Clinical Chemistry Tests Research Articles

A-367 Development of a Multimodal Point-of-Care Diagnostic Platform to Perform Rapid, Accurate, and Cost-Effective Molecular, Immunochemistry, Clinical Chemistry, and Cytometry Tests

Abstract Background Access to point-of-care (POC) testing can make a significant impact on the quality of care. However, because POC diagnostic platforms available today are expensive and only perform one type of test, clinicians are unable to implement all the POC tests they wish to perform. Fluxergy is developing a multimodal POC diagnostic platform that consolidates diverse diagnostic modalities into a single, compact platform to minimize the cost of POC testing and standardize testing workflow for the most common clinical chemistry, hematology, immunochemistry and molecular tests. This study describes feasibility studies performed to benchmark these assay modalities on the Fluxergy Analyzer. Methods Fluxergy Analyzer: The Fluxergy Analyzer integrates conventional detection systems—colorimetric, fluorometric, and electrochemical—into a singular POC platform. This unique design expands -omics testing capabilities, including molecular, immunochemistry, clinical chemistry, and hematology within a single instrument. Benchmarking Feasibility Studies: Molecular benchmarking was performed using a multiplex respiratory panel on contrived samples in UTM/VTM. Immunochemistry benchmarking was performed using a procalcitonin assay on spiked sodium citrate plasma samples. Cytometry benchmarking was performed using a white blood cell count (WBC) assay and testing contrived samples whole blood samples. Results For molecular testing, the Fluxergy Analyzer was able to accurately detect flu A, flu B, SARS-CoV-2, and RSV with agreements with the Luminex ARIES® Flu A/B & RSV Assay and Cepheid Xpert® SARS-CoV-2 test results. For immunochemistry testing, the Fluxergy Analyzer accurate quantified PCT levels at 0.3, 0.6, 1.25 and 2.5 ng/mL. For hematology testing, the Fluxergy Analyzer demonstrated a strong correlation across the reportable range against the standard of care HemoCue analyzer. For clinical chemistry testing, the Fluxergy Analyzer demonstrated a strong correlation against the Siemen’s epoc® Blood Analysis System. Conclusions The Fluxergy Analyzer is uniquely suited to offer a comprehensive menu of the most common POC tests on a single, cost-effective platform.

B-039 Evaluating Inter-Analytic Module Immunoassay Carryover

Abstract Background Integrated analytical systems contain both clinical chemistry analyzers and immunoassay analyzers. Immunoassays can be assigned high priority based on potential sample carryover from sample probes used in clinical chemistry analyzers. The priority designation, assigned by the vendor, determines if the immunoassay test (disposable pipette) is sampled prior to the clinical chemistry test (non-disposable pipette). However, in a modern-day core chemistry laboratory, add-on testing is prevalent. High priority assignment by analytical systems is only effective when a specimen’s tests are analyzed concurrently and doesn’t account for an add-on of any high priority immunoassays. Evaluation of carryover for high priority immunoassays on clinical chemistry analyzers provides insight on if there is clinical impact of allowing add-on testing of these analytes. Methods Intact human chorionic gonadotropin + β-subunit (HCG-BETA, Roche Diagnostics, cobas e602), Procalcitonin (PCT, Roche Diagnostics, cobas e602), and Elecsys Total Prostate-specific Antigen (TPSA, Roche Diagnostics, cobas e602) were the high priority immunoassays evaluated for carryover. High and low target pools were separated into aliquots and baselines for each pool established. High sampling volume assays to potentially generate carryover on the clinical chemistry analyzers were determined to be Sodium (Na, Roche Diagnostics, cobas ISE), Unsaturated Iron-Binding Capacity (UIBC, Roche Diagnostics, cobas c702), and Ammonia (NH3L2, Roche Diagnostics, cobas c502). The ordering sequence of high pool to low pool was then assayed in triplicate on each clinical chemistry analyzer. After potential carryover had been generated, the low pool was again assayed for the immunoassays to evaluate if carryover had occurred and if the carryover exceeded the analyte’s allowable error. Statistical analysis was then performed utilizing Microsoft Excel. Results Conclusions Add-on testing should be restricted for β-HCG and TPSA as a previous clinical chemistry analysis could lead to an errant add-on result due to carryover. PCT is unaffected by previous clinical chemistry analysis.

