Showing papers by "Gian Luca Salvagno published in 2013"
TL;DR: There is an urgent need to standardize the way manufacturers test and report their data on the lipemia interference by proposing that, instead of arbitrary limits, manufacturers use evidence based quality specifications for assessing the allowable biases.
48 citations
TL;DR: New insight is provided into biological aspects modulating the concordance between tissues and plasma methylation profiles, which may depend on levels of cfDNA, integrity index, as well as on different clinical–pathological features.
Abstract: Tumour-released DNA in blood represents a promising biomarker for cancer detection. Although epigenetic alterations such as aberrant promoter methylation represent an appealing perspective, the discordance existing between frequencies of alterations found in DNA extracted from tumour tissue and cell-free DNA (cfDNA) has challenged their practical clinical application. With the aim to explain this bias of agreement, we investigated whether protocadherin 10 (PCDH10) promoter methylation in tissue was associated with methylation pattern in matched cfDNA isolated from plasma of patients with colorectal cancer (CRC), and whether the strength of concordance may depend on levels of cfDNA, integrity index, as well as on different clinical–pathological features. A quantitative methylation-specific PCR was used to analyse a selected CpG site in the PCDH10 promoter of 67 tumour tissues, paired normal mucosae, and matched plasma samples. The cfDNA integrity index and cfDNA concentration were assessed using a real-time PCR assay. The PCDH10 promoter methylation was detected in 63 out of 67 (94.0%) surgically resected colorectal tumours and in 42 out of 67 (62.7%) plasma samples. The median methylation rate in tumour tissues and plasma samples was 43.5% (6.3–97.8%) and 5.9% (0–80.9%), respectively. There was a significant correlation between PCDH10 methylation in cfDNA and tumour tissue in patients with early CRC (P<0.0001). The ratio between plasma and tissue methylation rate increases with increasing cfDNA integrity index in early-stage cancers (P=0.0299) and with absolute cfDNA concentration in advanced cancers (P=0.0234). Our findings provide new insight into biological aspects modulating the concordance between tissues and plasma methylation profiles.
47 citations
TL;DR: Revision of national and supranational recommendations on blood collection by venipuncture should consider that the order of draw exerts a negligible effect on sample quality, and this aspect should no longer be considered a quality criterion when evaluating the performance of phlebotomists.
Abstract: Background: The potential for cross-contamination of additives among evacuated blood tubes has led to the development of the order of draw. This practice, however, is mainly based on scarce, anecdotal, and mostly outdated literature data. Therefore, the goal of this investigation was to definitely establish whether or not the indication of a specific order of draw is still justified. Methods: The study population consisted of 57 outpatients referred to the outpatient oral anticoagulant (OA) clinic of the Academic Hospital of Verona and 58 healthy volunteers enrolled from the laboratory personnel. In OA outpatients, one serum tube was collected immediately after needle insertion, followed by a buffered sodium citrate tube and another serum tube. In the healthy volunteers, one serum tube was collected immediately after needle insertion, followed by a potassium-ethylenediaminetetraacetic acid (K 2 -EDTA) tube and another serum tube. After separation, the serum was tested for potassium, sodium, calcium, magnesium, and phosphorus in the first and second serum tubes. Results: No significant difference could be observed between the first and the second serum tubes for any of the parameters. The bias calculated with Bland-Altman plots did not achieve statistical significance when the serum tube was collected after either a K 2 -EDTA or a sodium citrate tube. Conclusions: According to our data, revision of national and supranational recommendations on blood collection by venipuncture should consider that the order of draw exerts a negligible effect on sample quality, and this aspect should no longer be considered a quality criterion when evaluating the performance of phlebotomists.
44 citations
TL;DR: The proposed new procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety.
Abstract: Introduction: The phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time. Materials and methods: Thirty phlebotomists were invited to participate. Each phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet appli cation time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training. Results: The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (-88 s, P < 0.001). Conclusions: The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety.
41 citations
TL;DR: The good quality achieved by the analytical method for GA assessment and the reduced within-subject biological variation would allow to recommend this test in clinical practice for evaluation of glycemic control along with measurement of glycated hemoglobin.
36 citations
TL;DR: The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure, and to avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum tubes before EDTA vacuum tubes.
