Sample collection protocol

Regardless of species chosen in the final design, it is assumed that in most cases sampling would be done aimually. In addition, sample collection protocols (including considerations of season/time of year, age, sex, tissue, and samphng location within tissue) would have to be clearly specified. 

The QAPP included a QA/QC (quality assurance/quality control) sample collection protocol for the field data collection phase as well as for the laboratory analysis phase. 

Sample collection procedures for CDU may contribute to variability observed among CDU measurements. Sources of variation attendant to sampling include time-of-day, the interval since ingestion of liquids, and the introduction of external contamination during the collection process. Therefore, to minimize contributions from these variables, strict adherence to a sample-collection protocol is recommended. This protocol should include provisions for normalizing the conditions under which urine is collected. Every effort also should be made to collect samples during the same time of day. 

PbU as a measure of spontaneous, i.e., unstimulated, Pb excretion has not typically been a Pb-exposure biomarker with wide laboratory or diagnostic popularity for various reasons. First, early efforts at analytical measurement were plagued by various technical problems of matrix complexity, sensitivity, and specificity along with questions about reliable sample collection protocols and the most reliable way to index a PbU measurement 24-hour collections in outpatients, 24-hour collections adjusted for specific gravity, PbU level/liter urine, and PbU excretion rate per unit mass of creatinine. PbU as an adjunct measure in chelation therapy or provocative Pb chelation for evaluating the toxicologic ally active fraction has been less of a problem, inasmuch as the amounts of PbU were much higher than encountered in spontaneous excretions. 

Rule 1 All samples have been treated exactly the same. This means that a protocol has been developed for the entire process of sample collection, storage, and use. The defining of the sample collection protocol must be done with three main points in mind ... 

In the development of the sample collection protocol, one must keep in mind what is reasonable in the real world. If blood samples are being collected by a nurse in a hospital (for example) it would be unreasonable to think that the samples could be aliquoted and frozen 20 min after collection. 

Example Sera proteomic study. Here is an example of a sample collection protocol that is being used for sera proteomics study in a hospital. 

OPPTS 860.1500, p. 16, indicates that 3-5 sampling points should be included in the decline trials. For applications close to the normal harvest time, the RAC may be harvested at selected intervals between the time of final application and a normal harvest or slightly delayed harvest. If the application is made long before the normal harvest, then representative plant tissues (including immature RAC) may need to be harvested in order to stretch the harvest period. A single composite sample is all that is required from each selected time point, but two or more samples may be harvested to reduce uncertainty about the actual amount of residue present at each sample time interval. These decline samples should be collected and treated the same as normal RAC samples. The samples should be frozen as soon as possible after collection. The instructions for decline sample collection and handling described in the protocol should be followed closely. 

To be successful, an LSMBS requires a clear definition of the responsibilities of each participating individual or group. Preparation of an organization chart may be appropriate, as would its inclusion in the study protocol. Key study participants could include Study Directors, Principal Investigators in the sample collection and analytical phases, sponsor representatives, technical consultants, residue analytical laboratories, and QA specialists. 

The industry task forces (ARTF, ORETF, and others) are generating model protocols, efficient and accurate methods of sample collection, and analytical methods of appropriate detectability for use in field-worker exposure studies. Subsequently, the task forces are conducting field studies that will generate data for inclusion in several generic databases. It is understood that the databases will be the property of the member companies who have financed the work of the task forces. It is hoped, however, that the task forces will see fit to publish their protocols, methods, study designs, and other useful information in a volume like this one so that other scientists working in this discipline may access the information. 

The actual means by which pharmacokinetic information is collected is through the conduct of one or more specific studies, employing a wide range of available analytical techniques. Administered therapeutic molecules can be identified and quantified in relevant samples collected in accordance with carefully designed and executed protocols. 

Type of Container to Be Used. The specific type of contained used to collect blood or urine samples is sometimes indicated in a protocol, especially if a special anticoagulant or additive is required or if other specific conditions of sample collection and handling are required. It is generally not necessary to provide this information for commonly requested laboratory tests. 

In some cases, when petroleum and/or petroleum products are released to the environment, a free phase is formed and sample(s) of the hydrocarbon material can be collected directly for characterization. The ability to analyze free product greatly aids the determination of product type and potential source. The samples may be diluted prior to analysis EPA SW-846 3580 (waste dilution) gives some guidelines for proper dilution techniques. However, caution is advised since as part of the initial sample collection procedure, water and sediment may be included in the sample inadvertently. Several protocols involved in initial isolation and cleanup of the sample must be recognized. In fact, considerable importance attaches to the presence of water or sediment in crude oil (ASTM D1796, D4007), for they lead to difficulties in other analyses. 

System installation in a permanent location may require a sample conditioning system featuring some degree of automation, such as automatic cleaning (the system illustrated above features such a system) and outlier sample collection and the need to interface to an existing control system process computer. The latter may require that the system operates with a standardized communications protocol, such as Modbus, for the chemical industry. Certain specialized industries use different protocols, such as the semiconductor industry, which uses SECS and SEC-11 protocols. A standardized approach designated the Universal Fieldbus is another method/protocol for process analyzers which is being supported by certain hardware manufacturers. 

Samples are treated much like chemicals (excerpts 3F—3H). Complete sentences are used, and information is shared about the sample source and selection process. If sample collection follows an established procedure (e.g., a U.S. EPA protocol), that should be noted in the text (see excerpt 3H). 

Sample Collection. Multiple samples of PM2 5 that were used in the mechanistic studies were collected at the Louisiana Department of Environmental Quality station 0.1 mi from Interstate highway I-IO and 1.5 mi east of the junction of I-IO and 1-12 in Baton Rouge, LA, using the U.S. ERA protocol RFPS-0498-117 and a Rupprecht Patashnick Partisol-FRM model 2000 air sampler. Samples of PM 5 from the other four... 

These research efforts have resulted in many sampling and analytical methods for determining workplace exposures to toxic substances. However, there are still many substances for which no suitable methods exist. Much of the information and developmental protocols used in this study can be applied to future studies on these and other substances. In addition, some of the sorbents used for sampling may be directly extendable to passive monitor sampling. There is still a great deal to learn in the area of sorption and sample collection. 

Finally, we would like to point out that the statistical protocol for validation deals mainly with the last step in determining the validity of a monitoring method. The statistical protocol is not appropriate for application to a method that has not been completely developed. Tests for such items as sample collection efficiency, stability, and recovery sampler capacity and analytical range and calibration all should be evaluated prior to application of the statistical protocol in connection with laboratory validation testing. 

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