scholarly journals Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease

2020 ◽  
Vol 8 (3) ◽  
pp. 457
Author(s):  
Silvia Zannoli ◽  
Michela Fantini ◽  
Simona Semprini ◽  
Barbara Marchini ◽  
Barbara Ceccarelli ◽  
...  

Lyme disease (LD), caused by infection with Borrelia burgdorferi, is the most common tick-borne infection in many regions of Eurasia. Antibody detection is the most frequently used laboratory test, favoring a two-step serodiagnostic algorithm; immunoenzymatic detection of antibodies to C6 has been shown to perform similarly to a standard two-step workflow. The aim of this study was the performance evaluation of the C6 Lyme ELISA kit compared to a standard two-step algorithm in three laboratories located in the northeastern region of Italy which cater to areas with different LD epidemiology. A total of 804 samples were tested, of which 695 gave concordant results between C6 testing and routine workflow (564 negative, 131 positive). Wherever available, clinical presentation and additional laboratory tests were analyzed to solve discrepancies. The C6 based method showed a good concordance with the standard two-step algorithm (Cohen’s κ = 0.619), however, the distribution of discrepancies seems to point towards a slightly lower specificity of C6 testing, which is supported by literature and could impact on patient management. The C6 ELISA, therefore, is not an ideal stand-alone test; however, if integrated into a two-step algorithm, it might play a part in achieving a sensitive, specific laboratory diagnosis of LD.

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S61-S61
Author(s):  
Yosefa Hefter ◽  
Christina D’Arco ◽  
Travis Shute ◽  
Raymond Dattwyler ◽  
Paul Arnaboldi ◽  
...  

Abstract Background The sensitivity of current antibody detection assays against Borrelia burgdorferi in the early stage of Lyme disease is very low. In children especially, who commonly have febrile viral illnesses, manifestations of early Lyme disease can be misdiagnosed. We previously demonstrated that IFNγ secretion could be detected in whole blood collected from Lyme disease patients at first clinical presentation following overnight incubation of the blood with peptides derived from B. burgdorferi. In the present study, we further evaluated the utility of IFNγ release for the laboratory diagnosis of Lyme disease in children with varying stages of the illness. Methods Children ages 2–18 years with no prior history of Lyme disease and with manifestations of Lyme disease at any stage were enrolled in the study. Sick and healthy controls were enrolled for comparison. We collected history and physical examination data and blood samples at the time of enrollment, at 1 month, and at 6 months. Standard 2-tier testing with ELISA (whole cell sonicate [WCS] and C6) and western blot were run in parallel to the IFNγ release assay for all blood samples. Sensitivity and specificity of the study assay were determined for presentation at all stages of Lyme disease. Clinical data were summarized. Results Blood samples from 22 patients with Lyme disease and 7 controls (4 sick, 3 healthy) were obtained at the first visit. The IFNγ release assay detected early and early disseminated Lyme disease with 78% sensitivity compared with 59% sensitivity of 2-tier testing in our study. For patients presenting with a single erythema migrans (EM) lesion, the IFNγ release assay detected Lyme disease with 63% sensitivity compared with 14% sensitivity with 2-tier testing. The IFNγ release assay had only 25% sensitivity for detecting late disease. A single control patient was positive for both the IFNγ release assay and 2-tier serology. Conclusion A novel IFNγ release assay demonstrated significantly increased sensitivity when compared with 2-tier testing in the laboratory diagnosis of Lyme disease in patients presenting with a single EM lesion. Future study is needed to determine its utility in detecting early Lyme disease in patients with nonspecific febrile illness in the absence of erythema migrans. Disclosures R. Dattwyler, Qiagen: Collaborator, Research support. P. Arnaboldi, Qiagen: Collaborator, research materials.


