Reduces laboratory time and risk of errors
Advances in laboratory science and technology may be dominated by large and well-funded global companies, but occasionally, a small operation can make an impact on the clinical laboratory marketplace.
Consider Verichem Laboratories Inc. Since 1988, the small Providence, RI, company, founded and funded by three people, has focused on accurate, protein-based, liquid, clinical-chemistry reference materials for the in vitro market. “Ours is strictly a quality control function,” says Tony DiMonte, Verichem’s president and technical officer. “We’re not in the reagent or instrument business.”
Verichem’s most recent innovation is the first liquid HDL Cholesterol Verifier Kit for calibration verification of HDL and LDL cholesterol wet methods to help clinical labs meet CLIA requirements. “As a company, we wanted to get the accuracy of the National Institute of Standards and Technology (NIST) into products that people can use on a routine basis,” DiMonte says. “If your system can recover a Verichem concentration, it should recover an NIST concentration, since both values are accuracy-based.” The inability of Clinical Laboratory Improvement Ammendments (CLIA) regulations to define the term “accuracy” has left many labs confused about using true concentrations versus consensus targets.
The NIST Standard Reference Material has been costly—impractical for lab use on a regular basis, DiMonte says. So his company dedicated itself to commercializing the NIST accuracy. Its goal: to make the NIST standard more affordable and available for many more labs. Today Verichem has more than 1,400 direct, active customers worldwide plus a substantially larger roster of prospects as labs work toward CLIA compliance. Those customers include private medical labs, hospital labs, reference labs, and many of the largest manufacturers of analyzers.
From the day the HDL Cholesterol Verifier Kit became available last year, major analyzer vendors have used it for calibration verification during initial installations. Their positive “word of mouth” about the kit’s good design, uncommon stability, and ease of use has generated increasing inquiries and orders, DiMonte says.
In the past, clinical chemists were faced with reconstituting their HDL reference materials. That task was time-consuming and increased the possibility of errors in the lab. DiMonte says his company’s HDL Cholesterol Verifier Kit takes freeze-dried HDL calibrators (used in direct-reacting tests) and puts them in liquid format. The kit can serve as both a six-level calibration kit or work as a CLIA tool. Verichem’s kit contains up to 400 mg of human LDL and up to 200 mg of human HDL. Protein balance, pH, and ion content are constant across the six levels. That, says DiMonte, assures optimum linearity for even the most sensitive methods. The Verichem formulation is free of surfactants, glycols, and azide.
Verichem’s lipoprotein cholesterol reference material may be the first to be produced with 100% human serum lipoproteins with refrigerated storage, according to DiMonte. Verichem’s proprietary manufacturing process eliminates matrix variations common to other serum-based products. A by-product of the process is an unprecedented stability, DiMonte says.
In recent years, the trend has been toward the use of direct-reacting cholesterol reagents that use human serum calibrators or controls that are freeze-dried or frozen. But the new methods used for automating lipoprotein cholesterol are very sensitive to matrices, whether the formula was frozen or thawed, derived from humans or bovine-based. The result of these developments: calibrators and controls that are system-specific. In response, the new Verichem product breaks through this technical barrier; the new kit is universal and compatible with any method.
The Verichem product’s set-point design and matrix formulation reflect the latest approach toward lipoprotein reference material. Free of interfering substances, the matrix provides excellent performance with a wide selection of assays. Verichem’s serum-like matrix contains a critical blend of purified human serum albumin, human serum globulin, and bovine gamma globulin in saline.
The new cholesterol kit’s highly purified source materials help eliminate matrix variations and inaccuracy —a condition that seems to plague many serum-based products. “Pure source materials in combination with our stringent manufacturing tolerances and an exclusive stabilization process yield a verifier material with predictable recovery from lot to lot,” says Steven Pichette, Verichem’s co-owner and production manager.
Each HDL Cholesterol Verifier Kit contains one six-level set with 5 mL on each level, a product insert, Value Assignment Sheet, and organizer tray. The company packages the fluids in translucent polyethylene dropper vials. When properly refrigerated from 2° to 8°C, the kit offers a current shelf life of 12 months from the date of its manufacture. As Verichem produces more lipoprotein lots and gains more information on performance, it plans to extend dating to 18 months or more in its current unfrozen form.
“We’re a small company, and initially we rejected some OEM requests because we wanted to make sure our lipoprotein product could provide all the stability and universal appeal we felt was essential,” DiMonte says. “But now we’re ready for OEMs and going after them.” That includes reaching out to prospects in Europe and Canada. DiMonte believes Verichem’s advances in lipoprotein purification and stabilization will contribute to a higher standard in the important area of cardiac risk assessment.
Verichem has compensated for its initial lack of capital through hard work and skillful research, DiMonte says. “We’re dedicated to getting NIST accuracy links into the laboratory,” he continues. “We do not supply consensus targets or ranges. Instead, we give absolute or true concentrations and encourage labs to abide by CLIA tolerance limits.”
Each new Verichem offering has reflected a technical advancement. One of its early offerings—a liquid, protein-based Electrolyte Standard Kit for direct reading ISEs—was the first of its kind on the market. In 1992, Verichem introduced the first liquid, protein-based Matrix Plus™ Chemistry Reference Kit. A year later, Verichem debuted its Matrix Plus™ Cholesterol Reference Kit. The kit featured universal reference concentrations for total cholesterol and uric acid in liquid form.
Verichem began offering its liquid microprotein reference material with gravimetric concentrations in 1995. The company’s liquid Enzyme ER™ Verifier Kit—containing eight routinely monitored serum enzymes including lipase—first went on the market in 1999. Recently, Verichem released the only liquid standard reference material for urine chemistries in five levels: the Urine Chemistry Standard Kit.
The Verichem menu includes more than 40 routinely tested analytes in five or six concentration levels. Many of its standard reference materials are available to instrument manufacturers as FDA Class II Chemistry Calibrators.
For additional information, contact Lisa DiMonte, marketing director, Verichem Laboratories Inc, 90 Narragansett Avenue, Providence, RI 02907; (401) 461-0180; (800) 552-5859; fax: (401) 467-1540.
Nicholas Borgert is a contributing writer for Clinical Lab Products.