Abstract: Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The tubes drawing order were as follows: i) clot activator and gel separator (serum vacuum tube), ii) K,EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the vacuum tube holder system. The laboratory testing results from serum vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all vacuum tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum tubes before EDTA vacuum tubes.
34 citations
TL;DR: It is suggested that every laboratory management should both standardize the procedures and frequently evaluate the quality of in-vitro diagnostic devices.
Abstract: Sometimes in-vitro diagnostic devices (e.g. blood collection tubes) are not validated before use or when the producer's brand is changed. The aim of this study was to validate five brands of sodium citrate vacuum tubes. Blood specimens from 50 volunteers were collected in five different tube brands (I: Venosafe, II: VACUETTE, III: BD Vacutainer, IV: LABOR IMPORT and V: S-Monovette). Routine coagulation tests [activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen (FIB)] were performed on ACL TOP instrument using HemosIL reagents. The significance of the differences between samples was assessed by paired Student's t-test, set at P < 0.005. Significant differences were observed for: PT when comparing I vs. II, I vs. III, I vs. V, II vs. III, II vs. IV, II vs. V, III vs. IV, III vs. V and IV vs. V; aPTT when comparing I vs. II, I vs. III, I vs. IV, II vs. IV, III vs. IV and IV vs. V. No differences were observed among brands for FIB determination. We suggest that every laboratory management should both standardize the procedures and frequently evaluate the quality of in-vitro diagnostic devices.
34 citations
TL;DR: A paradigm suggesting that the incorrect primary blood tubes mixing promotes laboratory variability is dropped, suggesting that similar evaluation should be done using other brands of vacuum tubes by each laboratory manager.
34 citations
TL;DR: The results of this prospective, randomized study attest that failure to wipe alcohol at the site of venipuncture should not be considered as a potential source of spurious hemolysis when drawing blood.
Abstract: Background: It is still uncertain whether or not avoidance to let disinfectant alcohol dry at the site of venipuncture is a source of spurious hemolysis when drawing venous blood. Methods: In a consecutive series of 52 outpatients referred for routine laboratory testing, venous blood was drawn by direct venipuncture with (odd group) or without (pair group) wiping 70% isopropyl alcohol at the site of venipuncture. A 3.5 mL evacuated tube with clot activator and gel separator was drawn from a vein of the upper limb, serum was immediately separated with standard centrifugation and tested for potassium, lactate dehydrogenase (LD), aspartate aminotransferase (AST) and hemolysis index (HI) on Roche Cobas. Results: No specimen was discarded for unsatisfactory venipuncture. No diff erences for age and gender were observed between groups. As r egards the four parameters investigated, no signifi cant diff erences co uld be observed between patients in whom blood was drawn with or without letting the alcohol dry. It is also noteworthy that no sample in both groups exceeded the conventional sample rejection threshold of cell-free hemoglobin. Conclusions: The results of our prospective, randomized study attest that failure to wipe alcohol at the site of venipuncture should not be considered as a potential source of spurious hemolysis when drawing blood.
23 citations
TL;DR: The results of this study confirm that systematical measurement of serum indices does not impair instrument efficiency and suggests that major harmonization may be advisable for this measure among different manufacturers and instrumentations.
20 citations
TL;DR: MRI demonstrated the presence of HA in lip tissue even after 6 months and the absence of linear correlation between HYAL and HA revealed that the result clinically is probably dependent on systemic factors which can determine HYAL activity and therefore HA longevity.
Abstract: Background: No human model has emerged as an accepted standard to evaluate tissue filler longevity. Objectives: To validate a human model adequate to compare soft tissue filler degradation and tissue reaction. Materials and methods: We evaluated in 18 patients the persistence of hyaluronic acid (HA) filler injected into labial tissue analyzing hyaluronidase (HYAL) activity by means of in vitro and in vivo tests, MRI and histological and ultra-structural examination at 3 and 6 months postop. Results: MRI examination revealed the presence of HA filler in a clear hyperintense area. Histology demonstrated fibroblast activation. The amount and the degradation rate of HYAL and HA did not show a linear correlation. Conclusion: MRI demonstrated the presence of HA in lip tissue even after 6 months. Biopsies at 3 months revealed tissue maturation and at 6 months confirmed the ability of HA to reorganize and integrate the extracellular matrix. The absence of linear correlation between HYAL and HA revealed that the result clinically is probably dependent on systemic factors which can determine HYAL activity and therefore HA longevity.