Point-of-care blood tests using a smartphone-based colorimetric analyzer for health check-up.

A microscale colorimetric assay was designed and implemented for the simultaneous determination of clinical chemistry tests measuring six parameters, including glucose (GLU), total protein (TP), human serum albumin (HSA), uric acid (UA), total cholesterol (TC), and triglycerides (TGs) in plasma samples. The test kit was fabricated using chromogenic reagents, comprising specific enzymes and binding dyes. Multiple colors that appeared on the reaction well when it was exposed to each analyte were captured by a smartphone and processed by the homemade Check6 application, which was designed as a colorimetric analyzer and simultaneously generated a report that assessed test results against gender-dependent reference ranges. Six blood checkup parameters for four plasma samples were conducted within 12min on one capture picture. The assay achieved wide working concentration ranges of 10.45-600 mg dL-1 GLU, 1.39-10.0g dL-1 TP, 1.85-8.0g dL-1 HSA, 0.86-40.0 mg dL-1 UA, 11.28-600 mg dL-1 TC, and 11.93-400 mg dL-1 TGs. The smartphone-based assay was accurate with recoveries of 93-108% GLU, 93-107% TP, 92-107% HSA, 93-107% UA, 92-107% TC, and 99-113% TGs. The coefficient of variation for intra-assay and inter-assay precision ranged from 3.2-5.2% GLU, 4.6-5.3% TP, 4.3-5.3% HSA, 2.8-6.6% UA, 2.7-6.5% TC, and 1.1-3.9% TGs. This assay demonstrated remarkable accuracy in quantifying the concentration-dependent color intensity of the plasma, even in the presence of other suspected interferences commonly present in serum. The results of the proposed method correlated well with results determined by the microplate spectrophotometer (R2 > 0.95). Measurement of these six clinical chemistry parameters in plasma using a microscale colorimetric test kit coupled with the Check6 smartphone application showed potential for real-time point-of-care analysis, providing cost-effective and rapid assays for health checkup testing.

Multivariate anomaly detection models enhance identification of errors in routine clinical chemistry testing.

Conventional autoverification rules evaluate analytes independently, potentially missing unusual patterns of results indicative of errors such as serum contamination by collection tube additives. This study assessed whether multivariate anomaly detection algorithms could enhance the detection of such errors. Multivariate Gaussian, k-nearest neighbours (KNN) distance, and one-class support vector machine (SVM) anomaly detection models, along with conventional limit checks, were developed using a training dataset of 127,451 electrolyte, urea, and creatinine (EUC) results, with a 5 % flagging rate targeted for all approaches. The models were compared with limit checks for their ability to detect atypical EUC results from samples spiked with additives from collection tubes: EDTA, fluoride, sodium citrate, or acid citrate dextrose (n=200 per contaminant). The study additionally assessed the ability of the models to identify 127,449 single-analyte errors, a potential weakness of multivariate models. The KNN distance and SVM models outperformed limit checks for detecting all contaminants (p-values <0.05). The multivariate Gaussian model did not surpass limit checks for detecting EDTA contamination but was superior for detecting the other additives. All models surpassed limit checks for identifying single-analyte errors, with the KNN distance model demonstrating the highest overall sensitivity. Multivariate anomaly detection models, particularly the KNN distance model, were superior to the conventional approach for detecting serum contamination and single-analyte errors. Developing multivariate approaches to autoverification is warranted to optimise error detection and improve patient safety.

