The Return of IFA

Autoantibodies are considered to be significant markers in the diagnosis of autoimmune diseases (AID).


Background

Immunofluorescence Assays (IFA) used for screening of autoimmune diseases have a number of challenges. When performed manually, IFA is laborious, subjective and poorly standardized. With the advent of multiplex technologies in early-2000, the autoimmune community thought it had found a solution, until it became evident that multiplex technologies had limitations, which made them poor candidates for antinuclear antibody screening (ANA). Today, there are 30 to 50 clinically significant autoantibodies outside of the HEp-2 cell, which currently have no method for screening.1

The American College of Rheumatology (ACR) released a position statement on the methodology of testing ANAs, positioning HEp-2 by IFA as the gold standard. In Europe, many countries also mandate ANA screening by IFA.

Around 2005, there was increased demand for IFA automation, and the AI industry responded with solutions for semi-automation. These companies offer a solution based on connecting an existing slide processor (via software) to a microscope equipped with a camera. Such daisy-chained equipment, while an improvement compared to the manual method, still takes an extensive amount of valuable lab space and requires manual intervention (e.g., adding mounting medium and cover slip, transfer of slides from the slide processor to the microscope, etc.).

Complete Automation: HELIOS

AESKU.GROUP has developed the HELIOS: a compact, all-in-one slide processor and reader with result management and interpretation software.

The HELIOS is installed in more than 100 laboratories worldwide. Recent studies have shown that the HELIOS is the fastest (120 samples per hour) IFA processor/reader with the best balance of sensitivity vs. specificity (97.8 percent/94.1 percent).2

In a recent study, the HELIOS performance was assessed for ANA and ANCA detection.3 There was a 95 percent agreement between ANCA IFA performed on the HELIOS vs. the manual method in the investigation of routine samples. Based on these results, the HELIOS demonstrated high diagnostic performance for the automation of ANA and ANCA IFA interpretation. It showed a good correlation among all groups of samples.

With this type of solution, the industry has responded to the laboratory needs for automation, standardization and traceability for IFA methodologies. AESKU remains attentive and continues to innovate both in its systems and in terms of new markers associated with autoimmune diseases. The HELIA is the latest addition to AESKU’s product family for full automation of immunoblotting.

AESKU.DIAGNOSTICSwww.aesku.comPhone: 877-753-6240Booth #2745 1. Tozzoli, R., Bonaguri, C., Melegari, A., Antico, Bassetti, D., Bizzaro, N. “Current state of diagnostic technologies in the autoimmunology laboratory” Clin Chem Lab Med. 2013 Jan;51(1):129-38.2. Bizzaro, N., Antico, A., Platzgummer, S., Tonutti, E., Bassetti, D., Pesente, F., Tozzoli, R., Tampoia, M., Villalta, D., Study Group on Autoimmune Diseases of the Italian Society of Laboratory Medicine, Italy. “Automated antinuclear immunofluorescence antibody screening: A comparative study of six computer-aided diagnostic systems.” Autoimmun Rev. 2014 Mar; 13(3):292-8.3. Shovman, O., Agmon-Levin, N., Gilburd, B., Martins, A., Petzold, A., Matthias, T., Shoenfeld, Y. “A fully automated IIF system for the detection of antinuclear antibodies and antineutrophil cytoplasmic antibodies.” Immunol Res. 2015 Feb;61(1-2):135-40. HELIOS and HELIA registered trademarks of AESKU.Systems GmbH & Co. KG.

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