2014 ◽  
Vol 21 (10) ◽  
pp. 1426-1436 ◽  
Author(s):  
Paul M. Arnaboldi ◽  
Mariya Sambir ◽  
Raymond J. Dattwyler

ABSTRACTThe laboratory diagnosis of Lyme disease is based upon the detection of antibodies generated againstBorrelia burgdorferiusing a two-tier assay, typically consisting of an enzyme-linked immunosorbent assay (ELISA), followed by a Western blot. This system, put into place to address the nonspecificity associated with standalone first-tier assays, is insensitive for diagnosing early infection, when most people seek care. The use of bacterial lysates or whole-protein antigens as first-tier assay targets contributes to nonspecificity due, in part, to the presence of cross-reactive epitopes that are also found in other bacteria. This precludes their use as sensitive standalone assays. The use of peptides containing linear epitopes that are highly specific forB. burgdorferioffers a method for reducing this cross-reactivity. In the present study, we mapped the linear epitopes of the prominently expressedBorreliaadhesins decorin binding protein A (DbpA) and DbpB. We identified several epitopes in each protein that were highly conserved among North American strains ofB. burgdorferi, and we screened peptides containing specific epitopes using serum panels from early and late Lyme disease patients. The individual peptides primarily detected IgM but not IgG, while the proteins efficiently detected both IgM and IgG. While no individual peptide demonstrated better utility for antibody detection than its respective whole protein, an assay containing a combination of a DbpA and a DbpB peptide adequately detected both IgM and IgG, accurately identifying 87.5% (84/96) of the early Lyme disease patients and 80.0% (16/20) of the late Lyme disease patients.


2021 ◽  
Vol 6 (1) ◽  
pp. 18
Author(s):  
Javier A. Quintero ◽  
Raluchukwu Attah ◽  
Reena Khianey ◽  
Eugenio Capitle ◽  
Steven E. Schutzer

The diagnosis of Lyme disease, caused by Borrelia burgdorferi, is clinical but frequently supported by laboratory tests. Lyme arthritis is now less frequently seen than at the time of its discovery. However, it still occurs, and it is important to recognize this, the differential diagnoses, and how laboratory tests can be useful and their limitations. The most frequently used diagnostic tests are antibody based. However, antibody testing still suffers from many drawbacks and is only an indirect measure of exposure. In contrast, evolving direct diagnostic methods can indicate active infection.


2014 ◽  
Vol 21 (5) ◽  
pp. 357-360 ◽  
Author(s):  
Claire J. Cordina ◽  
Richard Culleton ◽  
Brian L. Jones ◽  
Catherine C. Smith ◽  
Alisdair A. MacConnachie ◽  
...  

2020 ◽  
Author(s):  
Sabe Mwape ◽  
Victor Daka ◽  
Scott Matafwali ◽  
Kapambwe Mwape ◽  
Jay Sikalima ◽  
...  

Background Medical laboratory diagnosis is a critical component of patient management in the healthcare setup. Despite the availability of laboratory tests, clinicians may not utilise them to make clinical decisions. We investigated utilsation of laboratory tests for patient management among clinicians at Ndola Teaching Hospital (NTH) and Arthur Davison Childrens Hospital (ADCH), two large referral hospitals in the Copperbelt Province, Ndola, Zambia. Method We conducted a descriptive cross-sectional study among clinicians. The study deployed self-administered questionnaires to evaluate clinician utilisation, querying and confidence in laboratory results. Additional data on demographics and possible laboratory improvements were also obtained. Data were entered in Microsoft excel and exported to SPSS version 16 for statistical analysis. Results Of the 80 clinicians interviewed, 96.2% (77) reported using laboratory tests and their results in patient management. 77.5% (62) of the clinicians indicated they always used laboratory results to influence their patient management decisions. Of the selected laboratory tests, clinicians were more confident in using haemoglobin test results (91.2%). There was no statistically significant association between the clinicians gender or qualification and use of test results in patient management. Conclusion Our findings show that despite the majority querying laboratory results, most of the clinicians use laboratory results for patient management. There is need for interactions between the laboratory and clinical area to assure clinician confidence in laboratory results. Key words: utilisation, clinicians, laboratory tests, Ndola Teaching Hospital, Arthur Davison Childrens Hospital