Recycling Opportunities in a High Volume Academic Clinical Chemistry Laboratory

Abstract Many sectors of industry, including the biomedical sector, have quantified waste, and created sustainability strategies to mitigate its environmental impact. One of these strategies utilizes the waste hierarchy, a model which ranks the concepts reduce, re-use and recycle in order of the most to least sustainable practice. However, to date, the clinical laboratory has seldom been evaluated for total waste production and mitigation strategies and additional public reporting of the physical amount of waste produced in these areas are lacking in the literature. In this study, we aimed to identify specific wastes produced from performing the CMP over the course of a year in our automated clinical chemistry laboratory and what proportion would be recyclable. The total in- and outpatient testing volumes as well as volumes of quality control and calibrations needed to perform the CMP at our institution were collected retrospectively from 07/14/2021 - 07/14/2022. We further identified disposables waste items such as calibrator kits, quality control kits, patient blood specimen tubes, shipping packaging and reagent wedge kits that are necessary to perform the CMP. In addition, to obtain a conservative and consistent evaluation to the total amount of waste produced from the CMP, the average weights for components of the reagent test wedge kits which includes plastic wedges, cardboard shipping boxes, and paper package inserts were calculated. These weights in conjunction with total testing volumes was used to determine the total, recyclable, and non-recyclable waste produced from these disposable items. A total of 1089.2 kg of reagent kit wastes were estimated to be produced by performing the CMP over the course of a year. Of this waste, cardboard shipping boxes and paper package inserts were determined to be recyclable (233.6 kg) and the plastic reagent wedges were determined to be non-recyclable (855.5 kg) as they were not labelled with the universally recognized recycling code, were composed of proprietary plastic material, and contained biohazardous contaminants. Overall, 21.4 % of the total specific waste weight was found to be recyclable. The CMP is a small subset of the clinical chemistry test menu that produces a considerable amount of recyclable and non-recyclable waste.

Evaluation of Coefficients of Variation for Clinical Chemistry Tests Based on Internal Quality Control Data Across 5,425 Laboratories in China From 2013 to 2022.

Clinical chemistry tests are most widely used in clinical laboratories, and diverse measurement systems for these analyses are available in China. We evaluated the imprecision of clinical chemistry measurement systems based on internal QC (IQC) data. IQC data for 27 general chemistry analytes were collected in February each year from 2013 to 2022. Four performance specifications were used to calculate pass rates for CVs of IQC data in 2022. Boxplots were drawn to analyze trends of CVs, and differences in CVs among different groups were assessed using the Mann-Whitney U-test or Kruskal-Wallis test. The number of participating laboratories increased significantly from 1,777 in 2013 to 5,425 in 2022. CVs significantly decreased for all 27 analytes, except creatine kinase and lipase. Triglycerides, total bilirubin, direct bilirubin, iron, and γ-glutamyl transferase achieved pass rates >80% for all goals. Nine analytes with pass rates <80% based on 1/3 allowable total error were further analyzed; the results indicated that closed systems exhibited lower CVs than open systems for all analytes, except total protein. For all nine analytes, differences were significant between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories. The CVs of IQC data for clinical chemistry have seen a continuous overall improvement in China. However, there is ample room for imprecision improvement for several analytes, with stricter performance specifications.

Application of the Analytical Performance Specification for Quality Management of Clinical Chemistry Tests

Application of the Analytical Performance Specification for Quality Management of Clinical Chemistry Tests

The transition from gel separatory serum tubes to lithium heparin gel tubes in the clinical laboratory

Aims: To assess the viability of replacing serum samples with plasma samples in various clinical chemistry and immunoassay tests and to examine the implications of turnaround time (TAT) and sample quality during the transition process.&#x0D; Methods: We compared the results of 27 paired clinical chemistry and 13 immunoassay tests from samples obtained using gel separator serum and gel separator lithium heparinized plasma (LIH) tubes. We used regression analysis, bias values, and Bland-Altman plots to compare the performance of serum and LIH tubes in various clinical chemistry and immunoassay tests. We collected and evaluated sample aspiration errors, hemolysis index values, and TAT data from the laboratory information system before and after switching to plasma in our study.&#x0D; Results: Most tests showed no significant difference between the serum and LIH. However, for some analytes, total error (TE) values exceeded the total allowable error (TEa) limits derived from the biological variation database. Notably, insulin TE value did not exceed TEa, but it consumed near all its error budget. Consequently, we determined the alternative allowable error limits for some tests and found that plasma tubes could be used instead of serum tubes for most tests, except for lactate dehydrogenase (LDH). Plasma tubes improved the sample quality, reduced the incidence of aspiration errors, and decreased TAT in the emergency laboratory. We observed significant reductions in TAT after switching to plasma tubes.&#x0D; Conclusion: Our study showed that LIH tubes can replace serum tubes in most clinical chemistry and immunoassay tests. Using LIH tubes in clinical laboratories can improve healthcare quality and reduce the workload of the laboratory staff.

