Skip to main content
. 2016 May 10;17(4):386–392. doi: 10.1038/tpj.2016.34

Table 1. Examples of calculating clinical validity and population impact.

Example Empirical data Hypothetical data
  Abacavir
Simvastatin
Study Mallal et al.9 Mallal et al.9 SEARCH collaborative group10 Voora et al.11
Variant HLA-B*5701 HLA-B*5701 SLCO1B1 c.521T>C (*5) SLCO1B1 c.521T>C (*5)
Risk genotype freq 6.7% 6.6% 25% 28%
Adverse event Clinically diagnosed abacavir hypersensitivity Immunologically confirmed abacavir hypersensitivity Severe myopathy Any side effect
Adverse event freq 8.5% 3.1% 0.8% 23%
ORa 30 1176b 8.5 2.8
Sensitivity 48% 100% 73% 45%
Specificity 97% 96% 76% 77%
PPV 60% 47% 2% 37%
NPV 95% 100% 99.7% 83%
PAF 44% 100% 64% 24%
NNT 2 3 49 6
NNG 27 33 195 19

Abbreviations: NNG, number needed to genotype; NNT, number needed to treat; NPV, negative predictive value; PAF, population attributable fraction; PPV, positive predictive value. Severe myopathy: muscle symptoms and creatine kinase level above 10 × upper limit of normal; any side effect: composite of any side effect, myalgia and/or creatine kinase level above 3 × upper limit of normal.

a

The odds ratios (OR) compare carriers versus non-carriers of HLA-B*5701 for abacavir and CC/CT versus TT genotype at SLCO1B1 rs4149056 for simvastatin.

b

Because the sensitivity is 100%, an adjusted cross table in which 0.5 was added to all cells was used for the calculation of the OR;42, 43 measures in bold were reported in the cited scientific articles.