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

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^XTRACT 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.

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.

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