Abstract
For laboratory diagnostics of Lyme neuroborreliosis (LNB), the recomBead Borrelia antibody index (AI) assay has shown promising results in a mixed age population, but has not previously been evaluated with specific focus on paediatric patients. The aim of the study was to evaluate the recomBead Borrelia AI assay in cerebrospinal fluid (CSF) for the laboratory diagnosis of LNB in children. We also wanted to explore whether early markers, such as CXCL13 in CSF and/or total IgM index could be useful as complementary diagnostic tools. Children being evaluated for LNB in a Swedish Lyme endemic area were included in the study (n = 146). Serum and CSF were collected on admission. Patients with other specific diagnoses were controls (n = 15). The recomBead Borrelia AI assay and the recomBead CXCL13 assay (Mikrogen) were applied together with total IgM index. The overall sensitivity for recomBead Borrelia AI (IgM and IgG together) was 74% and the specificity was 97%. However, the highest sensitivity (91%) at an acceptable level of specificity (90%) was obtained by recomBead Borrelia AI together with CXCL13 and total IgM index, showing a positive predictive value of 84% and a negative predictive value of 95%. Thus, the recomBead Borrelia AI assay performs with moderate sensitivity and high specificity in paediatric LNB patients. The major advantage seems to be increased sensitivity in the possible LNB group compared to the IDEIA assay. The diagnostic sensitivity may be further increased by using a combination of early markers, such as CXCL13 in CSF and total IgM index.
Highlights
Laboratory diagnosis of Lyme neuroborreliosis (LNB) has been hampered over the years with observed heterogeneity and unsatisfactory diagnostic accuracy [1]
The diagnostic sensitivity may be further increased by using a combination of early markers, such as CXCL13 in cerebrospinal fluid (CSF) and total IgM index
LNB = Lyme neuroborreliosis; AI = antibody index, i.e. intrathecally produced IgG and/or IgM anti-Borrelia antibodies detected by the recomBead assay; it.ab = intrathecally produced IgG and/or IgM anti-Borrelia antibodies detected by the IDEIA Lyme neuroborreliosis assay; pleo = pleocytosis in CSF; n (%) = number
Summary
Laboratory diagnosis of Lyme neuroborreliosis (LNB) has been hampered over the years with observed heterogeneity and unsatisfactory diagnostic accuracy [1]. The first generation of anti-Borrelia antibody tests, based on whole-cell sonicates, showed low specificity [2]. The second generation of antibody tests in serum/cerebrospinal fluid (CSF), based on purified native antigens, such as the flagella antigen, showed a higher specificity but could not distinguish between present and previous LNB due to prolonged antibody detection in CSF [3, 4]. Second-generation antibody tests may show an unsatisfactory sensitivity in patients with early LNB but are still considered the main diagnostic tool, together with CSF cell count and clinical assessment [5]. Paediatric patients often present as early LNB with short duration of symptoms, and antibody production in CSF may not always be present at the time of lumbar puncture [6,7,8].
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