An indirect hemagglutination antibody test to detect antibodies to Borrelia burgdorferi in patients with Lyme disease

An indirect hemagglutination antibody (IHA) test was evaluated for its abil ity to detect borrelial antibodies in serum samples from patients with Lyme disease. The key test reagent developed for this antibody detection system was tannic acid-treated and glutaraldehyde-fixed sheep red blood cells (SR BC) containing Borrelia burgdorferi (Bb) antigens attached to the outer sur face of the SRBC. In order to establish suitable cut-off titers, initial sp ecificity and sensitivity measurements were made using sera from 100 anonym ous healthy volunteers and 30 additional pre-determined samples known to be non-reactive or reactive Tor Lyme disease or syphilis. These results were compared with those obtained using a commercially available ELISA. At titer s greater than or equal to 64, the IHA test had a combined 98% specificity and 100% sensitivity for these 130 serum samples, 30 of which were known po sitives or negatives, whereas the ELISA was less specific (93%) and much le ss sensitive (80%). Subsequent testing was performed on sera from 65 patien ts with the erythema migrans (EM) rash and 20 patients with early dissemina ted (cardiac/neurologic) symptoms or with Lyme arthritis. At initial presen tation, 46-48% of the EM patients had IHA reactivity, with titers greater t han or equal to 128, while 42% were positive in the ELISA. Follow-up testin g performed on these EM patients, 8-12 days after receiving antibiotic trea tment, revealed that Bb antibodies were detected best by the IHA test (83-8 6% reactive) relative to the ELISA (81% reactive). Bb antibodies were readi ly detectable on all of the serum samples from the early disseminated and l ate stage Lyme disease cases in both assay systems. Based on these results and because of its technical and interpretive simplicity, the IHA test shou ld be considered as a useful and convenient alternative for the serological analysis of Bb infections. (C) 2000 Published by Elsevier Science B.V. All rights reserved.