Cell & Biomarker Preservation

PAXgene® Blood ccfDNA Tube CE

PAXgene Blood ccfDNA CE

The PAXgene Blood ccfDNA Tube (CE) is a plastic, evacuated tube intended for collection, storage, and transport of human blood and stabilization of DNA in a closed tube for preparation of circulating, cell-free DNA (ccfDNA) from plasma and genomic DNA (gDNA) from nucleated cellular fraction, for use with molecular test methods that require ccfDNA or gDNA.

Performance characteristics have been established with 18S ribosomal and DYS14 Y-chromosomal ccfDNA fragments in plasma. Users must validate use of product for their specific molecular diagnostic assay.

Technical expertise is available to support.

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The PAXgene Blood ccfDNA Tube enables an easier workflow that is more compatible with real-world conditions when working with circulating, cell-free DNA (ccfDNA). It extends the window for plasma separation up to 7 days at 2-30°C or 1 day at 37°C.

The unique, non–crosslinking stabilization chemistry in the PAXgene Blood ccfDNA Tube makes it compatible with a wide variety of downstream applications such as PCR based assays, including methylation assays, and next generation sequencing (NGS). The tube contains an additive that anticoagulates blood and prevents the release of intracellular DNA into the plasma, maintaining stable ccfDNA levels and minimizing hemolysis during sample transport and storage before processing.

The PAXgene Blood ccfDNA Tube is a plastic evacuated tube that uses the proven BD Vacutainer® technology and BD Hemogard™ safety closure. Each tube includes a barcode with tube ID, lot number and expiration date and a unique serial number.

References

Comparison with competitors’ products:

  1. 1. Alidousty C, Brandes D, Heydt C, Wagener S, Wittersheim M, Schäfer SC, Holz B, Merkelbach-Bruse S, Büttner R, Fassunke J, Schultheis AM. Comparison of Blood Collection Tubes from Three Different Manufacturers for the Collection of Cell-Free DNA for Liquid Biopsy Mutation Testing. J Mol Diagn. 2017 Sep;19(5):801-804.
  2. Warton K, Yuwono NL, Cowley MJ, McCabe MJ, So A, Ford CE. Evaluation of Streck BCT and PAXgene Stabilised Blood Collection Tubes for Cell-Free Circulating DNA Studies in Plasma. Mol Diagn Ther. 2017 Oct;21(5):563-570.
  3. Nikolaev S, Lemmens L , Koessler T, Blouin JL, Nouspikel T. Circulating tumoral DNA: Preanalytical validation and quality control in a diagnostic laboratory. Anal Biochem. 2017 Nov 11; 542:34-39.

Need for stabilization of ccfDNA:

  1. 1. Lo YM, Zhang J, Leung TN, Lau TK, Chang AM, Hjelm NM. Rapid clearance of fetal DNA from maternal plasma. Am J Hum Genet. 1999 Jan;64(1):218-24.
  2. Diehl F, Schmidt K, Choti MA, Romans K, Goodman S, Li M, Thornton K, Agrawal N, Sokoll L, Szabo SA, Kinzler KW, Vogelstein B, Diaz LA Jr. Circulating mutant DNA to assess tumor dynamics. Nat Med. 2008 Sep;14(9):985-90.
  3. Fleischhacker M, Schmidt B. Circulating nucleic acids (CNAs) and cancer--a survey. Biochim Biophys Acta. 2007 Jan;1775(1):181-232.

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BD Vacutainer® CPT™ Mononuclear Cell Preparation Tube

BD Vacutainer CPT Mononuclear Cell Preparation Tube

The BD Vacutainer® CPT™ tube is a fully-closed system for separation of mononuclear cells (PBMCs) from whole blood. Cell separation is carried out in the primary blood collection tube, thereby minimizing variability from sample processing.

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BD Vacutainer® CPT™ is a fully-closed system for separation of mononuclear cells from whole blood, where cell separation is carried out in the primary blood collection tube. This decreases the complexity of steps for mononuclear cell separation, thereby minimizing variability from sample processing.

