Blood Collection Devices Research Articles

Evaluation of blood collection filter papers for HIV-1 DNA PCR

BackgroundThe collection of dried blood spots (DBS) on Whatman 903 cards has facilitated for years the detection of HIV-1 in infants by DNA PCR as early as 4–6 weeks after birth in resource-limited settings (RLS), but alternate blood collection devices are proving to be necessary. ObjectivesThe qualitative detection of HIV-1 DNA by PCR from DBS prepared on three commercially available blood collection cards was evaluated at the Centers for Disease Control and Prevention (CDC) and in four laboratories in Africa. Study designDBS were prepared on Ahlstrom grade 226, Munktell TFN and Whatman 903, and stored under a variety of conditions. DBS were stored at ambient temperature (RT), 37°C with high humidity, and −20°C for varying lengths of time. The presence of HIV-1 DNA was tested using Roche Amplicor HIV-1 DNA (v 1.5) weekly for 4 weeks and at weeks 8 and 12 (RT and 37°C), at weeks 4, 8, and 18 (−20°C) of storage. DBS specimens were also tested after international shipment at RT. In addition, after nearly 3 years storage at −20°C, DBS were also evaluated independently using the COBAS Ampliprep/TaqMan HIV-1 Qual and Abbott RealTime HIV-1 Qualitative tests. ResultsHIV-1 DNA was detected equally well on the three blood collection cards regardless of storage conditions and PCR assay. ConclusionsAhlstrom 226 and Munktell TFN papers were comparable to Whatman 903 for HIV-1 DNA detection and may be considered as optional blood collection devices in resource-limited countries.

Letter to The Editor: Response To: Commentary on The History And Quantitative Nature of Filter Paper Used in Blood Collection Devices

BioanalysisVol. 4, No. 6 News & AnalysisFree AccessLetter to the Editor: Response to: Commentary on the history and quantitative nature of filter paper used in blood collection devicesPeter T KissingerPeter T KissingerPurdue University, 560 Oval Drive, West Lafayette, IN 47907, USA. Search for more papers by this authorEmail the corresponding author at kissingp@purdue.eduPublished Online:28 Mar 2012https://doi.org/10.4155/bio.12.35AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit My commentary on DBS elicited a huge number of private responses, not one of which focused on newborn screening. Thanks to Victor De Jesus and Donald H Chace for providing a useful review on this topic, with which I fully admit to having no practical experience. Furthermore, I have heard nothing but good things about this well-established screening approach to diagnosing a number of genetic polymorphisms (‘inborn errors of metabolism’) in neonates. Many millions of samples are processed each year. This well-established application is only peripherally related to the question being debated in my Commentary. There are a number of challenges in our use of language. For example, the term ‘bioanalytical’ means quite a different thing in the CRO world to what it means in an academic biochemistry department. ‘Clinical chemistry’ and ‘laboratory medicine’ are other terms that work in one environment, but less well in others. ‘Quantitative’ is yet another informal term when used without specification of accuracy and precision. For example, the meaning is quite different in bioanalysis and cGMP pharmaceutical analysis. Establishing that a number is more or less than an established cut-off value, as mentioned by De Jesus and Chace, is a specific context where the result is yes, no or maybe, with respect to a genetic abnormality. Many of us would label that goal by the equally ambiguous term ‘semi-quantitative’. Also keep in mind that we do not do drug trials for new molecular entities (NMEs) in neonates. We simply don’t.The question I was debating with myself is; ‘does the use of DBS for regulated bioanalytical chemistry in pharmaceutical research bring something new of real value or is this just an interesting alternative to conventional liquid samples?’ There is no doubt that for many analytes DBS can be demonstrated to be satisfactory for validated assays. New publications are appearing each month. Many, however, are questioning whether this provides new information and/or new economy. Others feel DBS unnecessarily complicates and limits well-established approaches. There are both proponents and opponents sitting on the jury. Time and the regulatory agencies will be the judge. The therapeutic drug monitoring question is also a very different environment with a number of contexts from establishing compliance in a Phase III trial, to optimizing therapy in an ICU/PICU/NICU, to monitoring for abused drugs. These also have different criteria for precision and accuracy that will vary with molecular structure, concentration and time postdose.We have six distinct environments: neonatal screening, preclinical toxicology, preclinical pharmacology, clinical trials, therapeutic drug monitoring and forensic drug monitoring. Only the first of these is widely accepted as routine, having passed the test of time for five decades. Enthusiasm for the other five contexts varies and the debate is far from settled. Theory guides, experiment decides. Thanks to all for the many emails and face-to-face debates. Thanks to De Jesus and Chace for sharing their thoughts from a context that very few of us in pharmaceutical R&D are familiar with day-to-day.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.FiguresReferencesRelatedDetailsCited ByA dried blood spot update: still an important bioanalytical technique?Neil Spooner16 April 2013 | Bioanalysis, Vol. 5, No. 8 Vol. 4, No. 6 Follow us on social media for the latest updates Metrics History Published online 28 March 2012 Published in print March 2012 Information© Future Science LtdFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

