Systems and methods for determining uch-l1, gfap, and other biomarkers in blood samples

A method comprising:

• performing at least one assay for (i) ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof;
• or (2) CK-MB, β-hCG, thyroid stimulating hormone (TSH), homocysteine, free thyroxine (free T4) or any combination thereof, on a blood sample obtained from a subject to determine an amount of (i) UCH-L1, GFAP, or a combination thereof;
• or (ii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof;
• and
• communicating the amount of (i) UCH-L1, GFAP, or combination thereof;
• or (ii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof, determined in the sample,
• wherein the sample is collected with the use of a syringe, standard needle, or combination thereof;
• and
• further wherein the sample is processed prior to performing the assay with a plasma separation device comprising an apparatus having:
• a) a hydrophobic layer comprising at least one microchannel having a first and second end and which defines a path for capillary fluid flow;
• and a top layer flanking the hydrophobic layer, wherein a surface of the top layer facing the hydrophobic layer is hydrophilic;
• or
• b) a pre-evacuated container or tube having an inlet and outlet end;
• a blood holding chamber at the inlet end of the container or tube;
• a detachable serum holding chamber at the outlet end of the container or tube;
• a filter located within the container between the blood holding chamber and the serum holding chamber.

A system comprising:

• a microsampling device to collect a capillary blood sample from a subject;
• a reaction vessel that receives the capillary blood sample and comprises an assay for (i) ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof;
• or (ii) CK-MB, β-hCG, thyroid stimulating hormone (TSH), homocysteine, free thyroxine (free T4), or any combination thereof;
• and
• an instrument to analyze the reaction vessel to provide an amount of (i) UCH-L1, GFAP, or UCH-L1 and GFAP;
• or (ii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof, in the sample.

A system comprising:

• a plasma separation device to process a whole blood sample obtained from a subject into serum and/or plasma;
• a reaction vessel that receives the serum and/or plasma from the subject and comprises an assay for (i) ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof:
• or (ii) CK-MB, β-hCG, thyroid stimulating hormone (TSH), homocysteine, free thyroxine (free T4), or any combination thereof;
• and
• an instrument to analyze the reaction vessel to provide an amount of (i) UCH-L1, GFAP, or UCH-L1 and GFAP;
• or (ii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof, in the sample,
• wherein the plasma separation device comprises an apparatus having:
• a) a hydrophobic layer comprising at least one microchannel having a first and second end and which defines a path for capillary fluid flow;
• and a top layer flanking the hydrophobic layer, wherein a surface of the top layer facing the hydrophobic layer is hydrophilic;
• or
• b) a pre-evacuated container or tube having an inlet and outlet end;
• a blood holding chamber at the inlet end of the container or tube;
• a detachable serum holding chamber at the outlet end of the container or tube;
• a filter located within the container between the blood holding chamber and the serum holding chamber.

An apparatus comprising:

• machine readable instructions;
• and
• processor circuitry to at execute the machine readable instructions to:
• at least one of determine, obtain, or interpret results of at least one assay for:
• (i) ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof:
• (ii) CK-MB, β-hCG, thyroid stimulating hormone (TSH), homocysteine, free thyroxine (free T4), or any combination thereof, on a blood sample obtained from a subject to determine an amount of (i) UCH-L1, GFAP, or a combination thereof in the blood sample:
• or
• (iii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof in the blood sample;
• and
• cause communication, in less than about 30 minutes from the time the sample is collected, of the amount of (i) UCH-L1, GFAP, or combination thereof;
• or (ii) CK-MB, BB-hCG, TSH, homocysteine, free T4, or any combination thereof, determined in the sample, wherein the sample is to be collected:
• (1) from a location on the subject other than a digit;
• (2) in a decentralized setting;
• (3) without the use of a syringe, standard needle, or combination thereof;
• (4) by a user not trained in collecting blood samples from a subject;
• (5) by a robot;
• (6) by a self-administered blood collection device, or
• (7) any combination of (1)-(6).

A non-transitory machine readable storage medium comprising instructions to cause one or more processors to at least:

• access results of at least one assay for:
• (i) ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof;
• (ii) CK-MB, β-hCG, thyroid stimulating hormone (TSH), homocysteine, free thyroxine (free T4), or any combination thereof, on a blood sample obtained from a subject to determine an amount of (i) UCH-L1, GFAP, or a combination thereof in the blood sample;
• or
• (iii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof in the blood sample;
• and
• cause communication, in less than about 30 minutes from the time the sample is collected, of the amount of (i) UCH-L1, GFAP, or combination thereof;
• or (ii) CK-MB, β-hCG, TSH, homocysteine, free T4, or any combination thereof, determined in the sample,
• wherein the sample is to be collected:
• (1) from a location on the subject other than a digit;
• (2) in a decentralized setting:
• (3) without the use of a syringe, standard needle, or combination thereof;
• (4) by a user not trained in collecting blood samples from a subject;
• (5) by a robot;
• (6) by a self-administered blood collection device, or
• (7) any combination of (1)-(6).