Application progress on export vaccine traceability labeling system based on Global Standard 1 / 中国生物制品学杂志

@#COVID-19 is a respiratory disease caused by SARS-CoV-2 infection,which has strong infectivity and seriously threatens human health all over the world. Vaccination is the most effective means to prevent SARS-CoV-2 infection. World Health Organization(WHO)has required the use of Global Standard 1(GS1)for the tracking and traceability of COVID-19vaccines and therapeutics. Traceability identification system is the basis and core of traceability system,as well as the premise of implementation of traceability,throughout the whole product traceability process. By carrying out unique global coding for all levels of packaging and logistics units of export vaccine products,and establishing vaccine traceability codes and logistics unit traceability codes,we can help export vaccine manufacturers establish traceability systems,realize the traceability of product information in production,circulation,use and other links,strengthen the quality and safety supervision of export vaccine products,strengthen the risk monitoring,early warning and effective disposal,as well as strengthen the recall of defective products and analysis of causes,so as to enhance the international market's trust and recognition of Chinese vaccine safety. This paper summarizes the importance of establishing traceability system for export vaccine products,the application of GS1 system in medical field at home and abroad,the traceability identification coding,barcode representation and quality requirements of export vaccine products,in order to provide a reference for establishing traceability identification system for export vaccine products in China and meeting the requirements of international standards and regulations.

High frequency of Y chromosome microdeletions in male infertility patients with 45,X/46, XY mosaicism

The mosaic 45,X/46,XY karyotype is a common sex chromosomal abnormality in infertile men. Males with this mosaic karyotype can benefit from assisted reproductive therapies, but the transmitted abnormalities contain 45,X aneuploidy as well as Y chromosome microdeletions. The aim of this study was to investigate the clinical and genetic characteristics of infertile men diagnosed with 45,X/46,XY mosaicism in China. Of the 734 infertile men found to carry chromosomal abnormalities, 14 patients were carriers of 45,X/46,XY mosaicism or its variants, giving a prevalence of 0.27% (14/5269) and accounting for 1.91% (14/734) of patients with a chromosomal abnormality. There were ten cases (71.43%, 10/14) of 45,X mosaicism exhibiting AZF microdeletions. Case 1 and Case 4 had AZFc deletions, and the other eight cases had AZFb+c deletions. A high frequency of Y chromosome microdeletions were detected in male patients with 45,X/46,XY mosaicism. Preimplantation genetic diagnosis should be offered to men having intracytoplasmic sperm injection for hypospermatogenesis caused by 45,X/46,XY mosaicism, to avoid the risk of transfering AZF microdeletions in addition to X monosomy in male offspring.

Clinical features of carriers of reciprocal chromosomal translocations involving chromosome 2: report of nine cases and review of the literature

ABSTRACT Objective: To explore the clinical features of carriers of chromosome 2 translocations, enabling informed genetic counseling of these patients. Materials and Methods: Eighty-two male carriers of a translocation who were infertile or receiving fertility counseling were recruited. Cytogenetic analyses were performed using G-banding. A search of PubMed was performed to determine whether the identified translocations on chromosome 2 are involved in male infertility. The relationships of translocation breakpoints with male infertility and recurrent pregnancy loss were analyzed. Results: Of the 82 translocation carriers, 9 (11%) were carriers of a chromosome 2 translocation. Four cases had oligozoospermia or infertility, while five had normal semen. In an analysis of the literature, 55 patients who were carriers of chromosome 2 translocations were also reviewed. Breakpoints at 2p13 and 2q31 were observed in six patients each, and were the most common. Breakpoints at 2p23, 2p13, 2p11.2, 2q31, and 2q37 were associated to both pre-gestational and gestational infertility, while other breakpoints were associated with gestational infertility. Conclusions: All breakpoints at chromosome 2 were correlated with gestational infertility. Carriers of chromosome 2 translocations should therefore receive counseling to continue with natural conception and use of different technologies available via assisted reproductive technology, such as preimplantation genetic diagnosis.

Live birth after transfer of vitrified-warmed embryo derived from vitrified-warmed oocyte and frozen-thawed sperm following failed ICSI: case report / Embarazo a partir de un embrión vitrificado derivado de oocitos vitrificados y espermios descongelados: reporte de un caso

Since the first successful pregnancy from a frozen human oocyte was reported, remarkable technological progress has been made in the area of cryopreservation of human oocytes. We report a successful delivery of two healthy babies after transfer of vitrified-warmed embryos derived from intracytoplasmic sperm injection (ICSI) with vitrified-warmed oocytes and frozen-thawed sperm. A female patient and her husband with severe oligoasthenspermia are reported. At the day of oocyte collection, very few inactive sperms were found in her husband semen. Multiple site open testicular biopsy was performed on her husband, but no sperm was retrieved. The patient did not become pregnant after transferring two embryos coming from half of oocytes and inactive sperms. The patient got pregnant and delivered two healthy babies after receiving a transfer of vitrified-warmed embryos from vitrified-warmed oocytes and frozen-thawed sperm.

La criopreservación de oocitos humanos ha progresado mucho desde que el primer embarazo exitoso desde un oocito congelado fue informado. Nosotros informamos el parto de dos bebés sanos después de transferir embriones vitrificados y recalentados y espermios descongelados. Se trata de una mujer y su marido con una oligoastenoespermia severa. En el día de la recolección de oocitos, se encontraron muy pocos espermios inactivos en el semen del marido. Se tomaron biopsias testiculares pero se encontraron muy pocos espermios inactivos. La mujer logró quedar embarazada y dio luz a dos bebés sanos después de recibir una trasferencia de embriones vitrificados y recalentados, y de espermios descongelados.