Value-assigned solutions of lipoprotein-associated phospholipase a2 having a long shelf-life
OwnerThomas D. SCHAAL, Shaoqiu Zhuoinventors
Life of this patent
Estimating the term…
Abstract
Value-assigned solutions having predetermined concentrations of recombinant Lp-PLA2 are described herein. In particular, described herein are solutions of rLp-PLA2 that are stable for an extended period of time. Kits and assays include these calibration solutions, as well as methods of making and using them are described.
Claims29
A value-assigned solution of lipoprotein-associated phospholipase A2 (Lp-PLA2) for use with an Lp-PLA2 assay as a control, standard, calibrator or re-calibrator, the value-assigned solution having a shelf-life of greater than 4 months, the value-assigned solution comprising:
- a first predetermined concentration of a recombinant Lp-PLA2 in
- a low-salt buffer solution having a salt concentration below about 1 M,
- wherein the low-salt buffer solution comprises a detergent forming a plurality of micelles that stabilize the recombinant Lp-PLA2.
A value-assigned solution of lipoprotein-associated phospholipase A2 (Lp-PLA2) for use with an Lp-PLA2 assay as a control, standard, calibrator or re-calibrator, the value-assigned solution having a shelf-life of greater than 4 months, the value-assigned solution comprising:
- a first predetermined concentration of a recombinant Lp-PLA2 in
- a low-salt buffer solution having a salt concentration below about 1 M,
- wherein the low-salt buffer solution comprises a detergent forming a plurality of micelles that stabilize the recombinant Lp-PLA2 and a second detergent to prevent aggregation of the recombinant Lp-PLA2.
A lipoprotein-associated phospholipase A2 (Lp-PLA2) kit for use with an Lp-PLA2 assay, the kit having a shelf-life of greater than 4 months, the kit comprising:
- a first value-assigned solution comprising a first predetermined concentration of a recombinant Lp-PLA2 in a first low-salt buffer solution having a salt concentration below about 1 M, wherein the first buffer solution comprises a cholate detergent forming a plurality of micelles that stabilizes the recombinant Lp-PLA2, a protein buffered matrix, a pH buffer and a preservative;
- and
- a second value-assigned solution comprising a second low-salt buffer solution having a salt concentration below about 1 M, wherein the second buffer solution comprises a plurality of micelles of the cholate detergent.
A lipoprotein-associated phospholipase A2 (Lp-PLA2) assay having recombinant value-assigned solutions having a shelf-life of more than 4 months, the assay comprising:
- a plurality of value-assigned solutions each comprising a predetermined concentration of a recombinant Lp-PLA2 in a low-salt buffer solution having a salt concentration below about 1 M, wherein the buffer solution comprises a cholate detergent forming a plurality of micelles that stabilizes the recombinant Lp-PLA2;
- a solution comprising an agent that interacts with Lp-PLA2 to produce a detectable signal;
- and
- a wash buffer.
Dependencies are inferred from the claim text.