TL;DR: The use of dipotassium EDTA vacuum tubes from different manufacturers represent a clinically relevant source of variation for HCT, MCV and PDW and are compared with current quality specifications.
Abstract: This study assesses the use of different dry K2 (dipotassium) EDTA vacuum tubes and whether or not they might represent a bias in haematological testing. Blood was collected in three dipotassium ED...
TL;DR: It is reported that patients treated with low gonadotoxic therapies, while being similar to age-matched controls in their ovarian reserve when evaluated within a few years from the end of the therapy, show a clear impairment over longer times.
Abstract: The impact of cancer therapy on the reproductive potential of patients is increasingly recognized because survival rates of patients have clearly improved in recent years. Different fertility preservation methods, either generally accepted or still experimental, are currently available, and counseling of patients requires a delicate balance between the efficacy and side effects of the proposed method and the characteristics of both the tumor and the therapy. Deeper knowledge of the effects of cancer therapy on the reproductive potential of patients over time is required to identify the most appropriate fertility preservation method. In this paper, we report a case-control study in which female patients who were diagnosed with hematological malignancies and treated with chemotherapy and/or radiotherapy were compared with age-matched controls in terms of ovarian reserve, as measured by ultrasound examination and hormonal status. By stratifying patients for gonadotoxicity of the therapy received and time elapsed from the end of the therapy, we report that patients treated with low gonadotoxic therapies, while being similar to age-matched controls in their ovarian reserve when evaluated within a few years from the end of the therapy, show a clear impairment over longer times. We also report that anti-Mullerian hormone is the most sensitive hormonal parameter in detecting changes in ovarian reserve when compared with follicle-stimulating hormone or inhibin-B. This study stresses the importance of accurate counseling at the time of diagnosis of cancer and emphasizes the risks of infertility with low gonadotoxic therapies that may reduce the reproductive window of survivors.
TL;DR: The results show that the MPA system improves the quality of laboratory testing as shown in the before and after storage results.
Abstract: Our aim was to evaluate whether automation for the preanalytical phase improves data quality. Blood from 100 volunteers was collected into two vacuum tubes. One sample from each volunteer was respectively assigned to (G1) traditional processing, starting with centrifugation at 1200 g for 10 min, and (G2) the MODULAR PRE-ANALYTICALS EVO-MPA system. The routine clinical chemistry tests were performed in duplicate on the same instrument Cobas 6000 module. G1 samples were uncapped manually and immediately placed into the instrument. G2 samples were directly fed from the MPA system to the instrument without further staff intervention. At the end, (1) the G1 samples were stored for 6 h at 4 °C as prescribed in our accredited laboratory and (2) the G2 samples were stored for 6 h in the MPA output buffer. Results from G1 and G2, before and after storage, were compared. Significant increases were observed in G1 compared with G2 samples as follows: (1) before storage for alkaline phosphatase (ALP), lactate dehydrogenase (LDH), phosphate (P), magnesium (MG), iron (FE), and hemolysis index and (2) after storage for total cholesterol (COL), triglycerides (TG), total protein (TP), albumin (ALB), blood urea nitrogen (BUN), creatinine (CRE), uric acid (UA), ALP, pancreatic amylase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyltransferase (GGT), LDH, creatine kinase (CK), calcium (CA), FE, sodium (NA), potassium (K), and hemolysis index. Moreover, significant increases were observed in (3) G1-after versus G1-before storage samples for COL, high-density lipoprotein cholesterol, TG, TP, ALB, BUN, CRE, UA, AST, ALT, GGT, LDH, P, CA, MG, FE, NA, K, and hemolysis index and (4) G2-after versus G2-before storage only for BUN, AST, LDH, P, and CA. In conclusion, our results show that the MPA system improves the quality of laboratory testing.
TL;DR: Urinary prostasin correlates with the aldosterone to renin ratio (ARR), and it is physiologically modulated by natriuresis in normotensive individuals.
