11.100.30 - Analysis of blood and urine
ICS 11.100.30 Details
Analysis of blood and urine
Analiza krvi in urina
General Information
Frequently Asked Questions
ICS 11.100.30 is a classification code in the International Classification for Standards (ICS) system. It covers "Analysis of blood and urine". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 39 standards classified under ICS 11.100.30 (Analysis of blood and urine). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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ABSTRACT
This specification covers two dimensionally different (short and long) disposable glass micropipets used primarily to collect whole human blood specimens for clinical analysis and testing. Short and long pipets are available as coated with heparin (Type I) or uncoated (Type II).The pipets shall be fabricated from borosilicate glass, Type I, Class B, or soda lime glass, Type II. Heparin shall be the ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin and shall meet the specified heparin potency. The physical requirements including design, dimensions, workmanship, color coding, capillarity, fluidity, lot or control number, resistance to centrifugal force, and heparin coating are specified. The following tests shall be performed: capillarity test, fluidity test, sheep plasma test, human whole blood test, resistance to centrifugal force test, and heparin content test. The physical requirements for short Caraway pipet and long Natelson pipet are illustrated as well.
SCOPE
1.1 This specification covers two dimensionally different disposable glass micropipets used primarily to collect whole human blood specimens for clinical analysis and testing. They are available as coated with heparin or uncoated.
1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers reusable Sahli hemoglobin pipets. The pipets shall be made of common spirit bore white back tubing. Pipet design shall be straight and of one-piece construction. Pipet delivery tips shall be made with a gradual or concave taper. Pipet dimensions shall be within tolerance limit indicated in this specification. The pipet shall have markings which include graduation line, volumetric designation, identification, and capacity deviation. Testing methods include capacity test, capacity deviation, pigmentation test, and strain free test.
SCOPE
1.1 This specification covers reusable pipets calibrated “to contain” 20 cmm of whole blood and used for hemoglobin determinations.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers disposable blood sedimentation tubes suitable for determining sedimentation rates and the volume of packed red blood cells. This specification covers a tube intended for one-time use only. The tubes shall be fabricated borosilicate glass, Type I, Class B, or from soda lime glass, Type II. The tubes shall be tested for their marking permanency and resistance to centrifugal test.
SCOPE
1.1 This specification covers disposable blood sedimentation tubes suitable for determining sedimentation rates and the volume of packed red blood cells.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 The following precautionary statement pertains only to the test method portion, Section 7 of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification3 pagesEnglish languagesale 15% off
ABSTRACT
This specification describes the physical requirements and corresponding test methods for disposable glass blood sample capillary tubes for use in microhematocrit procedures. Covered here are two different types of capillary tubes, namely, Type I (coated with heparin), and Type II (uncoated). The tubes shall be fabricated from Type I, Class B borosilicate glass, or Type II soda lime glass. Conversely, the heparin used for coating Type I tubes shall be of ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin. The tubes shall conform to specified requirements for design, dimension, workmanship, color coding, and lot or control number. They should also pass the following tests for capillarity, fluidity, sheep plasma, positive and negative controls, human whole blood, heparin potency assay, and resistance to centrifugal force.
SCOPE
1.1 This specification covers disposable glass blood sample capillary tubes for use in microhematocrit procedures.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers reusable blood sedimentation tubes suitable for determining sedimentation rates and the volume of packed red blood cells. The tubes shall be fabricated from borosilicate glass, Type I, Class B, or sodalime glass, Type II. A resistance to centrifugal force test shall be performed on the tubes.
SCOPE
1.1 This specification covers reusable blood sedimentation tubes suitable for determining sedimentation rates and the volume of packed red blood cells.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification2 pagesEnglish languagesale 15% off
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom.
RNA in pathogens present in blood is not covered by this document.
- Standard28 pagesEnglish languagee-Library read for1 day
- Standard28 pagesEnglish languagee-Library read for1 day
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document.
NOTE Circulating cell free DNA in blood is covered in ISO 20186-3.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
DNA in pathogens present in blood is not covered by this document.
- Standard28 pagesEnglish languagee-Library read for1 day
- Standard28 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 Significance—Dried blood represents a significant challenge to cleaning surgical instruments. The water-soluble components of blood are easily rendered insoluble when exposed to heat, chemical solutions, or time at room temperature. The water insoluble component of blood is fibrin built up during coagulation. These proteins bind quite readily to the surfaces of surgical instruments making them difficult to remove even with the aid of chemical cleaning agents. Instruments contaminated with blood residue after reprocessing represent a significant threat for infection to healthcare workers and patients. Healthcare facilities typically employ the use of automated instrument washers. These devices combine mechanical action along with chemical cleaning agents in a staged cleaning cycle designed to thoroughly clean surgical instruments. To function properly, these machines must be performing at targeted mechanical efficiency and deliver the correct chemical cleaning agents at the correct temperature, at the correct dosage for the correct period of time. Manufacturers of automated washers and manufacturers of cleaning detergent need to evaluate the performance of their products utilizing a surrogate for surgical instruments soiled with blood. The results of the performance testing will be used to improve product design and for validation of the performance of their product for various regulatory requirements.
