A machine learning model for the prediction of down syndrome in second trimester antenatal screening.

Background: Down syndrome (DS) is the most common human chromosomal abnormality. About 1200 laboratories carry out antenatal screening for DS in second trimester pregnancies in China. Their prenatal assessment of DS pregnancy risk is based on biometric calculations conducted on maternal serum biochemical markers and ultrasonic markers of fetal growth.

Comparison of glycation degrees of HbG-Coushatta and HbG-Taipei with HbA using liquid chromatography with tandem mass spectrometry.

Background: Hemoglobin A(HbA) is widely used to measure glycemic status and control in diabetes testing and treatment and is an important risk factor forcomplications of diabetes. Hemoglobin variants can interfere with the HbA testing method by reducing the life span of erythrocytes or due to differences in glycation degrees. In this study, glycation levels of the HbA, HbG-Coushatta, and HbG-Taipei β-chains (βA, βG-Coushatta, and βG-Taipei, respectively) were examined.

A study based on four immunoassays: Hepatitis C virus antibody against different antigens may have unequal contributions to detection.

Background: All commercial Hepatitis C virus antibody (anti-HCV) assays use a combination of recombinant antigens to detect antibody response. Antibody responses to individual antigenic regions (core, NS3/4 and NS5) used in assays have not been investigated.

Methods: In this study, we quantified HCV viral load, tested anti-HCV with four commercial assays (Ortho-ELISA, Murex-ELISA, Architect-CMIA and Elecsys-ECLIA) in 682 plasma specimens.

Downregulation of GSK3B by miR-132-3p Enhances Etoposide-Induced Breast Cancer Cell Apoptosis.

Objective: MicroRNAs (miRNAs) have been confirmed to play an essential role in modulating cancer cell proliferation, metastasis, and sensitivity to chemotherapy. However, the correlation between miR-132-3p expression and etoposide (VP16) induced apoptosis in human breast cancer cells remains poorly understood.

Methods: Six datasets, including three gene expression profile datasets and three microRNA (miRNA) expression profile datasets, were downloaded from the NCBI Gene Expression Omnibus (GEO) database to identify miR-132-3p and GSK3B expression in breast cancer.

Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.

Background: This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China.

Methods: Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis.

Caffeic acid prevents non-alcoholic fatty liver disease induced by a high-fat diet through gut microbiota modulation in mice.

Caffeic acid (CA) is derived from many plants and may have the ability to reduce hepatic lipid accumulation. The gut microbiota produces lipopolysaccharides and further influences hepatic lipid metabolism, and thus plays an important role in the development of nonalcoholic fatty liver disease (NAFLD). However, whether the beneficial effects of CA are associated with the gut microbiota remains unclear.

Detection of Epstein-Barr virus encoded RNA in fixed cells and tissues using CRISPR/Cas-mediated RCasFISH.

Identification of Epstein-Barr virus (EBV)-infected cells is critical for the diagnosis and clinical management of EBV-associated diseases. EBV-encoded RNA (EBER) located in the nucleus is a reliable marker due to its high levels of expression and inherent stability in tissue specimens. EBER in situ hybridization has long been the gold standard for detecting tumor-associated latent EBV infection and is valuable in determining the primary site and radiation fields of EBV-related malignancies.

A Longitudinal Case Study of Concurrent Infection with Syphilis and Human Immunodeficiency Virus During the Early Phase.

Due to the low incidence of concurrent human immunodeficiency virus (HIV) and syphilis infection identified during the early phase, such as window period (WP), little is known about the clinical manifestations, diagnosis, and treatment efficacy at very early stages. One longitudinal study was conducted in a 42-year-old blood donor who was concurrently infected with syphilis and HIV. This blood donor was treated with a penicillin-based regimen and early antiretroviral therapy (ART).

[Application analysis of noninvasive prenatal testing for fetal chromosome copy number variations in Chinese laboratories].

To investigate the general situation, detection range, testing reagents, and clinical performance of non-invasive prenatal testing (NIPT) for fetal chromosomal copy number variations (CNVs) in Chinese laboratories. The National Center for Clinical Laboratories of the National Health Commission designed a questionnaire for the detection of CNVs by NIPT, which included the investigation of whether the laboratory has carried out NIPT to detect CNVs and its testing scope, reagents/platforms, intended uses, screening populations and clinical performance. The questionnaires were distributed to 355 laboratories in 31 provinces, autonomous regions, and municipalities across the country on October, 2020.

Paradoxical HBsAg and anti-HBs coexistence among Chronic HBV Infections: Causes and Consequences.

Hepatitis B surface antigen (HBsAg) and Hepatitis B surface antibody (anti-HBs) were reported simultaneously among Hepatitis B virus (HBV) infections. HBsAg is a specific indicator of acute or chronic HBV infections, while anti-HBs is a protective antibody reflecting the recovery and immunity of hosts. HBsAg and anti-HBs coexist during seroconversion and then form immune complex, which is rare detected in clinical cases.

High-fidelity detection of DNA combining the CRISPR/Cas9 system and hairpin probe.

Methods that enable specific and sensitive detection of DNA are greatly required for high-fidelity sequence measurement and single-nucleotide variations (SNVs) genotyping. The CRISPR (clustered regularly interspaced short palindromic repeats)/Cas systems have provided revolutionary tools for detecting nucleic acids. However, most of the current CRISPR/Cas-based DNA biosensing platforms suffer from inherent off-target effects of Cas proteins and require pre-amplification processes, which compromise the analytical fidelity.

Development of novel quality control material based on CRISPR/Cas9 editing and xenografts for MLH1 protein deficiency testing.