A-189 Volume Matters: Continuous Improvement to Reduce Blood Collection Volumes and Collection Tube Utilization

Abstract Background Clinical laboratories are constantly changing with automated analyzers and total lab automation (TLA) implemented and replaced over time. Some benefits of newer technologies include decreased specimen volume requirements, less need for repeat testing, and greater throughput. Recent implementation of new analyzers and replacement of TLA in the Central Clinical Laboratory (CCL) at Mayo Clinic, Rochester, MN, prompted the laboratory to reassess blood collection volumes for commonly ordered tests. Objectives The aim of this study was to evaluate whether updating the blood collection volumes for clinical chemistry and immunoassay tests performed in the CCL could reduce the volume of blood collected from patients and the number of blood collection tubes utilized. Methods Nearly 100 different serum assays from the CCL test menu were reviewed including the basic and comprehensive metabolic, hepatic function, renal function, electrolyte, and lipid panels as well as thyroid function tests, enzymes, hormones, electrolytes, and iron status tests. Cortisol, ferritin, folate, and Vitamin B12 testing were performed on the Beckman DxI800; all other testing was on Roche Diagnostics Cobas 8000 chemistry (ISE, c701, c502) and immunoassay (e801) analyzers. Updated blood volumes for each assay were calculated utilizing manufacturer’s analytical volumes and “dead volume” requirements. Baseline data retrieved from the laboratory information system (LIS) included blood collection volumes and number of tubes collected for 128 patients with physician-orders for laboratory testing on 5/2/21. The collection logic was then updated in the test LIS environment using the new blood volumes requirements and applied to the same 128 orders. Blood volumes and number of tubes collected per order were compared before and after the volume updates. Results Baseline data from 128 unique orders showed that 414 total tubes were collected with a median(range) of 3 (2–6) tubes per order and 5 (1–18) tests per tube. The total volume of blood requested at baseline was 2065 mL. Post-intervention, 197 tubes were needed with a median(range) of 2 (1–3) tubes per order and 13 (1–30) tests per tube. The total volume of blood requested after updating volumes was 851 mL. Conclusions The practice of reviewing and updating specimen volume requirements when replacing or implementing new analyzers or TLA can greatly reduce the volume of blood collected from patients and the number of blood collection tubes per order. In this study of 128 physician orders for common laboratory tests, updating blood collection information in the LIS reduced the requested blood collection volumes by 59% and decreased the number of blood collection tubes required by 52%. This not only benefits patients because less blood is collected but also conserves blood collection tubes and reduces supply chain demands. Additionally, fewer tubes on the TLA system has the potential to improve throughput and test turnaround time.

The effect of hormonal contraceptive therapy on clinical laboratory parameters: a literature review.

Hormonal contraceptives (HC) are widely used among women in reproductive ages. In this review, the effects of HCs on 91 routine chemistry tests, metabolic tests, and tests for liver function, hemostatic system, renal function, hormones, vitamins and minerals were evaluated. Test parameters were differently affected by the dosage, duration, composition of HCs and route of administration. Most studies concerned the effects of combined oral contraceptives (COC) on the metabolic, hemostatic and (sex) steroids test results. Although the majority of the effects were minor, a major increase was seen in angiotensinogen levels (90-375 %) and the concentrations of the binding proteins (SHBG [∼200 %], CBG [∼100 %], TBG [∼90 %], VDBP [∼30 %], and IGFBPs [∼40 %]). Also, there were significant changes in levels of their bound molecules (testosterone, T3, T4, cortisol, vitamin D, IGF1 and GH). Data about the effects of all kinds of HCs on all test results are limited and sometimes inconclusive due to the large variety in HC, administration routes and dosages. Still, it can be concluded that HC use in women mainly stimulates the liver production of binding proteins. All biochemical test results of women using HC should be assessed carefully and unexpected test results should be further evaluated for both methodological and pre-analytical reasons. As HCs change over time, future studies are needed to learn more about the effects of other types, routes and combinations of HCs on clinical chemistry tests.

