Interlaboratory-concordance of PD-L1 IHC for NSCLC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20508-e20508
Author(s):  
Andreas H. Scheel ◽  
Gudrun Bänfer ◽  
Gustavo Bruno Baretton ◽  
Manfred Dietel ◽  
Rolf Diezko ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quality Control ◽  
Image Analysis ◽  
Tissue Microarray ◽  
Carcinoma Cell ◽  
Staining Intensity ◽  
Round Robin Test ◽  
Assay Performance ◽  
Set Up ◽  
L1 Protein

e20508 Background: Immunohistochemistry (IHC) of the PD-L1 protein has become a mandatory diagnostic test for NSCLC. We conducted a two-step round robin test to analyze interobserver- and interlaboratory-concordance of PD-L1 IHC and to compare four clinical trial assays (CTAs; 28-8, 22C3, SP264, SP142) and laboratory-developed tests (LDTs). Results of step-one showed that reproducible PD-L1 IHC scoring is feasible; here we present the data on interlaboratory concordance Methods: Interlaboratory-concordance was tested by a centrally prepared tissue-microarray containing 21 NSCLC specimens that was stained at ten sites using CTAs and LDTs. Assay-performance was assessed with a second tissue-microarray containing eleven cell-lines with defined PD-L1 expression. Slides were evaluated by central quality-control and image-analysis. Results: The four CTAs yielded reproducible IHC-stainings at all sites while the results of the LDTs were mixed: Six protocols showed appropriate IHC quality with staining patterns similar to 22C3 and 28-8 CTAs, five protocols yielded less DAB-deposits and reduced staining intensity. Interlaboratory-concordance of carcinoma cell scoring using the 6-step system was moderate (κ = 0.43-0.69) while the included cut-offs ≥1% and ≥50% showed substantial concordance for the CTAs (κ = 0.73-0.89) and moderate concordance for the LDTs (κ = 0.50). No significant differences in interlaboratory-concordance were found among the CTAs. However, differences in the resulting staining patterns were noticed: While 22C3 and 28-8 showed similar staining patterns, SP263 showed minor differences in some cases and SP142 showed distinct patterns. Conclusions: The data show that the PD-L1 CTAs can be reproducibly employed and scored at different sites. LDTs with staining patterns similar to the CTAs are possible yet have to be carefully calibrated to match the appropriate intensity-range. The choice of assay and the set-up of the IHC-protocol may strongly influence the resulting staining.

DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

scholarly journals Fast and Efficient 5′P Degradome Library Preparation for Analysis of Co-Translational Decay in Arabidopsis

Plants ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 466
Author(s):  
Marie-Christine Carpentier ◽  
Cécile Bousquet-Antonelli ◽  
Rémy Merret
Keyword(s):  
Gene Expression ◽  
Quality Control ◽  
Transcriptional Regulation ◽  
High Throughput ◽  
Library Preparation ◽  
Working Day ◽  
Set Up ◽  
Post Transcriptional Regulation ◽  
Commercial Kit

The recent development of high-throughput technologies based on RNA sequencing has allowed a better description of the role of post-transcriptional regulation in gene expression. In particular, the development of degradome approaches based on the capture of 5′monophosphate decay intermediates allows the discovery of a new decay pathway called co-translational mRNA decay. Thanks to these approaches, ribosome dynamics could now be revealed by analysis of 5′P reads accumulation. However, library preparation could be difficult to set-up for non-specialists. Here, we present a fast and efficient 5′P degradome library preparation for Arabidopsis samples. Our protocol was designed without commercial kit and gel purification and can be easily done in one working day. We demonstrated the robustness and the reproducibility of our protocol. Finally, we present the bioinformatic reads-outs necessary to assess library quality control.

