Future clinical prospects of C-peptide testing in the early diagnosis of gestational diabetes

Gestational diabetes is typically diagnosed in the late second or third trimester of pregnancy.It is one of the most common metabolic disorders among expectant mothers,with potential serious short-and long-term complications for both maternal and offspring health.C-peptide is secreted from pancreatic beta-cells into circulation in equimolar amounts with insulin.It is a useful biomarker to estimate the beta-cell function because it undergoes negligible hepatic clearance and consequently it has a longer half-life compared to insulin.Pregnancy induces increased insulin resistance due to physiological changes in hormonal and metabolic homeostasis.Inadequate compensation by islet beta-cells results in hyperglycemia.The standard oral glucose tolerance test at 24-28 wk of gestation sets the diagnosis.Accumulated evidence from prospective studies indicates a link between early pregnancy C-peptide levels and the risk of subsequent gestational diabetes.Elevated C-peptide levels and surrogate glycemic indices at the beginning of pregnancy could prompt appropriate strategies for secondary prevention.

Semen analysis standardization： is there any problem in Polish laboratories？

The aim of the study was to determine the degree of compliance of Polish laboratories with World Health Organization （WHO） recommendations, with regard to semen analysis methodology. A survey requesting information about methods of semen analysis was distributed to employees of 55 laboratories. Respondents who had participated in external seminological workshops （31%） were termed certified respondents （CR）, the remaining （69%）--non-certified respondents （NCR）. Only one laboratory （6%） in the CR group and none in the NCR were compliant with WHO guidelines for methods and equipment used to evaluate seminal volume, sperm motility, concentration, vitality and morphology. Most problems were of volume measurement （weighing method was reported by 17% of CR and 10% of NCR） and staining method for sperm morphology （Papanicolau or Diff-Quik were found in 33% of CR and 23% of NCR）. A three- or four-point grading of sperm motility was used by the majority of respondents; however, 17% of CR and 37% of NCR did not use a laboratory counter to tally spermatozoa. Although a haemocytometer method was used by 80% of laboratories in each group, the improved Neubauer chamber was used only by 42% of CR and 19% of NCR. In each group, 24% of laboratories did not perform a vitality test. Procedural errors and the interchangeable utilization of two or even three methods to analyse a given parameter was observed in both groups. The results indicate a need for standardisation of the methods and continuous, unified training in semen analysis in Polish laboratories.

Viral Contamination Source in Clinical Microbiology Laboratory

To understand the potential causes of laboratory-acquired infections and to provide possible solutions that would protect laboratory personnel, samples from a viral laboratory were screened to determine the main sources of contamination with six subtypes of Rhinovirus. Rhinovirus contamination was found in the gloves, cuffs of protective wear, inner surface of biological safety cabinet （BSC） windows, and trash handles. Remarkably, high contamination was found on the inner walls of the centrifuge and the inner surface of centrifuge tube casing in the rotor. Spilling infectious medium on the surface of centrifuge tubes was found to contribute to contamination of centrifuge surfaces. Exposure to sodium hypochlorite containing no less than 0.2 g/L available chlorine decontaminated the surface of the centrifuRe tubes from Rhinovirus after 2 min.

Evaluation of Clinical Laboratory Tests’ Turnaround Time in a Tertiary Hospital in Democratic Republic of the Congo

The delay in the delivery of laboratory results can be fatal and can even lead to the death of patients. This study was conducted at the clinical laboratory of the University Hospital of Kinshasa (UHK) from October 2020 to April 2021, aimed to evaluate the laboratory tests’ turnaround time (TAT) and to identify reasons for delay. TAT was quantified using a time and motion analysis approach. The evaluation of TAT consisted of comparing the overall intra-lab TAT with the suggested TAT using student t-test at 95% confidence intervals. Brainstorming was the root cause analysis tool used for identifying reasons for delay. In this study, the laboratory tests’ TATs were significantly higher (p < 0.001) comparing to international guidelines (60 minutes) and customers’ suggested TAT (120 minutes). Only 0.98% of the samples were reported within 60 minutes of patient reception and 1.47% within 120 minutes, i.e. an outlier rate of 98.5%. Root causes of delay related to Machinery, Management, Manpower, Materials, Method and Milieu. Because of many reasons, the laboratory is not meeting the established TAT. Preventive and curative measures must be undertaken to reduce the delay and improve the TAT.