4.2 Use—The regular, periodic use of the blood soil test is a systemic challenge to the functioning of an automated washer. To properly challenge the cleaning device, the test must be analogous to the dried blood soil, to the stainless steel substrate, and to the physical barriers presented by surgical instruments. These physical barriers include the box lock, or pivot joint of a hinged instrument, the serrated tips, and crevices of surgical instruments. On the test coupon, the components of blood are similar to the state of dried blood on instruments. By utiliz...
SCOPE
1.1 This guide is based on a standardized test soil correlating to coagulated blood suitable for screening tests and the evaluation of the cleaning efficiency of washer-disinfectors used for reprocessing of surgical instruments. This guide strictly deals with cleaning and does not describe any methods that are related to disinfection. See Referenced Documents D5343, D4008, D4265, D2960, and D3050 in Section 2 for additional information.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 The purpose of this practice is to determine if thrombus formation has occurred by comparing platelet and leukocyte counts in the blood exposed to the test material relative to the blood cell counts in the control blood that has not been exposed to the test material. A large number of platelets and leukocytes becoming entrapped/incorporated in thrombi adhering to the material will be reflected by a decrease in their counts in blood. Thrombogenic materials should not be used for cardiovascular medical devices, unless the purpose of the device is to promote thrombosis.
SCOPE
1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as in accordance with ANSI/AAMI/ISO 10993–4. See also Test Method F2382.
1.2 All safety policies and practices shall be observed during the performance of this practice. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means.
1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control/National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood and handled/manipulated using standard precautions.
Note 1: The results of this in-vitro test may not correspond to actual human response.
1.4 The values stated in SI (International System of Units) units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 8 on Hazards.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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- Standard5 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for a medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway.
4.2 The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate. The results are reported as a percentage of the negative control.
SCOPE
1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.
1.2 All safety policies and practices shall be observed during the performance of this test method.
1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. This practice is useful as a simple, inexpensive screening method for determining functional whole complement activation by solid materials in vitro.
5.2 This practice is composed of two parts. In Part A (Section 11), human serum is exposed to a solid material. Complement may be depleted by the classical or alternative pathways. In principle, nonspecific binding of certain complement components also may occur. The alternative pathway can deplete later acting components common to both pathways, that is components other than C1, C4, and C3 (1) .4 In Part B (Section 12), complement activity remaining in the serum after exposure to the test material is assayed by classical pathway-mediated lysis of sensitized RBC.
5.3 Assessment of in vitro whole complement activation, as described here, provides one method for predicting potential complement activation by medical materials intended for clinical application in humans when the material contacts the blood. Other test methods for complement activation are available, including assays for specific complement components and their split products (see X1.3 and X1.4).
5.4 This in vitro test method is suitable for adoption in specifications and standards for screening solid materials for use in the construction of medical devices intended to be implanted in the human body or placed in contact with human blood.
SCOPE
1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood.
1.2 This practice is intended to evaluate the acute in vitro whole complement activating properties of solid materials intended for use in contact with blood. For this practice, the words “serum” and “complement” are used interchangeably (most biological supply houses use these words synonymously in reference to serum used as a source of complement).
1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum, using a 0.1-mL serum/13 x 100-mm disposable test tube. Cellulose acetate powders and fibers are used as examples of test materials. Procedure B describes assaying the exposed serum for significant functional whole complement depletion as compared to control samples.
1.4 This practice does not address function, elaboration, or depletion of individual complement components, nor does it address the use of plasma as a source of complement.
1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 Autologous PRP and platelet gels are utilized in a wide range of orthopedic, sports medicine, regenerative medicine, and surgical applications (3-5). PRP and platelet gels are layered, sprayed, injected, molded, or packed, alone or in combination with graft material or TEMPs, into a variety of anatomical sites, tissues, and voids (3, 6). These platelet concentrates can provide an assortment of bioactive molecules, cells, and physical properties that are potentially attractive for promoting healing and other cell therapy applications (7). Unfortunately, the term “platelet-rich plasma” or “PRP,” which is ubiquitous in early and contemporary medical literature related to a variety of platelet concentrates, only unambiguously denotes one critical parameter of a platelet suspension—increased platelet concentration. Without further context, this common description of PRP offers no information about other important physical and cellular aspects of platelet concentrations. As scientific and clinical understanding of PRP and other cellular therapies increases standardization of nomenclature and terminology is critical for defining key properties, standardizing processing parameters and techniques, and developing repeatable assays for quality assurance and scientific evaluation (5, 8-13). This guide outlines basic guidelines to describe key properties of unique PRP and platelet gel formulations in a standardized fashion. Reliable, standardized descriptions can provide valuable context to PRP end users, such as clinicians seeking a PRP or platelet gel with certain biological attributes or scientific investigators seeking to duplicate a published formulation or to correlate a given PRP or platelet gel feature to other biological properties or outcomes.