CPT is an evacuated, sterile blood collection tube containing buffered sodium citrate or sodium heparin anticoagulant, liquid density medium and an inert gel barrier. It is intended for the collection of whole blood and the subsequent separation of mononuclear blood cells for the purposes of in vitro diagnostic examination.

Whole blood is drawn directly into the CPT using standard phlebotomy techniques and processed in the same tube. During centrifugation, the gel forms a physical barrier between the mononuclear cells in plasma and the erythrocytes and granulocytes. The separated, concentrated suspension of mononuclear cells in plasma can then be transported in the primary blood collection tube.

References

General

  1. Schlenke P, Klüter H, Müller-Steinhardt M, Hammers HJ, Borchert K, Bein G. Evaluation of a Novel Mononuclear Cell Isolation Procedure for Serological HLA Typing. Clin Diagn Lab Immunol 1998;5:808-813.
  2. Weinberg A, Betensky RA, Zhang L, Ray G. Effect of Shipment, Storage, Anticoagulant, and Cell Separation on Lymphocyte Proliferation Assays for Human Immunodeficiency Virus-Infected Patients. Clin Diagn Lab Immunol 1998;5:804-807.
  3. Ruitenberg J, Mulder C, Maino V, Landay A, Ghanekar S. Vacutainer CPT and Ficoll Density Gradient Separation Perform Equivalently in Maintaining the Quality and Function of PBMC from HIV Seropositive Blood Samples. BMC Immunol 2006;7:1-8.

CPT for pre-enrichment prior to isolation of CTCs

  1. Hughes A, Mattison J, Western L, Powderly J, et al. Microtube Device for Selectin-Mediated Capture of Viable Circulating Tumor Cells from Blood. Clin Chem 2012;58:846-853.
  2. Wu P, McCart A, Hewitt S, Turner E, et al. Isolated Organ Perfusion Does Not Result in Systemic Microembolization of Tumor Cells. Ann Surg Oncol 1999;6:658-663.

CPT for pre-enrichment prior to characterization of stem cells

  1. Pierini M, Dozza B, Lucarelli E, Tazzari P, et al. Efficient Isolation and Enrichment of Mesenchymal Stem Cells from Bone Marrow. Cytotherapy 2012;14:686-693.

Nucleic Acid Analysis for Gene Expression, Infectious Disease, and Cancer Studies

