Table 3.

Methods of new TB diagnosis immediately before ART and in the first 6 months of ART in the SOC, EC, and EC+X phases of XPRES

	SOC phase		EC phase		EC+X phase
	n	%	n	%	n	%
Pulmonary TB
Microbiologically confirmed pulmonary TB (smear microscopy in SOC and EC, Xpert during EC+X)	22	18	23	34	113	57
Microbiologically confirmed pulmonary TB through culturea (missing or negative smear and Xpert)	0	0	12	18	16	8
Clinical diagnosis of pulmonary TB with negative sputum test (negative smear, Xpert, or culture documented)	6b	5	6d	9	17f	9
Clinical diagnosis of pulmonary TB with no documented sputum test result	95c	77	27e	40	52g	26
Sub-total pulmonary TB	123	100	68	100	198	100
All TB
Pulmonary TB total	123	95	68	79	198	81
Extra-pulmonary TB total	6	5	18	21	46	19
Total	129	100	86	100	244	100

Abbreviations: SOC standard of care, EC enhanced care, EC+X enhanced care plus Xpert, TB tuberculosis, XPRES Xpert Package Rollout Evaluation using a Stepped-wedge design

^aTo meet other study objectives related to estimation of diagnostic accuracy of the smear microscopy-based and Xpert-based TB diagnostic algorithms, one spot sputum and the morning sputum were sent to the National TB Reference Laboratory (NTRL) for liquid culture in mycobacteria growth indicator tubes (MGIT). The liquid culture results were also returned to the clinics, although average turnaround times exceeding 49 days were expected per existing standard of care

^b5 (83%) of 6 had documentation that x-ray findings were suggestive of pulmonary TB

^c13 (14%) of 95 had documentation that x-ray findings were suggestive of pulmonary TB

^d3 (50%) of 6 had documentation that x-ray findings were suggestive of pulmonary TB

^e16 (59%) of 27 had documentation that x-ray findings were suggestive of pulmonary TB

^f8 (47%) of 17 had documentation that x-ray findings were suggestive of pulmonary TB

^g20 (38%) of 52 had documentation that x-ray findings were suggestive of pulmonary TB