A Comparison of Excessive Postpartum Blood Loss Estimates Among Three Subgroups of Women Attending Births in Matlab, Bangladesh

Postpartum hemorrhage (PPH) is the leading cause of maternal death and disability worldwide. Recognition depends on subjective visual quantification. This study sought to assess and compare the thresholds for excessive postpartum blood loss reported by skilled birth attendants (SBA), traditional birth attendants (TBA), and laywomen in Matlab, Bangladesh. Data from six questions asking about excessive blood loss in the postpartum period were analyzed using analysis of variance (ANOVA), Hochberg test, Kruskal-Wallis and standard descriptive statistics. Thresholds for excessive blood loss estimated by laywomen and TBAs exceed biomedical standards for PPH. Skilled birth attendant reports are consistent with the definition of severe acute PPH. Further research on locally validated blood collection devices, in birth kits, for diagnostic aid or referral indication is needed. Areas where coverage and uptake of skilled birth attendance are low should be targeted due to the number of home births attended by TBAs and laywomen in such settings. A comparison of excessive postpartum blood loss estimates among skilled birth attendants, traditional birth attendants and laywomen in Matlab, Bangladesh.

Serum or Plasma Samples?

Dysregulations of the synthesis and breakdown of the extracellular matrix (ECM) is a key processes in the physiopathology of vascular remodeling and the development of atherothrombotic syndromes.1–4 Matrix metalloproteinases (MMPs) are endopeptidases, belonging to the matrixin family that can degrade almost all the ECM components.5 Although there is little doubt that MMPs are an important components in cancer invasion and metastasis,6 they are also regarded as key regulatory molecules in degenerative processes and inflammation,5,7 as playing roles also in physiopathological remodeling of the vascular wall2,8 and as the pathogenesis of cardio- and cerebrovascular diseases.9,10 Thus, MMPs have emerged as potential biomarkers of atherothrombotic risk and predictors of coronary and cerebrovascular disease recurrence.8 ATVB 2008;28:e15–e16. Normal and diseased blood vessel wall cells may upregulate and activate MMPs in a multistep fashion, driven in part by soluble cytokines and cell–cell interactions with platelets and white blood cells. Enhanced MMP activation (alone or in concert with the fibrinolytic system) contributes to increased matrix turnover, which may have beneficial effects (eg, in vascular repair and atherosclerotic plaque stabilization)11 but also detrimental effects (eg, in vascular intimal thickening, atherosclerosis, and in thrombotic syndromes).12 Because the changes on the cellular level are reflected in body fluids, determination of MMPs in blood have been recommended as noninvasive tools in the diagnosis and monitoring of several diseases.13 It has been demonstrated repeatedly that both the MMP/tissue inhibitor of matrix metalloproteinase (TIMP) assay and zymography essentially depend on the blood sampling procedures, with some MMPs and TIMPs having higher concentrations in serum than in plasma.14–41 Although assays for an ever-increasing number of MMPs are now commercially available, the …

Differences in both matrix metalloproteinase 9 concentration and zymographic profile between plasma and serum with clot activators are due to the presence of amorphous silica or silicate salts in blood collection devices

Matrix metalloproteinases (MMPs) are promising diagnostic tools, and blood sampling/handling alters MMP concentrations between plasma and serum and between serum with and without clot activators. To explain the higher MMP-9 expression in serum collected with clot accelerators relative to serum with no additives and to plasma, we analyzed the effects of increasing amounts of silica and silicates (components of clot activators) in citrate plasma, serum, and buffy coats collected in both plastic and glass tubes from 50 healthy donors, and we analyzed the effects of silica and silicate on cultured leukemia cells. The levels of MMP-2 did not show significant changes between glass and plastic tubes, between serum and plasma, between serum with and without clot accelerators, or between silica and silicate treatments. No modification of MMP-9 expression was obtained by the addition of silica or silicate to previously separated plasma and serum. Increasing the amounts of nonsoluble silica and soluble silicate added to citrate and empty tubes prior to blood collection resulted in increasing levels of MMP-9 relative to citrate plasma and serum. Silica and silicate added to buffy coats and leukemia cells significantly induced MMP-9 release/secretion, demonstrating that both silica and silicate induce the release of pro- and complexed MMP-9 forms. We recommend limiting the misuse of serum and avoiding the interfering effects of clot activators.

