Safety approach for diagnostic systems

Abstract

The present invention provides a diagnostic safety method, a diagnostic device, a computer program and a diagnostic system for analyzing a plurality of samples with regard to the presence of contaminations. More particular, the present invention provides a diagnostic safety method, a diagnostic device, a computer program and a diagnostic system for analyzing a plurality of samples based on redundant diagnostic results.

Description

DESCRIPTION OF THE FIGURES

FIG. 1: Flowchart picture of the safety method according to the present invention.

FIG. 2: Schematic plots illustrating the sensitivity regain.

Claims

1. A safety method for a diagnostic system that analyzes a plurality of samples with regard to the presence of contaminations comprising the steps: a) taking an aliquot of a first sample,b) dividing said aliquot into at least two aliquot parts,c) analyzing each of said at least two aliquot parts with respect to the presence of contaminations simultaneously, andd) comparing the sample results obtained for each of said at least two aliquot parts in step c) in order to verify the presence or absence of contaminations in said sample and/or to detect failures of the diagnostic system, whereinsteps a) to d) are repeated with another sample from said plurality of samples until all samples of said plurality of samples are analyzed.

2. The safety method according to claim 1, wherein each sample comprises an internal control and said analyzing in step c) provides additional control results for each aliquot part that are optionally compared in step d) in addition to the comparison of said sample results in order to verify the presence or absence of contaminations in said sample and/or to detect failures of the diagnostic system.

3. The safety method according to claim 1, wherein said analyzing of each of said at least two aliquot parts in step c) is performed simultaneously on identical analyzers or simultaneously on one analyzer having at least two identical processing lanes.

4. The safety method according to claim 1, wherein in step a) said aliquot is a blent sample of aliquots taken from each member of a group of samples chosen from said plurality of samples, said blent sample is divided into at least two aliquot parts in step b) and the comparison of sample results in step d) is performed in order to verify the presence or absence of contaminations in said group of samples and/or to detect failures of the diagnostic system.

5. The safety method according to claim 2, wherein the presence of contaminations is verified, if: (i) each analysis in step c) provides a sample result and said sample results compared in step d) are equal or,(ii) each analysis in step c) provides a sample result, said sample results compared in step d) are different and the control results are valid or,(iii) not all analyses in step c) provide a sample result and the control results are valid.

6. The safety method according to claim 2, wherein a failure of the diagnostic system is detected, if: (i) the sample results from step c) that are compared in step d) are different or,(ii) not all control results are valid,

7. The safety method according to claim 2, wherein the absence of contaminations is verified, if no analysis in step c) provides a sample result and the control results are valid.

8. The safety method according to claim 1, further comprising a combination step e), wherein the sample results obtained for each analysis in step c) are combined to verify the presence or absence of contaminations in said sample.

9. A diagnostic device capable of analyzing samples with regard to the presence of contaminations comprising: A) at least two identical processing lanes each equipped with a sample input means and means for the analysis of said samples in order to obtain redundant diagnostic results of a sample, andB) means for the comparison of said redundant diagnostic results of the at least two identical processing lanes in order to verify the presence or absence of contaminations in said sample and/or to detect failures of the diagnostic device.

10. A computer program executable by a diagnostic device to analyze samples with regard to the presence of contaminations comprising the steps: aa) obtaining at least two redundant diagnostic results of a sample with respect to the presence of contaminations,bb) comparing said redundant diagnostic results in order to verify the presence or absence of contaminations in said sample and/or to detect failures of the diagnostic device.

11. A diagnostic system to analyze samples with regard to the presence of contaminations comprising: AA) a diagnostic device andBB) a computer program according to claim 10.