Author(s):  
Michael Thurm ◽  
Helen Craggs ◽  
Merlin Watts ◽  
Anthony Brooks

Background The growing number of laboratory investigation requests is placing an increased burden upon NHS resources. Around a quarter of all tests are unnecessary repeats, and almost a third have no impact on patient management. Doctors recognise that tests should only be performed when clinically indicated, but a culture persists of undertaking unnecessary repeat investigations. Methods A cohort study was undertaken at a district general hospital to observe the impact of introducing educational interventions in the form of a poster and a series of educational lectures, encouraging clinicians to consider whether an investigation was clinically indicated. Data was collected from nine different sites across the hospital run by different medical teams regarding the number of tests undertaken and the impact on patient care. Results Data from over 13,000 tests and over 2000 patients was analysed from nine different sites across the hospital. There was a significant reduction (33%, p = 0.0001) in the number of blood tests performed. This reduction in testing saved £7006 over the course of 1 month, in addition to other benefits. There was a reduction in testing in eight out of the nine sites in which the study was undertaken, demonstrating good generalisability of results. There was no significant increase in length of admission or mortality. Conclusion Educational interventions to doctors have a significant and safe impact in reducing the number of unnecessary investigations, providing cost saving benefits to the NHS.


1998 ◽  
Vol 40 (4) ◽  
pp. 215-218 ◽  
Author(s):  
Patrícia BRASIL ◽  
Daurita D. DE PAIVA ◽  
Dirce B. DE LIMA ◽  
Edson Jurado DA SILVA ◽  
José Mauro PERALTA ◽  
...  

Enterocytozoon bieneusi is the most prevalent microsporidian parasite that causes gastrointestinal infection in persons with AIDS. Microsporidia are increasingly recognized as important opportunistic pathogens all over the world but in Brazil only few cases have been reported due either to the non awareness of the clinical presentation of the disease or to difficulties in the laboratory diagnosis. We report a 3-year follow-up of a Brazilian HIV-positive patient in whom microsporidial spores were detected in stools and were identified as E. bieneusi using electron microscopy and PCR. The patient presented with chronic diarrhea, CD4 T-lymphocytes count below 100/mm3 and microsporidial spores were consistently detected in stools. Albendazole was given to the patient in several occasions with transient relief of the diarrhea, which reappeared as soon as the drug was discontinued. Nevertheless, a diarrhea-free period with weight gain up to 18 Kg occurred when a combination of nucleoside and protease inhibitors was initiated as part of the antiviral treatment.


2019 ◽  
Vol 6 (6) ◽  
pp. e604 ◽  
Author(s):  
Alberto Vogrig ◽  
Marine Fouret ◽  
Bastien Joubert ◽  
Géraldine Picard ◽  
Véronique Rogemond ◽  
...  

ObjectiveTo report the induction of anti–Ma2 antibody–associated paraneoplastic neurologic syndrome (Ma2-PNS) in 6 patients after treatment with immune checkpoint inhibitors (ICIs). We also analyzed (1) patient clinical features compared with a cohort of 44 patients who developed Ma2-PNS without receiving ICI treatment and (2) the frequency of neuronal antibody detection before and after ICI implementation.MethodsRetrospective nationwide study of all patients with Ma2-PNS developed during ICI treatment between 2017 and 2018.ResultsOur series of patients included 5 men and 1 woman (median age, 63 years). The patients were receiving nivolumab (n = 3), pembrolizumab (n = 2), or a combination of nivolumab and ipilimumab (n = 1) for treatment of neoplasms that included lung (n = 4) and kidney (n = 1) cancers and pleural mesothelioma (n = 1). Clinical syndromes comprised a combination of limbic encephalitis and diencephalitis (n = 3), isolated limbic encephalitis (n = 2), and a syndrome characterized by ophthalmoplegia and head drop (n = 1). No significant clinical difference was observed between our 6 patients and the overall cohort of Ma2-PNS cases. Post-ICI Ma2-PNS accounted for 35% of the total 17 Ma2-PNS diagnosed in our center over the 2017–2018 biennium. Eight cases had been detected in the preceding biennium 2015–2016, corresponding to a 112% increase of Ma2-PNS frequency since the implementation of ICIs in France. Despite ICI withdrawal and immunotherapy, 4/6 patients died, and the remaining 2 showed a moderate to severe disability.ConclusionsWe show a clear association between ICI use and increased diagnosis of Ma2-PNS. Physicians need to be aware that ICIs can trigger Ma2-PNS because clinical presentation can be challenging.


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