Informed consent and ethics committee approval in laboratory medicine

Borovečki, Ana; Mlinarić, Ana; Horvat, Martina; Smolčić, Vesna Šupak

doi:10.11613/bm.2018.030201

Cited by 36 publications

(25 citation statements)

References 17 publications

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“…Crude DNA extracts from the following specimens were used for this study: Frozen pure cultures of Borrelia burgdorferi sensu stricto strain B31 (ATCC 53210) and Borrelia coriaceae (ATCC 43381) in liquid media purchased from ATCC;Venous blood specimens collected from U.S. patients submitted by licensed physicians for “Lyme bacteria” tests as part of routine patient management and 25 blind-coded simulated patient blood specimens from New York State (NYS) Department of Health (DOH) for a Borrelia burgdorferi proficiency test; the patients’ informed consent was not required because it is implied that informed consent was previously given for the scope of the treatment and because the patients’ identities were not revealed; ethical approval was not required because it is considered that this was not research but clinical/laboratory practice [41]. Blind-coded archived serum samples derived from patients with and without “Lyme disease” from the CDC under two Material Transfer Agreements (MTA No.…”

Section: Methodsmentioning

confidence: 99%

“…Venous blood specimens collected from U.S. patients submitted by licensed physicians for “Lyme bacteria” tests as part of routine patient management and 25 blind-coded simulated patient blood specimens from New York State (NYS) Department of Health (DOH) for a Borrelia burgdorferi proficiency test; the patients’ informed consent was not required because it is implied that informed consent was previously given for the scope of the treatment and because the patients’ identities were not revealed; ethical approval was not required because it is considered that this was not research but clinical/laboratory practice [41].…”

Section: Methodsmentioning

confidence: 99%

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Single Core Genome Sequencing for Detection of both Borrelia burgdorferi Sensu Lato and Relapsing Fever Borrelia Species

Lee

Healy

Lambert

2019

IJERPH

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Lyme disease, initially described as Lyme arthritis, was reported before nucleic-acid based detection technologies were available. The most widely used diagnostic tests for Lyme disease are based on the serologic detection of antibodies produced against antigens derived from a single strain of Borrelia burgdorferi. The poor diagnostic accuracy of serological tests early in the infection process has been noted most recently in the 2018 Report to Congress issued by the U.S. Department of Health and Human Services Tick-Borne Disease Working Group. Clinical Lyme disease may be caused by a diversity of borreliae, including those classified as relapsing fever species, in the United States and in Europe. It is widely accepted that antibiotic treatment of Lyme disease is most successful during this critical early stage of infection. While genomic sequencing is recognized as an irrefutable direct detection method for laboratory diagnosis of Lyme borreliosis, development of a molecular diagnostic tool for all clinical forms of borreliosis is challenging because a “core genome” shared by all pathogenic borreliae has not yet been identified. After a diligent search of the GenBank database, we identified two highly conserved segments of DNA sequence among the borrelial 16S rRNA genes. We further developed a pair of Borrelia genus-specific PCR primers for amplification of a segment of borrelial 16S rRNA gene as a “core genome” to be used as the template for routine Sanger sequencing-based metagenomic direct detection test. This study presented examples of base-calling DNA sequencing electropherograms routinely generated in a clinical diagnostic laboratory on DNA extracts of human blood specimens and ticks collected from human skin bites and from the environment. Since some of the tick samples tested were collected in Ireland, borrelial species or strains not known to exist in the United States were also detected by analysis of this 16S rRNA “core genome”. We recommend that hospital laboratories located in Lyme disease endemic areas begin to use a “core genome” sequencing test to routinely diagnose spirochetemia caused by various species of borreliae for timely management of patients at the early stage of infection.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Single Core Genome Sequencing for Detection of both Borrelia burgdorferi Sensu Lato and Relapsing Fever Borrelia Species

Lee

Healy

Lambert

2019

IJERPH

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“…DC-2008-642). In line with the regulations set out by the French National Data Protection Commission and international guidelines, written, informed consent was neither required nor requested for this non-interventional study ( 8 ).…”

