scholarly journals Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Blood Collection ◽  
Test Results ◽  
Sample Collection ◽  
Rapid Separation ◽  
Cell Counts ◽  
Collection Device ◽  
Precision Study ◽  
Clinically Significant ◽  
Blood Specimens

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.

Comparison of some biochemical tests in different blood collection tubes in hemodialysis patients

2019 ◽  
Vol 45 (1) ◽  
pp. 26-36 ◽  
Author(s):  
Arzu Kösem ◽  
Canan Topçuoğlu ◽  
Sevilay Sezer ◽  
Şimal Köksal Cevher ◽  
Ezgi Coşkun Yenigün ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Statistical Significance ◽  
Blood Collection ◽  
Test Results ◽  
Biochemical Tests ◽  
Becton Dickinson ◽  
Two Samples ◽  
Clinically Significant ◽  
Roche Diagnostics ◽  
Blood Collection Tubes

Abstract Objective Blood collection tubes (BCTs) related interferences in test results can adversely influence on patient outcomes. We compared test results of samples in BD (Becton-Dickinson, Franklin Lakes, NJ, USA) Vacutainer Serum Separator Tubes (SST), BD Vacutainer® Barricor™ Plasma BCTs (Barricor™) and BD Vacutainer® Rapid Serum Tube (RST). Materials and methods Thirty-two samples were obtained from patients after the hemodialysis were included in this study. Eight routine clinical chemistry parameters (AST, creatinin, urea, PTH, glucose, LDH, K, calcium) were measured on Roche Cobas Analyzer (Roche Diagnostics, North America). The results of samples obtained from RST and Barricor™ were compared with SST as reference tubes. Results Results of Glucose, K, Urea, PTH from the SST and Barricor™ were statistically significantly different (p = 0.017, p < 0.001, p = 0.011, p < 0.001, respectively). In addition, results of PTH, LDH from SST and RST were significantly different (p < 0.001, p = 0.019). However, statistical significance of test results was not clinically significant for the biochemical parameters. Conclusion Working with Barricor™ may provide not just a fast, clean, high-quality plasma samples, safety results, but also time and cost-effectivity. Therefore, these types of tubes, which are less costly than other BCTs, may be preferred to obtain plasma.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Michael Cornes ◽  
Edmée van Dongen-Lases ◽  
Kjell Grankvist ◽  
Mercedes Ibarz ◽  
Gunn Kristensen ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Blood Draw ◽  
Preanalytical Phase ◽  
Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

scholarly journals Pre-analytical errors in clinical chemistry laboratory of a tertiary care hospital

2019 ◽  
Vol 7 (10) ◽  
pp. 3815
Author(s):  
Priyanka Prasad ◽  
Rakesh Kumar ◽  
Rekha Kumari
Keyword(s):  
Clinical Chemistry ◽  
Total Error ◽  
Tertiary Care ◽  
Chemistry Laboratory ◽  
Blood Collection ◽  
Laboratory Diagnostics ◽  
Care Hospital ◽  
Sample Collection ◽  
Repeated Testing ◽  
Analytical Errors