Evaluation of the HealthID PSD microsampling device for the simultaneous determination of cholesterol, high-density lipoprotein, triglycerides, creatinine, and HbA1c in capillary blood

IntroductionThe use of dried capillary microsamples for clinical chemistry testing is an interesting alternative to conventional phlebotomy. Sampling devices capable to produce plasma from whole blood application are particularly useful. The aim of this study was to validate theHealthID PSDmicrosampling device for the determination of cholesterol (CHOL), high-density lipoprotein (HDL), triglycerides (TRIG), creatinine (CRE), and glycated hemoglobin (HbA1c) after collection of capillary blood. MethodsDried blood and plasma extracts were analyzed using modified methods in an open-channel biochemistry analyzer. The plasma volume in the extracts was corrected by the concentration of chloride (CL). Linearity, imprecision, bias, stability, and comparability to conventional samples were evaluated. ResultsDried plasma assays presented total error (TE) within acceptable limits. The analytes were stable for up to 14 days at 40 °C. Predicted serum concentrations of CHO, HDL, TRI, and CRE and predicted whole blood levels of HbA1c, using dried extracts measurements, did not presented systematic or proportional differences to serum and whole blood levels. ConclusionsDried sample extracts obtained with capillary blood applied to the HealthID PSD allowed the determination of CHO, HDL, TRI, CRE, and HbA1c, as well as the calculation of LDL level, using only 5 drops of blood. This sampling strategy can be useful for population screening programs, particularly in Developing Countries.

Harmonization in Laboratory Medicine: The Big Picture

Harmonization of laboratory testing refers to ability to achieve the same result, within clinically acceptable limits and the same interpretation irrespective of the measurement procedure used, the unit or reference interval applied, and when and/or where a measurement made is in agreement. 1 The purpose of harmonizing laboratory data is to enhance patient care quality, leading to better patient outcomes and safety. Initiatives for harmonization and standardization have primarily concentrated on analytical processes carried out within the laboratories, particularly clinical chemistry testing. 2

Stratifying the risks of venous thromboembolism in the lateral skull base surgery using Caprini risk assessment model

To analyze and stratify the possible risk factors of venous thromboembolism (VTE) in lateral skull base surgery (LSBS) using the Caprini risk assessment model. In a single center, a retrospective study was conducted with patients who underwent LSBS from June 2016 to August 2021. The clinical characteristics and blood chemistry tests were collected. The incidence of VTE within 30days of surgery was recorded. The Caprini risk score was calculated to assess the postoperative VTE risk. Among the 123 patients in this study, the VTE incidence within 30 postoperative days was 8.9%. The total Caprini risk score in VTE patients (5.6 ± 1.9 points) was significantly higher than that of non-VTE patients (4.6 ± 1.4 points; p = 0.028). The binary logistic regression showed the total Caprini score as the only independent indicator of postoperative VTE. The receiver operating characteristic curve analysis showed that the Caprini score at 6.5 points had low sensitivity (36.4%) but high specificity (91.1%), with the largest area under the curve being 0.659. The VTE rate was significantly higher in patients with a total Caprini score ≥ 7 points (28.6%) compared to those with a total Caprini score ≤ 6 points (7.3%; p = 0.022). LSBS patients have a high risk of developing postoperative VTE. Patients with a Caprini score ≥ 7 points had a significantly higher risk of developing VTE after LSBS. The Caprini risk system was useful in assessing the VTE risk in LSBS. However, more data, calibration, and validation are necessary to establish an exclusive Caprini risk system for LSBS.

Longitudinal trajectory of vascular age indices and cardiovascular risk factors: a repeated-measures analysis

This study aimed to identify the modifiable cardiovascular risk factors associated with longitudinal changes, which are nine functional and structural biological vascular aging indicators (BVAIs), to propose an effective method to prevent biological vascular aging. We conducted a longitudinal study of 697 adults (a maximum of 3636 BVAI measurements) who were, at baseline, aged between 26 and 85 years and whose BVAIs were measured at least twice between 2007 and 2018. The nine BVAIs were measured using vascular testing and an ultrasound device. Covariates were assessed using validated questionnaires and devices. During the mean follow-up period of 6.7 years, the average number of BVAI measurements ranged from 4.3 to 5.3. The longitudinal analysis showed a moderate positive correlation between the common carotid intima-media thickness (IMT) and chronological age in both men (r = 0.53) and women (r = 0.54). In the multivariate analysis, BVAIs were associated with factors such as age, sex, residential area, smoking status, blood clinical chemistry test levels, number of comorbidities, physical fitness, body mass, physical activity, and dietary intake. The IMT is the most useful BVAI. Our findings suggest that modifiable cardiovascular risk factors are associated with longitudinal changes in BVAI as represented by IMT.