  1. Smieja M, Mahony J, Petrich A, Boman J, Chernesky M. Association of Circulating Chlamydia Pneumoniae DNA with Cardiovascular Disease: A Systematic Review. BMC Infectious Diseases 2002;2:1-10.
  2. Mahony J, Chong S, Coombes B, Smieja M, Petrich A. Analytical Sensitivity, Reproducibility of Results, and Clinical Performance of Five PCR Assays for Detecting Chlamydia Pneumoniae DNA in Peripheral Blood Mononuclear Cells. J Clin Microbiol 2000;38:2622-2627.
  3. Smieja M, Chong S, Natarajan M, Petrich A, Rainen L, Mahony J. Circulating Nucleic Acids of Chlamydia Pneumoniae and Cytomegalovirus in Patients Undergoing Coronary Angiography. J Clin Microbiol 2001;39:596-600.
  4. Tondella M, Talkington D, Holloway B, Dowell S, Cowley K, et al. Development and Evaluation of Real-Time PCR-Based Fluorescence Assays for Detection of Chlamydia Pneumoniae. J Clin Microbiol 2002;40:575-583.
  5. Bhattacharya S, Tyagi S, Srisuma S, DeMeo D, Shapiro S, et al. Peripheral Blood Gene Expression Profiles in COPD Subjects. J Clin Bioinformat 2011;1:1-12.
  6. Mole L, Margolis D, Carroll R, Todd J, Holodniy J. Stabilities of Quantitative Plasma Culture for Human Immunodeficiency Virus, RNA, and p24 Antigen from Samples Collected in Vacutainer CPT and Standard Vacutainer Tubes. J Clin Microbiol 1994;32:2212-2215.
  7. Holodniy M, Mole L, Yen-Lieberman B, Margolis D, Starkey C, et al. Comparative stabilities of Quantitative Human Immunodeficiency Virus RNA in Plasma from Samples Collected in Vacutainer CPT, Vacutainer PPT and Standard Vacutainer Tubes. J Clin Microbiol 1995;33:1562-1566.
  8. Fischer M, Huber W, Kalivroussis A, Ott P, Opravil M, et al. Highly Sensitive Methods for Quantitation of Human Immunodeficiency Virus Type 1 RNA from Plasma, Cells and Tissues. J Clin Microbiol 1999;37:1260-1264.
  9. Baechler E, Battliwalla F, Karypis G, Gaffney P, et al. Interferon-inducible Gene Expression Signature in Peripheral Blood Cells of Patients with Severe Lupus. PNAS 2003;100:2610-2615.
  10. Slawin K, Shariat S, Nguyen C, Leventis A, Song W, et al. Detection of Metastatic Prostate Cancer using a Splice Variant-Specific Reverse Transcriptase-Polymerase Chain Reaction Assay for Human Glandular Kallikrein. Cancer Research 2000;60:7142-7148.
  11. Shariat S, Gottenger E, Nguyen C, Song W, Kattan M, et al. Preoperative Blood Reverse Transcriptase-PCR Assays for Prostate-Specific Antigen and Human Glandular Kallikrein for Prediction of Prostate Cancer Progression after Radical Prostatectomy. Cancer Research 2002;62:5974-5979.
  12. Balasuriya U, Snijder E, Heidner H, Zhang J, Zevenhoven-Dobbe J, Boone J, et al. Development and Characterization of an Infectious cDNA Clone of the Virulent Bucyrus Strain of Equine Arteritis Virus. J Gen Virol 2007;88:918-924.

Pharmaceutical Studies and Intracellular Drug Level Measurements

  1. Becher F, Pruvosat A, Schlemmer D, Creminon C, Goujard C, et al. Significant Levels of Intracellular Stavudine Triphosphate are Found in HIV-Infected Zidovudine-treated Patients. AIDS 2003;17:555-561.
  2. Azoulay S, Nevers MC, Creminon C, Heripret L, Durant J, et al. Sensitive Enzyme Immunoassay for Measuring Plasma and Intracellular Nevirapine Levels in Human Immunodeficiency Virus-Infected Patients. Antimicrob Agents Chemother 2004;48:104-109.
  3. Cronin AJ, Aucutt-Walter NM, Budinetz T, Bonafide CP, DiVittore, NA, et al. Low Dose Remifentanil Infusion Does Not Impair Natural Killer Cell Function in Healthy Volunteers. Br J Anaesth 2003;91:805-809.
  4. Green LJ, Marker P, Ray C, Cook CA, Jaken S, et al. Development and Validation of a Drug Activity Biomarker that Shows Target Inhibition in Cancer Patients Receiving Enzastaurin, a Novel Protein Kinase C-B Inhibitor. Clin Cancer Res 2006;12:3408-3415.
  5. Ramanathan R, Egorin M, Eiseman J, Ramalingam S, Friedland D, Agarwala S, et al. Phase I and Pharmacodynamic Study of 17-(Allylamino)-17-Demethoxygeldanamycin in Adult Patients with Refractory Advanced Cancers. Clin Cancer Res 2007;13:1769-1774.
  6. Katial RK, Brandt BL, Moran EE, Marks S, Agnello V, Zollinger W. Immunogenicity and Safety Testing of a Group B Intranasal Meningococcal Native Outer Membrane Vesicle Vaccine. Infect Immun 2002;70:702-707.
  7. Rouzes A, Berthoin K, Zuereb F, Djabarouti S, Pellegrin I, et al. Simultaneous Determination of the Antiretroviral Agents: Amprenavir, Lipinavir, Ritonavir, Saquinavir and Efavirenz in Human Peripheral Blood Mononuclear Cells by High Performance Liquid Chromatography—Mass Spectrometry. J Chromatograph B 2004;813:209-216.
  8. Colombo S, Beguin A, Telenti A, Biollaz J, Buclin T, et al. Intracellular Measurements of anti-HIV Drugs Indinavir, Amprenavir, Saquinavir, Nelfinavir, Lipinavir, Atazanavir, Efavirenz and Nevirapine in Peripheral Blood Mononuclear Cells by Liquid Chromatography Coupled to Tandem Mass Spectrometry. J Chromatograph B 2005;819:259-276.
  9. Ehrhardt M, Mock M, Haefeli W, Mikus G, Burhenne J. Monitoring of Lopinavir and Ritonavir in Peripheral Blood Mononuclear Cells, Plasma, and Ultrafiltrate using a Selective and Highly Sensitive LC/MS/MS Assay. J Chromatograph B 2007;850:249-258.

