Table 4

Idylla NRAS-BRAF mutation test results compared with the reference test (MassARRAY) results

(a) NRAS testing
Idylla		MassARRAY
		Mutation	No mutation	Total
	Mutation	36	1	37
	No mutation	0	205	205
	Total	36	206	242
Idylla performance	Overall agreement	241/242 (99.59%, lower bound of one-sided 95% CI=98.17%)
	Positive agreement	36/36 (100%, lower bound of one-sided 95% CI=93.0%)
	Negative agreement	205/206 (99.51%, lower bound of one-sided 95% CI=97.85%)
(b) BRAF testing
Idylla		MassARRAY
		Mutation BRAF c.1799T>A p.(Val600Glu)	No mutation	Total
	Mutation BRAF c.1799T>A p.(Val600Glu)	52	0	52
	No mutation	0	190	190
	Total	52	190	242
Idylla performance	Overall agreement	242/242 (100%, lower bound of one-sided 95% CI=98.89%)
	Positive agreement	52/52 (100%, lower bound of one-sided 95% CI=95.05%)
	Negative agreement	190/190 (100%, lower bound of one-sided 95% CI=98.60%)