Specimen collection and transport is not the sexiest aspect of laboratory technology, but it is where it all begins and where it can all go wrong. A bad sample will mean bad results. “If a specimen is not collected correctly, transported correctly, or preserved correctly, the result could be nonsense,” says Norman Sharples, executive VP of Copan Diagnostics Inc, Murrieta, Calif.
Specimen collection and transport technology varies with the type of specimen, the test to be run, and the manufacturer. Standardization is therefore one of the bigger challenges. “When laboratories have to use different products from different manufacturers, there are a range of issues,” says Jeff Papi, SM(ASCP), senior vice president of marketing, product development, and technical support for PML Microbiologicals, Wilsonville, Ore.
These include staff training. Users must be educated on which collection tool should be used for which specimen as well as how to collect that specimen and preserve it properly. A lack of standardization across manufacturers can lead to confusion with color schemes and labels, but proper training and management can eliminate potential problems. “Laboratories need to maintain processes and assure that sites don’t have out-of-date materials on hand and that proper storage is always possible,” Papi says.
Wasted space can be a large problem with laboratory and specimen storage. “Specimen storage formats are not conducive to stacking or other efficient storage methods, which can result in haphazard storage, particularly in small labs without a big electronic system,” says Kacey Wiley Pouliot, product manager for sample storage and microplates with Thermo Fisher Scientific, Waltham, Mass.
This can make it difficult to find specimens when needed. Additional dangers lie in losing the labels while in transport or in storage. Adhesive labels can fall off while handwritten labels can be obliterated. “Everything is lost with a lost label,” Wiley Pouliot says, citing traceability, safety, biohazard, and efficiency concerns.
Despite the importance of accuracy in this portion of preanalytics, few manufacturers devote themselves to this technology entirely. “There is lots of investment in testing, but very little research and development in the front end, which has become more of a commodity,” Sharples says.
“There was a day when there were studies performed on collection systems and there was a fair amount of literature generated with different types of transport media for microbiology collection in particular,” Papi says, concurring that specimen collection and transport is now a commodity. Yet, he notes, there have still been many changes.
The challenge lies in determining which new systems are reliable and proven. “It’s important for laboratories to do their own qualifying because there aren’t a lot of third parties that do those studies anymore. So it’s one of the challenges laboratories will face, especially as new products are developed,” Papi says. But the effort may be worth it since new systems can offer improvements over previous methods and technologies.
Copan is one of the few companies that has devoted its entire portfolio to specimen collection and transport. Subsequently, it can lay claim to some of the innovations that have occurred in the past decade. One of those is the flocked swab.
According to Sharples, ESwab is the first collection and transport system to have been cleared by the FDA since the CLSI performance standards were implemented in 2003. The system uses flocked swabs, in which the mattress core of traditional swabs is replaced with short, perpendicular nylon strands. They pull in more sample with capillary action and also release more. The swab is placed into a tube with buffer or preservation media into which the specimen elutes, providing the microbiology lab with a liquid specimen at delivery.
“We’ve spent the last 10 years trying to do the best job we can in preserving samples, but the elephant in the room was always access. Mattress swabs were called mattress swabs because they absorbed well but released badly,” Sharples says. The different material and shape of the flocked swab permits more of the sample to be drawn in and then eluted than with traditional swabs. Only about 20% of a sample will elute from a mattress swab versus 80% from the flocked swab. “The ‘e’ in ESwab stands for elution,” Sharples says.
The difference in the amount and type of specimen has a positive impact for the lab. A greater volume of specimen means more tests can be run. “In the past, when you had a swab sample, you had one swab. If you did a rapid assay, you used your sample and could do nothing else,” Sharples says. With 1 milliliter of sample collected with the ESwab, the lab can run multiple tests. “There will be enough for antigen testing, culturing, PCR, and the archive,” Sharples says.
More sample also can mean more accurate results for an individual test. Sharples notes that rapid antigen tests lack the amplification step common to PCR and nucleic assay testing, meaning the results are more dependent on the amount of sample. “With the flocked swab, QNS (quantity not sufficient) results have almost disappeared,” Sharples says.
A final advantage, Sharples notes, is the work that is saved by the technologist. “With the ESwab, because the sample elutes automatically into solution, we now have a swab sample that is totally liquid and can be handled with a liquid handling system,” Sharples says. This will free technologists from the time-consuming “drudgery” of planting and streaking.
To realize this potential, the company has introduced WASP, an automated accessioning system. The instrument is able to accession, plant, and streak samples, including urine and ESwab specimens. Designed to be an open system, it also will accept samples from other manufacturers. The value lies in freeing up personnel for other, more complicated tasks. “A laboratory could see a return on their investment within 3 years,” Sharples estimates.
|In the ESwab system, the traditional mattress core of a swab is replaced with perpendicular nylon fibers, creating greater capillary action.|
|Copan’s WASP is an automated accessioning system designed to remove the manual element of planting and streaking.|
|Thermo Fisher Scientific’s 2D barcoded tubes are stackable to save storage space and share a microplate footprint compatible with liquid handling systems and multichannel pipettes.|
|Copan offers collection devices for a wide variety of specimens and tests.|
Returns on investment are typically much more vague with specimen collection and transport systems, though the cost of a bad specimen can run quite high. There are economic and medical ramifications if the wrong laboratory diagnosis is given because the wrong specimen was collected and used. “The problem is that nobody really knows. If you have a culture that yields no growth in a patient with an infected wound, how do you know if it was the quality of the specimen or the collection system, or if it was truly an accurate result?” Papi asks.