An assessment of various blood collection and transfer methods used for malaria rapid diagnostic tests

BackgroundFour blood collection and transfer devices commonly used for malaria rapid diagnostic tests (RDTs) were assessed for their consistency, accuracy and ease of use in the hands of laboratory technicians and village health workers.MethodsLaboratory technicians and village health workers collected blood from a finger prick using each device in random order, and deposited the blood either on filter paper or into a suitable casette-type RDT. Consistency and accuracy of volume delivered was determined by comparing the measurements of the resulting blood spots/heights with the measurements of laboratory-prepared pipetted standard volumes. The effect of varying blood volumes on RDT sensitivity and ease of use was also observed.ResultsThere was high variability in blood volume collected by the devices, with the straw and the loop, the most preferred devices, usually transferring volumes greater than intended, while the glass capillary tube and the plastic pipette transferring less volume than intended or none at all. Varying the blood volume delivered to RDTs indicated that this variation is critical to RDT sensitivity only when the transferred volume is very low.ConclusionNone of the blood transfer devices assessed performed consistently well. Adequate training on their use is clearly necessary, with more development efforts for improved designs to be used by remote health workers, in mind.

Stability of Clinical Chemistry Analytes in Blood Collection Devices

During the AACC Annual Meeting in New Orleans in July 1999, Greiner Meditech Inc. (Bel Air, MD), distributed sample packages with labeling claiming that their serum and plasma Vacuette® blood collection tubes with clot activator and separation gel for clinical chemistry analyses are capable of maintaining the stability of all analytes during storage for 48 h without affecting the serum or plasma values (1). I found similar 48-h stability claims for the Vacuette blood collection devices on Greiner’s Web sites in the United States and Europe (2)(3). In addition, colleagues in laboratories in Spain had received Greiner Vacuette product information with universal 48-h stability claims (4). Data supporting the claims described above were not provided in any of the above instances and could not be found during an extensive literature …

Advancements in Blood Collection Devices

Medical device manufacturers have made substantial improvements toward safer blood collection products. Customers and manufacturers of blood collection devices have emphasized prevention of injury and reduction of bloodborne pathogen exposure. Blood collection involves the use of many types of equipment and devices supplied by several manufacturers. This article discusses advances in and safety features of blood collection devices, as well as differences among evaluated tube types for products sold in the United States.

Interaction of divalent metal lons with normal and lead-inhibited human erythrocytic porphobilinogen synthase in vitro

The effects of Zn 2+, Hg 2+, Cd 2+, and Cu 2+ on normal and lead-inhibited erythrocytic porphobilinogen synthase (PBG-S) were studied in vitro using human whole blood hemolysate. The results demonstrate that each of the divalent ions tested has a characteristic effect on the pH-activity relationship of PBG-S. The effects for a given ion are concentration- and pH-dependent. For Zn 2+ these effects are also time-dependent. The results obtained provide an explanation for the contradictory reports of the action of some of the metals in vtro and indicate that future investigations of the effects of metals on an enzyme such as PBG-S are best performed over a judiciously selected pH range rather than at a single pH value. It is also shown that the metals studied will only have a significant effect on the proposed PBG-S activity ratio test for lead intoxication in instances of gross contamination of blood collection devices. The activation and/or inhibition of PBG-S and associate pH-activity profile changes resulting from interaction with the four metal ions tested were attributed to their respective affinity for the thiol and other groups at the active sites. The occurrence of a relatively specific pH optimum for PBG-S after interaction with each ion investigated remains unexplained.

Blood-collection devices that do not contaminate measurements of anticonvulsant drugs.

Journal Article Blood-collection devices that do not contaminate measurements of anticonvulsant drugs. Get access M I Arranz Peña M I Arranz Peña Search for other works by this author on: Oxford Academic Google Scholar Clinical Chemistry, Volume 31, Issue 9, 1 September 1985, Pages 1577–1578, https://doi.org/10.1093/clinchem/31.9.1577 Published: 01 September 1985

Effects of contaminants in blood-collection devices on measurements of therapeutic drugs.

Substances in evacuated blood-collection devices produce gas-chromatographic peaks with retention times similar to those of drugs. All tubes tested except the serum separator tubes contained tris(2-butoxyethyl) phosphate, as determined by mass spectrometry. In addition, the partition coefficient during the solvent-extraction step increased for some drugs by as much as 40%, while for other drugs it decreased by as much as 30%, depending on the drug and the collection tube. The Becton Dickinson serum separator tube also contains several other compounds identified by mass spectrometry to be dibasic esters used in the preparation of the polyester gel. The Corning serum separator tube and the Venoject serum tube contain still other impurities. The Becton Dickinson royal-blue-stoppered tube contained the least amount of impurities of the tubes tested. CVs of 25 commonly measured drugs in plasma pools increased from 5% for samples collected in glass tubes to greater than 20% for samples collected in evacuated blood-collection tubes. Clearly, accuracy and precision of measurements of therapeutic drugs can be seriously compromised if an inappropriate blood-collection device is used.

Microsampling for Blood-Lead Analysis

Abstract We detail the technique, procedure, and equipment required to properly obtain a micro-scale capillary (fingerstick) blood specimen for subsequent determination of its lead content. We divide the microsampling procedure into preparation of sampling equipment and subject, the fingerstick, micro blood collection devices, and transport and storage. The concept of a total-system approach to quality control for sampling and analysis is presented. For realistic quality control, the sampling component and the analysis component are inseparable. We describe types and sources of errors encountered. Most of the variability in the total system is associated with sampling.