Preparation of the UPOV Guidelines for the Conduct of Tests for Distinctness, Uniformity and Stability–Tea Plant [Camellia sinensis (L.) O. Kuntze]

Distinctness, Uniformity and Stability （DUS） testing is the technical base of Plant Variety Protection （PVP） and the scientific basis for the approval of Plant Breeder＇s Rights （PBR）. DUS Test Guidelines are not only the technical manuals for the DUS testing authorities to conduct the testing, but also the technical standards for the competent authorities to examine the DUS of new varieties of plants. Tea plant, originated from Yunnan Province, China, is a very important woody cash species in the world. The International Union for the Protection of New Varieties of Plants （UPOV） DUS Test Guidelines for tea plant is the first Test Guidelines prepared by China for the UPOV. In this article, the subject, selection, and determination of characteristics, states of expression of characteristics and the selection of example varieties, assessment of the UPOV DUS Test Guidelines for tea plant were elucidated in detail. Finally, the proposal of PVP for tea plant in China was also proposed. The preparation of UPOV DUS Test Guidelines for tea plant will have important significance both for promoting the development of PVP and increasing the status of international PVP fields for China.

Selection of Example Varieties Used in the DUS Test Guideline of Tagetes L.

[Objective] Taking the characteristic of flower diameter of Tagetes L.as an example,this study aimed to select example varieties used in the DUS Test Guideline of Tagetes L.[Method] Two continuous years of measurements of flower diameter of 25 varieties were collected and then analyzed by using the box plot to illustrate the uniformity and stability of flower diameter of each variety.[Result] According to the information of variability,distribution symmetry of measurements and outliers of flower diameter of varieties provided by box plots,variety 16,2 and 4 were selected as the example varieties for the three expression states with respective flower diameter of 3.0-4.4,6.0-7.4 and 9.0-10.4 cm.[Conclusion] The box plot is an efficient method for the general analysis of varieties,which provides information covering the actual and possible expression range,median and outliers of measurements of flower diameter of each variety.It also provides references for selecting example varieties for other quantitative characteristics and evaluating the quality of varieties.

Application of Statistic Analysis on the Selection of Quantitative Characteristics Listed in the DUS Test Guideline of Tagetes L.

[Objective] This paper researched how to use specific approach to select quantitative characteristics which would be listed in the DUS Test Guideline of Tagetes L. [Method] With the aid of statistic analysis, the uniformity, stability and correlation of 14 pre-selected characteristics were analyzed. [Result] The expression of peduncle length of terminal flower had low uniformity within a variety; the expres- sion of main stem thickness was not stable in continuous growing cycles; there were four pairs of quantitative characteristics which are （very） significantly correlated, namely, leaf length and leaf width, diameter of flower head and length of outer ligu- late floret, number of ligulate floret whorls and number of ligulate floret, leaf width and width of terminal leaflet of pinnate leaves. Based on the requirements of char- acteristic selection and the results of statistic analysis, five characteristics including peduncle length of terminal flower, thickness of the main stem, leaf width, length of outer ligulate floret and number of ligulate floret were deleted. [Conclusion] For the first time, this paper introduced the application of statistic analysis on the selection of quantitative characteristics.

Analysis on the Functions and Properties of the Preliminarily Determined Characteristics Listed in DUS Test Guideline of Tagetes L.

[Objective] This study aimed to investigate the functions and properties of the preliminarily determined characteristics listed in DUS test guideline of Tagetes L., and explore the representativeness and comprehensiveness of this group of characteristics in DUS test. [Method] Based on the functions and properties of the characteristics, the described plant part （s）, observation stage, expression pattern and observation method of each characteristic were analyzed to illustrate the representativeness and comprehensiveness of the combination of this group of characteristics in above functions and properties. [Result] As for described plant part（s）, there are 5 characteristics describing plant as a whole, 3 characteristics describing stem, 6 characteristics describing leaf, 23 characteristics describing flower and 1 characteristic describing physiological feature. As for observation stage, there are 1 characteristic needing to be observed in the stage of seedling, 1 characteristic in the stage of beginning of flowering and other 36 characteristics in the stage of fully flowering. As for the expression pattern, there are 10 qualitative characteristics, 9 pseudo-qualitative characteristics and 19 quantitative characteristics. As for the observation method, there are 30 characteristics using VG as the observation method, and 8 characteristics using MS. [Conclusion] In view of the variation and morphological properties of marigold, this group of characteristics are representative and comprehensive, and ensure the accuracy and easiness of DUS test of Tagetes L., thereby achieving the reasonable combination of characteristics in described plant parts, observation stages, expression patterns and observation methods.

Statistic Analysis on Quantitative Characteristics for Developing the DUS Test Guideline of Ranunculus asiaticus L.

Selection of quantitative characteristics, division of their expression ranges, and selection of example varieties are key issues on developing DUS Test Guidelines, which are more crucial for quantitative characteristics since their expressions vary in different degrees. Taking the development of DUS Test Guideline of Ranunculus asiaticus L. as an example, this paper applied statistic-based approaches for the analyses of quantitative characteristics. We selected 9 quantitative characteristics from 18 pre-selected characteristics, based on within-variety uniformity, stability between different growing cycles, and correlation among characteristics, by the analyses of coefficient of variation, paired-samples t-test and partial correlation. The expression ranges of the 9 selected quantitative characteristics were divided into different states using descriptive statistics and distribution frequency of varieties. Eight of the 9 selected quantitative characteristics were categorized as standard characteristics as they showed one peak in distribution frequency of 120 varieties in various expressions of the characteristics, whereas, plant height can be categorized as grouping characteristic since it gave two peaks, and can group the varieties into pot and cut varieties. Finally, box-plot was applied to visually select the example varieties, and varieties 7, 12, and 28 were determined as the example varieties for plant height. The methods described in this paper are effective for the selection of quantitative characteristics, division of expression ranges, and selection of example varieties in Ranunculus asiaticus L. for DUS test, and may also be interest for other plant genera.

