Budgets aren't the only things getting squeezed in the lab...

Carobene A^1,2, Røraas T³, Sølvik UØ⁴, Sylte MS⁵, Sandberg S^3,4,5,2, Guerra E⁶, Marino I⁶, Jonker N^7,2, Barla G⁷, Bartlett WA^8,2, Fernandez-Calle P^9,2, Díaz-Garzón J⁹, Tosato F¹⁰, Plebani M¹⁰, Coşkun A^11,2, Serteser M¹¹, Unsal I¹¹, Ceriotti F⁶; European Biological Variation Study of the EFLM Working Group on Biological Variation

 

If we just focus on the desirable allowable total error (TEa), we can see some significant tightening in the performance specifications:

 

Test	TEa - REVISED	TEa - 2014	Reduction
ALT	14.4	27.48	47.6%
AST	13.4	16.69	19.7%
GGT	15.7	22.11	29.0%
ALP	10.7	12.04	11.1%
LDH	7.7	11.4	32.5%
CK	20.4	30.3	32.7%
AMY	13.4	14.6	8.2%
LIP	12.6	37.88	66.7%

 

If we think for a moment what this means for manufacturers, it's a massive change. If you essentially cut the target in half, your current methods probably have to be re-engineered to meet this new level of performance.

 

Put a different way, these new goals may be more accurate, but far less applicable. More ideal, but less practical.

 

For years, there have been complaints that the Ricos goals were too large, that they overestimated the amount of allowable error. Indeed, even after these revisions, there will still be those who claim that we need to be even more demanding about assay performance than how the Ricos allowable total error goals are structured and implemented.

 

But if we shrink our goals down to the point where no method on the market can hit the target, what have we actually accomplished? We will have a perfect set of goals that are impossible to achieve. That may be helpful to research and design departments at the manufacturers when they contemplate their next generation of instruments, but for laboratories that are operating today, with today's methods, they face the prospect of either having to massively increase the amount of QC they run and effort they devote to QC, or they will need to switch to goals that are more achievable and practical for today's clinical use.

 

The phrase that comes to mind here is, Don't let the perfect be enemy of the good. An obsession with constructing the perfect performance specification may make for great papers and publications and conference lectures, but it may also have the practical effect of leaving laboratories struggling with goals they can't achieve and performance they can't change.

 

These revisions may represent the goals of the perfected future. But we may need a set of goals for our imperfect today.