Advanced Desiccant Solutions Improve Diabetes Diagnostic Kits

• By Nancie Hudson, Mark Schmitt
• Nov 01, 2000

There are approximately 15.7 million Americans suffering from diabetes, a hormonal disorder in which the body is unable to produce or properly use insulin to convert sugar and starch. Each day 2,200 new cases are diagnosed, making it the fastest growing disease in the United Stares. Since diabetics are unable to process glucose efficiently, diagnostic tests to monitor glucose concentrations in the bloodstream are essential. Patients must ensure that glucose levels do not rise too high, requiring the tests to be performed several times a day.

San Diego-based LXN Corp. manufactures three diagnostic kits exclusively for diabetes control: the Duet for healthcare professionals and the InCharge and ExpressView for patient use at home. Such kits require desiccants for stringent moisture protection since once test strips are exposed to moisture, they start losing effect almost immediately.

Recently, LXN switched to an advanced desiccant technology for its tubes and stoppers and saved 60 percent in package protection costs by using the diagnostic-PAK from SÚd-Chemie Performance Packaging, located in Belen, N.M. (Formerly known as United Desiccants/Humidial, the company's new name more clearly reflects its global ability and commitment to provide value-added packaging solutions for a broad range of applications, and symbolizes a strategic focus and capability to design and manufacture custom packaging products for the pharmaceutical, electronics, diagnostics, nutraceutical and shipping industries.)

In addition to providing superior moisture protection, SÚd-Chemie customized the diagnostic-PAK tubes to add protection from light exposure and helped LXN meet production goals more efficiently by cutting supply lead time in half.

"The switch to diagnostic-PAK has improved our product," said Ralph Hanna, LXN's director of materials. "We are a growing company. SÚd-Chemie was able to work with our volume requirements, and they offered us local storage options, helping our operations run much more smoothly."

LXN's kits are sold through multiple levels of distribution, making the time from manufacture to actual use as long as one year. Without moisture protection, the shelf life of these diagnostic kits would be a week at best.

"Moisture and dry reagent diagnostic test strips are a bad combination," Hanna explains. "Low humidity is therefore the key to diagnostic kit shelf life; it is critical that the desiccants work, and work reliably every time."

LXN, founded in 1994, began selling products in 1998 after several years of research and development. Currently the company packages 15,000 diagnostic-PAK tubes per week, and production has been doubling every quarter, due in part to the rising demand for diabetes care products.

Customizing The Right Tube

SÚd-Chemie's diagnostic-PAK tubes and stoppers are made from rigid, high-density plastic for crush-resistant damage protection. The tubes are two and one-half inches long and one inch in diameter, and desiccants are incorporated directly into the plastic cap. After resealing, the desiccants absorb any ambient moisture from within the tube, protecting strips during the life of the product.

SÚd-Chemie worked with LXN to customize the tube color, offering different samples of colored tubes for LXN to conduct light transmission tests.

"Our products are extremely light sensitive," said Hanna. "Over time, light will actually cause the chemicals in the diagnostic kit to react." LXN chose a shade of black in which the pigmentation was high enough to prevent light transmission. SÚd-Chemie then produced and delivered the desired tube, in the quantity needed, in less than ten weeks. This value-added service came at minimal expense, helping LXN better protect its products without breaking the bank.

LXN uses a paper label on the tubes; however, diagnostic-PAK can also be preprinted with four-color graphics, which improves product appearance and enhances brand value. Preprinted tubes also save on package labeling costs.

The Advantages Over Foil Pouches

LXN uses manual and automated lines to package its kits, and at one point, had considered foil pouch packaging. This is a common option for the diagnostic industry, however it requires the purchase of costly machinery.

"Foil packaging would have been a huge capital investment for us," Hanna said. "Additionally, special feed mechanisms would have to have been put in place, and foil pouching requires that everything be lined up precisely and counted." He explained that when dealing with small plastic strips that tend to be slippery, this can be a logistical nightmare.

LXN also based its choice of tubes and stoppers on customer appeal and user-friendliness.

"Patients don't need to fumble with finding the slit on a foil pouch, and they have all their strips in one place," Hanna said.

New Test Drives Responsibility Back To The Patient

LXN's InCharge kit is the only rapid fructosamine test available for at-home use. The test measures concentrations of fructosamine in the bloodstream, giving patients an indication of overall glycemic control. Fructosamine, a glycated protein, gives patients a measurement similar to the HbA test, a long-range test that measures blood glucose levels over the previous two to three months.

The four-minute InCharge test gives patients a better idea of how effectively they are controlling their diabetes over time.

"Up to now, patients had to focus on daily or hourly glucose levels," Hanna explains. "By taking this test every two weeks or so, patients get an overall picture of their condition. They can make better informed choices concerning diet, exercise and medication, and it encourages them to take more personal responsibility for controlling the disease."

Currently, SÚd-Chemie ships diagnostic-PAK supplies to LXN twice a week, however Hanna expects production of InCharge kits to increase in the coming year.

"SÚd-Chemie has really helped us keep up with production, from ordering to stocking to shipping. The logistics side has been remarkable."

This article originally appeared in the November 2000 issue of HME Business.