DiaPat certification

The DiaPat® diagnostic method complies with the EU directive on in-vitro diagnostic medical devices (IVD) (98/79/EG). The method is therefore approved for use by qualified medical staff.

Urine sample analysis performed at our laboratories together with our quality management system guarantees the highest standards for reliability and reproducibility of results. DiaPat® meets the highest clinical standards.

A diagnostic test is finally considered medically and significantly validated once the test has lead to a statistically significant improvement of the medical diagnosis benefiting the patient in a prospective blinded study (in a blinded study it is not known if subjects are healthy or affected by the diseases). Right from the beginning, DiaPat® felt obliged to meet this standard and has been in favour of a comprehensive discussion of the potential advantages of this method. Each study was conducted according to required scientific criteria and conditions:

 

• Clear definition of the clinical problem and determination of the innovation potential for diagnosis and therapy

• Determination of suitable patient and control populations, required clinical data and protocols for sample collection and preparation

• Validation of the analytical platform for the development process

• Obtaining official approval and informed consent of study participants

• Conducting a pilot study using the validated platform

• Case number calculations based on pilot study to determine the number of study participants required for clinical validation

• Conducting a blinded prospective study for clinical validation

• Complete disclosure of study results in publications

• Monitoring the diagnostic efficacy of the test in current clinical routine

 

quod vide:

Recommendations for biomarker identification and qualification in clinical proteomics.

Mischak H, Allmaier G, Apweiler R, Attwood T, Baumann M, Benigni A, Bennett SE, Bischoff R, Bongcam-Rudloff E, Capasso G, Coon JJ, D'Haese P, Dominiczak AF, Dakna M, Dihazi H, Ehrich JH, Fernandez-Llama P, Fliser D, Frokiaer J, Garin J, Girolami M, Hancock WS, Haubitz M, Hochstrasser D, Holman R, Ioannidis JPA, Jankowski J, Julian BA, Klein JB, Kolch W, Luider T, Massy Z, Mattes WB, Molina F, Monsarrat B, Novak J, Peter K, Rossing P, Sánchez-Carbayo M, Schanstra JP, Semmes OJ, Spasovsk G, Theodorescu D, Thongboonkerd V, Vanholder R, Veenstra T, Weissinger E, Yamamoto T, Vlahou A

Sci Transl Med. 2010 Aug 25;2(46):46ps42

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