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Development and laboratory evaluation of a new recombinant ELISA for the serodiagnosis of Lyme disease.

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Abstract

OBJECTIVE:

The use of recombinant proteins for serologic testing represents a modern approach for the improved laboratory diagnosis of
Lyme disease (LD). The aim of the present study was to develop and evaluate a new recombinant ELISA (RE) for the detection of specific IgG and IgM antibodies against Borrelia burgdorferi.

MATERIALS AND METHODS:

The RE (Biotest AG, Dreieich, Germany) uses mixtures of recombinant p100, OspC, p18 of Borrelia afzelii and a fusion protein of recombinant internal fragments of the flagellum protein (p41) of Borrelia garinii strain PBi and Borrelia afzelii strain PKo. Serologic testing was performed on a commercially available ELISA processor without pre-absorption of sera. The sensitivity of the RE was determined by testing 226 sera obtained from patients suffering from
Lyme disease (stage I: n = 148, stage II: n = 35, stage III: n = 43). Specificity of the RE was evaluated in 1107 sera from healthy blood donors and 275 sera from patients with other infectious diseases or autoimmune illnesses (leptospirosis: n = 53, syphilis: n = 70, toxoplasmosis: n = 60, herpes simplex virus: n = 30, HIV: n = 30; rheumatoid-factor positive: n = 32). In addition, 394 routine samples were prospectively tested in comparison with a well established whole-cell lysate extract ELISA (ENZYGNOST Borreliosis, DadeBehring, Germany) for relative sensitivity and specificity.

RESULTS:

Overall specificity, determined in 1107 healthy blood donors and 275 sera from patients with other diseases, was 94% for IgG and 91% for IgM. The overall sensitivities in 226 sera obtained from patients suffering from different stages of LD were 67-95%. Moreover, as revealed by prospective testing of 394 routine samples, the relative sensitivity of the RE in comparison with an established whole-cell lysate extract ELISA in the detection of seropositive samples was 81.1% for IgG and 86.5% for IgM with a relative specificity of 98.5% and 93% respectively. The ELISAs showed an overall agreement of 97% for IgG and 92.4% for IgM test results.

CONCLUSION:

The RE proved to be a reliable and specific screening test in the routine serodiagnosis of LD. In addition, the RE is easy to perform and requires no pre-absorption.

Wien Klin Wochenschr. 2002 Jul 31;114(13-14):580-5. Comparative Study; Evaluation Studies

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