Annals of Clinical Biochemistry最新文献

Background: Blood collection tubes with sodium fluoride (NaF) added as a glycolytic inhibitor are widely used for glucose measurement. However, the glycolytic inhibitory effects of NaF are insufficient, and decreases in glucose levels over time after blood collection have become a problem.

Methods: Blood from a volunteer collected using an NaF tube was used to compare the glycolysis inhibitory abilities of ATP and ADP. Blood samples from 10 volunteers were collected in NaF tubes and NaF tubes with added ATP (NaF-ATP tubes). The stability of glucose and haemoglobin (Hb)A1c after whole-blood storage from immediately after blood collection to 24 h later was compared.

Results: ATP and ADP had similar inhibitory effects on glycolysis, but ATP was selected as an additive for blood collection tubes because ADP was more haemolytic than ATP. We verified the ability of NaF blood collection tubes supplemented with ATP to inhibit glycolysis. Mean (± standard deviation) glucose levels (n=10) after storage for 24 h after blood collection decreased to -9.0 ± 2.7 mg/dL (-0.50 ± 0.15 mmol/L) in conventional NaF tubes. NaF-ATP(20) tubes with 20 mg (0.036 mmol) ATP added showed a reduced decrease, with a mean of -5.8 ± 2.9 mg/dL (-0.32 ± 0.16 mmol/L). NaF-ATP tubes also had no effect on HbA1c measurement.

Conclusion: This study reports on a blood collection tube that enables the measurement of glucose and HbA1c. Based on the results of validation, we conclude that NaF-ATP tubes can reduce decreases in glucose over time in stored whole blood compared to conventional NaF tubes.

Introduction and aims: Sodium can be measured with direct or indirect methods; abnormal plasma total protein concentration can impact on sodium measured by indirect ion-selective electrodes (ISE). Serum sodium is an important item to determine the Model for End Stage Liver Disease Sodium (MELD-Na) score, commonly used for liver graft allocation. Patients with cirrhosis usually have hypoproteinemia. The aim of this study was to determine if there was a significant difference between the MELD-Na scores calculated based on the results of two different serum sodium ISE: indirect and direct.

Methods: This was a retrospective study; we included 166 patients that underwent liver transplant assessment, and that had paired (i.e. same date and time) direct and indirect sodium determinations. We calculated the MELD-Na scores with both sodium determinations, and we compared them.

Results: There was a significant difference between MELD-Na scores; the mean difference was 0.4±1.3. If MELD-Na score had been determined by the sodium measured by the direct ISE, 69 patients (42%) would have stayed in the same place on the waiting list, 67 patients (40%) would have moved up, and 30 patients (18%) would have moved down.

Conclusions: There was a statistically significant difference between the MELD-Na scores calculated based on the two different sodium concentrations, which would theoretically result in changes in the order of the waiting list. This finding should prompt studies to assess if MELD-Na calculated based on direct methods has a better performance to predict clinically relevant outcomes.

This case report describes the positive interference of the commonly used skin protective barrier cream used together with urine collection bags on the benzethonium chloride method for urine protein measurements in a 6-month-old female baby, leading to falsely elevated results. The interference was identified by both artificially mixing urine samples with this cream and comparing the results obtained using the benzethonium chloride method with those obtained using the pyrogallol red method.

Background: Transgender people may avoid seeking medical care due to previous negative experiences and fear of discrimination. Clinical laboratories can contribute to a poor patient experience and clinical outcome when the design and functionality of laboratory information management systems (LIMS) do not consider the needs of transgender patients. This survey aimed to capture current practices in United Kingdom and Republic of Ireland clinical laboratories concerning how transgender patient data and test requests are managed throughout the total testing process.

Methods: An anonymous survey was distributed to clinical laboratory professionals in November 2021. Thirty-three questions covered how gender variables are recorded for transgender patients and used to inform gender-specific calculations, test access, and reference intervals (RIs).

Results: Of the 66 respondents, 70% were based in laboratories in England, with a majority of laboratories having ISO 15189 accreditation and processing 1000-10,000 blood samples daily. Eighty-five percent stated that their LIMS had a single field recording sex or gender information. Forty-three percent did not limit test access based on gender, but 68% did not append RIs for patients with unknown or indeterminate gender.

Conclusions: This survey was the first to quantify how clinical laboratories manage sex and gender information and report results for transgender and non-binary patients, and details several key recommendations based on the survey responses.

Creatinine-based estimated glomerular filtration rate equations (eGFRcreatinine) are used to measure excretory kidney function in clinical practice. Despite inter and intra-patient variability, eGFRcreatinine has excellent clinical utility and provides the basis for the classification system for chronic kidney disease (CKD), for kidney function monitoring, treatment interventions and referral pathways. The 4-variable modification of diet in renal disease (MDRD) eGFRcreatinine equation was introduced in 2000 and recommended by the National Institute for Health and Care Excellence (NICE) in 2008. Subsequently, the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFRcreatinine equation was introduced in 2009 and is more accurate than MDRD in patients with mild and moderate CKD. In 2014, NICE recommended that CKD-EPI eGFRcreatinine replace MDRD eGFRcreatinine in routine clinical practice across England. Both equations originally incorporated adjustments for age, gender and ethnicity. However, the evidence for ethnicity adjustment has been increasingly questioned, and in 2021 NICE recommended that kidney function should be estimated by CKD-EPI eGFRcreatinine without using ethnicity adjustment. Recently, a CKD-EPI equation has been presented without ethnicity adjustment; however, this has not been validated outside of North America and NICE continues to recommend CKD-EPI 2009. We review the status of eGFRcreatinine in clinical practice, including the limitations of eGFRcreatinine and the rationale for removal of ethnicity adjustment and the potential impact of this change on clinical care for patients with kidney disease.

