The AtheNA Multi-Lyte® Test System: becoming the new gold standard.

The AtheNA Multi-Lyte® test system uses multiplexing and microsphere-based immunoassay technology to offer a simple and streamlined alternative to subjective IFA and labor-intensive ELISA.

• Based on powerful xMAP® technology, which allows for simultaneous measurement of multiple analytes in a single assay.
• Provides both qualitative and quantitative detection.
• Intra-Well Calibration Technology®1 provides patient-specific calibration ensuring accuracy and virtually eliminating drift.
• Reduces the number of steps required by 50% when compared to typical IFA and ELISA tests.
• Provides 50-times the confidence of IFA and ELISA†.
• Reduces hands-on labor costs by up to 95%*.
• SAVe DiluentTM color-changing diluent assures sample verification and increases confidence that no well is missed.

The AtheNA Multi-Lyte® Test System has the capability to:
• Report individual analytes separately and/or simultaneously.
• Generate additional results long after the sample is discarded, by analyzing data stored within the system.

Wampole Laboratories offers the broadest FDA-cleared xMAP® technology testing menu on the market today – the Autoimmune tests currently available for the AtheNA Multi-Lyte® System, include a 10 test ANA panel, ANCA, RF, and TPO/Tg.

ANA Test System

Using patented multiplexing xMAP®technology, the AtheNA Multi-Lyte® ANA Test System:

• Simultaneously performs ANA screening and reflex testing for 9 specific auto-antibodies:
– DsDNA
– Scl-70
– SSA
– Jo-1
– SS
– Centromere-B
– Sm
– Histones
– RNP

• All from one sample. All in one well. The system provides significant savings in cost and improvements in productivity:
• No need to split samples.
• No need to purchase or inventory 10 different immunoassay kits.
• Test all 10 significant ANA markers with one system, one kit, in one hour.
• Reflex results are more accurate because you perform testing on the same sample at the same time as the ANA screen.
• Report additional auto-antibodies without having to re-test the sample, because you’re able to archive all test results.

TPO/Tg Test System

• The AtheNA Multi-Lyte® TPO/Tg Test System is used to detect IgG class antibody to Thyroid Peroxidase (TPO) and Thyroglobulin (Tg) in human serum simultaneously in a single well.
• The AtheNA Multi-Lyte® TPO/Tg Test System has been calibrated to standards provided by the World Health
Organization (WHO). TPOhas been calibrated to WHO66/387 and Tg has been calibrated to WHO 65/93.

Rheumatoid Factor (RF) Test System

• The AtheNA Multi-Lyte® Rheumatoid Factor Test System is used to detect Rheumatoid Factor IgM in human serum.
• The AtheNA Multi-Lyte® Rheumatoid Factor Test System has been calibrated to a standard provided by the World Health Organization (WHO). It has been calibrated to WHO 64/2.

ANCA Test System

• The AtheNA Multi-Lyte® ANCA Test System, is used for the qualitative and semi-quantitative detection of 2 separate IgG class anti-neutrophil cytoplasmic anti-bodies (ANCA) – Myeloperoxidase (MPO) and Proteinase 3 (PR3) – in human serum simultaneously in a single well.
• The test system may be used as an aid in the diagnosis of various autoimmune vasculitic disorders, such as Wegener’s Granulomatosis, ICGN, MPA and PRS.

The AtheNA Multi-Lyte® Test System

A High-Performance, Step-Saving Alternative to IFA & ELISA

The new AtheNA Multi-Lyte® test system is a breakthrough in diagnostic testing. Now laboratory technologists have a simple alternative to indirect fluorescent assay (IFA) and enzyme-linked immunosorbent assay (ELISA) tests.

• Based on the Luminex® xMAP® technology, this multiplexed, micro-sphere-based immunoassay is far more advanced than conventional IFA and ELISA methods.
• The AtheNA Multi-Lyte® system allows you to perform multiple assays in 1 well—an accomplishment that can never be achieved using conventional IFA and ELISA methods. For example, it can perform both an ANA screen test and a battery of reflex tests, including dsDNA, SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere-B and Histones, simultaneously. All from one sample. All in one well.
• The AtheNA Multi-Lyte® System eliminates the need to have patients with positive results return for another sample draw, and another round of costly, time- consuming tests to differentiate the diagnosis.
• This breakthrough technology saves the lab valuable time and money, leading to faster diagnosis and start of treatment.

Qualitative & Quantitative Results

• Each microsphere set is treated with a unique combination
of two fluorescent dyes and conjugated to a different antigen making it possible for the system to identify
mixed microsphere sets.
• Different microsphere sets are mixed together in a single
well to create a multiplexed assay capable of simultaneously analyzing a single specimen for up to 100 multiple analytes.
• As the microspheres in a fluid stream pass through the
instrument’s two laser beams, high-speed digital signal
processors and computer algorithms distinguish which
assay is being carried on each bead. It quantitates the
reaction based on fluorescent reporter signals.
• Using the AtheNA Multi-Lyte® instrument, reactions are read on every microsphere at a rate of up to 20,000 microspheres per second.
Accuracy in Every Well

The AtheNA Multi-Lyte®system’s innovative proprietary Intra-Well Calibration Technology®
and SAVe DiluentTM provide added confidence in result accuracy.

• Intra-Well Calibration Technology®includes a multipoint standard curve within the microsphere suspension. Each patient sample is calibrated internally without any user intervention. The standard curve is designed to self-adjust based upon the unique characteristics of the patient or control serum.
• Sample verification is accomplished visually through
Sample Addition Verifier (SAVe) DiluentTM. This proprietary color-changing diluent is visible throughout the sample incubation interval and increases confidence
that no well has been missed, and assures the highest quality of results.