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BD Vacutainer® PPT™ Plasma Preparation Tube

BD Vacutainer PPT Plasma Preparation Tube

The BD Vacutainer® PPT™ tube is a closed system allowing separation and storage of undiluted EDTA plasma in the primary blood collection tube for molecular diagnostic testing.

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BD Vacutainer® PPT™ is a closed system allowing separation and storage of undiluted EDTA plasma in the primary blood collection tube. It is intended for the purposes of molecular diagnostic testing.

PPT is an evacuated, sterile blood collection tube that contains an inert gel and spray-dried K2EDTA anticoagulant for achieving plasma separation. When the sample-filled tube is subjected to centrifugation, the gel migrates and forms a physical barrier between the plasma and most of the cellular elements. Since the tube uses spray-dried K2EDTA as opposed to liquid additives, the plasma obtained is undiluted.

References

General

  1. Holodniy M, Rainen L, Herman S, Yen-Lieberman B. Stability of Plasma HIV Viral Load in VACUTAINER® PPT™ Plasma Preparation Tubes During Overnight Shipment. J Clin Microbiol 2000;38:323-326.
  2. Fernandes H, Morosyuk S, Abravaya K, Ramanathan M, Rainen L. Evaluation of Effect of Specimen Handling Parameters for Plasma Preparation Tubes on Viral Load Measurements obtained by using the Abbott RealTime HIV-1 Load Assay. J Clin Microbiol 2010;48:2464-2468.
  3. Holodniy M, Mole L, Yen-Lieberman B, Margolis D, Starkey C, et al. Comparative stabilities of Quantitative Human Immunodeficiency Virus RNA in Plasma from Samples Collected in Vacutainer CPT, Vacutainer PPT and Standard Vacutainer Tubes. J Clin Microbiol 1995;33:1562-1566.

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Product inserts referencing PPT

  • VERSANT® HIV-1 RNA 3.0 Assay
  • Procleix Ultrio Assay

BD™ P100 Blood Collection System

BD P100 Blood Collection System

BD™ P100 blood collection tubes contain a proprietary protease inhibitor cocktail that minimizes preanalytical variability in plasma protein analysis. Inclusion of a patented, innovative, non-gel mechanical separator in the larger format of BD™ P100 Tubes provides better separation of cellular components from plasma than gel-based separators.

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Human plasma contains a wide variety of proteins that hold potential as biomarkers for proteomics-based diagnostic and prognostic assays. These proteins are subject to proteolytic degradation and modification during and after blood collection.

The BD™ P100 blood collection tubes minimize preanalytical variability in plasma protein analysis. The tubes are spray coated with K2EDTA anticoagulant and proprietary protease inhibitor cocktail, specifically formulated for stabilization of human plasma proteins at the point of collection. Inclusion of a novel mechanical separator within the 8.5ml BD™ P100 Tubes provides better separation of cellular components from plasma than gel-based separators.

BD™ P100 is for research use only – it is not for use in diagnostic procedures.

