Dataset Information

Comparative Analysis of the Euroimmun CXCL13 Enzyme-Linked Immunosorbent Assay and the ReaScan Lateral Flow Immunoassay for Diagnosis of Lyme Neuroborreliosis.

ABSTRACT: Diagnosis of Lyme neuroborreliosis (LNB) is challenging, as long as Borrelia-specific intrathecal antibodies are not yet detectable. The chemokine CXCL13 is elevated in the cerebrospinal fluid (CSF) of LNB patients. Here, we compared the performances of the Euroimmun CXCL13 enzyme-linked immunosorbent assay (CXCL13 ELISA) and the ReaScan CXCL13 lateral flow immunoassay (CXCL13 LFA), a rapid point-of-care test, to support the diagnosis of LNB. In a dual-center case-control study, CSF samples from 90 patients (34 with definite LNB, 10 with possible LNB, and 46 with other central nervous system [CNS] diseases [non-LNB group]) were analyzed with the CXCL13 ELISA and the CXCL13 LFA. Classification of patients followed the European Federation of Neurological Societies (EFNS) guidelines on LNB. The CXCL13 ELISA detected elevated CXCL13 levels in all patients with definite LNB (median, 1,409?pg/ml) compared to the non-LNB controls (median, 20.7?pg/ml; P?0.0001), with a sensitivity of 100% and a specificity of 84.8% (cutoff value, 78.6?pg/ml; area under the receiver operating characteristic [ROC] curve, 0.93). Similarly, the CXCL13 LFA yielded elevated CXCL13 levels in 31 patients with definite LNB (median arbitrary value, 223.5) compared to the non-LNB control patients (median arbitrary value, 0; P?0.0001) and had a sensitivity and specificity of 91.2% and 93.5%, respectively (cutoff arbitrary value, 22.5; area under the ROC curve, 0.94). The correlation between the CXCL13 levels obtained by ELISA and LFA was strong (Spearman correlation coefficient r?=?0.89; P?0.0001). The CXCL13 ELISA and the CXCL13 LFA are comparable diagnostic tools for the detection of CXCL13 in the CSF of patients with definite LNB. The advantage of the CXCL13 LFA is the shorter time to result.

SUBMITTER: Ziegler K

PROVIDER: S-EPMC7448647 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Comparative Analysis of the Euroimmun CXCL13 Enzyme-Linked Immunosorbent Assay and the ReaScan Lateral Flow Immunoassay for Diagnosis of Lyme Neuroborreliosis.

Ziegler Katharina K Rath Anca A Schoerner Christoph C Meyer Renate R Bertsch Thomas T Erbguth Frank F Bogdan Christian C Steinmann Jörg J Held Jürgen J

Journal of clinical microbiology 20200824 9

Diagnosis of Lyme neuroborreliosis (LNB) is challenging, as long as <i>Borrelia</i>-specific intrathecal antibodies are not yet detectable. The chemokine CXCL13 is elevated in the cerebrospinal fluid (CSF) of LNB patients. Here, we compared the performances of the Euroimmun CXCL13 enzyme-linked immunosorbent assay (CXCL13 ELISA) and the ReaScan CXCL13 lateral flow immunoassay (CXCL13 LFA), a rapid point-of-care test, to support the diagnosis of LNB. In a dual-center case-control study, CSF sampl ...[more]

PMID: 32434781

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Project description:BACKGROUND:Alpha defensin was proposed as a new biomarker in synovial fluid for the diagnostic workup of failed joint prostheses. To our knowledge, no comparative study of the performance of the quantitative enzyme-linked immunosorbent assay (ELISA) and qualitative lateral flow alpha defensin test has been reported. QUESTIONS/PURPOSES:(1) Using the proposed European Bone and Joint Infection Society (EBJIS) criteria for defining periprosthetic joint infection (PJI), is there a difference in the diagnostic accuracy of quantitative ELISA and qualitative lateral flow alpha defensin tests? (2) Is there a difference in the performance of the two alpha defensin tests when using three definition classification systems (Musculoskeletal Infection Society [MSIS], Infectious Diseases Society of America [IDSA], and proposed EBJIS)? METHODS:In this retrospective study of samples collected earlier as part of a related longitudinal study, we included patients in whom aspiration of the prosthetic hip or knee was performed as routine investigation before every revision arthroplasty. Between October 2016 and April 2017, a total of 73 patients were eligible for inclusion. As a result of an insufficient fluid volume for analysis (< 5 mL), two patients were excluded. Among the 71 patients in the final analysis, 54 had a knee and 17 a hip arthroplasty. Using the proposed EBJIS criteria, PJI was diagnosed in 22 patients (31%) and aseptic failure in 49 (69%). The alpha defensin ELISA and lateral flow tests were performed in synovial fluid. Patients were classified as having PJI or aseptic failure using the MSIS, the IDSA, and the proposed EBJIS criteria. Sensitivity and specificity of ELISA and the lateral flow alpha defensin test were calculated. Based on receiver operating characteristic analysis, area under the curve values were compared. RESULTS:When measured against the proposed EBJIS criteria, the sensitivity of alpha defensin ELISA and the lateral flow test was low and not different from one another with the numbers available at 50% (95% confidence interval [CI], 31%-69%) and 46% (95% CI, 27%-65%; p = 0.857), respectively, whereas both methods showed high specificity (98% [95% CI, 88%-100%]; p = 1.000). For sensitivity, the highest values were seen when compared against the MSIS criteria (ELISA: 85% [95% CI, 56%-97%], lateral flow: 77% [95% CI]; p = 0.871), intermediate with IDSA criteria (ELISA: 73% [95% CI, 48%-89%], lateral flow: 67% [95% CI]; p = 0.867), and lowest with proposed EBJIS criteria (ELISA: 50% [95% CI, 31%-69%], lateral flow: 46% [95% CI]; p = 0.763). Specificity, however, was high regardless of the criteria used, where ELISA and lateral flow produced results that were not different (MSIS: 98% [95% CI, 90%-100%], IDSA: 98% [95% CI, 90%-100%], EBJIS: 98% [95% CI, 88%-100%]; p = 1.000). The area under the curve of alpha defensin ELISA and the lateral flow test was similar, regardless of the definition criteria used (EBJIS: p = 0.566; IDSA: p = 0.425; MSIS: p = 0.339). CONCLUSIONS:There is no difference between the quantitative and qualitative alpha defensin test for confirmation of PJI, irrespective of applied definition criteria. Having the advantage of providing results within 10 minutes without the need for a laboratory facility, the qualitative test may be of interest in the intraoperative setting, however, at a cost of higher test expense. LEVEL OF EVIDENCE:Level I, diagnostic study.