The Importance of Molecular and Clinical Laboratory Tests in Diagnosis and Treatment of Coronavirus Disease

900 abusers were tested for the presence of drug abuse and coronavirus disease.In the early stage,the throat and noise samples of these patients were examined by polymerase chain reaction(PCR).The mean age of the study group is 42±23.Hematological and serological examinations were performed on 131 patients.All data were analyzed by t-test and one-way analysis of variance(ANOVA).Therefore,P<0.05 is considered as the significance of the test results.The results showed that 131 patients in the study group had positive results of PCR tests and nearby they had Covid-19.Approximately 90%of patients with coronavirus disease showed positive serological tests and lymphopenic condition.All of urine or blood samples in the 131 patients were positive for the presence of abuse drugs.C-reactive protein(CRP)is one of important serologic test that detected on these patients.This study showed the importance of molecular genetics test such as PCR and also hematology and serology tests in distinguish of coronavirus diseases.

Improving Clinical Laboratory Quality through Reduction of Tests’ Turnaround Time in Democratic Republic of the Congo: Key Strategies

In Democratic Republic of the Congo (DRC), the laboratory TAT is significantly very long and do not comply with either international standards or the suggestions of customers. However, there is neither a national nor a local strategy to improve the laboratory TAT. The aim of the present study is to develop practical management strategies to shorten clinical laboratory tests’ TAT. This was a qualitative study conducted in Kinshasa. Focus groups and Lean tools were used respectively to generate a wide range of views from a variety of laboratory staff and to eliminate several form of waste in the laboratory flow process. Based on the identified root causes of delay, focus groups participants reported that there is a lot of scope for the improvement of TAT in DRC. Consistent attendance and punctuality are essential. The hospital management should implement the Laboratory Information Systems (LIS) and install Middleware. Total laboratory automation, inventory system for all reagents and supplies used in the laboratory, expansion of the sampling area, sufficient number of high-power machine and a clear job description are indispensable. LIS, 3.5 mL BD vacutainer BarricorTM tube and point-of-care testing (POCT) are necessary for workflow improvement. A reduction of 312 minutes was achieved by eliminating or decreasing non-value-added activities. Applying the suggested key strategies, and particularly the new workflow process, is a basis for improving the laboratory tests’ TAT. The algorithm presented can be easily implemented in other laboratories that face this type of problem.

Analysis on the Development Dilemma and Opportunity of Independent Clinical Laboratory Based on PEST-SWOT

Objective To study the current status of independent clinical laboratory(ICL)in China to offer some suggestions for further development of the industry because independent clinical testing is gradually occupying an important position in the medical market with the change of medical service mode.Methods The PEST-SWOT matrix model was constructed to sort out the strength and weakness,opportunities and threats of ICL and medical institutions.Results and Conclusion ICLs should enhance their social recognition by improving testing technology and industry operating standards.At the same time,it is also necessary to enhance their position in the clinical diagnosis industry and promote diversified competition in the field of clinical diagnosis so as to better help the development of national grading diagnosis and precision medicine.From the perspectives of SO,ST,WO,and WT,the development strategies of ICL are proposed,including personalized clinical diagnosis services and the construction of a database,and the family doctor system with community+ICL services.The remote diagnostic services should be implemented to help national graded diagnosis and treatment,and different operation schemes should be made to conform to market development.Besides,the access standards for ICL must be strictly required.Then,differentiated operations of enterprises should be valued for establishing industry brands and social awareness.Lastly,enterprises must focus on talents construction and management.

Optimal laboratory testing protocol for patients with acne taking oral isotretinoin

BACKGROUND Isotretinoin is a widely prescribed drug for various dermatological conditions,especially acne.Blood tests are routinely performed to monitor its side effects.However,the optimal testing schedule remains controversial.AIM To evaluate the laboratory monitoring tests and schedules of patients with acne taking isotretinoin to determine the most efficient testing regimen.METHODS We retrospectively reviewed electronic medical records from the Dermatology Department of Dongguk University Ilsan Hospital from 2005 to 2020 for patients prescribed isotretinoin for acne who underwent monthly blood tests.RESULTS Aspartate aminotransferase(AST),alanine aminotransferase(ALT),and trigly-ceride(TG)levels significantly changed between 5 and 6 mo when the total prescription period and dose variables were considered altogether.The high-density lipoprotein level also significantly changed between 5 and 6 mo.However,low-density lipoprotein(LDL)and total cholesterol levels significantly changed between 1 and 2 mo.CONCLUSION We recommend testing AST,ALT,and TG levels once every 5 to 6 mo.We also suggest testing LDL and total cholesterol levels during the first and second months.

Does the ratio of the carpal tunnel inlet and outlet cross-sectional areas in the median nerve reflect carpal tunnel syndrome severity?

