Technical and clinical validation of three commercial real-time PCR kits for the diagnosis of neuroborreliosis in cerebrospinal fluid on three different real-time PCR platforms
| Autor: | M. Raymaekers, V. De Preter, L. Maes, Leen Braeken, T. Carolus, Benoit Kabamba, Veroniek Saegeman, Reinoud Cartuyvels, Sven Ignoul, P.-J. D’Huys |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Adult Male Validation study Adolescent 030106 microbiology Biology Real-Time Polymerase Chain Reaction Sensitivity and Specificity 03 medical and health sciences Young Adult 0302 clinical medicine Cerebrospinal fluid Borrelia burgdorferi Group medicine Humans Lyme Neuroborreliosis 030212 general & internal medicine Overall performance Borrelia burgdorferi Child Aged Cerebrospinal Fluid Retrospective Studies Aged 80 and over Borrelia DNA Reproducibility of Results General Medicine Middle Aged bacterial infections and mycoses medicine.disease biology.organism_classification Virology Infectious Diseases Real-time polymerase chain reaction Molecular Diagnostic Techniques Child Preschool Immunology Female Neuroborreliosis |
| Zdroj: | European journal of clinical microbiologyinfectious diseases : official publication of the European Society of Clinical Microbiology. 36(2) |
| ISSN: | 1435-4373 |
| Popis: | This study reports the evaluation of the technical and clinical validation of the O-DiaBorburg kit (DIA), Borrelia burgdorferi PCR kit, ISEX (GENE), and Borrelia burgdorferi sensu lato Real-TM (SAC) for the diagnosis of neuroborreliosis in cerebrospinal fluid based on both Borrelia DNA and CSF samples from patients with clinical suspicion of neuroborreliosis. This validation study was done by analysing the kits on the Rotorgene Q (RGQ), CFX96, and LightCycler480 (LC480). For all kits, the linear range was larger on RGQ than on CFX96 and LC480. A good reproducibility was obtained for all assays on all instruments. Storage at -20 °C resulted in a decreased reproducibility for SAC. Results of the limit of detection (LOD95) experiments indicated a better sensitivity than described in the kit insert for all kits on all PCR platforms. No cross-reactivity was found for genetically related organisms nor for other pathogens which may be present in CSF. All species of the Borrelia burgdorferi sensu lato complex were detected with the GENE and SAC kits. The DIA kit failed to detect B. lusitaniae. The results seemed to indicate a better overall performance for the GENE kit on RGQ. However, its diagnostic value could not be confirmed in the clinical validation study, wherein none of the 103 CSF samples from clinical neuroborreliosis cases showed a positive real-time PCR result with the GENE kit analysed on RGQ. |
| Databáze: | OpenAIRE |
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