Project description:IntroductionBreast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) commonly presents as a peri-implant effusion (seroma). CD30 (TNFRSF8) is a consistent marker of tumor cells but also can be expressed by activated lymphocytes in benign seromas. Diagnosis of BIA-ALCL currently includes cytology and detection of CD30 by immunohistochemistry or flow cytometry, but these studies require specialized equipment and pathologists' interpretation. We hypothesized that a CD30 lateral flow assay (LFA) could provide a less costly rapid test for soluble CD30 that eventually could be used by non-specialized personnel for point-of-care diagnosis of BIA-ALCL.MethodsWe performed LFA for CD30 and enzyme-linked immunosorbent assay (ELISA) for 15 patients with pathologically confirmed BIA-ALCL and 10 patients with benign seromas. To determine the dynamic range of CD30 detection by LFA, we added recombinant CD30 protein to universal buffer at seven different concentrations ranging from 125 pg/mL to 10,000 pg/mL. We then performed LFA for CD30 on cryopreserved seromas of 10 patients with pathologically confirmed BIA-ALCL and 10 patients with benign seromas.ResultsRecombinant CD30 protein added to universal buffer produced a distinct test line at concentrations higher than 1000 pg/mL and faint test lines at 250-500 pg/mL. LFA produced a positive test line for all BIA-ALCL seromas undiluted and for 8 of 10 malignant seromas at 1:10 dilution, whereas 3 of 10 benign seromas were positive undiluted but all were negative at 1:10 dilution. Undiluted CD30 LFA had a sensitivity of 100.00%, specificity of 70.00%, positive predictive value of 76.92%, and negative predictive value of 100.00% for BIA-ALCL. When specimens were diluted 1:10, sensitivity was reduced to 80.00% but specificity and positive predictive values increased to 100.00%, while negative predictive value was reduced to 88.33%. When measured by ELISA, CD30 was below 1200 pg/mL in each of six benign seromas, whereas seven BIA-ALCL seromas contained CD30 levels > 2300 pg/mL, in all but one case calculated from dilutions of 1:10 or 1:50.ConclusionsBIA-ALCL seromas can be distinguished from benign seromas by CD30 ELISA and LFA, but LFA requires less time (<20 min) and can be performed without special equipment by non-specialized personnel, suggesting future point-of-care testing for BIA-ALCL may be feasible.

Project description:The outer surface protein C (OspC) and the internal 14-kDa flagellin fragment of strain GeHo of Borrelia burgdorferi sensu stricto were expressed as recombinant proteins in Escherichia coli and were purified for use in an immunoglobulin M (IgM) enzyme-linked immunosorbent assay (OspC-14-kDa antigen ELISA). No hint at disturbing protein-protein interferences, which might influence the availability of immunoreactive epitopes, was found when the recombinant antigens were combined in the ELISA. The recombinant OspC-14-kDa antigen ELISA was compared to a commercial IgM ELISA that used a detergent cell extract from Borrelia afzelii PKo as the antigen. According to the manufacturer's information, the cell extract contains, in addition to other antigens, the following diagnostically relevant antigens: the 100-kDa (synonyms, 93- and 83-kDa antigens), 41-kDa, OspA, OspC, and 17-kDa antigens. The specificity was adjusted to 95% on the basis of data for 154 healthy controls. On testing of 104 serum samples from patients with erythema migrans (EM), the sensitivity of the recombinant ELISA (46%) for IgM antibodies was similar to that of the commercial ELISA (45%). However, when 42 serum samples from patients with polyclonal B-cell stimulation due to an Epstein-Barr virus infection were tested, false-positive reactions were significantly less frequent in the recombinant ELISA (10%) than in the whole-cell-extract ELISA (23%). OspC displays sequence heterogeneity of up to 40% according to the genomospecies. However, when the reactions of serum specimens from controls and EM patients with OspC from representative strains of B. burgdorferi sensu stricto (strain GeHo) and B. afzelii (strain PKo) were compared in an ELISA, almost no differences in specificity and sensitivity were seen. This demonstrates that the sera predominantly recognize the common epitopes of OspC tested in this study. In conclusion, we suggest that the OspC-14-kDa antigens ELISA is a suitable test for the detection of an IgM response in early Lyme disease.

Dataset Information

Comparative Analysis of the Euroimmun CXCL13 Enzyme-Linked Immunosorbent Assay and the ReaScan Lateral Flow Immunoassay for Diagnosis of Lyme Neuroborreliosis.

Publications

Comparative Analysis of the Euroimmun CXCL13 Enzyme-Linked Immunosorbent Assay and the ReaScan Lateral Flow Immunoassay for Diagnosis of Lyme Neuroborreliosis.

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