Proper workflow can help to ensure meaningful results. “Proper specimen collection, which includes everything from the right container with the right label and the right handling—meaning it hasn’t been exposed to the wrong temperature—improves lab workflow tremendously because the specimen can be processed with 100-percent integrity and no questions about it having been compromised,” Papi says.
Training and documentation are often part of this workflow. Most laboratories have standard operating procedures that govern not only the collection process but also the transit time and temperature storage. “Time and temperature are two of the biggest areas a lab has to deal with,” Papi says. If not delivered at the right temperature or within the right time frame, a specimen can begin to overgrow.
Typically, the time of collection is recorded at collection point, which provides information for the lab to determine if process has been followed. Steps such as these become more valuable when staff is not available to run specific tests 24 hours per day.
To ensure compliance, labs and manufacturers offer training. “I’ve been involved in previous companies where a technical representative would do in-services on the three different nursing shifts to make sure it was known how to use the transport system,” Papi says.
More companies are offering dedicated transport systems for specific specimens and tests. PML Microbiologicals customizes labeling and procedural charts, which laboratories can distribute to the collection sites. “By customizing these procedural sheets, it helps to get compliance on the proper use of the collection device. By customizing the labeling, it can also get compliance from patients, when they are actually collecting the specimen themselves,” Papi says.
PML offers a wide variety of collection and transport systems. Products include systems for collecting throat and wound samples, swab-based systems, a broad line of fixatives, and transport vials for stool samples. “We have some unique products, including one called EPT—enteric pathogen transport,” Papi says. The product is offered in a variety of customized containers designed to improve the collection of fecal samples.
One of the biggest areas for development, according to Papi, is a universal transport method, something that can collect a specimen that can then be used for a molecular test or a standard microbiology culture or a rapid test. “It’s kind of the holy grail, but no one has yet been able to develop something that is truly a universal transport,” Papi says.
Since there is currently no such product, hospitals must split specimens. Some do this in a specimen-accessioning area where the specimen is split and then sent to the various labs; others barcode the specimen immediately and then track it through the various laboratories using the LIS. “[The latter] is the preferred method, but in some situations, where, for instance, the laboratory is split throughout the hospital or there is an off-site lab, the specimens are more often split,” Papi says.
IDENTIFICATION AND STORAGE
Barcoding is preferred because it helps to ensure specimen integrity. However, at Thermo Fisher Scientific, a barcode label does not provide 100% security. Labels can fall off, and when they do, the specimen is no longer viable—all traceability and proof are gone.
To avoid the risk of losing a label, Thermo Fisher Scientific has designed tubes with the barcode etched onto the container itself. “They are very robust. We’ve never had a complaint regarding a code that can’t be read, and we have one hundred million tubes out there,” Wiley Pouliot says. Not only can the barcode not be lost, but it is also a unique identifier so there is no chance of a duplicate ID sample.
The codes can be read by a barcode reader, also available from the company, which provides both single-tube and multiple-tube reading options. The data can be imported into simple electronic documents, such as Excel spreadsheets, or more sophisticated systems, such as a LIS. “The readers work with any system the customer already has set up,” Wiley Pouliot says.
The system can help technologists save time as well as reduce errors. On the front end, the tubes save time eliminating the manual work in hand labeling and sample recording. On the back end, they save time locating specimens and retrieving information. “it’s a more standard way to get things accomplished. If tied into the LIMS, it can save time searching through computer files or unorganized notebooks,” Wiley Pouliot says.
Another advantage provided by the tubes impacts storage. To create space efficiency, the 2D barcoded storage tubes are stored in a very dense stackable format. Racks of the tubes come in 24, 48, or 96 with lids that pivot on and off. “You can store a large number of tubes densely in a specific spot and tie those locations into the information management system. It’s nice to tie in rather than have a mishmash of tube racks in a freezer or refrigerator,” Wiley Pouliot says.
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Stackable storage prevents wasted space as well as haphazard storage. In addition, the racks have a microplate footprint that matches the standard for automated liquid handling as well as multichannel pipettes.
The investment depends on the needs of the laboratory. Smaller labs may just need a single barcode reader and a smaller volume of tubes, while larger labs may mean multiple barcode readers and a lot more tubes. The return on the investment, however, is found in the time saved by the technologists, the greater efficiency in storage, and the reduced errors, which can impact the bottom line and the quality of results negatively. “The implications are often immeasurable,” Wiley Pouliot says. Specimen collection and transport may not be sexy, but it does have an impact.
RENEE DIIULIO IS A CONTRIBUTING WRITER FOR CLP.