Although ultrasound measurements have been used in previous studies on carpal tunnel syndrome to visualize injury to the median nerve, whether such ultrasound data can indicate the severity of carpal tunnel syndrome remains controversial. The cross-sectional areas of the median nerve at the tunnel inlet and outlet can show swelling and compression of the nerve at the carpal. We hypothesized that the ratio of the cross-sectional areas of the median nerve at the carpal tunnel inlet to outlet accurately reflects the severity of carpal tunnel syndrome. To test this, high-resolution ultrasound with a linear array transducer at 5–17 MHz was used to assess 77 patients with carpal tunnel syndrome. The results showed that the cut-off point for the inlet-to-outlet ratio was 1.14. Significant differences in the inlet-to-outlet ratio were found among patients with mild, moderate, and severe carpal tunnel syndrome. The cut-off point in the ratio of cross-sectional areas of the median nerve was 1.29 between mild and more severe（moderate and severe） carpal tunnel syndrome patients with 64.7% sensitivity and 72.7% specificity. The cut-off point in the ratio of cross-sectional areas of the median nerve was 1.52 between the moderate and severe carpal tunnel syndrome patients with 80.0% sensitivity and 64.7% specificity. These results suggest that the inlet-to-outlet ratio reflected the severity of carpal tunnel syndrome.

Methods, units and quality requirements for the analysis of haemoglobin A_(1c) in diabetes mellitus

The formation of glycohemoglobin, especially the hemoglobin A1c(Hb_(A1c)) fraction, occurs when glucose becomes coupled with the amino acid valine in the β-chain of Hb; this reaction is dependent on the plasma concentration of glucose. Since the early 1970 s it has been known that diabetics display higher values of Hb_(A1c) because they have elevated blood glucose concentrations. Thus Hb_(A1c) has acquired a very important role in the treatment and diagnosis of diabetes mellitus. After the introduction of the first quantitative measurement of Hb_(A1c), numerous methods for glycohemoglobin have been introduced with different assay principles: From a simple minicolumn technique to the very accurate automated highpressure chromatography and lastly to many automated immunochemical or enzymatic assays. In early days, the results of the quality control reports for Hb_(A1c) varied extensively between laboratories, therefore in United States and Canada working groups(WG) of the Diabetes Controls and Complications Trial(DCCT) were set up to standardize the Hb_(A1c) assays against the DCCT/National Glycohemoglobin Standardization Program reference method based on liquid chromatography. In the 1990 s, the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) appointed a new WG to plan a reference preparation and method for the Hb_(A1c) measurement. When the reference procedureswere established, in 2004 IFCC recommended that all manufacturers for equipment used in Hb_(A1c) assays should calibrate their methods to their proposals. This led to an improvement in the coefficient of variation(CV%) associated with the assay. In this review, we describe the glycation of Hb, methods, standardization of the Hb_(A1c) assays, analytical problems, problems with the units in which Hb_(A1c) values are expressed, reference values, quality control aspects, target requirements for Hb_(A1c), and the relationship of the plasma glucose values to Hb_(A1c) concentrations. We also note that the acceptance of the mmol/mol system for Hb_(A1c) as recommended by IFCC, i.e., the new unit and reference ranges, are becoming only slowly accepted outside of Europe where it seems that expressing Hb_(A1c) values either only in per cent units or with parallel reporting of percent and mmol/mol will continue. We believe that these issues should be resolved in the future and that it would avoid confusion if mmol/mol unit for Hb_(A1c) were to gain worldwide acceptance.

Molecular detection and genetic diversity of Dientamoeba fragilis and Enterocytozoon bieneusi in fecal samples submitted for routine parasitological examination

Objective:To detect Dientamoeba(D.)fragilis and Enterocytozoon(E.)bieneusi and to assess their genetic characteristics in stool samples submitted for routine examination in a clinical laboratory in Southeastern Brazil.Methods:In this survey,348 stool samples from female and male individuals with age ranging from 0 to≥55 years were analyzed by PCR amplifying and sequencing based on the small subunit ribosomal RNA(SSU r RNA)gene of D.fragilis and the internal transcribed spacer of E.bieneusi.Results:D.fragilis and E.bieneusi isolates were observed in 2.29%(8/348)and 4.59%(16/348)of the samples,respectively.These parasites were detected in stool samples from individuals of both genders,including young children under nine until adults over 55 years old.No statistically significant differences were found.All D.fragilis isolates were classified as genotype 1 and E.bieneusi isolates included genotypes D(n=15)and A(n=1).Conclusions:The findings provide relevant findings on occurrence and genetic diversity of D.fragilis and E.bieneusi,pointing to the need for the diagnosis of these parasites in routine examinations in clinical laboratories.In addition to sensitive diagnostic methods,it is mandatory that these parasites be considered relevant for physicians and laboratory staff.

Huashan Hospital Clinical Laboratory receives accredi- tation from College of American Pathologists

Huashan Hospital Clinical Laboratory, Shanghai, China, has been awarded an accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists （CAP）, based on the results of a recent on-site inspection.