Appeal No. 1999-0161
Application 08/441,567
50. A method of reducing false positive results from a lipid-dependent diagnostic
assay performed on a blood sample obtained from a patient having an autoimmune
disorder characterized by the presence of anti-phospholipid antibodies, which comprises
pre-incubating the sample prior to conducting the assay with an aqueous phase
comprising a suspended phospholipid, wherein the phospholipid has a hexagonal (Hll)
organization in aqueous detergent free media, wherein the aqueous phase comprises a
detergent, wherein the phospholipid remains suspended in the aqueous phase for at least
one hour at a temperature of about 25 deg. C. and wherein the phospholipid and detergent
are [Sic, not] capable of interfering with the anticoagulant effect of heparin, anti-Factor
antibodies and factor deficiencies.
61. A method of determining the presence of lupus anticoagulants in a patient's
plasma which comprises the steps of:
(a) obtaining a first and a second sample of a patient's plasma;
(b) incubating the first sample with an aqueous suspension comprising a
phosphatidylethanolamine;
(c) performing a lipid-dependent diagnostic assay on both the first and the second
sample, the assay producing a positive reading when used on a sample which contains
lupus anticoagulants; and
(d) comparing the results of the assays performed on the first and second samples,
the presence of a normal result for the first sample and a positive result for the second
sample being indicative of the presence of lupus anticoagulants in the plasma;
wherein:
the suspension of the phosphatidylethanolamine further comprises a lupus assay-
compatible detergent;
the phosphatidylethanolamine remains in suspension at a temperature of 25AC for at
least one hour;
the detergent, in combination with the phosphatidylethanolamine, is capable of
inhibiting lupus anticoagulant, and not interfering with the anticoagulant effect of heparin,
anti-Factor antibodies and factor deficiencies; and
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