State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China. pangbo@icdc.cn.
Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, 310003, China. pangbo@icdc.cn.
State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China. kanbiao@icdc.cn.
Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, 310003, China. kanbiao@icdc.cn.
State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China.
Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, 310003, China.
State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, China.
Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, 310003, China.
Department of Veterinary Tropical Diseases, Faculty of Veterinary Science, University of Pretoria, Onderstepoort 0110, South Africa. lokisnyman@gmail.com.
Serum magnesium is the most frequently used laboratory test for evaluating clinical magnesium status. Hypomagnesemia (low magnesium status), which is associated with many chronic diseases, is diagnose...
We gathered and compared serum magnesium reference range values from our institutions, hospitals, and colleagues worldwide....
Serum magnesium levels designating "hypomagnesemia" differ widely. Of 43 collected values, only 2 met 0.85 mmol/L as the low cut-off point to define hypomagnesemia. The remainder had lower cut-off val...
Widely varying serum magnesium reference ranges render our use of this important medical tool imprecise, minimizing impacts of low magnesium status or hypomagnesemia as a marker of disease risk. To ap...
Peptides are an important class of therapeutics. Their quality is evaluated using a series of analytical tests, many of which depend on well-characterized reference standards to determine identity, pu...
Discuss approaches to producing peptide reference standards, including vialing, lyophilization, analytical testing and stability studies....
Case studies are used to illustrate analytical approaches to characterize reference standards, including methods for value assignment, content uniformity, and identity testing. Methods described inclu...
This report describes the analytical strategy used to establish peptide reference standard and illustrates how results from multiple labs are integrated to assign a value to the final lyophilized vial...
The methods and case studies described provide a benchmark for best practices in establishing the preparation, analytical testing, handling, and storage of peptide reference standards for the pharmace...
Female genital tuberculosis (FGTB) can be asymptomatic or even masquerade as other gynecological conditions. Conventional methods of FGTB diagnosis include various imaging, bacteriological, molecular,...
Blood glucose is an important monosaccharide functioning as the main source of energy for the human body. The accurate measurement of blood glucose is crucial for the screening, diagnosis, and monitor...
Raw serum samples were collected from residual samples after clinical testing, filtered, and repackaged under mild stirring. The homogeneity and stability of the samples were examined according to ISO...
The developed RMs was homogeneous and commutable enough for clinical use. They were also stable for 24 h at 2-8 ℃ or 20-25 ℃ and for at least 4 years at - 70 ℃. The certified values were 5.20 ± 0.18 m...
The developed RM could be used for the standardization of reference and clinical systems with satisfactory performance and traceable values, providing strong support for the accurate measurement of bl...
The reference standard in studies on delirium assessment tools is usually based on the clinical judgment of only one delirium expert and may be concise, unstandardized, or not specified at all. This m...
We tested the diagnostic accuracy of our standardized Delirium Interview by comparing delirium assessments of the reported results with live assessments. Our reference, the live assessment, was perfor...
We included 98 patients (62% male, mean age 69 ± 12 years), of whom 56 (57%) intensive care units (ICUs) patients, 22 (39%) patients with a Richmond Agitation Sedation Scale (RASS) < 0 and 26 (27%) no...
The Delirium Interview is a feasible reference method for large study cohorts evaluating delirium assessment tools since experts could assess delirium with high accuracy without seeing the patient at ...
The US National Institute of Standards and Technology (NIST) developed a Standard Reference Material® (SRM®) 3949 Folate Vitamers in Frozen Human Serum to replace SRM 1955 Homocysteine and Folate in H...
Radiomics features (RFs) serve as quantitative metrics to characterize shape, density/intensity, and texture patterns in radiological images. Despite their promise, RFs exhibit reproducibility challen...
To explore the diagnostic performance of routine magnetic resonance imaging (MRI) for the cross-sectional assessment of osteophytes (OPs) in all three knee compartments using computed tomography (CT) ...
The Strontium Ranelate Efficacy in Knee Osteoarthritis (SEKOIA) trial explored the effect of 3 years of treatment with strontium ranelate in patients with primary knee OA. OPs were scored for the base...
Included were 74 patients with available MRI and CT data. Mean age was 62.9 ± 7.5 years. Altogether 1,332 locations were evaluated. For the PFJ, MRI detected 141 (72%) of 197 CT-defined OPs with a w-k...
MRI underestimates presence of osteophytes in all three knee compartments. CT may be helpful particularly regarding assessment of small osteophytes particularly in early disease....
National reference standards for anti-HIV-1 antibody are needed to evaluate the performance and maintain the quality control of anti-HIV-1 antibody assays. The aim of this study was to prepare a mixed...
Nineteen serum samples from different HIV patients were obtained, along with 15 units of fresh frozen plasma samples with negative anti-HIV-1 antibody results. Ten anti-HIV-1 antibody-positive candida...
In the collaborative study, results of all five anti-HIV-1 antibody assays were positive for all 10 candidate standards prepared using HIV patient samples. The CV of each assay for every candidate sta...
The overall results suggest that the 12 candidate standards could serve as national reference standards for anti-HIV-1 antibody....
Are age-normalized reference values for human ovarian cortical follicular density adequate for tissue quality control in fertility preservation?...
Published quantitative data on the number of follicles in samples without known ovarian pathology were converted into cortical densities to create reference values. Next, a sample cohort of 126 girls ...
No difference was observed between Z-scores in samples from untreated patients (0.3 ± 3.5, n = 30) and patients treated with (0.5 ± 2.9, n = 48) and without (0.1 ± 1.3, n = 6) alkylating chemotherapy....
Z-scores allow the estimation of genetic- and treatment-related effects on follicular density in cortical tissue from young patients stored for fertility preservation. Understanding the quality of cry...