Background: Pre-analytical errors account for up to 70% of all mistakes made in laboratory diagnostics, most of which arise from problems in patient preparation, sample collection, transportation, and preparation for analysis and storage. Pre-analytical errors influence the total error thus hindering TQM in laboratory, consequently decreasing the accuracy and reliability of the results generated. This study was conducted with the aim to determine nature and frequency of the occurrence of pre-analytical errors.Methods: This prospective analytical study was designed to evaluate the pre-analytical errors observed in a total of 13,892 out-patient and inpatient samples. Samples received for routine clinical chemistry analysis were screened for pre-analytical errors. Samples received for other investigations were excluded. We recorded all nonconformities and errors occurring over a 3-month period and corrective measures were suggested to minimise them. Laboratory personnel were asked to register rejections, and pre-analytical causes for rejection of ward as well as out-patient samples collected in the laboratory. Types of inappropriateness were evaluated as follows: hemolyzed, blood collection in wrong tubes, clotted blood, inappropriate timing of collection, improperly labelled samples, insufficient volume of specimen and lipemic samples.Results: A total of 13,892 samples from the outpatient department and in-house patients were received by our clinical biochemistry laboratory during the period from April 2019 to June 2019. Out of these 404 samples were found unsuitable for further processing. This accounted for 2.9% of all samples collected in the laboratory and pre-analytical errors were responsible for these samples to be rejected over a period of 3 months. Rejections arose as a result of the following reasons: 0.92% were rejected due to hemolysis; 0.58% were blood collected in wrong tubes; 0.55% were clotted blood; 0.26% had inappropriate timing of collection; 0.24% were mislabeled samples; 0.20% had insufficient sample quantity and 0.14% were lipemic samples.Conclusions: Of all the samples received in the lab, the overall percentage of rejection is 2.9%. Substantial number of samples undergo repeated testing because of rejection owing to pre-analytical errors. The efforts should be aimed to reduce the rates of rejected samples can provide to improve the quality of laboratory based health care processes.

scholarly journals The Use of Saliva as a Diagnostic Specimen for SARS CoV-2 Molecular Diagnostic Testing for Pediatric Patients

2020 ◽  
Author(s):  
Meghan Delaney ◽  
Joelle Simpson ◽  
Bobbe Thomas ◽  
Christal Ralph ◽  
Michael Evangalista ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Molecular Diagnostic ◽  
Test Results ◽  
Sample Collection ◽  
Specimen Collection ◽  
Collection Device ◽  
Viral Transport Medium ◽  
Study Population ◽  
Saliva Collection ◽  
Pcr Assays

ABSTRACTBackgroundChildren are an important population to test for COVID-19 infection, particularly because they may shed the virus without displaying symptoms. Testing children for COVID-19 via sensitive molecular methods is important, although collecting nasopharyngeal (NP) specimens can be challenging. A less invasive mode of specimen collection that yields test results comparable to those from NP specimens would be beneficial to simplify sample collection.MethodsTo demonstrate that saliva is a suitable specimen for collection from children, the clinical usability/acceptability and the analytic performance of saliva were compared to NP specimens suspended in viral transport medium. Four different FDA EUA-approved real-time RT-PCR assays and one EUA approved saliva collection device were investigated.ResultsThe study population included 526 patients between the ages of 3 and 61 years, 461 (88%) were <18 years, 425 were asymptomatic (81.1%), 92 were symptomatic (17.6%). Saliva mixed with saliva stabilizing buffer was found to yield comparable sensitivity to NP specimens when tested on the AllPlex SARS-CoV-2 molecular test (Seegene Inc). The analytic sensitivity of the AllPlex assay during testing of spiked saliva mixed with SpectrumDNA saliva stabilizer was found to be 250 genomic copies/mL.ConclusionsOf the four FDA EUA-approved SARS-CoV-2 PCR assays studied, we found the AllPlex assay to be best suited for testing saliva specimens collected from children 5 years of age or older. The sensitivity of viral detection was equivalent to NP specimens when saliva specimens were mixed with the saliva stabilizer.

Heparin and citrate additive carryover during blood collection

2019 ◽  
Vol 57 (12) ◽  
pp. 1888-1896 ◽  
Author(s):  
Martin H. Keppel ◽  
Simon Auer ◽  
Giuseppe Lippi ◽  
Alexander von Meyer ◽  
Michael Cornes ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Relative Volume ◽  
Ionized Calcium ◽  
Blood Collection ◽  
Thrombin Time ◽  
Blood Samples ◽  
Published Evidence ◽  
Coagulation Testing ◽  
Coagulation Tests ◽  
Clinically Significant