Clinical chemistry laboratory test overuse in a cardiology clinic: a single-center study.

Diagnostic laboratory tests are frequently overused in healthcare entities, leading to an increased strain on laboratory resources, additional workload, and wastage of resources. Continuous monitoring of test ordering behavior is crucial to evaluate clinical necessity. This cross-sectional study aimed to estimate the necessity of ordering clinical chemistry tests in the cardiology clinic of a tertiary center in Saudi Arabia. We retrieved medical records of patients diagnosed with cardiovascular problems admitted at the cardiology clinic in 2020. The frequency and percentages of the ordered tests were calculated upon admission and follow-up, and the difference between necessary and unnecessary tests was compared for each category. Test ordering assessment included cardiac, renal, and liver functions, blood gases, thyroid and diabetic profile, iron indices, hormones, water and electrolytes, and inflammatory markers. The results showed a large number of clinical chemistry tests ordered without clinical necessity. While the number of necessary tests was significantly higher than that of unnecessary tests, 21% of the tests ordered between June-December 2021 at the center were unnecessary. Further studies are necessary to identify driving factors and develop strategies to reduce the overutilization of diagnostic laboratory tests in clinical practice. Eliminating this phenomenon will reduce the risk of unnecessary medical interventions and associated costs, improve patient outcomes, and reduce the overall burden on the healthcare system.

Leptospira spp. in Free-Ranging Capybaras (Hydrochoerus hydrochaeris) from Midwestern Brazil.

Background: Leptospirosis is a contagious disease that affects domestic and wild animals as well as humans. It is caused by infection with some pathogenic species of the genus Leptospira. In Brazil, studies on leptospirosis in capybaras are scarce or nonexistent in some regions, such as the Federal District. The objective of this study was to analyze the presence of DNA of the agent and/or anti-Leptospira spp. antibodies in capybaras. Materials and Methods: Blood samples were collected from 56 free-living capybaras captured in two different sites in the study region. The samples were submitted to hematology and clinical chemistry tests. To identify Leptospira positive samples, a conventional PCR (cPCR) and analysis of anti-Leptospira spp. antibodies by microscopic agglutination test (MAT) were used. Results: No animal showed cPCR amplification of the Lip32 gene, but 41.1% (23/56) of the animals had anti-Leptospira spp. antibodies on MAT. The serovars present were icterohaemorrhagiae (82.61%), copenhageni (65.22%), grippotyphosa (4.35%), and hardjo (4.35%). In the laboratorial tests, differences (p < 0.05) were observed in the biochemical assays of alkaline phosphatase, creatinine, albumin, and globulin. Although these values differed significantly between groups, they all remained within reference range (excluding albumin), and thus there is not enough to infer that this alteration could be caused by Leptospira infection. Conclusions: cPCR using whole blood samples to evaluate Leptospira spp. infection of free-living capybaras was not an efficient tool. The presence of Leptospira seroreactive capybaras shows that the bacteria are circulating in the urban environment of the Federal District.

Intestinal injury in cardiac arrest is associated with multiple organ dysfunction: A prospective cohort study

BackgroundThe impact of intestinal injury in cardiac arrest is not established. The first aim of this study was to assess associations between clinical characteristics in out-of-hospital cardiac arrest (OHCA) and a biomarker for intestinal injury, Intestinal Fatty Acid Binding Protein (IFABP). The second aim was to assess associations between IFABP and multiple organ dysfunction and 30-day mortality. MethodsWe measured plasma IFABP in 50 patients at admission to intensive care unit (ICU) after OHCA. Demographic and clinical variables were analysed by stratifying patients on median IFABP, and by linear regression. We compared Sequential Organ Failure Assessment (SOFA) score, haemodynamic variables, and clinical-chemistry tests at day two between the “high” and “low” IFABP groups. Logistic regression was applied to assess factors associated with 30-day mortality. ResultsSeveral markers of whole body ischaemia correlated with intestinal injury. Duration of arrest and lactate serum concentrations contributed to elevated IFABP in a multivariable model (p < 0.01 and p = 0.04, respectively). At day two, all seven patients who had died were in the “high” IFABP group, and all six patients who had been transferred to ward were in the “low” group. Of patients still treated in the ICU, the “high” group had higher total, renal and respiratory SOFA score (p < 0.01) and included all patients receiving inotropic drugs. IFABP predicted mortality (OR 16.9 per standard deviation increase, p = 0.04). ConclusionCardiac arrest duration and lactate serum concentrations were risk factors for intestinal injury. High levels of IFABP at admission were associated with multiple organ dysfunction and mortality.Trial registration: ClinicalTrials.gov: NCT02648061.