References

General

  1. Yi J, Craft D, Gelfand CA. Minimising Preanalytical and Analytical Variability in Plasma Peptidomics using MALDI-TOF MS. Methods Mol Biol 2011;728:137-149.
  2. Craft D, Yi J, Gelfand CA. Time-dependent and Sample-to-sample Variations in Human Plasma Peptidome are both minimised through use of Protease Inhibitors. Analytical Letters 2009;2:1398-1406.
  3. Yi J, Liu Z, Craft D, O'Mullan P, Ju G, Gelfand CA. Intrinsic Peptidase Activity Causes a Sequential Multi-step Reaction (SMSR) in Digestion of Human Plasma Peptides. J Proteomic Res 2008;7:5112-5118.
  4. Yi J, et al. Inhibition of Intrinsic Proteolytic Activities Moderates Preanalytical Variability and Instability of Human Plasma. J Proteomic Res 2007;6:1768-1781.
  5. Waters J, Dhere V, Benjamin A, Sekar A, Kumar A, Prahalad S, Okou DT, Kugathasan S. A Practical and Novel Method to Extract Genomic DNA from Blood Collection Kits for Plasma Protein Preservation. J Vis Exp. 2013; 75:e4241.
  6. Roy M.  Controlled Analysis of Preanalytical Variables in CSF and Blood Sample Collection, Processing and Storage: Implications for Best Practices in Clinical Research. Presented at ISBER, Orlando, FL, 2014.

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BD™ P800 Blood Collection System

BD P800 Blood Collection System

BD™ P800 delivers enhanced accuracy in measuring plasma metabolic markers such as Glucagon-like Peptide-1 (GLP-1), Glucagon, non-acyl Ghrelin, Gastric Inhibitory Polypeptide (GIP), and Oxyntomodulin (OXM) by stabilizing them at the point of collection.

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BD™ P800 delivers enhanced accuracy in measuring plasma metabolic markers such as Glucagon-Like Peptide-1 (GLP-1), Glucagon, non-acyl Ghrelin, Gastric Inhibitory Polypeptide (GIP), and Oxyntomodulin (OXM) by stabilizing them at the point of collection.

BD P800 is an evacuated blood collection tube containing a proprietary cocktail of protease inhibitors, specifically optimized for stabilization of metabolic markers. The plasma obtained by processing the BD P800 tube can be used immediately, transported, or stored frozen.

BD™ P800 is for research use only – not for use in diagnostic procedures.

References

General

  1. Yi J, Warunek D, Craft D. Degradation and Stabilization of Peptide Hormones in Human Blood Specimens. PLOS One 2015;1-21.
  2. Sloan JH, Siegel RW, Ivanova-Cox YT, Watson DE, et al. A novel high sensitivity electrochemiluminescence (ECL) sandwich immunoassay for the specific quantitative measurement of plasma glucagon. Clin Biochem 2012;45:1640-1644.
  3. Tatosian DA, Guo Y, Schaeffer AK, Gaibu N, Popa S, et al. Dipeptidyl Peptidase-4 Inhibition in Patients with Type 2 Diabetes Treated with Saxagliptin, Sitagliptin, or Vildagliptin. Diabetes Ther 2013;4:431-442.
  4. Troutt JS, Siegel RW, Chen J, Sloan JH, Deeg MA, et al. Dual-Monoclonal, Sandwich Immunoassay Specific for Glucose-Dependent Insulinotropic Peptide1-42, the Active Form of the Incretin Hormone. Clin Chem 2011;57:849–855.
  5. Kishimoto M, Noda M. Effect of the Addition of Sitagliptin and Miglitolon Insulin-Treated Type 2 Diabetes. Diabetes Ther 2012;3:11.
  6. Perala MM. Early Growth and Adult Health. Programming of postprandial responses, food intake and salt sensitivity. National Institute for Health and Welfare. Academic dissertation presented at the University of Helsinki, 2014.
  7. Kishimoto M, Noda M. Effects of Exenatide in a Morbidly Obese Patient with Type 2 Diabetes. Diabetes Ther 2014;5:323–332.
  8. Raines M, King C, Christensen S, Amin P, Schranz D. Glucagon Quantification: Comparison of Radioimmunoassay and Sandwich ELISA methods. Poster presented at the AACC, 2014.

