Reference intervals for 26 common biochemical analytes in term neonates in Jilin Province, China.

BACKGROUND: Biochemical analytes provide information for neonatal disease management and therapy, and population-based reference intervals (RIs) are essential to accurately interpret laboratory test results. This study aimed to establish local RIs for biochemical assays in term neonates. METHODS: A total of 195 healthy term neonates from birth to 3rd day were recruited as reference individuals prospectively. Analytes of 26 common biochemistries were measured using the VITROS 5600 Integrated System. The 3-level nested ANOVA was performed to assess the need for partitioning RIs of each analyte, and RIs were derived by a nonparametric method or robust method. Multiple regression analysis was used to evaluate specific correlations between the analytes and individual characteristics including age, gender, gestational age, birthweight and delivery mode. RESULTS: There were no between-sex differences in all analytes, whereas there were significant between-day-age differences in 6 analytes. Small between-delivery-mode differences were observed in the results for potassium, phosphorus, and urea. The major related factor of most analytes was postnatal age. During the first 3 days, values of iron, lipids and lipoproteins increased; creatinine, urea, uric acid, creatine kinase and lactate dehydrogenase decreased; other analytes showed slight changes or relatively stable trends. Reference limits of some analytes, particularly lactate dehydrogenase and alkaline phosphatase, were significantly different from adult and pediatric groups. CONCLUSIONS: RIs of 26 common biochemical analytes are established for term neonates aged 0 to 3 days in northeast China. Additionally, it is suggested that age-related changes should be valued in the clinical decision-making process for newborns.

Establishment of age- and sex-specific reference intervals for serum liver function tests in pediatric population aged 1-<18 years: A prospective study.

BACKGROUND: The diagnosis, treatment, and prognosis of pediatric diseases rely on the accurate establishment of the reference interval (RI). This study aimed to establish pediatric RIs for liver function tests and evaluated the correlation of the analytes. METHODS: Pediatric population (aged 1-<18 years) was prospectively recruited in Jilin Province, China. Analytes detected by Ortho VITORS 5600 automatic biochemical analyzer. All strata were divided using the regression tree and Harris and Boyd's method. The dynamic changes of RI were evaluated by the lambda-mu-sigma method. RESULTS: Reference individuals were comprised of 6,322 children and adolescents. Age and sex differences were present in all analytes except serum total protein. The serum albumin, total protein, γ-glutamyl transferase, total bilirubin, and unconjugated bilirubin levels increased with age while serum aspartate aminotransferase was opposite. The serum alanine aminotransferase level reached a trough at the age of 5 and later steadily in males but slowly decreased in females. The serum alkaline phosphatase level dropped rapidly after reaching a peak at 9 years old in females and 12 years old in males. RIs were divided into 11 partitions at most and 5 partitions at least. The strongest correlation between analytes was total bilirubin and unconjugated bilirubin (r = 0.788), followed by total bilirubin and albumin (r = 0.511). CONCLUSIONS: Analytes show unique dynamic changes in pediatric population. The correlations among liver function tests can inform future studies of particular variables. Age- and sex-special pediatric RIs should be established to help an accurate diagnosis of disease.

Evaluating the role of SARS-CoV-2 target genes based on two nucleic acid assay kits.

Background: Effective isolation and early treatment of coronavirus disease 2019 (COVID-19) relies on rapid, accurate, and straightforward diagnostic tools. In response to the rapidly increasing number of cases, reverse transcription-quantitative polymerase chain reaction (RT-qPCR) assays for multiple target genes have become widely available in the market. Methods: In total, 236 COVID-19 patients with positive results in both RT-qPCR and rapid antigen diagnosis (Ag-RDT) were enrolled in the study. The cycle threshold (Ct) was compared with different onset times and target genes. Comparison between groups was evaluated with the Kruskal-Wallis test and Dunn test. The correlation between target genes was analyzed by Spearman. Results: In samples of Ct ≤ 21, Ct was different for the nucleocapsid (N), open reading frame 1ab (ORF1ab), and envelope (E) genes (P < 0.05). Mild COVID-19 patients within 7 days of onset accounted for 67.80% of all enrolled patients. At the above stage, all target genes reached the trough of Ct, and N genes showed lower values than the other target genes. The Ct of the ORF1ab and N gene in asymptomatic patients differed from those of mild patients within 7 days and more than 14 days of onset. The kits used in the study showed strong consistency among target genes, with all correlation coefficients >0.870. Conclusion: RT-qPCR confirmed that the N gene performed well in Ct ≤ 21 and samples within 7 days of onset. Ag-RDT was discriminatory for patients within 7 days of onset. This study facilitated early identification and control of COVID-19 prevalence among patients.