Abstract Background Published evidence on the risk of additive carryover during phlebotomy remains elusive. We aimed to assess potential carryover of citrated and heparinized blood and the relative volume needed to bias clinical chemistry and coagulation tests. Methods We simulated standardized phlebotomies to quantify the risk of carryover of citrate and heparin additives in distilled water, using sodium and lithium as surrogates. We also investigated the effects of contamination of heparinized blood samples with increasing volumes of citrated blood and pure citrate on measurements of sodium, potassium, chloride, magnesium, total and ionized calcium and phosphate. Likewise, we studied the effects of contamination of citrated blood samples with increasing volumes of heparinized blood on heparin (anti-Xa) activity, lithium, activated partial thromboplastin time (APTT), prothrombin time (PT) and thrombin time (TT). We interpreted these results based on measurement deviations beyond analytical, biological and clinical significance. Results Standardized phlebotomy simulations revealed no significant differences in concentration of surrogate markers. Clinically significant alterations were observed after contamination of heparinized blood samples with volumes of citrated blood beyond 5–50 μL for ionized calcium and beyond 100–1000 μL for sodium, chloride and total calcium. Investigations of pure citrate carryover revealed similar results at somewhat lower volumes. Heparinized blood carryover showed clinically significant interference of coagulation testing at volumes beyond 5–100 μL. Conclusions Our results suggest that during a standardized phlebotomy, heparin or citrate contamination is highly unlikely. However, smaller volumes are sufficient to severely alter test results when deviating from phlebotomy guidelines.

Exact time of venous blood sample collection – an unresolved issue, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

2020 ◽  
Vol 58 (10) ◽  
pp. 1655-1662
Author(s):  
Alexander von Meyer ◽  
Giuseppe Lippi ◽  
Ana-Maria Simundic ◽  
Janne Cadamuro
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
Sampling Time ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Pilot Survey ◽  
Preanalytical Phase

AbstractObjectivesAn accurate knowledge of blood collection times is crucial for verifying the stability of laboratory analytes. We therefore aimed to (i) assess if and how this information is collected throughout Europe and (ii) provide a list of potentially available solutions.MethodsA survey was issued by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Preanalytical Phase (WG-PRE) in 2017, aiming to collect data on preanalytical process management, including sampling time documentation, in European laboratories. A preceding pilot survey was disseminated in Austria in 2016. Additionally, preanalytical experts were surveyed on their local setting on this topic. Finally, the current scientific literature was reviewed on established possibilities of sampling time collection.ResultsA total number of 85 responses was collected from the pilot survey, whilst 1347 responses from 37 European countries were obtained from the final survey. A minority (i.e. ~13%) of responders to the latter declared they are unaware of the exact sampling time. The corresponding rate in Austria was ~70% in the pilot and ~30% in the final survey, respectively. Answers from 17 preanalytical experts from 16 countries revealed that sampling time collection seems to be better documented for out- than for in-patients. Eight different solutions for sample time documentation are presented.ConclusionsThe sample collection time seems to be documented very heterogeneously across Europe, or not at all. Here we provide some solutions to this issue and believe that laboratories should urgently aim to implement one of these.

Factors Affecting the Interpretation of Canine and Nonhuman Primate Clinical Pathology

2003 ◽  
Vol 31 (1_suppl) ◽  
pp. 6-10 ◽  
Author(s):  
Robert L. Hall ◽  
Nancy E. Everds
Keyword(s):  
Study Design ◽  
Nonhuman Primate ◽  
Clinical Chemistry ◽  
Clinical Pathology ◽  
Data Interpretation ◽  
Pharmacokinetic Analysis ◽  
Test Results ◽  
Sample Collection ◽  
Test Species ◽  
Design Variables