Background: Mismatch repair deficiency (dMMR) status induced by MLH1 protein deficiency plays a pivotal role in therapeutic decision-making for cancer patients. Appropriate quality control (QC) materials are necessary for monitoring the accuracy of MLH1 protein deficiency assays used in clinical laboratories.

Methods: CRISPR/Cas9 technology was used to edit the MLH1 gene of GM12878Cas9 cells to establish MLH1 protein-deficient cell lines.

[Pay close attention to personnel training in molecular laboratories for hematological neoplasms].

There has consistently growing value of molecular detection to deliver clinical results for diagnosis, classification, prognosis, curative effect prediction and monitoring minimal residual disease of hematological neoplasms. Currently, some clinical laboratories are adopting hematological neoplasms-associated molecular detection in in our country. The increasing demands for clinical testing require that the particular attention need to be paid to the building of the team of professional staff.

Development of a designated comparison method for alkaline phosphatase measurements and its application to evaluating routine methods.

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) published the reference measurement procedure (RMP) for ALP measurement in 2011. However, the RMP is of high requirements for laboratories, complicated, time-consuming and high cost of reagents. Many manufacturers do not trace results to the higher procedure.

The influence of hepatitis B virus infection in pregnant women.

We carried out the investigation to evaluate hepatitis B virus (HBV) infection status and the influence of HBV infection in pregnant women in Tianjin of China. We founded that the prevalence of HBsAg was 3.77% (69/1829).

The prevalence of antibodies to SARS-CoV-2 among blood donors in China.

In this study, we investigate the seroprevalence of SARS-CoV-2 antibodies among blood donors in the cities of Wuhan, Shenzhen, and Shijiazhuang in China. From January to April 2020, 38,144 healthy blood donors in the three cities were tested for total antibody against SARS-CoV-2 followed by pseudotype SARS-CoV-2 neutralization tests, IgG, and IgM antibody testing. Finally, a total of 398 donors were confirmed positive.

Preparation, stability and commutability of candidate reference materials for lactate dehydrogenase (LDH).

Background: Lactate dehydrogenase (LDH) is a key enzyme that functions as a marker of cell damage. Its activity can be measured by a variety of laboratory methods. To eliminate inter-method bias and enhance equivalence among different measurement procedures, LDH detection needs to be standardized.

Measurement of serum 17-hydroxyprogesterone using isotope dilution liquid chromatography-tandem mass spectrometry candidate reference method and evaluation of the performance for three routine methods.

Objectives: Accurate measurements of serum 17-hydroxyprogesterone (17OHP) are essential for diagnosis and treatment monitoring for congenital adrenal hyperplasia patients. The performance of serum 17OHP routine methods remains highly variable that calls for a candidate reference measurement procedure (cRMP) to improve the standardization of serum 17OHP measurements.

Methods: Serum samples spiked with internal standards were extracted with a combination of solid-phase extraction and liquid-liquid extraction.

Reliability of the application of transvaginal color Doppler ultrasound in the identification of pelvic tumors in women of childbearing age.

Background: Recently, transvaginal color Doppler ultrasound (TVCDU) has been widely used in the diagnosis of pelvic tumors. This study aimed to assess the reliability of the application of TVCDU in the identification of pelvic tumors in women of childbearing age.

Methods: The clinical data of 209 patients with pelvic tumors at childbearing age admitted to our hospital from January 2016 to December 2019 were retrospectively analyzed.

Chinese Expert Consensus on the Nucleic Acid Detection of SARS-CoV-2.

The coronavirus disease 2019 (COVID-19) has already become a pandemic wherein the infection's timely diagnosis has proven beneficial to patient treatment and disease control. Nucleic acid detection has been the primary laboratory diagnostic method for the detection of SARS-CoV-2. To ensure laboratory staff safety and quality nucleic acid testing, the Chinese Society of Laboratory Medicine formulated this consensus, based on the Chinese National Recommendations and previous literature for nucleic acid detection.

Systemic RNA oxidation can be used as a biomarker of infection in challenged with .

More and more evidence support the concept that RNA oxidation plays a substantial role in the progress of multiple diseases; however, only a few studies have reported RNA oxidation caused by microbial pathogens. Urinary 8-oxo-7,8-dihydroguanosine (8-oxo-Gsn) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxo-dGsn), which are broadly used as indicators of oxidative damage of RNA and DNA, were analyzed in this study to determine which can be used as a biomarker of infection in challenged with (). In this work, 24 specific-pathogen-free (SPF) male SD rats were randomly divided into two groups: an infection group and a phosphate-buffered saline (PBS) control group.

Seroprevalence of human T-lymphotropic virus infection among blood donors in China: a first nationwide survey.

Background: So far, the prevalence of human T-lymphotropic virus (HTLV) type 1 and 2 in some highly populated countries such as China is still unknown. In this study, a multi-center nationwide serological survey was designed and performed, to reveal the seroprevalence of HTLV infection among Chinese blood donors.

Results: Among 8,411,469 blood donors from 155 blood establishments, 435 were finally confirmed as HTLV carriers.

Reliable assessment of BRCA1 and BRCA2 germline variants by next-generation sequencing: a multicenter study.

Background: BRCA1/2 gene mutation testing, based on next-generation sequencing (NGS), has been gradually applied in the clinic to serve as preventive early screening for predisposed individuals or to provide treatment options for patients with hereditary breast or ovarian cancers. Here, we evaluated the accuracy of NGS-based mutation detection in BRCA1/2 and the consistency in variant interpretation among clinical laboratories to find the possible reasons underlying inaccurate results and discrepant variant interpretation.

Methods: Laboratories were asked to use their routine procedures to detect six mimetic DNA samples with different BRCA1/2 germline variants.