Abstract: Prostasin, a glycosylphosphatidylinositol (GPI)-anchored serine protease, activates the epithelial sodium (Na) channel (ENaC), and prostasin is released in extracellular fluids, including urine. Previous data have suggested a direct association between urinary prostasin and the activation of an aldosterone-driven pathway, but a quantitative association has never been demonstrated in normotensive subjects. Similarly, physiological relationships with natriuresis or possible gender- or female hormone-related changes in urinary prostasin concentrations have never been investigated. We measured urinary prostasin by enzyme-linked immunosorbent assay in 43 healthy normotensive subjects of similar age presenting different urinary Na levels and in 15 women during the menstrual cycle and after oral estro-progestinic contraceptive (OC) therapy. Exosomal urinary prostasin was also estimated by western blotting of samples from six healthy subjects twice during the morning. Urinary prostasin presented a wide range of values (from 0.5 to 18.9 nM) without gender differences. It was positively correlated with the aldosterone to renin ratio (ARR) but not with circulating aldosterone or renin individually. Urinary prostasin was directly correlated with U-Na levels (up to 200 nmol Na), whereas it decreased for higher Na concentrations. In women, no significant changes of prostasin concentration were observed during menstrual phases. After OC therapy, prostasin increased (from 2.37±1.27 to 4.85±5.28 nM), although the increase was not statistically different (P=0.07). Prostasin was detectable in urinary exosomes and displayed a pattern similar to urinary prostasin in relation to urinary Na. In conclusion, urinary prostasin correlates with the ARR, and it is physiologically modulated by natriuresis in normotensive individuals.
TL;DR: The Buzzy® can be used during diagnostic blood specimens collection by venipuncture for the majority of the routine immunochemistry tests, but should be avoided during blood collection when protein, albumin and transferrin determinations should be performed.
Abstract: A new device called Buzzy® has been recently presented that combines a cooling ice pack and a vibrating motor in order to relieve the venipuncture pain. The aim of this study was to evaluate the impact of Buzzy® use during diagnostic blood specimen collection by venipuncture for routine immunochemistry tests. Blood was collected from 100 volunteers by a single, expert phlebotomist. A vein was located on the left forearm without applying tourniquet, in order to prevent any interference from venous stasis, and blood samples were collected using a 20-G straight needle directly into 5 mL vacuum tubes with clot activator and gel separator. In sequence, external cold and vibration by Buzzy® was applied on the right forearm—5 cm above the chosen puncture site—for 1 min before venipuncture and continued until the end of the same procedure already done in the left forearm. The panel of tests included the following: glucose, total cholesterol, HDL-cholesterol, triglycerides, total protein, albumin, c-reactive protein, urea, creatinine, uric acid, alkaline phosphatase, amylase, AST, ALT, g-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, phosphorus, calcium, magnesium, iron, sodium, potassium, chloride, lipase, cortisol, insulin, thyroid-stimulating hormone, total triiodothyronine, free triiodothyronine, total thyroxine, free thyroxine and haemolysis index. Clinically significant differences between samples were found only for: total protein, albumin and transferrin. The Buzzy® can be used during diagnostic blood specimens collection by venipuncture for the majority of the routine immunochemistry tests. We only suggest avoiding this device during blood collection when protein, albumin and transferrin determinations should be performed.
TL;DR: The results do not support arbitrary interchange among brands of plasma vacuum tubes, and laboratory managers are suggested to standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.
Abstract: The validation process is essential in accredited laboratory medicine, but is rarely regarded as an issue in the preanalytical management The aim of this study was to validate five kinds of lithium heparin vacuum tubes for routine clinical chemistry laboratory testing Blood specimens from 100 volunteers in five different plasma vacuum tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: PST® and Tube V: PST II®) were collected by a single expert phlebotomist The routine clinical chemistry tests were performed on a Cobas® 6000 module The significance of the differences between samples was statistically assessed at p < 0005 The biases from the different tubes were compared with the current desirable quality specifications Basically, significant differences could be confirmed by RM ANOVA for the results of the clinical chemistry tests on the following components: glucose, urea, creatinine, alkaline phosphatase, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, phosphate, Ca, Mg, Fe and K Clinically significant variations as compared with the current desirable quality specifications were found for glucose, creatinine, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, Ca, Mg and K In conclusion, our results do not support arbitrary interchange among brands of plasma vacuum tubes Future investigations are needed to understand the reasons of these observations; in the meantime, we suggest that laboratory managers standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices
TL;DR: The aim of this study was to investigate the potential associations between HPA axis dysregulation and SDS in individuals with Alzheimer’s disease and to evaluate the relationship between cortisol levels and changes in neuropsychiatric symptoms.
