Effect of exogenous lipids contamination on blood gas analysis.

Objectives: The purpose of this study was to investigate the effects of contamination of venous blood with a lipid-containing solution on parameters measured by a modern blood gas analyzer. Methods: We collected venous blood from 17 healthcare workers (46 ± 11 years; 53 % women) into three blood gas syringes containing 0 , 5 and 10 % lipid-containing solution. Blood gas analysis was performed within 15 min from sample collection on GEM Premier 5000, while triglycerides and serum indices were assays on Roche COBAS C702. Results: Triglycerides concentration increased from 1.0 ± 0.3 mmol/L in the uncontaminated blood gas syringe, to 39.4 ± 7.8 and 65.3 ± 14.4 mmol/L (both p<0.001) in syringes with 5 and 10 % final lipid contamination. The lipemic and hemolysis indices increased accordingly. Statistically significant variation was noted for all analytes except hematocrit and COHb in the syringe with 5 % lipids, while only COHb did not vary in the syringe with 10 % lipids. Significant increases were observed from 5 % lipid contamination for pO2, SO2 and lactate, while the values of pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, hematocrit (10 % contamination), hemoglobin and MetHB decreased. All these changes except lactate and CoHb exceeded their relative performance specifications. Conclusions: Artifactual hyperlipidemia caused by contamination with exogenous lipids can have a clinically significant impact on blood gas analysis. Manufacturers of blood gas analyzers must be persuaded to develop new instruments equipped with serum indices.

Opportunities and Drawbacks of Digitalized Morphologic Analysis of Body Fluids.

Body fluid analysis has become a critical component of diagnostic and clinical decision-making for a wide spectrum of human pathologies. An automated microscope, a high-quality digital camera, and a software designed to identify and automatically preclassify cells and other features in stained smears comprise the most recent generation of digital morphologic analyzers. The time necessary for expert operator reclassification is another aspect that must be considered at this stage of development, because identifying and sorting distinct elements in body fluids still necessitates the involvement of an expert morphologist.

EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) recommendations for reinforcing cyber-security and managing cyber-attacks in medical laboratories.

The healthcare systems are a prime target for cyber-attacks due to the sensitive nature of the information combined with the essential need for continuity of care. Medical laboratories are particularly vulnerable to cyber-attacks for a number of reasons, including the high level of information technology (IT), computerization and digitization. Based on reliable and widespread evidence that medical laboratories may be inadequately prepared for cyber-terrorism, a panel of experts of the Task Force Preparation of Labs for Emergencies (TF-PLE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has recognized the need to provide some general guidance that could help medical laboratories to be less vulnerable and better prepared for the dramatic circumstance of a disruptive cyber-attack, issuing a number of consensus recommendations, which are summarized and described in this opinion paper.

Red blood cell distribution width (RDW) reflects disease severity in patients with carbon monoxide poisoning: systematic literature review and meta-analysis.

No definitive prognostic biomarkers for carbon monoxide (CO) poisoning have been proposed. The aim of this study is to investigate, through a systematic literature review and pooled analysis, whether red blood cell distribution width (RDW) can predict disease severity in CO-poisoned patients. We performed an electronic search in Scopus and PubMed using the keywords: 'red blood cell distribution width' OR 'RDW' AND 'carbon monoxide' AND 'poisoning,' with no time or language restrictions (i.e. through August 2023) to find clinical studies that examined the value of RDW in patients with varying severity of CO poisoning. The analysis was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 reporting checklist. We identified 29 articles, seven of which were included in our analysis, with a total of 1979 CO-poisoned patients, 25.9% of whom were severely ill. In all but one of the studies, the RWD mean or median value was higher in CO-poisoned patients with severe disease. The weighted mean difference (WMD) of RDW was 0.36 (95% confidence interval (CI), 0.26-0.47)%. In the three articles in which the severity of illness in CO-poisoned patients was defined as cardiac injury, the WMD of the RDW was 1.26 (95%CI, 1.02-1.50)%. These results suggest that monitoring RDW in CO-poisoned patients may help to determine the severity of disease, particularly cardiac injury.

Analytical evaluation of the novel Mindray high sensitivity cardiac troponin I immunoassay on CL-1200i.

OBJECTIVES: The current study was designed to evaluate the analytical performance of the new Mindray highly sensitive cardiac troponin I (hs-cTnI) chemiluminescent immunoassay on Mindray CL-1200i, as a thorough validation of novel hs-cTnI methods is required before introduction into clinical practice. METHODS: The evaluation of the analytical performance of this hs-cTnI immunoassay encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, 99th percentile upper reference limit (URL) and concordance with another previously validated hs-cTnI chemiluminescent immunoassay. RESULTS: The LOB and LOD were 0.32 and 0.35 ng/L, whilst the functional sensitivity (expressed as cTnI value with <10 % imprecision), was 0.35 ng/L. The linearity was excellent throughout a wide range of clinically measurable values (r=1.00 between 0.8 and 9,726.9 ng/mL). The intra-assay, inter-assay and total imprecision were 1.1-1.3 %, 5.5-8.1 % and 5.6-8.2 %, respectively. The 99th percentile URL calculated using residual plasma from 246 ostensibly healthy blood donors was 9.2 ng/L (4.3 ng/L in women vs. 12.3 ng/L in men). The Spearman's correlation between Mindray hs-cTnI and Access hs-TnI was 0.97, with mean bias of 7.2 % (95 % CI, 2.6-11.9 %). CONCLUSIONS: Although we failed to confirm the very optimistic analytical characteristics previously reported for this method, our evaluation of the novel Mindray hs-cTnI immunoassay on CL-1200i demonstrated that the overall performance is comparable to that of other commercially available hs-cTnI techniques, making it a viable alternative to other methods.