Requirements for the valid quantification of immunostains on tissue microarray materials using image analysis

PROTEOMICS ◽  
2009 ◽  
Vol 9 (19) ◽  
pp. 4478-4494 ◽  
Author(s):  
Christine Decaestecker ◽  
Xavier Moles Lopez ◽  
Nicky D'Haene ◽  
Isabelle Roland ◽  
Saad Guendouz ◽  
...  
Keyword(s):  
Image Analysis ◽  
Tissue Microarray

Validation of mitosis counting by automated phosphohistone H3 (PHH3) digital image analysis in a breast carcinoma tissue microarray

Pathology ◽  
2015 ◽  
Vol 47 (4) ◽  
pp. 329-334 ◽  
Author(s):  
B.F. Dessauvagie ◽  
C. Thomas ◽  
C. Robinson ◽  
F.A. Frost ◽  
J. Harvey ◽  
...  
Keyword(s):  
Image Analysis ◽  
Breast Carcinoma ◽  
Tissue Microarray ◽  
Digital Image ◽  
Digital Image Analysis ◽  
Carcinoma Tissue ◽  
Phosphohistone H3

Liposomes

2017 ◽  
pp. 52-87
Author(s):  
Mangal Shailesh Nagarsenker ◽  
Megha Sunil Marwah
Keyword(s):  
Quality Control ◽  
Large Scale ◽  
Clinical Success ◽  
Scale Production ◽  
Large Scale Production ◽  
Diagnostic Applications ◽  
Set Up ◽  
Insight Into ◽  
Characterisation Techniques

The science of liposomes has expanded in ambit from bench to clinic through industrial production in thirty years since the naissance of the concept. This chapter makes an attempt to bring to light the impregnable contributions of great researchers in the field of liposomology that has witnessed clinical success in the recent times. The journey which began in 1965 with the observations of Bangham and further advances made en route (targeting/stealthing of liposomes) along with alternative and potential liposome forming amphiphiles has been highlighted in this chapter. The authors have also summarised the conventional and novel industrially feasible methods used to formulate liposomes in addition to characterisation techniques which have been used to set up quality control standards for large scale production. Besides, the authors have provided with an overview of primary therapeutic and diagnostic applications and a brief insight into the in vivo behaviour of liposomes.

scholarly journals 1337. Development, Maintenance, and Application of Opsonophagocytic Assays to Measure Functional Antibody Responses to Support a 20 Valent Pneumococcal Conjugate Vaccine

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S484-S484
Author(s):  
Ingrid L Scully ◽  
Mark W Cutler ◽  
Seema Gangolli ◽  
Todd Belanger ◽  
David Cooper ◽  
...  
Keyword(s):  
Quality Control ◽  
Antibody Responses ◽  
Antibody Activity ◽  
Pneumococcal Vaccines ◽  
Next Generation ◽  
High Quality ◽  
Assay Performance ◽  
Control Serum ◽  
Serological Data ◽  
Over Time

Abstract Background Opsonophagocytic assays (OPAs) are an important tool for assessing vaccine-induced functional antibody responses. OPAs are complex assays composed of many biological components (eg serum, complement sources, bacteria, and human phagocytes) which contribute to assay variability and may result in titer drift if not carefully controlled. Rigorous development and validation coupled with routine monitoring of assay performance are required to ensure that high-quality OPA serological data are consistently generated throughout the lifetime of existing and next-generation pneumococcal vaccines. Methods OPA specificity was demonstrated by competing functional antibody activity with pneumococcal polysaccharides. Assay qualification/validation assessed accuracy, precision, and sample linearity. Assay performance over time was assessed through the implementation of quality control serum data tracking systems and longterm serum proficiency panels that are routinely tested during assay performance. Human quality control sera are included on each assay plate to ensure that each plate meets pre-specified acceptance criteria. Proficiency serum panels are comprised of individual human serum samples derived from subjects immunized with pneumococcal vaccines and are used to monitor performance across a range of serological titers and over time. Results The OPAs were shown to be specific and reproducible. Monitoring of assay performance over time demonstrated that the assays are stable. For the 13 serotypes contained in 13vPnC reliable titers have been generated in over a decade of testing which is an essential prerequisite in the evaluation of next-generation pneumococcal conjugate vaccines such as 20vPnC, whose licensure depends on demonstration of non-inferiority to 13vPnC. Conclusion Maintenance and careful monitoring of high-quality assays to measure functional antibody responses, such as OPAs, is critical for the delivery of reliable serological data to support the advancement of pneumococcal vaccine programs. Pneumococcal OPAs must be rigorously maintained to ensure continuity of serological data over time and inform licensure decisions of next-generation vaccines as well as postmarketing and seroepidemiology studies. Disclosures All authors: No reported disclosures.

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