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Autoantibody Diagnostics in Neuroimmunology: Experience From the 2018 Italian Neuroimmunology Association External Quality Assessment Program.

ABSTRACT: Background: Neuroimmunology has impressively expanded in the past decade. Novel assays, especially cell-based assays (CBAs) can detect conformational antibodies (Abs) recognizing antigens in their native conformation. Generally, the availability of in-house and of commercial tests has improved the diagnostics, but introduced demanding laboratory tasks. Hence, standardization and quality controls represent a key step to promote accuracy. We report on the results of the 2018 external quality assessment program (EQAP) organized by the Italian Neuroimmunology Association. Methods: EQAP regarded 10 schemes, including oligoclonal bands (OCBs), intracellular-neuronal (ICN)-Abs, neuronal-surface (NS)-Abs, aquaporin-4 (AQP4)-Abs, myelin oligodendrocyte glycoprotein (MOG)-Abs, myelin-associated glycoprotein (MAG)-Abs, ganglioside-Abs, acetylcholine-receptor (AChR)-Abs, and muscle-specific-kinase (MuSK)-Abs, and 34 laboratories. Assays were classified as tissue-based assays (TBAs), solid-phase assays (SPAs), liquid-phase assays (LPAs), and CBAs. Thirty-three samples were provided. Results: Three-quarter of the tests were commercial. Median accuracy for the laboratories was 75% (range 50-100). In 8/10 schemes, at least one sample provided discrepant results. Inter-laboratory "substantial agreement" was found in 6/10 schemes (AChR, MuSK, MAG, AQP4, MOG, and NS-Abs), whereas the worst agreements regarded OCBs and ganglioside-Abs. Both commercial and in-house assays performed better in experienced laboratories. Conclusions: Assays could be divided in (a) robust commercial tests with substantial inter-laboratory agreement (MAG-Abs; AChR- and MuSK-Abs); commercial/"in-house" tests with (b) partial inter-laboratory agreement (AQP4-Abs, MOG-Abs, NS-Abs, ICN-Abs), and (c) with large inter-laboratory disagreement (OCBs, ganglioside-Abs). This real-life snapshot of the neuroimmunology test performances highlights shortcomings attributable to technician-dependent performances, assay structural limitations, and errors in test interpretations.

SUBMITTER: Gastaldi M

PROVIDER: S-EPMC6971200 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Autoantibody Diagnostics in Neuroimmunology: Experience From the 2018 Italian Neuroimmunology Association External Quality Assessment Program.

Gastaldi Matteo M Zardini Elisabetta E Scaranzin Silvia S Uccelli Antonio A Andreetta Francesca F Baggi Fulvio F Franciotta Diego D

Frontiers in neurology 20200114

<b>Background:</b> Neuroimmunology has impressively expanded in the past decade. Novel assays, especially cell-based assays (CBAs) can detect conformational antibodies (Abs) recognizing antigens in their native conformation. Generally, the availability of in-house and of commercial tests has improved the diagnostics, but introduced demanding laboratory tasks. Hence, standardization and quality controls represent a key step to promote accuracy. We report on the results of the 2018 external qualit ...[more]

PMID: 32010046

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Project description:BackgroundIn 1999, despite a longstanding use, the WHO manual for the examination of human semen finally proposed to assay several biochemical components of the seminal plasma for a functional exploration of the male accessory glands. At the same time, an international effort was made to standardize laboratory tests and to increase their performance through ISO 15189 accreditation. In this setting, participation to relevant external quality assessment (EQA) schemes is an essential requirement for laboratories. To fulfil this injunction, we have organized an EQA program for seminal biochemistry using presumed commutable samples. In this study, we aimed to report an overview of the French laboratory offer, the kinds of assays used, their performance as well as their likelihood of satisfying ISO15189 requirements for EQA.ResultsBetween 2014 and 2019, we performed seven surveys. A median of six laboratories participated to each survey giving a ratio of one laboratory per 11.2 million inhabitants. Seven biomarkers are routinely assayed but the core set shared by all laboratories comprised citrate and zinc (prostate), fructose (seminal vesicles) and α-1, 4 glucosidase (epididymis). The use of CE-IVD marked methods concerned between 0 to 75% of overall assays. According to analytical specifications, 100% of laboratories results were compliant for zinc, 75% for citrate and α-1,4 glucosidase and 67% for fructose. By combining overall data in an empirical scoring system, we identified several types of seminal biomarkers: citrate, fructose and zinc appear as good candidates for a full accreditation, α-1,4 glucosidase still presents an analytical weakness, but prostatic acid phosphatase, free L-carnitine and glycerophosphocholine cannot be accredited in the current state.ConclusionsWe organized the first French EQA program for seminal biochemistry to help local laboratories to face their legal requirement to be fully accredited by 2020. It could be improved still further but it gave us an oversight on the analytic landscape. Effective methods are available for a confident biochemical exploration of prostate and seminal vesicles. However, that of epididymis appeared unexpectedly fragile. This andrological issue should be addressed by dedicated recommendations from health authorities and scientific societies.

Dataset Information

Autoantibody Diagnostics in Neuroimmunology: Experience From the 2018 Italian Neuroimmunology Association External Quality Assessment Program.

Publications

Autoantibody Diagnostics in Neuroimmunology: Experience From the 2018 Italian Neuroimmunology Association External Quality Assessment Program.

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