Appendix Table 4.

Specificity of Enzyme-Linked Immunospot (ELISpot) and T-SPOT.TB in Bacille Calmette–Guérin (BCG)–Vaccinated and Non–BCG-Vaccinated Participants with an Expected Low Prevalence of Tuberculous Infection^*

Study, Year (Reference)	Industry Supported?†	Sample	Setting	Test (Antigens)	Not BCG-Vaccinated or Predominantly Nonvaccinated					BCG-Vaccinated or Predominantly Vaccinated
					No	ELISpot/T-SPOT.TB		TST		No	ELISpot/T-SPOT.TB		TST
						False- Positive Result, n	Specificity, %	False- Positive Result, n	Specificity, %		False- Positive Result, n	Specificity, %	False- Positive Result, n	Specificity, %
Lalvani et al., 2001 (41)	Yes	Adults	United Kingdom	ELISpot (ESAT-6)	–	–	–	–	–	40	0	100	NR	NR
Pathan et al., 2001 (42)	Yes	Adults	United Kingdom	ELISpot (ESAT-6)	–	–	–	–	–	32	0	100	NR	NR
Lalvani et al., 2001 (43)	Yes	Adults	United Kingdom	ELISpot (ESAT-6)	–	–	–	–	–	26	0	100	NR	NR
Chapman et al., 2002 (44)	Yes	Adults	United Kingdom	ELISpot (ESAT-6/CFP-10)	–	–	–	–	–	40	0	100	NR	NR
Lee et al., 2006 (11)‡	Yes	Adolescents	South Korea	T-SPOT.TB (ESAT-6/CFP-10)	–	–	–	–	–	131	20	84.7	NR	78.6||
Detjen et al., 2007 (25)	No	Children only	Germany	T-SPOT.TB (ESAT-6/CFP-10)	21	0	100	0	100||	–	–	–	–	–

CFP-10 = culture filtrate protein 10; ESAT-6 = early-secreted antigenic target 6; NR = not reported; TST = tuberculin skin test.

^*Participants were healthy volunteers from the general population, students, or recruits with no history of exposure to tuberculosis.

^†“Industry support” refers to any industry involvement or support (e.g., sponsorship, donation of test kits, participation in advisory boards, and involvement of test developers or ownership of patents).

^‡Because South Korea is an intermediate-incidence country, some of the low-risk participants may have been latently infected.

^||Cutoff value ≥10 mm.