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Eurofins IPL Nord SAS – 1 rue du professeur Calmette – 59046 LILLE cedex
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VIDAS LMX – Summary 2012 v01
Contents
1 Introduction ………………………………………………………………………………………………………….
1.1Validation references ……………………………………………………………………………………………
1.2Protocol and principle of the alternative method…………………………………………………………..
1.2.1 Protocol ………………………………………………………………………………………………….
1.2.2 Principle of the alternative method……… …………………………………………………………...
1.3Application scope………………………………………………………………………………………………..
1.4Reference method………………………………………………………………………………………………..
1.5Background of certification…………………………………………………………………………………….
2 Comparative study of methods…………………………………………………………………………………...
2.1 Relative accuracy, relative specificity and relative sensitivity……………………………………….….
2.1.1 Number and nature of the samples……………………………………………………………………...
2.1.2 Artificial contamination of the samples and percentage……………………………………………….
2.1.3 Results………………………………………………………………………………………………………
2.1.4 Calculation of relative accuracy (AC), relative specificity (SP) and relative sensitivity (SE)………
2.1.5 Analysis of discrepant results…………………………………………………………………………….
2.2 Relative detection level……………………………………………………………….………………………...
2.3 Inclusivity / exclusivity……………………………………………………………….…………………………
2.3.1 Protocols……………………………………………………………………………………………………
2.3.2 Results and conclusion…………………………………………………………………………………...
3 Interlaboratory study……………………………………………………………………………………………….
3.1Study organization……………………………………………………………………………………………….
3.2 Control of experimental parameters………………………………………………………………………….
3.2.1 Contamination levels obtained after artificial inoculation……………………………………………….
3.2.2 Problems of temperature recorded during transport, temperature on reception and reception
times ………………………………………………………………………………………………………………..
3.2.3 Conclusion…………………………………………………………………………………………………..
3.3 Results……………………………………………………………………………………………………………..
3.3.1 Results obtained by cooperating laboratories……………………………………………………………
3.3.2 Conclusion with comments (discordances with expected results, exclusion… for instance)..……...
3.4 Calculations………………………………………………………………………………………………………
3.4.1 Specificity (%SP) and sensitivity (%SE) for both methods……………………………………………..
3.4.2 Relative precision (AC) …………………………………………………………………………………….
3.4.3 Analysis of discrepant results……………………………………………………………………………...
3.5 Interpretation……………………………………………………………………………………………………..
3.5.1 Comparison of relative precision (AC), specificity (SP) and sensitivity (SE)values………………….
3.5.2 Accordance (DA) ……………………………………………………………………………………………
3.5.3 Concordance………………………………………………………………………………………………...
3.5.4 Odds Ratio (COR) ………………………………………………………………………………………….
4 Praticability…………………………………………………………………………………………………………...
5 General conclusion…………………………………………………………………………………………………
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