Abstract: To the Editor: Sundowning syndrome (SDS) in individuals with Alzheimer’s disease (AD) is a clinical phenomenon characterized by the intensification of neuropsychiatric symptoms in the late afternoon. This behavioral disorder is common in subjects with advanced dementia, with an incidence of 25%. Despite extensive clinical literature on the features of SDS, the etiology of this neuropsychiatric manifestation remains unknown. Limited exposure to sunlight, disordered circadian rhythm, low levels of melatonin, sleep disturbances, and the side effects of various medications have been proposed as potential triggers of SDS, although there is strong evidence that AD is associated with irregular glucocorticoid secretion, primarily caused by dysregulation of the hypothalamic–pituitary–adrenal axis (HPA axis) and consequently likely to contribute to the behavioral disorders that individuals with AD exhibit. It is not clear whether the high prevalence of HPA-axis dysfunction in individuals with AD is associated with SDS, so the aim of this study was to investigate the potential associations between HPA axis dysregulation and SDS in individuals with Alzheimer’s disease. Fifty-one individuals with a clinically confirmed diagnosis of severe AD were selected from among nursing home residents of the Mons Mazzali Geriatric Institute, Mantua, Italy. An additional 24 aged-matched individuals with no symptoms of dementia or depression were selected as controls. Individuals with AD and controls were assessed on separate days. On Day 1, the Mini-Mental State Examination (MMSE) was administered, a health history was taken, a physical examination was performed, blood pressure was measured, and a blood sample was taken. To evaluate changes in neuropsychiatric symptoms throughout the day, on Days 2 and 3, a battery of neuropsychological tests was performed in the morning at 7:00 a.m. and at sunset. An increase in neuropsychiatric symptoms of more than 15% between morning and sunset was regarded as an indicator of SDS. The neuropsychological evaluation battery consisted of the Neuropsychiatric Inventory (NPI), to measure the person’s behavior, and the Geriatric Depression Scale (GDS), to evaluate depression symptoms. Saliva samples were collected on Days 4 and 5 using collection devices (Sarstedt Salivette, N€ umbrecht, Germany). Samples were collected at 7:00 a.m., 11:00 a.m., 3:00 p.m., 8:00 p.m., midnight, and sunset. Samples were centrifuged for 2 minutes at 1,000 revolutions per minute, and purified saliva was stored at 20°C until it was analyzed in blind way using a cortisol assay on an immunoanalyzer system (ROCHE COBAS 6000; Roche Diagnostics, Mannheim, Germany). The relationship between cortisol levels and changes in neuropsychiatric
TL;DR: Quality and safety in diagnostic testing is, however, essential to furthering the goal of high-quality, beneficial healthcare outcomes and patient safety and it is time to standardize the fasting time for all diagnostic blood specimen collections.