Are anti-SARS-CoV-2 S/N IgG/IgM antibodies always predictive of previous SARS-CoV-2 infection?

Objectives: We planned this study to verify whether immunoassays for quantifying anti-SARS-CoV-2 IgG/IgM antibodies against both spike (S) and nucleocapsid (N) proteins may be used for identifying previous SARS-CoV-2 infections. Methods: The study population consisted of a cohort of fully vaccinated healthcare workers. All study subjects underwent regular medical visits and molecular testing for diagnosing SARS-CoV-2 infections every 2-4 weeks between 2020-2022. Venous blood was drawn for measuring anti-SARS-CoV-2 antibodies with MAGLUMI 2019-nCoV lgG/IgM CLIA Assays directed against both SARS-CoV-2 S and N proteins. Results: Overall, 31/53 (58.5%) subjects had tested positive for SARS-CoV-2 by RT-PCR throughout the study (24 once, 7 twice). No positive correlation was found between anti-SARS-CoV-2 S/N IgM antibodies and molecular test positivity. In univariate regression analysis, both a molecular test positivity (r=0.33; p=0.015) and the number of positive molecular tests (r=0.43; p=0.001), but not vaccine doses (r=-0.12; p=0.392), were significantly correlated with anti-SARS-CoV-2 S/N IgG antibodies. These two associations remained significant in multiple linear regression analysis (p=0.029 and p<0.001, respectively) after adjusting for sex, age, body mass index, and vaccine doses. In ROC curve analysis, anti-SARS-CoV-2 S/N IgG antibodies significantly predicted molecular test positivity (AUC, 0.69; 95% CI; 0.55-0.84), with the best cutoff of 0.05 AU/mL displaying 67.9% accuracy, 0.97 sensitivity, and 0.27 specificity. Conclusions: Although anti-SARS-CoV-2 S/N IgG antibodies provide helpful information for identifying previous SARS-CoV-2 infections, a lower cutoff than that of sample reactivity should be used. Anti-SARS-CoV-2 S/N IgM antibodies using conventional cutoffs seem useless for this purpose.

Urine dipstick for screening plasma glucose and bilirubin in low resource settings: a proof-of-concept study.

Objectives: The purpose of this proof-of-concept study was to investigate whether a commercially available urine dipstick may provide potentially useful information for screening plasma glucose and bilirubin in human plasma samples. Methods: Glucose and bilirubin were assayed in 60 anonymized lithium-heparin residual plasma samples using the Roche COBAS 8000 or after pipetting 10 µL of plasma onto the pads of a commercial urine dipstick. Semiquantitative urine test results obtained with the dipstick were directly compared to paired test results obtained with COBAS. Results: Median plasma glucose values between COBAS and dipstick were slightly different (5.8 vs. 5.6 mmol/L; p=0.040), while no significant difference was found in bilirubin values between COBAS and dipstick (11.2 vs. 8.6 µmol/L; p=0.090). The Spearman's correlation between COBAS and dipstick was 0.83 (95% CI, 0.73-0.90; p<0.001) for plasma glucose and 0.78 (95% CI, 0.66-0.87; p<0.001) for plasma bilirubin, respectively. Cumulative agreement between COBAS and dipstick was high for both glucose (88%; kappa statistic statistics, 0.75; 95% CI, 0.58-0.92; p<0.001) and bilirubin (88%; kappa statistics, 0.76; 95% CI, 0.60-0.92; p<0.001). Conclusions: The results of this proof-of-concept study indicate that the commercial urine test strip used in our study provides acceptable performance for screening plasma glucose and bilirubin levels compared with reference laboratory assays.

Updated statistics on Influenza mortality.

OBJECTIVES: We have planned this analysis to provide current statistics on mortality directly caused by Influenza viruses in recent years in the US. METHODS: We performed an electronic search in the online database CDC WONDER to obtain current statistics on direct mortality caused by Influenza viruses in the US. Mortality data are derived from information on all death certificates issued in the 50 states and the District of Columbia, excluding deaths of nonresidents. Our basic query criteria included Influenza-specific ICD-10 codes. RESULTS: Influenza caused an average of 7,670 deaths per year from 2018 to 2020 based on Influenza-specific ICD-10 codes, with a corresponding mean death rate of 2.3 × 100,000. The death rate increased in parallel with the age of the US resident population, from 0.2 × 100,000 in the 5-24 age group to 37.4 × 100,000 in US residents aged 85 years or older. No substantial differences were observed in males vs. females. CONCLUSIONS: The results of this analysis show that Influenza remains a significant clinical burden in the general population, with a cumulative mortality rate of approximately 2.3 × 100,000, but increasing more than tenfold (to over 37 × 100,000) in older persons.

