Blood collection tubes as medical devices: The potential to affect assays and proposed verification and validation processes for the clinical laboratory.

Blood collection tubes (BCTs) are an often under-recognized variable in the preanalytical phase of clinical laboratory testing. Unfortunately, even the best-designed and manufactured BCTs may not work well in all clinical settings. Clinical laboratories, in collaboration with healthcare providers, should carefully evaluate BCTs prior to putting them into clinical use to determine their limitations and ensure that patients are not placed at risk because of inaccuracies due to poor tube performance.

Performance of chemically modified plastic blood collection tubes.

Objective: The objective of this study was to compare newly-modified and aged chemoPET tubes, which contain no problematic surfactants, with commercially available serum blood collection tubes (BCTs) for use in analysis of cortisol, total triiodothyronine (TT3), total thyroxine (TT4), and routine clinical chemistry analytes in serum from apparently healthy volunteers and pooled quality control (QC) specimens.

Materials And Methods: Blood specimens collected from 60 apparently healthy volunteers (18 males, 42 females) and pooled QC specimens poured into seven different BCTs were analyzed by a trained phlebotomist. Cortisol, TT3, and TT4 levels were measured on an Immulite 1000 instrument and routine chemistry tests were analyzed on a Siemens RxL instrument.

Transforming plastic surfaces with electrophilic backbones from hydrophobic to hydrophilic.

We demonstrate a simple nonaqueous reaction scheme for transforming the surface of plastics from hydrophobic to hydrophilic. The chemical modification is achieved by base-catalyzed trans-esterification with polyols. It is permanent, does not release contaminants, and causes no optical or mechanical distortion of the plastic.

Maternal proteinuria in twin compared with singleton pregnancies.

Objective: To compare 24-hour urinary protein excretion in twin and singleton pregnancies not complicated by hypertension.

Methods: We prospectively evaluated mean 24-hour urinary protein excretion in twin and singleton pregnancies between 24 0/7 weeks and 36 0/7 weeks of gestation. Women with urinary tract infections, chronic hypertension, pregestational diabetes, and renal or autoimmune diseases were excluded.

Interferences from blood collection tube components on clinical chemistry assays.

Improper design or use of blood collection devices can adversely affect the accuracy of laboratory test results. Vascular access devices, such as catheters and needles, exert shear forces during blood flow, which creates a predisposition to cell lysis. Components from blood collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into specimens and/or adsorb analytes from a specimen; special tube additives may also alter analyte stability.

Blood collection tube-related alterations in analyte concentrations in quality control material and serum specimens.

Objectives: Several previous studies have described the effects of interfering substances on clinical assay results; however, the effects of exogenous substances, particularly additives from blood collection tubes on quality control (QC) specimens and serum specimens have not been well examined. This study examines the effects of blood-collection tube additives on total triiodothyronine (TT3), and thyroxine (TT4), cortisol, and routine clinical chemistry tests in QC and serum specimens from apparently healthy volunteers.

Methods: QC and serum specimens were poured or collected into different blood collection tubes.

Preanalytical quality improvement: in quality we trust.

Total quality in laboratory medicine should be defined as the guarantee that each activity throughout the total testing process is correctly performed, providing valuable medical decision-making and effective patient care. In the past decades, a 10-fold reduction in the analytical error rate has been achieved thanks to improvements in both reliability and standardization of analytical techniques, reagents, and instrumentation. Notable advances in information technology, quality control and quality assurance methods have also assured a valuable contribution for reducing diagnostic errors.

Serum testosterone quantitation by liquid chromatography-tandem mass spectrometry: interference from blood collection tubes.

Objectives: During the development of a testosterone assay by LC-MS/MS, we encountered significant assay interference introduced by blood collection tubes. We examined a number of commonly used blood collection tubes for the presence of interference and its impact on testosterone quantitation.

Design And Methods: A number of commonly used blood collection tubes were examined by incubation of zero, low and high testosterone concentration samples with them over time, followed by sample preparation using liquid-liquid extraction and analysis by LC-MS/MS.

Elevated vitamin B₁₂ levels in autoimmune lymphoproliferative syndrome attributable to elevated haptocorrin in lymphocytes.

Objective: Identify the etiology of elevated B(12) in autoimmune lymphoproliferative syndrome (ALPS).

Design: Peripheral blood of ALPS patients with elevated B(12) and controls were evaluated.

Results: Total and holo-haptocorrin (HC) levels were 26- and 23-fold higher in ALPS patients, respectively.

Impact of blood collection devices on clinical chemistry assays.

Blood collection devices interact with blood to alter blood composition, serum, or plasma fractions and in some cases adversely affect laboratory tests. Vascular access devices may release coating substances and exert shear forces that lyse cells. Blood-dissolving tube additives can affect blood constituent stability and analytical systems.

