TABLE 1.

Comparison of detection of M. genitalium to detection by the consensus expanded gold standard

Assay	Result category	Consensus M. genitalium resulta			% sensitivity/% specificity (95% CI)	% positive predictive value/% negative predictive value (95% CI)
		No. positive	No. negative	Total no.
MG-TMA	Positive	88	6b	94	100 (95.8–100)/99.4 (98.7–99.8)	93.6 (86.6–97.6)/100 (99.6–100)
	Negative	0	986	986
	Total	88	992	1,080
Alt-TMA	Positive	88	7c	95	100 (95.8–100)/99.3 (98.6–99.7)	92.6 (85.4–97.0)/100 (99.6–100)
	Negative	0	985	985
	Total	88	992	1,080
MgPa qPCR	Positive	84	7d	91	91.3 (83.6–96.1)/99.3 (98.6–99.7)	92.3 (84.8–96.6)/99.2 (98.4–99.7)
	Negative	8e	981	989
	Total	92	988	1,080
16S qPCR	Positive	82	0	82	89.1 (80.9–94.7)/100 (99.6–100)	100 (95.6–100)/99.0 (98.2–99.5)
	Negative	10f	988	998
	Total	92	988	1,080

^aConsensus results for M. genitalium detection represent positivity for 2 of 3 tests (not including the test being evaluated) and were used as the expanded gold standard to compare test performances.

^bAll 6 results were negative by 16S and MgPa qPCRs; 4 of the 6 were Alt-TMA positive.

^cAll 7 results were negative by 16S and MgPa qPCRs. All were positive by MG-TMA.

^dAll 7 results were negative by MG-TMA, Alt-TMA, and 16S assay. All gave high quantification cycle (C_q) values (over 40).

^eAll 8 results were positive by MG-TMA and Alt-TMA, with only 2 being positive by 16S assay. All had high C_q values (over 40) on 16S qPCR.

^fAll 10 results were positive by MG-TMA and Alt-TMA, with only 5 being positive by MgPa.