Method and apparatus for determining deficiencies in enzymatic reactors particularly clotting factor levels in blood plasmas

Claim 1

A method of determining clotting factor levels (other than fibrinogen) in blood plasma, comprising the steps of: generating an electric signal proportional to the optical density of an unknown blood plasma undergoing clotting over a period of time; electronically differentiating said optical density-time signal to generate a first differential signal; electronically determining the peak value of said first differential signal; and, to determine clotting factor level activity of the unknown plasma; electronically comparing said peak value to a predetermined standard logarithmic function based on standard plasmas having known factor activity levels, said standard logarithmic function relating the peak values of the first differential of the optical density-time signal of said standard plasmas to corresponding known factor activity levels.

Claim 2

A method of determining clotting factor levels (other than fibrinogen) in blood plasma, comprising the steps of: generating an electric signal proportional to the optical density of an unknown blood plasma undergoing clotting over a period of time; electronically differentiating said optical density-time signal to generate a first differential signal; electronically determining the peak value of said first differential signal; and, to determine clotting factor level activity of the unknown plasma; electronically comparing said peak value to a predetermined standard logarithmic function based on standard plasmas having known factor activity levels, said standard logarithmic function relating the peak values of the first differential of the optical density-time signal of said standard plasmas to corresponding known factor activity levels.

Claim 3

A method of determining clotting factor levels (other than fibrinogen) in blood plasma, comprising the steps of: generating an electrical signal proportional to the optical density of a first standard blood plasma undergoing clotting over a period of time, said first standard bloos plasma having a known factor activity level (A 1 ); electronically differentiating said first standard optical density-time electric signal to generate a first standard differential signal; electronically determining the peak value (V 1 ) of said first standard first differential signal; generating an electric signal proportional to the optical density of a second standard blood plasma undergoing clotting over a period of time, said second standard blood plasma having a known factor activity level (A 2 ) different from the factor activity level of said first standard blood plasma; electronically differentiating said second standard optical density-time electrical signal to generate a second standard first differential signal; electronically determining the peak value (V 2 ) of said second standard first differential signal; electronically determining the slope of the logarithmic relationship: ##EQU7## where: A = percent factor activity of the unknown blood plasma (which is equal to the Antilog of log A) V = peak amplitude of dO.D/dt of the unknown plasma (voltage) A 1 = factor activity level of first standard plasma V 1 = amplitude of dO.D./dt of A 1 (voltage) A 2 = factor activity level of second standard plasma V 2 = peak amplitude of dO.D./dt of A 2 (voltage). generating an electric signal proportional to the optical density of an unknown blood plasma undergoing clotting over a period of time; electronically differentiating said optical density-time electric signal to generate a first differential signal for said unknown blood plasma; determining the peak value (V) of said first differential signal for said unknown blood plasma; and electronically comparing the peak value (V) of the unknown blood plasma with the slope of said logarithmic relationship to determine the factor activity level (A) in the unknown plasma.

Claim 4

A method of determining clotting factor levels (other than fibrinogen) in blood plasma, comprising the steps of: generating an electrical signal proportional to the optical density of a first standard blood plasma undergoing clotting over a period of time, said first standard bloos plasma having a known factor activity level (A 1 ); electronically differentiating said first standard optical density-time electric signal to generate a first standard differential signal; electronically determining the peak value (V 1 ) of said first standard first differential signal; generating an electric signal proportional to the optical density of a second standard blood plasma undergoing clotting over a period of time, said second standard blood plasma having a known factor activity level (A 2 ) different from the factor activity level of said first standard blood plasma; electronically differentiating said second standard optical density-time electrical signal to generate a second standard first differential signal; electronically determining the peak value (V 2 ) of said second standard first differential signal; electronically determining the slope of the logarithmic relationship: ##EQU7## where: A = percent factor activity of the unknown blood plasma (which is equal to the Antilog of log A) V = peak amplitude of dO.D/dt of the unknown plasma (voltage) A 1 = factor activity level of first standard plasma V 1 = amplitude of dO.D./dt of A 1 (voltage) A 2 = factor activity level of second standard plasma V 2 = peak amplitude of dO.D./dt of A 2 (voltage). generating an electric signal proportional to the optical density of an unknown blood plasma undergoing clotting over a period of time; electronically differentiating said optical density-time electric signal to generate a first differential signal for said unknown blood plasma; determining the peak value (V) of said first differential signal for said unknown blood plasma; and electronically comparing the peak value (V) of the unknown blood plasma with the slope of said logarithmic relationship to determine the factor activity level (A) in the unknown plasma.

