Implementation of the External Quality Assessment Program in Brazil

Fleury, Marcos K.; Menezes, María Elizabeth; Corrêa, Jane

doi:10.11613/bm.2017.012

Cited by 5 publications

(3 citation statements)

References 3 publications

(3 reference statements)

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“…The ability of recombinant antigens to efficiently differentiate between T. pallidum-positive and negative samples was evaluated by LMA, using a well-characterized set of samples obtained from the AEQ panel [28], and by ELISA, using samples of T. pallidum-infected and non-infected sera obtained from the HEMOBA, HEMOPE, LACTFAR-UFBA, UFG, LACEN/ PE and FIOCRUZ/PE.…”

Section: Laboratory Assaysmentioning

confidence: 99%

Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

et al. 2020

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Syphilis serodiagnosis is challenging because distinct clinical forms of the infection may influence serological performance and discordant results between tests make clinical decisions difficult. Several recombinant Treponema pallidum-proteins have already been tested for syphilis diagnosis and they are critical to achieve high accuracy in serological testing. Our aim was to assess the varied from performance of T. pallidum-recombinant proteins TmpA, TpN17 and TpN47 for syphilis serodiagnosis. The proteins were evaluated using sera of 338 T. pallidum-negative, 173 T. pallidum-positive individuals and 209 sera from individuals infected with unrelated diseases. The diagnostic potential was validated by analysis of ROC curves. In the liquid microarray analyses, the ROC curve varied from 99.0% for TmpA and TpN17 to 100% for TpN47. The sensitivity score yielded values of up to 90% for TpN17, 100% for TpN47 and 80.0% for TmpA. The lowest and highest specificity values were presented by TpN47 (91.9%) and TmpA antigens (100%), respectively. TpN47 showed the highest accuracy score (95.5%) among all the recombinant proteins assayed. For the ELISA, the ROC curve was 97.2%, 91.8% and 81.6% for TpN17, TmpA and TpN47, respectively. TpN17 and TmpA yielded a sensitivity of 69.9%, while TpN47 obtained a value of 53.8%. Specificity was almost 100% for all three proteins. No cross-reaction was observed for TpN17 in the serum samples from non-bacterial infections. Regarding leptospirosis-positive samples, cross-reactivity score was varied from 8.6 to 34.6%. This is most probably due to conservation of the epitopes in these proteins across bacteria. The use of recombinant proteins in immunoassays for syphilis diagnosis was showed provide greater reliability to results of the treponemal assays. Despite the low sensitivity, the proteins showed high diagnostic capacity due to the AUC values found. However, an improvement in sensitivity could be achieved when antigenic mixtures are evaluated.

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Section: Laboratory Assaysmentioning

confidence: 99%

Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

et al. 2020

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“…On the other hand, the lyophilized samples were delivered to ensure quality and stability under normal conditions because of the complex geographical topography of the management area and transportation difficulties. In Brazil, the National Program of Quality Control sent the lyophilized EQA samples to participants to maintain superior quality conditions [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Model of implementing proficiency testing in Vietnam, a developing country

Van,

Tran,

et al. 2023

Practical Laboratory Medicine

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“…All of this gels perfectly with the design of proficiency or inter-laboratory testing programs; proficiency testing programs successfully used in other areas include biological analysis laboratories and laboratory diagnostics, radio-toxicology [ 44 , 45 ], laboratory or analytical medicine [ 46 , 47 , 48 , 49 ], and therapeutic drug monitoring [ 50 , 51 , 52 ].…”

Section: Proposal Of a Strategy For Overall Improvement In The Person...mentioning

confidence: 99%

An Adequate Pharmaceutical Quality System for Personalized Preparation

2023

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The pharmacy compounding of personalized preparations has evolved a great deal, and with it, the way of working and the legal requirements have also evolved. An adequate pharmaceutical quality system for personalized preparations presents fundamental differences with respect to the system designed for industrial medicines since the size, complexity, and characteristics of the activity of the manufacturing laboratory and the applications and uses of the manufactured medicines must be taken into account. Legislation must advance and adapt to the needs of personalized preparations, filling the deficiencies currently found in this field. The limitations of personalized preparation in its pharmaceutical quality system are analysed and a method based on a proficiency testing program specially designed to overcome these limitations is proposed: the Personalized Preparation Quality Assurance Program (PACMI). This method makes it possible to expand the samples and destructive tests, and dedicate more resources, facilities, and equipment. It allows for more in-depth knowledge of the product and the processes used, and for proposed improvements that increase the overall quality for improved patient health. PACMI introduces tools used in risk management in order to guarantee the quality of an essentially heterogeneous service: personalized preparation.

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Implementation of the External Quality Assessment Program in Brazil

Cited by 5 publications

References 3 publications

Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

Model of implementing proficiency testing in Vietnam, a developing country

An Adequate Pharmaceutical Quality System for Personalized Preparation

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