Field logisticsHow is the specimen collected? What supplies are needed?The requirements for specimen collection are driven entirely by the specimen type and assay procedures. Once the decision is made about what is to be measured, the research staff should consult a laboratory expert in that assessment to help develop collection and storage protocols. The laboratory manuals, used by the National Health and Nutrition Examination Survey (NHANES), provides detailed information about specimen collection and storage. Several CPC projects have collected specimens, including the following:
The following have not been collected by CPC projects, but should be considered if the resulting measurements aid the project goals.
Does the specimen require a cold chain between the collection site and the laboratory storage or assay site?The need for a cold chain (rapid refrigeration or freezing) from the point of specimen collection to the lab for assay can preclude inclusion of a biomarker in a study. Therefore, it is important to consider the study site and available resources when evaluating whether a specimen can be collected in the field. In many cities, sources of dry ice can facilitate shipment of specimens to other sites (e.g., labs in the US). In some countries, liquid nitrogen may be more readily available than dry ice. These logistical arrangements must be in place prior to the start of field work. The number of high-quality rapid assays and tests that can be used in the field has increased dramatically in the past few years. Such test kits may allow inclusion of an assessment in a population-based field study now that could not have been considered 10 years ago. How is the specimen processed for assay or storage?For details about processing or storing specimens, consult the lab that will conduct the assay and/or the assay kit instructions. Most kits provide detailed protocols about collection materials and procedures, and how to store and ship the specimen. Most manufacturers also have technical support available via email or phone to answer questions about specific protocol issues. How will the specimen and any associated aliquots be labeled?Labeling the specimens is critical to tying the assay results to information the individual provided through questionnaires or other sources. Handwritten labels have been used routinely, recording subject ID number, collection date, specimen type (if needed), and any other critical information. Some CPC projects are now using bar codes that code this information and allow scanning within the laboratory when specimens are pulled to be sent for assay or when the assays are done. If the specimen is to be frozen, it is critical to use cryolabels that have a special adhesive that can withstand extremely cold temperatures, and handwritten labels should be made with special markers available from laboratory supply sources that can withstand being wet or frozen at ultralow temperatures. How and where should specimens be stored?Promising developments for population-based research include specimen collection and assay techniques that do not require refrigeration or freezing, including rapid field assessments (e.g., pregnancy tests, glucose monitors) and filter-paper blood spots. Unfortunately, many assessments of interest cannot be done on such specimens (e.g., sensitive hormones, some sexually transmitted diseases) and require storage in refrigerators or freezers, some requiring ultralow temperatures such as -80° C. How can freezer storage problems be averted?Research specimens should not be stored in a self-defrosting freezer because heater coils in the walls of the freezer that melt the frost can also melt specimens, compromising their quality. Other considerations include having backup freezer space or loaner freezers available in case of freezer failures, backup generators for power failures, and alarm systems that monitor the freezer temperature. Alarms in the CPC freezer room monitor the power supply and the temperature of all freezers; campus HVAC staff provide service and loaner freezers as needed. CPC also has a generator to connect to the freezer room in case of extended power outages. Such arrangements for remote field sites are not likely to be available; however, the researcher needs to consider what precautions are feasible (e.g., liquid nitrogen, generators) and include them in the planning and budgeting for biomarker collection. What special training is required for staff?The collection of biological specimens requires additional planning and consideration when selecting field staff. Blood collection requires phlebotomy training, and all other protocols are likely to require special training in handling equipment, collecting, storing and shipping specimens, and ensuring compliance with Universal Precautions for handling potentially infectious materials. What are the OSHA and other safety precautions for handling and disposing specimens?The safety of the field and laboratory staff is critical to any project collecting biological specimens. Certain specimens pose a low risk to study staff (e.g., saliva and blood spots), while collection and handling procedures can pose a significant risk (e.g., venipuncture and blood processing). The UNC Environment, Health, and Safety office requires anyone handling specimens (including moving boxes of them) to go through blood-borne pathogen training. Training information is available to UNC projects through this office. At the Environment, Health, and Safety Web site, see Training, or go to Self Study Units for online classes. What are the US and international requirements for shipping biological specimens?The International Air Transport Association's (IATA) information about shipping dangerous goods provide detailed guidance for the transport of biological specimens via any air carrier. Additionally, US government regulations for handling hazardous materials, which differ somewhat from the IATA guidelines, govern the handling of such specimens within the US. Proper packing materials, labels, and shipping documentation are critical. The Federal Aviation Administration can inspect research activities including training records regarding the handling of specimens for shipment by research project staff and can impose substantial fines for improper handling.The UNC Environment, Health, and Safety office can provide this training to field staff and will maintain training records to satisfy an FAA inspection. What is the best way to ship the specimens to the lab doing the assays?The laboratory doing the assay should be consulted regarding shipping requirements. It is customary to ship frozen specimens in dry ice via an overnight carrier. Such shipments should occur early in the week to allow for delays or problems in shipping. Dry ice is available from the UNC Scientific Storeroom for such shipments. The receiving lab should be notified when the shipment is sent, and that lab should report back to the research project staff when the shipment is received.
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