Section: Methodsmentioning

confidence: 99%

Classical pathway activity C3c, C4 and C1-inhibitor protein reference intervals determination in EDTA plasma

López

Bertier²,

Ledoult

et al. 2019

Biochem. med. (Online)

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Introduction: Reference intervals (RIs) for complement assays in EDTA plasma samples have not previously been published. The objectives of the present study were to validate and/or determine RIs for classical pathway (CP50) activity and C3c, C4 and C1 inhibitor protein (C1INH) assays and to assess the need for age-specific RIs in EDTA plasma. Materials and methods: We retrospectively evaluated a cohort of 387 patients attending our university hospital and known to be free of complement- modifying diseases. The need for age partitioning was assessed and RIs were calculated according to the CLSI protocol. Results: No need for age partitioning was evidenced for CP50 activity, C3c and C4 concentrations and RIs (90% CI) were calculated from the pooled data: 35.4 (33.1-37.2) to 76.3 (73.7-83.6) U/mL for CP50 activity, 0.80 (0.75-0.87) to 1.64 (1.59-1.72) g/L for C3c, and 0.12 (0.10-0.14) to 0.38 (0.36- 0.40) g/L for C4. Our results highlight a positive association between age and C1INH concentrations. We derived 3 age partitions (6 months to 30 years, 30-50 and > 50 years) and the related RIs: 0.20 (0.18-0.21) to 0.38 (0.36-0.40) g/L, 0.22 (0.20-0.24) to 0.39 (0.36-0.41) g/L and 0.25 (0.22-0.27) to 0.41 (0.40-0.43) g/L, respectively). Conclusions: The newly determined RIs for CP50 activity were higher than those provided by the manufacturer for EDTA plasma samples, whereas those for C3c and C4 RIs were similar to the values provided for serum samples. The C1INH concentration and activity were found to be associated with age and age-specific RIs are mandatory for this analyte.

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“…The study was conducted in accordance with the Principles of Good Clinical Practice and the Declaration of Helsinki and was in agreement with the Ethical code of PTP Science Park (Lodi, Italy) (https://www.ptp.it/it/about-us#governance). The collection of fecal samples from donors healthy volunteers was performed after Written informed consent in an anonimyzed way, and any information cannot be directly related to each volunteer [33].…”

Section: Declarations Ethics Approval and Consent To Participatementioning

confidence: 99%

Healthy Protection Of Bergamot Is Linked To The Modulation Of Microbiota

Riva¹,

Longo²,

Berlanda³

et al. 2020

Preprint

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Background: The present study aimed to evaluate the effects of a new food-grade bioavailable delivery system of bergamot on human gut microbiota, in order to demonstrate the potential correlation of microbiota modulation in cardiovascular health.The identification of human gut microbiota modification was performed after ex-vivo incubation with bergamot phytosome (Vazguard™) of individual faecal slurries from healthy women (45–53 years) as follows: after incubation at 37°C in anaerobic condition, DNA was extracted and a 16S Metagenomic Sequencing Analysis performed. Results: Twenty-five different phyla were identified, among which 4 were modulated: Firmicutes, Proteobacteria, Bacteroidetes, Actinobacteria. The decreased Firmicutes/Bacteroidetes ratio and the increase of Proteobacteria were observed indicating a positive modulation of microbiota possibly linked to cardiovascular health. 418 different genera were also identified, among which several of them were mildly modulated.Conclusions: For the first time, a gut microbiome modulation was associated to the new delivery system of bergamot phytosome, supporting its clinical efficacy for cardiovascular health. New potential applications in weight control and gastrointestinal benefits were suggested.

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Informed consent and ethics committee approval in laboratory medicine

Cited by 36 publications

References 17 publications

Single Core Genome Sequencing for Detection of both Borrelia burgdorferi Sensu Lato and Relapsing Fever Borrelia Species

Single Core Genome Sequencing for Detection of both Borrelia burgdorferi Sensu Lato and Relapsing Fever Borrelia Species

Classical pathway activity C3c, C4 and C1-inhibitor protein reference intervals determination in EDTA plasma

Healthy Protection Of Bergamot Is Linked To The Modulation Of Microbiota

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