Comparative Evaluation ofThreeProducts fortheDetection of Borrelia burgdorferi Antibody inHumanSerum

Eighty humanserumspecimens tested concomitantly byimmunoblot andanenzyme-linked immunosorbent assay developed jointly attheUniversity ofConnecticut School ofMedicine andtheConnecticut Agricultural Experiment Station wereusedtoevaluate three commercially available diagnostic products forLyme borreliosis. Thesources ofthekitswereHillcrest Biologicals, Cypress, Calif.; Whittaker Bioproducts, Walkersville, Md.;andCambridge Bioscience, Worcester, Mass.Whencompared withWestern blot analysis, thesensitivities andspecificities, respectively, forthediagnostic assays wereasfollows: Hillcrest Biologicals, 93 and75%;Whittaker Bioproducts, 73and100%;Cambridge Bioscience, 89and100%;andUniversity of Connecticut School ofMedicine, 96and92%. Since thediscovery ofBorrelia burgdorferi asthecausative agent ofLymedisease (2,12), increasing numbers of humancases havebeenreported frombothEurope andthe United States. Because culture anddirect visualization of spirochetes areoften negative inLymedisease (1,11,12), antibody detection witheither immunofluorescence assay or enzyme-linked immunosorbent assay (ELISA) hasbeenthe onlylaboratory method useful fordiagnosis (3,9,12). Lymedisease ischaracterized initsearly stages by symptoms offever, headache, generalized muscle pain, and possibly fatigue andweight loss (13). Approximately 60%of patients will exhibit erythema chronicum migrans, theclassicskin lesion whichisusually found atthesite ofthetick bite. Early diagnosis andantibiotic treatment areimportant forpreventing neurologic, cardiac, orjoint abnormalities that canoccur late inthedisease (10). Problems exist inthe early diagnosis ofLymedisease, since specific immunoglobulin M (IgM) antibody response toB.burgdorferi doesnot peakuntil 3to6weeksafter onset ofthedisease andpeak IgGantibodies arenotobserved until after months oryears ofillness (12). Presently, there arealimited numberofcommercially available assays forthediagnosis ofLymedisease. This study determined thesensitivities andspecificities ofthe Hillcrest Biologicals (HB),Cypress, Calif.; Whittaker Bioproducts (WB),Walkersville, Md.;andCambridge Bioscience (CB),Worcester, Mass.,assays compared with Western blot(immunoblot) analysis forthedetection of Lymedisease antibody in80selected patient serumspecimens.