Background: Running means for total calcium (Ca) results at our laboratory exhibit a stable time-of-day (TOD) periodic pattern. We examined use of TOD-dependent targets for running means in patient-based quality control (PBQC) for Ca.

Methods: Primary data were Ca results over a 3 month interval, restricted to weekday data within the Ca reference interval (8.5-10.3 mg/dL; 2.12-2.57 mmol/L). Running means were evaluated as sliding averages of 20 samples (20-mers).

Results: Data comprised 39,629 consecutive Ca measurements (75.3% inpatient (IP)) for which Ca was 9.29±0.47 mg/dL. The all data average for 20-mers was 9.29 ± 0.18 mg/dL. When parsed in 1 h TOD intervals, however, averages among 20-mers ranged from 9.1 to 9.5 mg/dL, with blocs of contiguous results above (0800-2300 h; 53.3% of results; IP = 75.3%) and below (2300-0800 h; 46.7% of results; IP = 99.9%) the all-data mean. There was thus an inherent TOD-dependent pattern of deviation of means from target when using a fixed PBQC target. Using Fourier series analysis as an example approach, characterization of the pattern to produce TOD-dependent PBQC targets eliminated this inherent inaccuracy.

Conclusions: In circumstances of periodic variation in running means, simple characterization of that variation can reduce the probability of both false positive and false negative flags in PBQC.

Background: The European Society of Cardiology (ESC) guidelines recommend a dynamic (0-1h) cardiac troponin (cTn) determination for non-ST elevation myocardial infarction diagnosis. For patients with low cTn levels, a discharge from emergency can be considered. Nevertheless, cTn cutoffs for discharge are lower than the limits of quantification proposed by laboratory reagent suppliers.

Aim: Validate cTn assay on the Elecsys STAT kit.

Materials and methods: Precision, trueness, repeatability and within-laboratory variability were calculated from internal quality control and plasma pooled at 5.78 and 10.73 ng/L. Accuracy was calculated from external quality control. Uncertainty of measurement was calculated from (i) the uncertainty of the standard and control values and (ii) by precision from pooled plasma. Distribution of precision results from pooled plasma has been evaluated by bootstrap simulations. Dilution linearity tests with patient plasma were performed to evaluate the method for values near 5 ng/L.

Results: Precision and trueness ranged from 1.35 to 4.45% and from 0.14 to -3.74%, respectively. Accuracy results ranged from 101.40 to 104.90%. Within laboratory variability was 2.91%. Uncertainty ranged from 3.66% to 19.90% for higher (2188) to lower values (5.78 ng/L). Bootstrap simulations allowed utilization of precision data from pooled plasma to evaluate cTn assay. The method was linear from 4.48 to 39.80 ng/L. A linear regression model best described the data.

Conclusion: Elecsys STAT method provides accurate cTn results, including patients with cTn results categorizing them as 'rule-out' in the ESC guidelines.

Introduction: The prevalence of vitamin B12 deficiency is high in at-risk populations with sometimes irreversible consequences. Beside total B12 (TVB12), active B12 (AVB12) is a promising first-line marker. Only Abbott AVB12 assays were largely evaluated and generally demonstrated benefit in clinical practice. More recently developed Roche AVB12 still requires some investigations.

Objectives: Our study aimed to evaluate the Roche Elecsys® AVB12 immunoassay performance versus Roche Elecsys® TVB12 competition assay.

Design: and Methods: We included 175 patients at Rouen University Hospital who had a TVB12 value <300 pmol/L. We evaluated performance of AVB12 by comparing the results with TVB12 and MMA values in case of disagreement.

Results: Positive correlation was found between the AVB12 and TVB12. We found a disagreement between TVB12 and AVB12 in 18.8% of cases. Among 33 cases of disagreement, 76% had normal AVB12 but low TVB12, whereas 24% had low AVB12 and normal TVB12. Thirty-one MMA determinations were performed: 71% showed agreement between MMA and AVB12, versus 29% between MMA and TVB12. TVB12 reported a sensitivity (Se) at 66.7%, specificity (Sp) at 20%, positive predictive value (PPV) at 16.7% and negative predictive value (NPV) at 71.4% for the prediction of MMA elevation. We determined an optimized cut-off value of 45.5 pmol/L for AVB12, which reported a Se 66.7%, Sp 60%, PPV 30.7%, and NPV 88.9%.

Conclusions: Our results provide preliminary evidence that Roche AVB12 may offer better discrimination than Roche TVB12 in the diagnosis of vitamin B12 deficiency. Further more detailed evaluation is warranted.