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Objectives <p>Diagnosing hemoglobinopathies through reverse hybridization with Globin StripAssays (ViennaLab, Vienna, Austria) is widely performed. There are only two authorized hands-on DNA extraction methods for these assays: the spin Micro DNA Extraction Kit (ViennaLab, Vienna, Austria) for the α‑Globin StripAssay and GEN<sup>X</sup>TRACT Blood DNA Extraction System (ViennaLab, Vienna, Austria) for the β‑Globin StripAssay. We set out to evaluate the performance of the automated DNA extraction with MagNA Pure&#xa0;24 (Roche, Rotkreuz, Switzerland) for further testing with Globin StripAssays.</p> Methods <p>We analyzed blood samples of 41&#xa0;patients with clinical suspicion of hemoglobinopathies. As the gold standard we stipulated the ViennaLab DNA extraction methods and compared them to the MagNA Pure&#xa0;24 Total Isolation Kit performed on MagNA Pure. The results of the different test strips were qualitatively classified with respect to good and weak read outs, background signals as well as true/false positives or negatives.</p> Results <p>A&#xa0;total of 6226 StripAssay lines were analyzed. After extraction with the gold standard 98.3% had a&#xa0;good read out, 0.9% a&#xa0;weak read out and in 0.9% a&#xa0;background signal was identified. After extraction with MagNA Pure 99.4% had a&#xa0;good read out, 0.2% a&#xa0;weak read out and a&#xa0;background signal was found in only 0.5% of the lines (<i>P</i> &lt; 0.001) and there were no false positives or negatives (sensitivity and specificity 100.0%).</p> Conclusion <p>The automated DNA extraction with MagNa Pure showed noninferior results when compared with the Spin Micro and GEN<sup>X</sup>TRACT DNA extraction kits enabling the usage of the MagNa Pure for the purpose of DNA extraction for further genetic testing with Globin StripAssays.</p>

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Performance of the automated DNA extraction with MagNA Pure 24 for further genetic testing for hemoglobinopathies with Globin StripAssays

  • 期刊论文

  • 发表日期：

    2025年12月12日

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  • Georg Leixner,
  • Astrid Voill-Glaninger,
  • Julia Gaugeler-Kurzweil,
  • Tanja Kusstatscher,
  • Tanja Panic-Jankovic,
  • Wolfgang Novak,
  • Leo Kager,
  • Christian Oberkanins,
  • André Viveiros

摘要

Objectives

Diagnosing hemoglobinopathies through reverse hybridization with Globin StripAssays (ViennaLab, Vienna, Austria) is widely performed. There are only two authorized hands-on DNA extraction methods for these assays: the spin Micro DNA Extraction Kit (ViennaLab, Vienna, Austria) for the α‑Globin StripAssay and GENXTRACT Blood DNA Extraction System (ViennaLab, Vienna, Austria) for the β‑Globin StripAssay. We set out to evaluate the performance of the automated DNA extraction with MagNA Pure 24 (Roche, Rotkreuz, Switzerland) for further testing with Globin StripAssays.

Methods

We analyzed blood samples of 41 patients with clinical suspicion of hemoglobinopathies. As the gold standard we stipulated the ViennaLab DNA extraction methods and compared them to the MagNA Pure 24 Total Isolation Kit performed on MagNA Pure. The results of the different test strips were qualitatively classified with respect to good and weak read outs, background signals as well as true/false positives or negatives.

Results

A total of 6226 StripAssay lines were analyzed. After extraction with the gold standard 98.3% had a good read out, 0.9% a weak read out and in 0.9% a background signal was identified. After extraction with MagNA Pure 99.4% had a good read out, 0.2% a weak read out and a background signal was found in only 0.5% of the lines (P < 0.001) and there were no false positives or negatives (sensitivity and specificity 100.0%).

Conclusion

The automated DNA extraction with MagNa Pure showed noninferior results when compared with the Spin Micro and GENXTRACT DNA extraction kits enabling the usage of the MagNa Pure for the purpose of DNA extraction for further genetic testing with Globin StripAssays.