US4199471A — Freeze-stable liquid blood control standard

Claim 1

Independent Claim 141 words

A freeze-stable blood control standard for the quality control of the measurement of blood pH and gases comprising a sealed receptacle containing treated erythrocytes and a gaseous head space having a volume which is at least equal to about the volume of said erythrocytes, said erythrocytes being treated by thorough washing in saline solution, mild admixing with a solution of aldehyde and saline, thorough washing in saline solution, then slow admixing with a cryoprotective agent selected from the group consisting of lower aliphatic diols and triols to a concentration of from about 20 to about 40 volume percent of said cryoprotective agent, said gaseous head space comprising from about 0% to about 15% CO 2 , from about 0% to about 25% O 2 and the balance selected from the group consisting of N 2 and inert gases and mixtures thereof.

Claim 2

Dependent Claim 141 words

A freeze-stable blood control standard for the quality control of the measurement of blood pH and gases comprising a sealed receptacle containing treated erythrocytes and a gaseous head space having a volume which is at least equal to about the volume of said erythrocytes, said erythrocytes being treated by thorough washing in saline solution, mild admixing with a solution of aldehyde and saline, thorough washing in saline solution, then slow admixing with a cryoprotective agent selected from the group consisting of lower aliphatic diols and triols to a concentration of from about 20 to about 40 volume percent of said cryoprotective agent, said gaseous head space comprising from about 0% to about 15% CO 2 , from about 0% to about 25% O 2 and the balance selected from the group consisting of N 2 and inert gases and mixtures thereof.

Claim 3

Dependent Claim 16 words

The freeze-stable blood control standard of claim 1 in which the cryoprotective agent is ethylene glycol.

Claim 4

Dependent Claim 22 words

The freeze-stable blood control standard of claim 2 in which the ethylene glycol concentration is about one-half the volume of the erythrocytes.

Claim 5

Dependent Claim 41 words

The freeze-stable blood control standard of claim 1 wherein the erythrocytes are buffered to a pH of from about 7 to about 7.7 and admixed with bicarbonate ion to a pCO 2 of from about 20 to about 55 mm Hg.

Claim 6

Dependent Claim 23 words

The freeze-stable blood control standard of claim 4 in which the buffer is selected from the group consisting of HEPES and TES buffers.

Claim 7

Dependent Claim 24 words

The freeze-stable blood control standard of claim 1 in which the aldehyde is an aliphatic aldehyde having from 1 to about 6 carbon atoms.

Claim 8

Dependent Claim 14 words

The freeze-stable blood control standard of claim 6 in which the aldehyde is formaldehyde.

Claim 9

Dependent Claim 21 words

The freeze-stable blood control standard of claim 1 in which the aldehyde concentration is from about 0.1 to about 0.6 molar.

Claim 10

Dependent Claim 31 words

The freeze-stable blood control standard of claim 1 in which the mild admixing with aldehyde is at about 20° to about 26° C. for about 15 minutes to about 4 hours.

Claim 11

Dependent Claim 38 words

The freeze-stable blood control standard of claim 1 in which at least a portion of the erythrocytes are treated with carbon monoxide and then combined with that portion of the erythrocytes that have been untreated with carbon monoxide.

Claim 12

Dependent Claim 16 words

The freeze-stable blood control standard of claim 1 in which the saline is normal physiological saline.

Claim 13

Dependent Claim 73 words

The freeze-stable blood control standard of claim 1 in which the erythrocytes are buffered to a pH of from about 7 to about 7.7, and in which at last a portion of the erythrocytes are treated with carbon monoxide and then combined with that portion of the erythrocytes that have been untreated with carbon monoxide and admixed with bicarbonate ion to a pCO 2 of from about 20 to about 55 mm Hg.

Claim 14

Dependent Claim 16 words

The freeze-stable blood control standard of claim 12 in which the cryoprotective agent is ethylene glycol.

Claim 15

Dependent Claim 14 words

The freeze-stable blood control standard of claim 12 in which the aldehyde is formaldehyde.

Claim 16

Dependent Claim 16 words

The freeze-stable blood control standard of claim 12 in which the saline is normal physiological saline.

Claim 17

Independent Claim 150 words

The method of making a freeze-stable blood control standard for the quality control of the measurement of blood pH and gases comprising thoroughly washing erythrocytes in saline solution, mildly admixing with a solution of aldehyde and saline, thoroughly washing in saline solution, then slowly admixing with a cryoprotective agent selected from the group consisting of lower aliphatic diols and triols to a concentration of from about 20 to about 40 volume percent of said cryoprotective agent, transferring to receptacles while leaving a gaseous head space of at least about equal to the volume of said erythrocytes, flushing said head space with a gas comprising from about 0% to about 15% CO 2 , from about 0% to about 25% O 2 and the balance selected from the group consisting of N 2 and inert gases and mixtures thereof, and immediately thereafter sealing said receptacles to form a gas tight closure.

Claim 18

Independent Claim 150 words

The method of making a freeze-stable blood control standard for the quality control of the measurement of blood pH and gases comprising thoroughly washing erythrocytes in saline solution, mildly admixing with a solution of aldehyde and saline, thoroughly washing in saline solution, then slowly admixing with a cryoprotective agent selected from the group consisting of lower aliphatic diols and triols to a concentration of from about 20 to about 40 volume percent of said cryoprotective agent, transferring to receptacles while leaving a gaseous head space of at least about equal to the volume of said erythrocytes, flushing said head space with a gas comprising from about 0% to about 15% CO 2 , from about 0% to about 25% O 2 and the balance selected from the group consisting of N 2 and inert gases and mixtures thereof, and immediately thereafter sealing said receptacles to form a gas tight closure.

Claim 19

Dependent Claim 77 words

The method of claim 16 in which following the admixing with the cryoprotective agent the erythrocytes are buffered to a pH of from about 7 to about 7.7, and in which at least a portion of the erythrocytes are treated with carbon monoxide and then combined with that portion of the erythrocytes that have been untreated with carbon monoxide and admixed with bicarbonate ion to a pCO 2 of from about 20 to about 55 mm Hg.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1983-04-22	1983-10-22	1984-04-22	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1987-04-22	1987-10-22	1988-04-22	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1991-04-22	1991-10-22	1992-04-22	$7700.00	Window Closed / Lapsed

Freeze-stable liquid blood control standard

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