Interpreting canine and nonhuman primate clinical pathology data from preclinical studies can be challenging. Relatively few animals are tested (typically beagles and macaques), and they often undergo study-related procedures (eg, sample collection for pharmacokinetic analysis) that can affect clinical pathology test results. Data interpretation requires an understanding of the significance of each test, species differences for each test, normal interanimal and intraanimal variability, the effects of study design variables, and supporting data from other disciplines. Interpretation of hematology, coagulation, clinical chemistry, and urinalysis parameters are discussed, with emphasis on species peculiarities and study design variables that may affect clinical pathology test results.

scholarly journals Effect of Blood Collection Tubes on Total Triiodothyronine and Other Laboratory Assays

2005 ◽  
Vol 51 (2) ◽  
pp. 424-433 ◽  
Author(s):  
Raffick AR Bowen ◽  
Yung Chan ◽  
Joshua Cohen ◽  
Nadja N Rehak ◽  
Glen L Hortin ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Reference Interval ◽  
Blood Collection ◽  
Serum Samples ◽  
Becton Dickinson ◽  
Total Triiodothyronine ◽  
Patient Values ◽  
Clinically Significant ◽  
Age Range ◽  
Blood Collection Tubes

Abstract Background: Increased total triiodothyronine (TT3) assay results in apparently euthyroid patients triggered an investigation of the effect of blood collection tubes on serum TT3 and other laboratory assays. Methods: We examined potential assay interference for three types of tubes: plastic Greiner Bio-One™ Vacuette™; glass Becton Dickinson (BD) Vacutainer™; and plastic BD Vacutainer SST™ tubes. Serum samples from apparently healthy volunteers (age range, 30–60 years; 15 males and 34 females) were collected in different tube types and analyzed in 17 immunoassays (n = 49), 30 clinical chemistry tests (n = 20), and 33 immunology assays (n = 15). Tube effects were also examined by adding pooled serum to different tube types. Results: TT3 values, when measured by the IMMULITE™ 2000 but not the AxSYM™ analyzer, were significantly higher (P &lt;0.0001) for SST (2.81 nmol/L) than either glass (2.15 nmol/L) or Vacuette (2.24 nmol/L) tubes. The effect was large enough to substantially shift the distribution of patient values, increasing the percentage of values above the reference interval from 11.3% to 35.8%. The degree of interference from SST tubes on TT3 differed among various tube lots and could be attributed to a tube additive shared by other plastic tubes. Results from several other tests statistically differed among tube types, but differences were not considered to be clinically significant. Conclusions: Assay interferences from blood collection tubes represent challenges to clinical laboratories because they are not detected by the usual quality-control or proficiency testing programs. Laboratories can, however, address this problem by monitoring distribution of patients’ results.

scholarly journals SneakPeek snap: a painless microneedle-based pushbutton device for early fetal sex determination

2021 ◽  
Vol 7 (3) ◽  
pp. 74-78
Author(s):  
Nina Hoang ◽  
Haley Milot ◽  
Christopher Jacob
Keyword(s):  
Sex Determination ◽  
Ease Of Use ◽  
Blood Collection ◽  
Dramatic Reduction ◽  
Sample Collection ◽  
Fetal Sex ◽  
Blood Samples ◽  
Collection Device ◽  
Perceived Pain ◽  
Collection Time

The advancement of prenatal DNA technology and growing demand for early fetal sex determination have created a need for a simple and easy-to-use blood collection device that eliminates the pain and difficulty individuals encounter when utilizing traditional methods of blood collection such as venipuncture or lancet fingerstick. In this study, Gateway Genomics, the leading provider of fetal sex testing, introduces “SneakPeek Snap”, a novel microneedle-based, self-administered blood collection device that simplifies at-home blood collection for fetal sex testing. Our data confirms that, compared to lancet finger sticks, the SneakPeek Snap device provides users several advantages including significant reduction in perceived pain, greater ease of use, a shorter sample collection time, and a dramatic reduction in risk of sample contamination. Notably, blood samples collected using the Snap device were shown to be highly accurate for fetal sex determination — with an accuracy greater than 99%

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