New combination test for hepatitis C virus genotype and viral load determination using Amplicor GT HCV MONITOR test v2.0

AIM: To develop a new sensitive and inexpensive hepatitis C virus (HCV) combination test (HCV Guideline test) that enables the determination of HCV genotypes 1, 2 and 3, and simultaneous determination of HCV viral load using commercial Amplicor GT HOV MONITOR test v2.0 (microwell version). METHODS: The HCV Guideline test used the PCR product generated in commercial Amplicor GT HCV Monitor test v2.0 for viral load measurement using microwell plate version of Amplicor HCV Monitor and also captured on separate plates containing capture probes and competitive oligonucleotide probes specific for HCV genotypes 1, 2 and 3, The HCV genotype was subsequently determined using the biotin-labeled PCR product and five biotin-labeled HCV-specific probes. RESULTS: The sensitivity of the HCV Guideline test was 0.5 KIU/mL. Specificity of the HCV Guideline test was confirmed by direct sequencing of HCV core region and molecular evolutionary analyses based on a panel of 31 samples. The comparison of the HCV Guideline test and an in-house HCV core genotyping assay using 252 samples from chronic hepatitis C patients indicated concordant results for 97.2% of samples (59.5% genotype 1, 33.7% genotype 2, 6.0% genotype 3, and 0.8% mixed genotypes). Similarly, the HCV Guideline test showed concordance with a serological test, and the serological test failed to assign any serotype in 12.7% of the samples, indicating a better sensitivity of the HCV Guideline test. CONCLUSION: Clinically, both viral load and genotypes (1, 2 and 3) have been found to be major predictors of antiviral therapy outcome regarding chronic hepatitis C based on guidelines and they are, in normal circumstances, performed as separate stand-alone assays. The HCV Guideline test is a useful method for screening large cohorts in a routine clinical setting for determining the treatment regimen and for predicting the outcome of antiviral therapy of chronic hepatitis C.

Endocrine Disruption of Cadmium in Rats Using the OECD Enhanced TG 407 Test System

Objective To evaluate the endocrine disrupting effects of cadmium （Cd） using OECD enhanced TG407 test guideline. Methods Sprague-Dawley （SD） rats were randomly divided into six groups and accordingly administered with 0, 1, 2.5, 5, 10, 20 mg/kg.BW/day of Cd by gavage for 28 days. Body weight, food consumption, hematology, biochemistry, sex hormone levels, urinary β2-microglobulin, organ weights and histopathology and estrous cycle were detected. Results Cd could significantly decrease animals＇ body weight （P〈0.05）. Serum luteinizing hormone （LH） at 10-20 mg/kg.BW groups and testosterone （T） at 2.5 and 10 mg/kg.BW groups decreased significantly （P〈0.05）. However, no statistically significant change was found in urinary β2-microglobulin among Cd-treatment groups （P〉0.05）. Endpoints related to female reproduction including uterus weight and histopathological change at 10-20 mg/kg.BW groups showed significant increase （P〈0.05）. While among male rats in 2.5, 10, 20 mg/kg.BW groups, weight of prostate, thyroids, and seminal vesicle glands significantly decreased （P〈0.05）. Moreover, no histopathological change was observed in kidney. Conclusion Results suggested that Cd can cause endocrine disrupting effects in SD rats. Comparing with possible renal toxicity of Cd, its toxicity on endocrine system was more sensitive.

Characters Selection and Assessment for Spathiphyllum DUS Testing Guideline

[Objectives]This study was conducted to provide technical standards for domestic Spathiphyllum variety description and resource evaluation.[Methods]Through field trials and character surveys of the collected 83 Spathiphyllum varieties,after several revisions by fellow experts,and with reference to the Guidelines for Testing the Specificity,Consistency and Stability of New Plant Varieties:Spathiphyllum(TG/135/3)issued by the International Union For The Protection of New Varieties of Plants,the DUS testing guidelines for Spathiphyllum have been developed,and statistical analysis and other methods were used to study the traits for the guideline.[Results]Thirty two testing traits,including 11 mandatory traits,8 basic traits,10 new traits,and 3 optional traits were finally determined;five traits including plant height,plant width,and leaf length were divided into 7 grades,and 9 traits such as leaf width,spathe length,and spathe width were divided into 5 levels;and the observation method and trait code of the trait spathe depth were adjusted.[Conclusions]The development of this guideline provides a basis for judging the specificity,consistency and stability of Spathiphyllum varieties,and is of great significance to the breeding and protection of Spathiphyllum varieties.

HER2-low metastatic breast cancer: molecular insights and therapeutic strategies

The identification of HER2-low metastatic breast cancer as a novel subgroup with therapeutic implications underscores the intricacies in breast cancer classification.This subset,comprising 45%-60%of breast cancer cases,presents a challenge due to its heterogeneous nature,characterized by varying HER2 protein expression levels.This heterogeneity complicates diagnosis and treatment decisions.The advent of trastuzumab deruxtecan(T-DXd),a second-generation antibody-drug conjugate(ADC),instills renewed hope for HER2-low breast cancer patients,having demonstrated effectiveness in clinical trials.The article also explores the evolution of HER2 testing guidelines,notably the 2023 ASCO/CAP guidelines that acknowledge the potential benefits of HER2-targeted therapies for this subgroup.In summary,this article emphasizes the significance of collaborative efforts between Pathologists and Oncologists in the era of precision medicine.It also highlights the potential for innovative,tailored therapies for HER2-low breast cancer,promising enhanced treatment outcomes and a broader range of therapeutic options.