Transportation of diagnostic specimens is a major concern for regulators. Diagnostic specimens are typically collected from a patient at a clinical site. However, due to economies of scale and other factors it is often not feasible to conduct the desired tests on the diagnostic specimen at the clinical site. Therefore, it may be necessary to transport the diagnostic specimen from the clinical site to a laboratory to conduct the required testing on the specimen.
Centralized laboratory testing facilities offer economies of scale. Laboratory testing equipment may be very expensive. Due to this significant expense, it may not be cost effective for each clinical site to have such equipment on location in order to analyze the limited number of diagnostic samples collected at that clinic. Centralized laboratory testing facilities, however, provide the ability to make a single investment in laboratory testing equipment with the ability to test samples from numerous clinics. The centralized laboratory facility may perform tests on samples collected at dozens or even more clinical sites.
In order to take advantage of centralized laboratory facilities and the corresponding economies of scale, diagnostic specimens must be transported from the clinical site to the centralized facility. The distance between the clinical site and centralized laboratory facility may be significant, requiring transport through local mail service or private courier service. In order to maintain the diagnostic specimen during transportation, the specimen must preferably be kept in an environment below −20° C. This is done by packaging the specimen in a transport case with dry ice or liquid nitrogen to maintain the proper temperature. Even after the diagnostic specimen reaches the centralized laboratory facility it may need to be preserved for a prolonged period of time. Such preservation is accomplished by placing the specimen in a freezer requiring handling of the specimen packaging.
Problems arise with prior art methods of transporting diagnostic specimens. For example, the pressure vessel described in U.S. Pat. No. 5,509,255 requires a user to place the specimen into an inner specimen bag. The specimen bag is sealed by peeling off the tape, exposing an adhesive. Once the specimen bag is sealed, it is placed in a containment envelope. The containment envelope is sealed by removing the tape and exposing a pressure sensitive adhesive on a flap. The flap is folded towards the body of the containment envelope and sealed. However, pressure sensitive adhesives have been known to fail in temperatures below −20° C. Such a failure of the pressure sensitive adhesive used to seal the containment envelope may expose those handling the bag during transport and storage to the specimen. It is possible that the diagnostic specimen contains an infectious substance, such as the HIV virus. Such exposure to diagnostic specimens during transport is both undesirable and unacceptable to regulators.
Other methods of transportation involve placing the diagnostic specimens in rigid containers. Rigid containers can be problematic for several reasons. For example, when the specimens are packaged with dry ice or liquid nitrogen, under the extreme cold produced by these methods, rigid containers have been known to collapse. Additionally, when the rigid container is removed from the packing conditions and begins to return to room temperature, the container can rupture or explode due to pressure increases from within. A breach in the container could lead to damage to the specimen or to potentially harmful exposure to infectious specimens for individuals.
Central repositories of biological and infectious substances have been a major growth industry recently. Tens of millions of specimens are on deposit with private and government agencies such as the Center for Disease Control, USAMRID and others. These specimens represent a highly valuable resource for researches, public health officials and scientists. Specimens need to be transported to, stored and dispensed from these cites. Typically these specimens are also refrigerated by dry ice or liquid nitrogen at temperatures at least below −20° C. Certain embodiments of the present invention permit the transport of large quantities of specimens in a convenient fashion. Package design is much easier due to the size and flexibility of the containment jacket and inner bladder.