• Published: 11/20/2014
• Est. Priority Date: 12/05/2012
• Status: Abandoned Application

• Current Assignee: Theranos IP Company, LLC
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A.
• Application Number:
  US14/446,080
• Publication Number:
  US 20140342371A1
• Time in Patent Office: Days
• US Class Current: 435/6.12
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/185 Long distance transport, e.g. mailing
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/1822 using Peltier elements
• CPC Class Codes: B01L 2300/1855 using phase changes in a medium
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples

Abstract

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.

Claims

1-95. -95. (canceled)

96. A method of performing two or more laboratory tests with a small volume bodily fluid sample from a single subject, the method comprising:

obtaining at a sample collection site at least a first vessel containing a first portion of a sample and a second vessel containing a second portion of the sample, wherein the sample is a small volume bodily fluid sample collected from a single subject, and wherein the total volume of the sample collected from the single subject is no greater than 400 microliters;

transporting the first vessel and the second vessel from the sample collection site to a sample receiving site; and

performing at the sample receiving site one or more steps of a first laboratory test with at least a portion of the first portion of the sample and one or more steps of a second laboratory test with at least a portion of the second portion of the sample.

97. The method of claim 96, wherein the first portion of the sample and the second portion of the sample each comprise an anticoagulant.

98. The method of claim 97, wherein the anticoagulant in the first portion of the sample differs from the anticoagulant in the second portion of the sample.

99. The method of claim 98, wherein the anticoagulant in the first portion of the sample is EDTA and the anticoagulant in the second portion of the sample is heparin.

100. The method of claim 96, wherein the sample collection site and sample receiving site are separated by at least 1 kilometer.

101. The method of claim 100, wherein the first vessel and second vessel arrive at the sample receiving site no more than 12 hours after the bodily fluid sample was obtained from the subject.

102. The method of claim 96, wherein the sample is obtained from the subject'"'"'s digit, which has been punctured to release the sample from the subject.

103. The method of claim 96, wherein the first portion of the sample is maintained in liquid form during the transporting of the first vessel from the sample collection site to the sample receiving site.

104. A method of performing two or more laboratory tests with a small volume bodily fluid sample from a single subject, the method comprising:

obtaining at a sample collection site at least a first vessel containing a first portion of a sample and a second vessel containing a second portion of the sample, wherein the sample is a small volume bodily fluid sample collected from a single subject, and wherein the total volume of the sample collected from the single subject is no greater than 400 microliters;

transporting the first vessel and the second vessel from the sample collection site to a sample receiving site;

removing at the sample receiving site from the first vessel a first vessel original sample, wherein the first vessel original sample is at least a portion of the first portion of the sample;

generating a first vessel dilution sample from the first vessel original sample, wherein the first vessel dilution sample;

i) is diluted at least 3-fold as compared to the first vessel original sample, and ii) has a total volume of no more than 1000 microliters, and

performing at the sample receiving site one or more steps of a first laboratory test with at least a portion of the first vessel dilution sample and one or more steps of a second laboratory test with at least a portion of the second portion of the sample.

105. The method of claim 104, wherein the first portion of the sample and the second portion of the sample each comprise an anticoagulant.

106. The method of claim 105, wherein the anticoagulant in the first portion of the sample differs from the anticoagulant in the second portion of the sample.

107. The method of claim 104, further comprising centrifuging the first vessel prior to transporting the first vessel from the sample collection site to the sample receiving site.

108. The method of claim 104, wherein the first portion of the sample is maintained in liquid form during the transporting of the first vessel from the sample collection site to the sample receiving site.

109. The method of claim 104, wherein the sample is obtained from the subject'"'"'s digit, which has been punctured to release the sample from the subject.

110. The method of claim 104, further comprising generating a second vessel dilution sample from a second vessel original sample, wherein the second vessel original sample is at least a portion of the second portion of the sample, wherein the second vessel dilution sample:

i) is diluted at least 10-fold as compared to the second vessel original sample, and ii) has a total volume of no more than 1000 microliters, and wherein the one or more steps of the second laboratory test are performed with at least a portion of the second vessel dilution sample.

111. A method of performing two or more laboratory tests with a small volume bodily fluid sample from a single subject, the method comprising:

obtaining at a sample collection site a vessel, the vessel containing a small volume bodily fluid sample obtained from a single subject, wherein the volume of the small volume bodily fluid sample in the vessel is no greater than 400 microliters;

transporting the vessel from the sample collection site to a sample receiving site;

removing at the sample receiving site from the vessel an original sample, wherein the original sample is at least a portion of the small volume bodily fluid sample transported in the vessel;

generating from the original sample at least a first dilution sample and a second dilution sample, wherein the first dilution sample;

i) is diluted at least 2-fold as compared to the original sample, and ii) has a total volume of no more than 1000 microliters, and wherein the second dilution sample;

i) is diluted at least 5-fold as compared to the original sample, and ii) has a total volume of no more than 1000 microliters; and

performing at the sample receiving site one or more steps of a first laboratory test with at least a portion of the first dilution sample and one or more steps of a second laboratory test with at least a portion of the second dilution sample.

112. The method of claim 111, wherein at the sample receiving site and prior to the removal of the original sample from the first vessel, the first vessel and second vessel are inserted into a sample processing device comprising an automated fluid handling apparatus.

113. The method of claim 112, wherein prior to the insertion of the first vessel and second vessel into the sample processing device, the first vessel and second vessel are inserted into a cartridge, and the cartridge is then inserted into the sample processing device.

114. The method of claim 111, wherein the first laboratory test is an immunoassay, and the second laboratory test is a nucleic acid amplification assay.

115. The method of claim 111, wherein the sample is obtained from the subject'"'"'s digit, which has been punctured to release the sample from the subject.