Table 1.

Sensitivity and specificity of rK39 dipsticks in various subgroups

Subgroups	No of studies	Sensitivity (95% CI)	No of studies	Specificity (95% CI)
All studies	13	93.9 (87.7 to 97.1)	13	95.3 (88.8 to 98.1)
Trial phase:
I	5	86.0 (67.1 to 94.9)	5	96.9 (86.3 to 99.4)
II	4	96.5 (86.0 to 99.2)	4	96.8 (90.7 to 98.9)
III	4	94.8 (87.6 to 97.9)	4	91.2 (66.8 to 98.2)
Region:
South Asia	7	97.1 (91.7 to 99.0)	7	95.3 (87.3 to 98.3)
East Africa	2	79.0 (46.7 to 94.2)	2	85.2 (28.2 to 98.8)
Elsewhere	4	88.8 (83.7 to 92.4)	4	97.0 (79.4 to 99.6)
Leishmania species:
L donovani	10	94.6 (86.1 to 98.0)	10	95.2 (87.3 to 98.3)
Other	3	90.0 (84.9 to 93.5)	3	95.7 (62.7 to 99.7)
Brand:
Kalazar Detect* (InBios International)	7	95.1 (89.5 to 97.8)	7	93.1(84.1 to 97.2)
Other	6	91.2 (74.3 to 97.3)	6	97.2 (79.1 to 99.7)
Sample size:
Cases or controls ≤100	8	89.6 (77.4 to 95.6)	6	89.0 (71.5 to 96.3)
Cases or controls >100	5	95.6 (88.2 to 98.5)	7	97.2 (94.1 to 98.7)
Quality assessment of studies of diagnostic accuracy:
Score ≤7	4	92.7 (80.6 to 975)	4	93.9 (67.8 to 99.1)
Score >7	9	94.2 (85.6 to 97.8)	9	95.9 (89.2 to 98.5)
Health states of controls†:
Healthy non-endemic	—	NA	0	NA
Healthy endemic	—	NA	10	95.9 (90.6 to 98.3)
Cross reacting diseases	—	NA	7	97.1 (88.5 to 99.3)
Clinically suspected disease	—	NA	7	93.0 (77.5 to 98.1)
Clinically suspected disease in phase III studies	—	NA	4	90.6 (66.8 to 97.9)

NA=not applicable.

^*Previously known as Insure Rapid Test for Visceral Leishmaniasis.

^†Several studies included more than one type of control.