Disruption of laboratory activities during the COVID-19 pandemic: results of an EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) survey.

Background: The EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) created a survey that has been distributed to its members for gathering information on the key hazards experienced by European medical laboratories during the COVID-19 pandemic. Methods: The survey was distributed to over 12,000 potential contacts (laboratory workers) via an EFLM newsletter, with responses collected between May 8 and June 8, 2023. Results: Two hundred replies were collected and examined from European laboratories. 69.7% and 78.1% of all responders said they were short on non-COVID and COVID reagents, respectively. Exactly half of respondents (50.0%) said that they could not complete all laboratory tests required for a specific period, but this figure climbed to 61.2% for COVID tests. Finally, 72.3% of respondents expressed exhaustion during the pandemic, and 61.2% reported increasing patient hostility. Conclusions: The COVID-19 pandemic had a significant impact on laboratory medicine in Europe. Cultural change, proactive planning, and even re-engineering in some parts of the laboratory industry may thus be necessary to prepare for future challenges.

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA).

Background: This article presents a critical literature review and meta-analysis of diagnostic performance of Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA), a rapid diagnostic antigen test (RDT-Ag) adapted for automatic reading with portable instruments, thus potentially combining the advantages of point-of-care testing with those of a laboratory-based immunoassay. Methods: We conducted an electronic search in PubMed and Scopus with the keywords "Quidel" OR "SOFIA" AND "Antigen" AND "SARS-CoV-2" OR "COVID-19" up to March 24, 2023, for identifying articles containing data on accuracy of Quidel Sofia SARS antigen FIA for diagnosing acute SARS-CoV-2 infections. We selected those where test accuracy was compared to that of a reference SARS-CoV-2 molecular assay, and with sufficient information for constructing a 2×2 table. Results: A total number of 18 articles (48165 samples; 9.8% positive at molecular testing) were included in this meta-analysis, averaging 24 sample cohorts. The diagnostic accuracy (summary area under the curve), sensitivity and specificity were 0.980, 0.76 and 1.00 in all samples, 0.981, 0.81 and 0.99 in samples collected from symptomatic patients, 0.931, 0.55 and 1.00 in those taken from asymptomatic patients, and 0.960, 0.77 and 0.99 in samples from mixed cohorts of patients, respectively. Minor and clinically negligible differences of accuracy could be found by comparing test results in nasal and nasopharyngeal swabs. Conclusion: Quidel Sofia SARS Ag FIA meets the minimum performance criteria of accuracy for SARS-CoV-2 antigenic testing, thus combining satisfactory diagnostic performance with the advantages of being potentially used as a portable device.

Topographic anatomy of the submental artery and its clinical implications for reconstructive surgery.

Knowledge about the anatomy of the submental artery (SA) is of immense importance when performing plastic and reconstructive procedures. A retrospective study was performed to analyze the topographic anatomy of the SA. The measurements were performed on 80 consecutive patients who underwent head and neck computed tomography angiography (CTA). The SA was present in 131 out of 137 hemifaces (95.6%). The vessel originated from the facial artery in all cases (100.0%). Moreover, the SA was found to have 0-4 branches. However, most commonly, the said artery had no branches of considerable size (51.1%). Due to the high variability of the course of the said artery, the authors of the present study created a novel classification system presenting the most prevalent courses of the SA in the submental region. The current study utilized 131 hemifaces of 80 (CTA) to create a heat map of the SA, illustrating its precise origin and course in the submental region. The findings of this study could assist surgeons in developing a mental map of the arterial anatomy of the submental region, potentially improving the efficiency of localizing the SA and reducing the risk of complications during plastic and reconstructive procedures.

Safety monitoring of drug-induced muscle injury and rhabdomyolysis: a biomarker-guided approach for clinical practice and drug trials.

Skeletal muscle tissue (SKM) may be damaged due to mechanical, metabolic, and exertional causes. However, drug-induced myopathy is among the most frequent causes of muscle disease. The clinical picture of drug-induced myopathies may be highly variable. It may present as asymptomatic or mild myalgias, with or without muscle weakness, which are likely underreported. However, it may also appear as chronic myopathy with severe weakness and, rarely, even as massive rhabdomyolysis with acute kidney injury (AKI). Unfortunately, the available biomarkers for SKM injury do not fully meet the needs for satisfactory detection of drug-induced damage, both in clinical and research settings, mainly due to their low sensitivity and specificity. Therefore, the present study proposes a strategy for drug safety monitoring using the available biomarkers of SKM injury. Moreover, we will discuss mechanisms of drug-induced SKM injury, traditional laboratory testing for SKM injury, and novel skeletal myocyte biomarkers under investigation. This can be incredibly useful in both clinical practice and for de-challenge/re-challenge investigational trials where the risk of drug-induced SKM injury is present.