Abstract: Diagnostic methods in medical sciences (i.e. laboratory hematology testing) is an essential part of the decision-making process, wherein results of laboratory testing often influence diagnosis and treatment of a variety of hematology disorders [1]. We have read with interest the article by Klop et al. where the authors address important aspects of preanalytical variability as regards the postprandial period [2]. Preanalytical variability, including biological variability and patient preparation (i.e. adequate fasting time before blood collection) is still an important source of variability in laboratory testing [3, 4]. Therefore, the preanalytical phase actually represents the most critical area to target for achieving major improvements in the total quality of laboratory diagnostics. Quality and safety in diagnostic testing is, however, essential to furthering the goal of high-quality, beneficial healthcare outcomes and patient safety. Klop et al. had shown that transitory changes in leukocyte cell population in the 4 to 8 hours postprandial period – due to oral fat loading test are similar to alterations detected during various infections [2]. Thus, caring physicians unaware of the real patient situation might abstain from appropriate treatments as a consequence of such variations in the postprandial period. In a previous study Lippi et al. evaluated the influence of a regular, light meal on hematological tests at one, two and four hours after a standardized food intake. The different leukocyte populations showed the following after-meal variations: i) at one hour, significant increases in neutrophils (7.4%, P=0.009), whereas lymphocytes and monocytes, were significantly decreased (-17.4%, P<0.0001 and -6.9%, P=0.014 respectively); ii) at two hours, the neutrophil count remained significantly increased (7.6%, P=0.043), whereas lymphocyte and eosinophil counts were significantly decreased (-18.7%, P<0.0001 and -15.4%, P=0.001 respectively); and iii) at four hours, eosinophils were significantly decreased (-23.2%, P=0.003) [5]. As regards lymphocytes Klop et al. had shown a significant increase four and eight hour after meals (10%, P<0.05 and 25%, P<0.001 respectively) [2]. In order to compare Lippi et al. vs. Klop et al. results we calculated the mean % differences (Table 1). Looking at the results: i) Klop et al. could have missed an initial decrease in lymphocyte counts during the first hours of the oral fat loading test; ii) the comparison between studies is challenging since different meal compositions were used (light meal versus a fat load) [2]. We hence wonder whether Klop et al. actually observed a significantly increase (3.4× higher than that specified by desirable bias based on biological variation, see Table 1) eight hour after fat load, or this was rather due to preanalytical variability? Unfortunately this question remains unanswered because essential details about specimen handling are missing (i.e., staff that performed blood collection, time of tourniquet application, mixing tubes, etc). Previous study had shown that the venous stasis per se can increase lymphocytes from 0.8 to 2.8% [6]. We believe that the 25% lymphocyte variation shown by Klop et al. really represents an important information about postprandial-induced variability but a better description as suggested by Rifai et al. [7] could add reliability to this important study. Presently in daily practice the laboratory staff and/or phlebotomists only ask patients about fasting time for glucose and/or lipid profile (triglycerides and cholesterol fractions). In our opinion it is time to standardize the fasting time for all diagnostic blood specimen collections. In the hospital setting the most important question should be “What time was your last food intake?” at patient admission. With this information the laboratories could provide a personalized blood collection during hospitalization period, thus minimizing the variability due to the postprandial period, able to influence both diagnosis and follow-up.
14 Nov 2013
TL;DR: In this paper, a sintetica checklist for prelievo venoso is presented, which is a strumento modulabile e potenzialmente adattabile ai differenti contesti locali, diffondibile in maniera facile e graduale, supportata da evidenze scientifiche e dal consenso di esperti, redatta con il contributo di professionisti di diversi contesta sanitari, aderente alle best practice e richiede risorse minime per
Abstract: Il prelievo venoso rappresenta una procedura inevitabile per ottenere campioni biologici per l’esecuzione dei test di laboratorio. Malgrado la pratica della flebotomia sia sovente considerata semplice e scevra da complicazioni e complicanze, essa causa la maggior parte degli errori di laboratorio, determinando inaccuratezza dei risultati se eseguita con imperizia, negligenza e scarsa professionalita. Si e quindi ritenuto opportuno provvedere alla redazione di un documento nella forma semplificata di checklist, composta da un semplice ma esaustivo elenco di attivita da svolgere o da verificare da parte del prelevatore, al fine di prevenire i principali errori di prelievo. Nell’intento dei redattori e delle Societa italiane di Medicina di Laboratorio, questa sintetica checklist rappresenta uno strumento modulabile e potenzialmente adattabile ai differenti contesti locali, diffondibile in maniera facile e graduale, supportata da evidenze scientifiche e dal consenso di esperti, redatta con il contributo di professionisti di diversi contesti sanitari, aderente alle best practice e che richiede risorse minime per essere implementata. E ragionevole supporre che questo strumento sia in grado di sostenere sia i cambiamenti di sistema sia i cambiamenti dei comportamenti individuali, rafforzando gli standard per la sicurezza di operatori e pazienti, contrastando i possibili fattori di fallimento. Auspichiamo, inoltre, che la checklist possa essere adottata dalle strutture sanitarie in cui si renda necessaria la raccolta di campioni di sangue venoso, adattandola alle caratteristiche dell’organizzazione locale.