Real Benefits with 3gAllergy™
Run both routine immunoassay and allergy testing at the same time. With a menu of about 350 allergens and allergy panels.

The future is now: DPC's 3gAllergy, the only third-generation allergy assay
Finding the right solution for allergy testing has been a challenge for many—until now. DPC's 3gAllergy™, the only FDA-cleared third-generation allergen-specific IgE assay, is a revolutionary in vitro blood test that has brought laboratories everything they have been waiting for: speed, convenience and quality performance, all in one assay. 3gAllergy stands apart from all others, on the basis of its system attributes and assay design. While its evolution has spanned three generations of technology, 3gAllergy has proved to be well worth the wait.

The first generation
Allergy testing began with the development of the radioallergosorbent test (RAST), which resulted in the detection of allergen-specific IgND antibodies. The presence of these antibodies in serum was concordant with skin testing. The subsequent discovery of IgE prompted the development of the first generation of IgE immunoassays. The acronym RAST has been used as a generic term for in vitro allergy testing ever since.

RAST methodology offers diagnostic values of serum allergen-specific IgE similar to those of the skin prick test (SPT), but RAST demonstrates much higher reproducibility and is the test of choice with patients suffering from severe urticaria and eczema. Another noticeable clinical advantage of RAST concerns patients prone to anaphylactic reactions with exposure to even minute amounts of allergen. In addition, the diagnostic values of RAST are not affected by pharmacotherapy administered for allergy symptoms. RAST became an established laboratory tool to assist in allergy diagnostics on the basis of its clinical features, dependable results, and the convenience it offers patients. In Europe, allergy specialists were receptive to the first-generation RAST methodology.

The second generation
The limitations of first-generation in vitro allergen-specific IgE assays signaled the need for an improved second-generation assay that could be run on an automated instrument. The criteria for development of a second-generation in vitro allergy test focused on the following characteristics:

		Conformance to NCCLS guidelines for precision and functional sensitivity
		WHO (World Health Organization) calibration standardization (75/502)
		Timely incubation (time-to-first-result)
		Superior detection signal
		Improved detection and binding to antibody
		Improved and uniform test results to report IgE classes.

The advent of the second-generation in vitro allergy test, also known as modified RAST (mRAST), turned the second-generation in vitro allergy test into a mainstream assay. On account of several unrelated issues, allergy specialists refrained from fully endorsing RAST and mRAST in the US. The key determining factor for taking this stance was that SPT was deemed to be more sensitive than RAST and mRAST. Owing to the alarming growth of allergy in the US, however (where approximately 50 million Americans suffer from allergy-related symptoms), and since the cost for allergy was approaching $20 billion per year, the American healthcare system favorably incorporated the first- and second-generation assays into its formulary.

Still, the needs of laboratories were not being adequately met. Extrinsic pressures on laboratories mandated substantial improvements to first- and second-generation methodologies for in vitro allergy testing. Economic forces dictated radical changes to improve assay performance and to develop an instrument capable of justifying its cost by addressing the day-to-day expectations of laboratory managers and fulfilling the demands of business managers.

The third generation
A manufacturing pioneer and a worldwide leader in the development of immunoassays, Diagnostic Products Corporation (DPC) was among the few companies that recognized the diagnostic value of IgE in the detection of allergies. During the last 20 years, DPC has dedicated considerable research and development resources towards the latest generation in vitro allergen-specific IgE testing methodology. DPC has successfully transitioned from first-generation in vitro allergen-specific IgE assays to the only FDA-cleared third-generation in vitro allergen-specific IgE assay, marketed under the name 3gAllergy. For a better understanding of the added attributes of first-, second- and third-generation in vitro allergen-specific IgE assays, and how they are differentiated, see Table 1.

Table 1. A generational classification of allergen-specific IgE assays.

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3gAllergy™ runs on the IMMULITE® 2000 and the IMMULITE® 2500 systems. Ask your DPC representative for more information.

The prevalence of allergic disease and the drastic changes in the US healthcare paradigm require that primary care physicians, pediatricians and other medical specialists manage and treat patients with allergies. The ongoing changes in the healthcare system have created a stronger diagnostic role for laboratories.

Early on, DPC recognized the global healthcare market's need for a new in vitro allergy assay and an automated system. During the first DPC International Conference on Allergy, held in June, 2003 in Paris, France, Michael Ziering, President and CEO, announced DPC's commitment to dedicate appropriate resources to allergy diagnostics over the coming years and to provide the most advanced methodology to laboratories, along with the necessary educational programs and support.

3gAllergy has enabled DPC to meet the needs of laboratories of any size. From a simple serum sample, laboratories are able to generate fast and accurate test results that provide physicians with valuable clinical information. DPC's unique liquid allergens contribute greatly to 3gAllergy's sensitivity, specificity and reliability. The soluble polymer/copolymer support for the allergens increases the accessibility of binding sites and their accessibility to allergen-specific IgE antibodies. DPC's proprietary wash technique maximizes the removal of excess reagent and ensures adequate separation of bound from unbound materials.

The enzyme-enhanced chemiluminescence technology allows for greater accuracy and precision compared to other signal detection methods. A zero calibrator ensures a true 0.1 kU/L detection limit. 3gAllergy's calibrators are standardized against the WHO 2nd International Reference Preparation (IRP) 75/502. Assay results are reported quantitatively as well as in standard and extended class scores.

Today's solution
3gAllergy is the right solution for today's laboratories. It is now universally accepted that the gold standard in allergy testing consists of either of the following: 1) a patient clinical history + an in vitro test or 2) a patient clinical history + an in vivo test.

As the unique features and benefits of DPC's third-generation methodology have fulfilled the expectations of laboratories, it is essential to create awareness among physicians. First- and second-generation in vitro allergy tests have demonstrated their usefulness as laboratory diagnostic tests to physicians. Numerous studies have concluded the clinical utility of in vitro allergen-specific IgE tests. 3gAllergy can assist physicians in identifying allergens responsible for evoking allergy symptoms, predicting future allergy development, and guiding clinical management and treatment of allergy patients. Its functional sensitivity of 0.2 kU/L allows for the detection of existing allergies in infants and can help predict the future risk of developing allergy-induced diseases such as asthma¹. It also facilitates timely therapeutic intervention. DPC is determined to cooperate on a worldwide basis with key research centers and opinion leaders to evaluate the clinical significance of third-generation criteria, and share its findings with healthcare providers for the ultimate benefit of patients.