Claim 6

A method of making differential detection of factor activity level to detect mild factor activity level deficiencies in the intrinsic or extrinsic clotting system, comprising the steps of: electronically sequentially determining the peak values of the first differential of the optical density of a series of known activity level blood plasmas undergoing clotting over a period of time pursuant to a first clotting test procedure; electronically sequentially determining the peak value of the first differential of the optical density of said known activity level blood plasmas undergoing clotting over a period of time pursuant to a second clotting test procedure; electronically comparing the peak values of the first test procedure to the peak values of the second test procedure to determine the slope of a statistical regression line; electronically determining the peak value of the first differential of the optical density of an unknown blood plasma and comparing it with the slope of the regression line to determine whether said unknown plasma falls within the statistical normal range, the statistical intrinsic deficiency range, or the statistical extrinsic deficiency range.

Claim 7

A method of making differential detection of factor activity level to detect mild factor activity level deficiencies in the intrinsic or extrinsic clotting system, comprising the steps of: electronically sequentially determining the peak values of the first differential of the optical density of a series of known activity level blood plasmas undergoing clotting over a period of time pursuant to a first clotting test procedure; electronically sequentially determining the peak value of the first differential of the optical density of said known activity level blood plasmas undergoing clotting over a period of time pursuant to a second clotting test procedure; electronically comparing the peak values of the first test procedure to the peak values of the second test procedure to determine the slope of a statistical regression line; electronically determining the peak value of the first differential of the optical density of an unknown blood plasma and comparing it with the slope of the regression line to determine whether said unknown plasma falls within the statistical normal range, the statistical intrinsic deficiency range, or the statistical extrinsic deficiency range.

Claim 11

A method of determining clotting factor levels (other than fibrinogen) in blood plasma, comprising the steps of: generating an electrical signal proportional to the optical density of a first standard blood plasma undergoing clotting over a period of time, said first standard blood plasma having a known factor activity level; electronically differentiating said first standard optical density-time electrical signal to generate a first standard differential signal; electronically determining the peak value of said first standard first differential signal; generating an electric signal proportional to the optical density of a second standard blood plasma undergoing clotting over a period of time, said second standard blood plasma having a known factor activity level different from the factor activity level of said first standard blood plasma; electronically differentiating said second standard optical density-time electrical signal to generate a second standard first differential signal; electronically determining the peak value of said second standard first differential signal; electronically determining the slope of the logarithmic function relating said standard peak values to the first and second known standard activity levels; generating an electrical signal proportional to the optical density of an unknown blood plasma undergoing clotting over a period of time, said unknown blood plasma having an unknown factor activity level which is to be determined; electronically differentiating said unknown optical density-time electrical signal to generate a first differential signal for said unknown blood plasma; electronically determining the peak value of said first differential signal for said unknown blood plasma; and electronically comparing this peak value of the first differential for said unknown blood plasma with the slope of said logarithmic relation to determine the factor activity level of the unknown plasma.

Claim 12

A method of determining clotting factor levels (other than fibrinogen) in blood plasma, comprising the steps of: generating an electrical signal proportional to the optical density of a first standard blood plasma undergoing clotting over a period of time, said first standard blood plasma having a known factor activity level; electronically differentiating said first standard optical density-time electrical signal to generate a first standard differential signal; electronically determining the peak value of said first standard first differential signal; generating an electric signal proportional to the optical density of a second standard blood plasma undergoing clotting over a period of time, said second standard blood plasma having a known factor activity level different from the factor activity level of said first standard blood plasma; electronically differentiating said second standard optical density-time electrical signal to generate a second standard first differential signal; electronically determining the peak value of said second standard first differential signal; electronically determining the slope of the logarithmic function relating said standard peak values to the first and second known standard activity levels; generating an electrical signal proportional to the optical density of an unknown blood plasma undergoing clotting over a period of time, said unknown blood plasma having an unknown factor activity level which is to be determined; electronically differentiating said unknown optical density-time electrical signal to generate a first differential signal for said unknown blood plasma; electronically determining the peak value of said first differential signal for said unknown blood plasma; and electronically comparing this peak value of the first differential for said unknown blood plasma with the slope of said logarithmic relation to determine the factor activity level of the unknown plasma.