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PAXgene® Blood RNA Tube

PAXgene Blood RNA System

The PAXgene® Blood RNA Tube is intended for immediate stabilization of intracellular RNA for accurate and reproducible gene expression analysis. It is part of the PAXgene Blood RNA System that integrates the key steps of whole blood collection, intracellular RNA stabilization, and RNA purification.

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The PAXgene® Blood RNA Tube is intended for immediate stabilization of intracellular RNA, thereby yielding accurate and reproducible gene expression data. It is part of the PAXgene Blood RNA System that integrates the key steps of whole blood collection, intracellular RNA stabilization, and RNA purification.

The PAXgene Blood RNA tube contains a proprietary reagent for stabilization of intracellular RNA immediately upon collection. Intracellular RNA is stabilized for up to three days at room temperature or five days at 2-8°C. PAXgene tubes can be frozen at temperatures of -20°C to -70°C for long-term storage.

The PAXgene Blood RNA System is the first IVD marketed product for the collection, storage, and transportation of blood and stabilization of intracellular RNA in a closed tube with subsequent isolation and purification of intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing. Performance characteristics for the PAXgene Blood RNA System have been established with FOS and IL1B gene transcripts.

References

General

  1. Rainen L, Oelmueller U, Jurgensen S, Wyrich R, Ballas C, et al. Stabilization of mRNA Expression in Whole Blood Samples. Clin Chem 2002;48:1883-1890.
  2. Zhang H, Korenkova V, Sjoback R, Svec D, Bjorkman J, et al. Biomarkers for Monitoring Preanalytical Quality Variation of mRNA in Blood Samples. PLoS One 2014;9:e111644.

Use with Illumina HumanRef-12 V4 BeadChip

  1. Hoang LT, Shimizu C, Ling L, Naim A, et al. Global Gene Expression Profiling Identifies New Therapeutic Targets in Acute Kawasaki Disease. Genome Med 2014;6:102.

Use with Affymetrix microarrays

  1. Thach DC, Baochuan L, Walter E, Kruzelock R, et al. Assessment of Two Methods for Handling Blood in Collection Tubes with RNA Stabilizing Agent for Surveillance of Gene Expression Profiles with High Density Microarrays. J Immunol Methods 2003;283:269-279.
  2. Field FA, Jordan RM, Hadix JA, Dunn MA, et al. Functional Identity of Genes Detectable in Expression Profiling Assays Following Globin mRNA Reduction of Peripheral Blood Samples. Clin Biochem 2007;40:499-502.

miRNA analysis

  1. Leidinger P, Backes C, Deutscher S, Schmitt K, et al. A Blood Based 12-miRNA Signature in Alzheimer Patients. Genome Biol 2013;14:R78.
  2. miRNA: Tech note showing that PAXgene Blood RNA Tube and the PAXgene Blood miRNA Kit optimized for enrichment of small RNA, recovered 3–20 fold higher amounts of miRNA from whole blood than the combination of the Tempus Blood RNA Tube and the Tempus RNA Spin Kit. miRNA levels measured by qRT-PCR.

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PAXgene® Blood DNA Tube

PAXgene Blood DNA System

The PAXgene® Blood DNA Tube (CE) is the first blood collection tube designed specifically for in vitro diagnostic DNA testing.

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The PAXgene® Blood DNA Tube (CE) is the first blood collection tube designed specifically for in vitro diagnostic DNA testing. It is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of high quality DNA for use with molecular diagnostic test methods that require DNA.

References

General

  1. Rainen L, et al. Performance of the PAXgene® Blood DNA Tube for the Collection, Transport, and Storage of Whole Blood and the Purification of DNA Using the QIAsymphony® Instrument, 2013.

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