SCOPE
1.1 This guide defines terminology and identifies key fundamental properties of autologous platelet-rich plasma (PRP) and PRP-derived platelet gels intended to be used for tissue engineered medical products (TEMPS) or for cell therapy applications. This guide provides a common nomenclature and basis for describing notable properties and processing parameters for PRP and platelet gels that may have utility for manufacturers, researchers, and clinicians. Further discussion is also provided on certain aspects of PRP processing techniques, characterization, and quality assurance and how those considerations may impact key properties. The PRP characteristics outlined in this guide were selected based n a review of contemporary scientific and clinical literature but do not necessarily represent a comprehensive inventory; other significant unidentified properties may exist or be revealed by future scientific evaluation. This guide provides general recommendations for how to identify and cite relevant characteristics of PRP, based on broad utility; however, users of this standard should consult referenced documents for further information on the relative import or significance of any particular PRP characteristic in a particular context.
1.2 The scope of this guide is confined to aspects of PRP and platelet gels derived and processed from autologous human peripheral blood. Platelet-rich plasma, as defined within the scope of this standard, may include leukocytes.
1.3 The scope of this document is limited to guidance for PRP and platelet gels that are intended to be used for TEMPS or for cell therapy applications. Processing of PRP, other platelet concentrates or other blood components for direct intravenous transfusion is outside the scope of this guide. Apheresis platelets and other platelet concentrates utilized in transfusion medicine are outside the scope of this document. Production of PRP or platelet gels for diagnostic or research applications unrelated to PRP intended for TEMPS or cell therapy is also outside the scope of this guide. Fibrin gels devoid of platelets are also excluded from discussion within this document.
1.4 This standar...
- Guide8 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
3.1 This guide provides information for the sampling of seized-drug submissions.
3.2 The principal purpose of sampling in the context of this guide is to answer relevant questions about a population by examination of a portion of the population. For example:
What is the net weight of the population?
What portion of the units of a population can be said to contain a given drug at a given level of confidence?
3.3 By developing a sampling strategy and implementing appropriate sampling schemes, as illustrated in Fig. 1, a laboratory will minimize the total number of required analytical determinations, while ensuring that all relevant legal and scientific requirements are met.
SCOPE
1.1 This guide covers minimum considerations for sampling of seized drugs for qualitative and quantitative analysis.
1.2 This guide cannot replace knowledge, skill, or ability acquired through appropriate education, training, and experience and should be used in conjunction with sound professional judgment.
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- Guide4 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This test method should generate data to identify the majority of chronic effects and shall serve to define long-term dose response relationships. In addition the test should allow for the detection of general toxic effects including neurological, physiological, biochemical, and hematological effects and exposure-related morphological (pathology) effects.
5.2 This test method should provide information on target organs, the possibilities of accumulation, and may be used for establishing safety criteria for human exposure. It provides information on potential health hazards likely to arise from repeated exposure over a long period of time.
SCOPE
1.1 This test method covers a long-term study to determine the effects of a substance in a mammalian species such as the rat following prolonged and repeated oral exposure. Under the conditions of the chronic toxicity test, effects that require a long latency period or that are cumulative should become manifest.
1.2 This test method assumes that the user is knowledgeable in mammalian toxicology and related pertinent areas, and relies heavily on the judgment of the evaluator.
1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For specific hazard statements, see Section 6.
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ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
- Standard57 pagesEnglish languagee-Library read for1 day
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Different dedicated measures need to be taken for preserving blood cell free circulating DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations -Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification.
Pathogen DNA present in blood is not covered by this Technical Specification.
- Technical specification21 pagesEnglish languagee-Library read for1 day
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage.
Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in FprCEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4].
Pathogen DNA present in blood is not covered by this Technical Specification.
- Technical specification15 pagesEnglish languagee-Library read for1 day
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage.
Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in FprCEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4].
Pathogen DNA present in blood is not covered by this Technical Specification.
- Technical specification15 pagesEnglish languagee-Library read for1 day
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Different dedicated measures need to be taken for preserving blood cell free circulating DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations -Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification.
Pathogen DNA present in blood is not covered by this Technical Specification.
- Technical specification21 pagesEnglish languagee-Library read for1 day
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage.
Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification.
RNA in pathogens present in blood is not covered by this Technical Specification.
- Technical specification20 pagesEnglish languagee-Library read for1 day
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