Non-commutability of results of highly sensitive troponin I and T immunoassays

Introduction:

The measurement of cardiospecific troponins is pivotal in the diagnostic and prognostic approach of patients with suspected acute myocardial infarction (AMI). However, no information is available on the commutability of results between the novel highly-sensitive (HS) troponin T (TnT) and I (TnI) immunoassays.

Materials and methods:

The study population consisted in 47 consecutive patients presenting at the emergency department (ED) of the Academic Hospital of Parma with suspected AMI. TnI was measured with the novel prototype Beckman Coulter HS-AccuTnI immunoassay on Access 2, whereas TnT was measured with the Roche HS-TnT immunoassay on Cobas.

Results:

Eight out of the 47 patients (17%) were finally diagnosed as having an AMI. The overall correlation between TnT and TnI for total patient group was acceptable (r = 0.944; P < 0.01). Nevertheless, when the analysis of data was carried out in separate groups according to the final diagnosis of AMI, two different equation results were obtained, i.e., HS-TnT = HS-AccuTnI × 0.349 + 20 (r = 0.823; P < 0.01) in non-AMI patients, and HS-TnT = HS-AccuTnI × 0.134 + 67 (r = 0.972; P < 0.01) in those with AMI.

Conclusions:

This study suggests the existence of two biological relationships between TnI and TnT in plasma, depending on the source of release from the myocardium. Moreover, the non-commutability of data between HS-TnT and HS-AccuTnI jeopardizes the clinical decision making, makes it impossible to calculate the delta or reference change value using the two biomarkers and to finally establish a reliable kinetics of troponin release from the injured myocardium.     

In vitro diagnostic company recalls and medical laboratory practices: an Italian case

Introduction

In vitro human diagnostic (IVD) company recalls are a common practice aimed to either minimize a potential error or eliminate an existing failure. In this case report, we aim to provide a critical analysis of a recent IVD recall and to provide a practical framework about what to do when an IVD company recalls product(s) based on the International Organization for Standardization - ISO 15189:2012 standard.

Case report

In 2014, Abbott Laboratories® (Green Oaks, IL) published an urgent field safety notice regarding a product recall (Architect Intact parathyroid hormone (PTH) Assay List Number 8K25) with immediate action required. The IVD company explained the reasons for the recall as follows: i) Abbott has confirmed that a performance shift in the Architect Intact PTH assay has the potential to generate falsely elevated results on patient samples; ii) results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. This issue may also impact established Architect Intact PTH reference ranges; iii) the magnitude of shift averages approximately 13% to 45%; iv) Abbott Architect Intact PTH controls do not detect the shift; and v) all current reagent, calibrator, and control inventory are impacted. The recall could have resulted in ~40,000 inaccurate laboratory tests reported by 18 laboratories from Italy (Lombardy region).

Conclusion

IVD company recalls have a serious impact on the patient safety and require a thorough investigation and responsible approach to minimize the possible damage. Medical laboratories accredited according to the ISO 15189 standard have procedures in place to manage such situations and ensure that patient safety is maintained when such recalls are issued.Key words: clinical laboratory techniques, patient safety, laboratory variability, reference standards, quality control, parathyroid hormone     

ADHD expressive writing difficulties of ADHD children: when good declarative knowledge is not sufficient

A large body of evidence shows that many of the academic difficulties Attention Deficit Hyperactivity Disorder (ADHD) children have may be related to their problems in executive control. However, the particular case of expressive writing has not been deeply explored. The present study examines the typical school exercise of writing a letter. Participants were 33 third, fourth, and fifth graders referred by teachers for the presence of ADHD symptoms plus 33 controls. The task consisted of describing an aspect of their life in the form of a letter. Texts of ADHD children were poorer than those of the controls for structure, vocabulary, grammar, length, and accuracy. Furthermore, the difference persisted even when a guide was used to support the writing task. However, the two groups were not significantly different in a metacognitive test measuring knowledge on critical factors affecting expressive writing. Results show that ADHD children may encounter severe difficulties in expressive writing that are not due to differences in knowledge about how to write. Educational implications are discussed.     

Preanalytical management: serum vacuum tubes validation for routine clinical chemistry

Introduction

The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing.

Materials and methods:

Blood specimens from 100 volunteers in five diff erent serum vacuum tubes (Tube I: VACUETTE^®, Tube II: LABOR IMPORT^®, Tube III: S-Monovette^®, Tube IV: SST^® and Tube V: SST II^®) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas^® 6000 module. The significance of the diff erences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation.

Results and conclusions:

Basically, our validation will permit the laboratory or hospital managers to select the brand’s vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.     

Development of subjective recollection: understanding of and introspection on memory States

The development of subjective recollection was investigated in participants aged 6-18 years. In Experiment 1 (N = 90), age-related improvements were found in understanding of the subjective experience of recollection, although robust levels of understanding were observed even in the youngest group. In Experiment 2 (N = 100), age-related differences were found in subjective recollection during a memory task, suggesting development not only in the ability to reflect on memory states, but also in the informational basis of subjective recollection. Lower understanding of memory states was associated with increased propensity to claim recollection. These results indicate that subjective recollection develops considerably during childhood and suggest that the development of metamemory supports this capacity.     

Quality Impact on Diagnostic Blood Specimen Collection Using a New Device to Relieve Venipuncture Pain

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.     

The effective reduction of tourniquet application time after minor modification of the CLSI H03-A6 blood collection procedure

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 application 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.     

A rapid screening measure for the identification of visuospatial learning disability in schools

Verbal and nonverbal forms of developmental learning disabilities have been reported. Whereas there are several instruments for evaluating children for the presence of verbal learning disabilities at school, no screening tool is available to identify children who have nonverbal learning disabilities. This study aimed at devising and validating a short screening questionnaire that can be used by teachers in primary schools to identify those children who need to be referred for clinical services because they have a visuospatial learning disability (VSLD). An 18-item Shortened Visuospatial Questionnaire (SVS) was derived from an earlier, longer version. Its validation procedure was twofold and was achieved by (a) verifying that children who had been identified with the SVS questionnaire as having a VSLD actually showed visuospatial deficits on psychometric evaluation and by (b) rating with the SVS a clinically identified population of children with VSLD. The results of the validation procedure showed that the SVS is a quick, reliable, and valid instrument that may be helpful in identifying children with VSLD in primary school.     

e-university: a cross-case study in four Italian universities

This paper describes the aims, the methods, the stages and the results of the research project 'e-University. Information and communication technologies (ICTs) as a factor of change in Italian universities', undertaken between 2003 and 2006 by the Universities of Trento, Perugia and Sassari and the Catholic University of Milan.
The characteristics of the four institutions' subjects and objects of the investigation are analysed as case studies and then compared as a cross-case study in the light of the factors that we feel constitute the main areas of concern in the four institutions as to the implementation of ICTs in the teaching/learning process, ie, the characteristics of the governance strategic plan, the choices relating to technology and the choices related to pedagogy. The paper describes the collaborative effort characterising the community of researchers through the different stages of the research. It also analyses how the individual features of each university—relating to its history, the number of students, the range of faculties, the diffusion of e-learning, the driving factors for innovation, the institution's policies—have fostered a lively and fruitful discussion between different view points, thus engendering deeper reflections for each context.