What clinical metabolomics will bring to the medicine of tomorrow

The purpose of this review is to explore how clinical metabolomics could help physicians in the future. The recent advent of medical genomics brings new and interesting technological tools to measure genetic predispositions to a disease. But metabolomics will allow us to go even further by linking the patient’s pathological phenotype with gene expression defects and metabolic disorders. It is in this context that the clinical chemist must adapt and be a force of proposal to meet these health challenges. He must help the clinician by mastering these new innovative tools, in order to participate in the implementation of clinical studies for the discovery of biomarkers, but also to propose the assays of biomarkers called “signatures,” which can be composite biomarkers or fingerprints, which will ultimately guide the clinician. He will have to propose them as clinical chemistry tests. In the first part, we will look at some concrete examples of the use of clinical metabolomics in clinical research projects that have led to the identification of a new biomarker. We will use the example of trimethylamine N-oxide (or TMAO) and review the clinical studies that have proposed TMAO as a biomarker for cardiovascular diseases. In a second part, we will see through bibliographic studies, how the metabolomic fingerprint can be useful to build a supervised model for patient stratification. In conclusion, we will discuss the limitations currently under debate.

The development of a machine learning algorithm for early detection of viral hepatitis B infection in Nigerian patients

Access to Hepatitis B Virus (HBV) testing for people in low-resource settings has long been challenging due to the gold standard, enzyme immunoassay, being prohibitively expensive, and requiring specialised skills and facilities that are not readily available, particularly in remote and isolated laboratories. Routine pathology data in tandem with cutting-edge machine learning shows promising diagnostic potential. In this study, recursive partitioning (“trees”) and Support Vector Machines (SVMs) were applied to interrogate patient dataset (n = 916) that comprised results for Hepatitis B Surface Antigen (HBsAg) and routine clinical chemistry and haematology blood tests. These algorithms were used to develop a predictive diagnostic model of HBV infection. Our SVM-based diagnostic model of infection (accuracy = 85.4%, sensitivity = 91%, specificity = 72.6%, precision = 88.2%, F1-score = 0.89, Area Under the Receiver Operating Curve, AUC = 0.90) proved to be highly accurate for discriminating HBsAg positive from negative patients, and thus rivals with immunoassay. Therefore, we propose a predictive model based on routine blood tests as a novel diagnostic for early detection of HBV infection. Early prediction of HBV infection via routine pathology markers and pattern recognition algorithms will offer decision-support to clinicians and enhance early diagnosis, which is critical for optimal clinical management and improved patient outcomes.

Striving for a pragmatic contribution of biomarkers results to lifelong health care.

The increased role of preventive medicine in healthcare and the rapid technological advancements, have deeply changed the landscape of laboratory medicine. In particular, increased investments in newborn screening tests and policies have been observed. Aim of this paper is to characterize how laboratory professionals engaged in clinical chemistry or newborn screening, in collaboration with experts in econometric, bioinformatics, and biostatistics may address a pragmatic use of laboratory results in the decision-making process oriented toward improvement of health care outcomes. The effectiveness of biomarkers on healthcare depends on several factors such as analytical performance, prevalence of the disease, integration of the test within thediagnostic algorithm, associated costs, and social/economic impact of false positive and false negative results. Cost-effectiveness analysis needs to be performed and reliability achieved, by overcoming analytical pitfalls andby improving interpretative criteria. These are challenging issues common to clinical chemistry and newborn screening tests. Following the experience in clinical chemistry, one of the main issues to be approached in newborn screening tests, is the lack of harmonization of results obtained by different methods and the limited healthcare effectiveness. The focus on prevention is a crucial opportunity for laboratory medicine to change how to approach the effectiveness of biomarkers on healthcare. The consolidation within clinical laboratories of professionals with different technical and methodological expertise coupled with the need to produce and manage large sets of data, require the cooperation of professionals from other disciplines to characterize the impact of the tests on epidemiological outcomes for health care policy making process.