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• W1925274372 abstract "In a previous report in CMI [1Jansson C Carlsson S‐A Granlund H Wahlberg P Nyman D Analysis of Borrelia burgdorferi IgG antibodies with a combination of IgG ELISA and VlsE C6 peptide ELISA.Clin Microbiol Infect. 2005; 11: 147-150Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar], we showed that an ELISA for VlsE C6 peptide antibodies could replace immunoblotting in the laboratory as a confirmatory test for Lyme borreliosis (LB) antibodies following initial screening with an IgG ELISA. When both tests were concordantly positive or negative, the combination reflected the presence or absence of specific antibodies as demonstrated by immunoblotting. According to standard assays, the seropositivity level is high in the normal population in this region [2Carlsson S‐A Granlund H Nyman D Wahlberg P IgG seroprevalence of Lyme borreliosis in the population of the Åland Islands in Finland.Scand J Infect Dis. 1998; 30: 501-503Crossref PubMed Scopus (34) Google Scholar]. This makes the diagnosis of LB disease especially difficult. We now report how this modified two-step antibody testing approach performs in the clinical diagnostic setting. We also determined whether serum C6 antibodies against Borrelia burgdorferi s. l. would correlate better with ongoing infection than the antibodies used previously. In total, 183 patients with suspicion of stage II or III LB were studied. Clinical diagnosis was based on the signs and symptoms listed by the European Union Concerted Action on Lyme Borreliosis (http://www.eucalb.com). The serological methods used for initial diagnosis were an IgG ELISA (RecomWell Borrelia IgG; Mikrogen, Martinsreid, Germany) and an immunoblot of specific antibodies using recombinant antigens (RecomBlot; Mikrogen). The effect on post-test probability was considered low with a positive likelihood ratio (PLR) of 1.5–2. If inconclusive results were obtained, a second analysis after a further 4–6 weeks was performed. If intrathecal production of specific antibodies was detected, the PLR was scored as 10. These methods were used for pre-test classification of disease probability, which was performed after a 1-year follow-up period. The C6 antibody analysis method was performed as described previously [1Jansson C Carlsson S‐A Granlund H Wahlberg P Nyman D Analysis of Borrelia burgdorferi IgG antibodies with a combination of IgG ELISA and VlsE C6 peptide ELISA.Clin Microbiol Infect. 2005; 11: 147-150Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar], with the results blinded until the end of the study. Sensitivity, specificity, positive predictive value, PLR, negative likelihood ratio, 95% CIs, significance testing by χ2, regression and receiver operating characteristic were calculated by standard methods. The group of ‘definitely not’ LB patients was used as the reference standard for calculations. The clinical probability of LB was graded as definite (>0.8), high (0.5–0.8), medium (0.2–0.4), low (<0.2) or not LB. The test results for these groups are shown in TABLE 1, TABLE 2. The difference in sensitivity between the C6-positive fractions was significant (p ≤ 0.05–≤ 0.001) for the definite, high-probability and medium-probability groups. The correlation with disease probability was significant (p ≤ 0.001; r = 0.96 for C6 alone; r = 0.98 for the combination).TABLE 1Diagnostic performance of the C6 assay, the C6 assay with the IgG ELISA, and the IgG ELISA with the immunoblot assay, with each of the clinical subgroups for the diagnosis of Lyme borreliosis (LB)aStandard serology (IgG ELISA + immunoblot), but not C6 antibody, was included in the diagnostic process.Diagnostic groupsSensitivity (95% CI)C6 antibodybSpecificity 0.56 (95% CI, 0.39–0.73).C6 antibody and IgG ELISAcSpecificity 0.68 (95% CI, 0.52–0.83).IgG ELISA and immunoblotdSpecificity 0.44 (95% CI, 0.27–0.61).Definite LB1.0 (0.94–1.0)0.94 (0.87–1.00.94 (0.87–1.0)High probability0.75 (0.62–0.88)0.75 (0.62–0.88)1.0 (0.97–1.0)Medium probability0.69 (0.56–0.82)0.67 (0.53–0.80)1.0 (0.97–1.0)Low probability0.46 (0.31–0.60)0.46 (0.31–0.60)0.96 (0.90–1.0)Not LB (positive fraction)0.44 (0.27–0.66)0.32 (0.16–0.48)0.56 (0.27–0.61)a Standard serology (IgG ELISA + immunoblot), but not C6 antibody, was included in the diagnostic process.b Specificity 0.56 (95% CI, 0.39–0.73).c Specificity 0.68 (95% CI, 0.52–0.83).d Specificity 0.44 (95% CI, 0.27–0.61). Open table in a new tab TABLE 2Diagnostic performance parameters for the C6 assay alone and in combination with the IgG ELISADefinite LBHigh probabilityMedium probabilityLow probabilityC6 antibody PPV (95% CI)0.70 (0.54–0.83)0.50 (0.32–0.68)0.69 (0.56–0.82)0.58 (0.42–0.74) PLR (95% CI)2.20 (1.50–3.23)1.70 (1.08–2.68)1.56 (1.02–2.31)1.03 (0.63–1.69) NLR (95% CI)0.05 (0.01–0.30)0.45 (0.20–1.01)0.56 (0.33–0.94)0.97 (0.65–1.45)C6 antibody and IgG ELISA PPV (95% CI)0.75 (0.62–0.88)0.58 (0.39–0.77)0.74 (0.61–0.87)0.66 (0.49–0.82) PLR (95% CI)2.94 (1.78–4.77)2.32 (1.34–4.01)2.06 (1.22–3.49)1.41 (0.79–2.52) NLR (95% CI)0.08 (0.02–0.33)0.45 (0.20–1.01)0.49 (0.31–0.78)0.80 (0.56–1.14)PPV, positive predictive value; PLR, positive likelihood ratio; NLR, negative likelihood ratio. Open table in a new tab PPV, positive predictive value; PLR, positive likelihood ratio; NLR, negative likelihood ratio. Assay of C6 antibodies clearly improved the diagnostic performance for the group with definite LB. The combination of C6 and IgG ELISA tests was marginally better in the calculations, with the reservation that IgG ELISA was also included in the standard diagnostic process. Analysis of the receiver operating characteristic showed an area under the curve of 0.76, with a sensitivity of 0.71 and a specificity of 0.68. The C6 analysis, alone and in combination with IgG ELISA, improved the diagnosis of LB by a PLR of 2–3 compared with the standard two-step serological approach. This provides a clear advantage, especially for clinical material with a high background level of seropositivity, when difficulties are met that are not encountered when dealing with sporadic cases of Borrelia infection. However, the above calculations are not appropriate for areas with a low prevalence of LB. This study was supported by grants from the Wilhelm and Else Stockmann Foundation and from the Foundation for Åland Medical Research of the Åland Culture Foundation." @default.
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• W1925274372 date "2006-05-01" @default.
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• W1925274372 title "VlsE C6 peptide and IgG ELISA antibody analysis for clinical diagnosis of Lyme borreliosis in an endemic area" @default.
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