In Technical document TD2010DL, WADA updated the Decision Limits (DL) of Threshold Substances. The finding of a value that exceeds the DL in a confirmatory analysis results in an Adverse Analytical Finding.
WADA accepts that the uncertainty associated to analytical findings may be different for different accredited laboratories. Therefore WADA formulated maximum limits for this uncertainty (called the Maximum Combined Standard Uncertainty, uc, Max) at the Threshold level (T) for such substances present in the urine or blood. WADA distinguishes three levels (expressed as a percentage of T) of this uncertainty: 5, 10 and 15%. By participating in the EQAS programme, laboratories should demonstrate their compliance to this uncertainty requirement. We will discuss this aspect later on.
Based on uc, Max WADA defines a guard band (g) which is a multiple of the Maximum Combined Standard Uncertainty. This guard band (g) should be added to the Threshold value in order to obtain the Decision Limt (DL).
DL= T + g
A value > DL is considered an Adverse Analytical Finding. A clean athlete with a value above DL is a false positive.
Question now is what the false positive rate is for clean athletes (thus also without involuntary intake of a Threshold Substance by self-medication or by using supplements). For that we need to make some assumptions. For instance, we assume a normal distribution (not evident) for the natural fluctuation of these substances in urine and/or blood. Furthermore we assume a normal distribution (not evident) for the test variability. We have also to assume that T is defined such that in only 2.5% (or perhaps 5%) of a large group of clean athletes a Threshold Substance may be present above T just by chance. The establishment of T is still a debate in literature and media.
For all substances that are measured with an allowed maximum uncertainty of 10% , WADA defined DL and the guard zone (g) such that (DL – T)/g = 2. For a normal distribution this gives a probability of 2, 27% of finding a value above DL when the true value equals T.
However, as we assumed that only 2.5% of clean athletes will have values above T (by chance), the probability that a false positive is found for a clean athlete is 2,5% of 2,27% equal to 0,0567%. This is 1 on 1764 samples! Is this good enough? It all depends on the consequences.
From the WADA statistics over 2008 we read that 274615 samples were analyzed with a total of 5523 adverse findings. If we assume no false positives in these findings, then there are 269092 clean samples and therefore expect a limit of 153 false positive samples (=0,0567% of 269092 clean samples) (this number can be refined by iteration). A total of 5523 adverse findings were reported over 2008. This means that maximally 2,77% of these findings may be a false positive.
It is questionable whether this is good enough to protect athletes against unfair allegations.
Ironically, the athlete is better off here when a laboratory with a high performance level (uncertainty less than uc, Max ) analyzes his/her samples as the guard band (g) is a multiple of uc, Max !
So contrary to the situation with Prohibited Substances, better Laboratory Performance than required is now an advantage for the athlete in the situation of Threshold substances.