Composition and method for testing to predict and/or diagnose allergy to penicillins

Abstract

The invention relates to the testing of humans or other animals, such as horses, cattle or dogs, for allergic reaction or hypersensitivity to penicillins. The tests can be used both to predict and to diagnose allergy. The invention comprises new penicilloyl-polylysine (PPL) preparations, new materials for use in minor determinant mixture (MDM) compositions and novel test methods employing such materials. The new PPL preparations comprise homogeneous, high purity, maximally coupled, .alpha.-diastereoisomeric, penicilloyl conjugates of low molecular weight PPLs. The PPL materials of the invention have the molecular structure in accordance with the following generic formula: ##STR1## wherein: R is selected from the group consisting of H and penicilloyl groups or similar groups derived from cephaolosporins or other .beta.-lactam antibiotics; and n is an integer of from 4 to 10, at least about 66% and up to 100% of the R groups are other than hydrogen. Solutions containing this PPL material are useful in skin testing for penicillin allergy or hypersensitivity alone, but preferably are utilized in a two-part test with MDM solutions containing the novel MDM materials of the invention. The new MDM materials are N-penicilloyl amines of an aliphatic amine or .alpha.-aminoacid having the following molecular structure: ##STR2## wherein: R.sub.1 =a side chain which defines the type of penicillin-e.g., where R.sub.1 = ##STR3## the new material is a derivative of benzylpenicillin; and R.sub.2 is an alkyl group of C.sub.2 -C.sub.6 length, preferably ethyl or propyl, or an aminoacid residue as described herein. The tests are preferably carried out by applying solutions of the materials to the skin of the patient or other test animal and pricking or scratching the skin, or by injecting the materials intradermally, and then observing for wheal and flare reactions. The preferred test method comprises a two-solution test using a solution of the novel PPL preparations applied on or into one area of the patient's skin and a separate solution containing the new minor determinant material alone or as part of an MDM solution with other constituents applied on or into another area of the patient's skin.

Dependencies are inferred from the claim text.