Differential effect of blood collection tubes on total free fatty acids (FFA) and total triiodothyronine (TT3) concentration: a model for studying interference from tube constituents.

Background: Besides total triiodothyronine (TT3), total free fatty acids (FFA) concentrations were higher with serum separator tube (SST) than Vacuette tubes.

Methods: The effects of surfactant, rubber stopper, and separator gel from various tubes were investigated on FFA, beta-hydroxybutyrate (beta-HB), and TT3 with 8 different tube types in blood specimens of apparently healthy volunteers.

Results: Compared to Vacuette tubes, serum FFA and TT3 concentrations were significantly higher in SST than glass tubes.

Markedly increased vitamin B12 concentrations attributable to IgG-IgM-vitamin B12 immune complexes.

Background: High serum vitamin B12 concentrations have been reported in patients with hepatic disease, disseminated neoplasia, myeloproliferative disorders, and hypereosinophilic syndromes. We recently discovered an extraordinarily increased vitamin B12 concentration in a patient without these underlying conditions.

Methods: Affinity and size-exclusion chromatography, sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), and ELISA methods were used to determine the cause of the increased vitamin B12 concentrations in this patient's serum.

Immunoassay interference by a commonly used blood collection tube additive, the organosilicone surfactant silwet L-720.

Background: A small number of immunoassays on several different types of analyzers were recently adversely affected by tube additives in Becton Dickinson (BD) Vacutainer SST, SST II, and Microtainer blood collection tubes. We examined the effect of a commonly used tube surfactant, Silwet L-720, on immunoassays and the mechanism for the interference.

Methods: Immunoassays were performed on serum supplemented with Silwet L-720 on the IMMULITE 2500 and AxSYM analyzers.

Maternal dietary 22 : 6n-3 is more effective than 18 : 3n-3 in increasing the 22 : 6n-3 content in phospholipids of glial cells from neonatal rat brain.

One of the debates in infant nutrition concerns whether dietary 18 : 3n-3 (linolenic acid) can provide for the accretion of 22 : 6n-3 (docosahexaenoic acid, DHA) in neonatal tissues. The objective of the present study was to determine whether low or high 18 : 3n-3 v. preformed 22 : 6n-3 in the maternal diet enabled a similar 22 : 6n-3 content in the phosphatidylcholine (PC), phosphatidylethanolamine (PE), phosphatidylinositol (PI) and phosphatidylserine (PS) of glial cells from whole brain (cerebrum and cerebellum) of 2-week-old rat pups.

Whole genome amplification of buccal cell DNA: genotyping concordance before and after multiple displacement amplification.

While buccal cells provide an easily accessible source of genomic DNA, the amount extracted may be insufficient for many studies. Whole genome amplification (WGA) using multiple displacement amplification (MDA) may optimize buccal cell genomic DNA yield. We compared the usefulness, in epidemiological surveys, of DNA derived from buccal cells collected by alcohol mouthwash and amplified by WGA protocol and standard protocols.

Effect of blood collection tubes on total triiodothyronine and other laboratory assays.

Background: Increased total triiodothyronine (TT(3)) assay results in apparently euthyroid patients triggered an investigation of the effect of blood collection tubes on serum TT(3) 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).

Population-based differences in frequency of the transcobalamin II Pro259Arg polymorphism.

Objective: A common polymorphism of the transcobalamin II (TC-II) gene, Pro250Arg, has been implicated as a possible genetic factor in population-based differences in vitamin B(12) metabolism. Our objective was to determine whether the prevalence of TC-II Pro259Arg polymorphism differs significantly between Caucasian, Asian and African-American groups.

Methods: Genomic DNA was available on 187 Caucasians and 43 Asians from the Toronto area, and 51 African-Americans from Northeastern United States.

Dietary low linolenic acid compared with docosahexaenoic acid alter synaptic plasma membrane phospholipid fatty acid composition and sodium-potassium ATPase kinetics in developing rats.

The objective of this study was to investigate if maternal dietary 20:4n-6 arachidonic acid (AA) and 22:6n-3 compared with adequate or low levels of 18:3n-3 linolenic acid (LNA) increases synaptic plasma membrane (SPM) cholesterol and phospholipid content, phospholipid 20:4n-6 and 22:6n-3 content, and Na,K-ATPase kinetics in rat pups at two and five weeks of age. At parturition, Sprague-Dawley rats were fed semi-purified diets containing either AA + docosahexaenoic acid (DHA), adequate LNA (control; 18:2n-6 : 18:3n-3 ratio of 7.1 : 1) or low LNA (18:2n-6 : 18:3n-39 ratio of 835 : 1).