Laboratory Biosafety Considerations of SARS-CoV-2 at Biosafety Level 2.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes coronavirus disease 2019 (COVID-19), which was first detected in Wuhan, China. Recent studies have updated the epidemiologic and clinical characteristics of COVID-19 continuously. In China, diagnostic tests and laboratory tests of specimens from persons under investigation are usually performed in a biosafety level 2 environment. Laboratory staff may be at greater risk of exposure due to a higher concentration and invasiveness of emerging pathogens. Current infection prevention strategies are based on lessons learned from severe acute respiratory syndrome, expert judgments, and related regulations. This article summarizes biosafety prevention and control measures performed in severe acute respiratory syndrome coronavirus 2 testing activities and provides practical suggestions for laboratory staff to avoid laboratory-acquired infections in dealing with public health emergencies.

Age- and Sex-Specific Pediatric Reference Intervals of Serum Electrolytes in Jilin Province of China Using the A Priori Approach.

OBJECTIVES: The purpose of this study was to establish age- and sex-specific pediatric reference intervals of serum potassium (K), sodium (Na), chlorine (Cl), calcium (Ca), magnesium (Mg), and phosphorus (P) using a direct sampling technique. METHODS: In accordance with the a priori approach, healthy individuals (n = 6,466, aged 1 month to <18 years) were enrolled from five regions in Jilin Province, China, and all analytes were performed in the center laboratory. Reference intervals were divided according to the regression tree and Harris and Boyd's method, and then they were calculated by the nonparametric rank method. The dynamic changes of reference intervals were evaluated by the lambda-mu-sigma (LMS) method. RESULTS: Reference intervals of serum Na and Ca were divided into three age-specific partitions. The concentrations of K, Cl, and Mg remained stable with age. However, only dramatic sex-specific changes of P were shown in those 11 to less than 13 years old and 13 to less than 15 years old, with an earlier peak time in females than in males. The correlation between Na and Cl was the strongest among all serum electrolytes (r = 0.31). CONCLUSIONS: Serum electrolyte reference intervals for children and adolescents were established by regression tree, z test, and the LMS method, which provide a more accurate interpretation for diagnosis and prognosis evaluation of clinical pediatric diseases.

A Prognostic Model to Predict Recovery of COVID-19 Patients Based on Longitudinal Laboratory Findings.

The temporal change patterns of laboratory data may provide insightful clues into the whole course of COVID-19. This study aimed to evaluate longitudinal change patterns of key laboratory tests in patients with COVID-19, and identify independent prognostic factors by examining the associations between laboratory findings and outcomes of patients. This multicenter study included 56 patients with COVID-19 treated in Jilin Province, China, from January 21, 2020 to March 5, 2020. The laboratory findings, epidemiological characteristics and demographic data were extracted from electronic medical records. The average value of eosinophils and carbon dioxide combining power continued to significantly increase, while the average value of cardiac troponin I and mean platelet volume decreased throughout the course of the disease. The average value of lymphocytes approached the lower limit of the reference interval for the first 5 days and then rose slowly thereafter. The average value of thrombocytocrit peaked on day 7 and slowly declined thereafter. The average value of mean corpuscular volume and serum sodium showed an upward trend from day 8 and day 15, respectively. Age, sex, lactate dehydrogenase, platelet count and globulin level were included in the final model to predict the probability of recovery. The above parameters were verified in 24 patients with COVID-19 in another area of Jilin Province. The risk stratification and management of patients with COVID-19 could be improved according to the temporal trajectories of laboratory tests.