Table 1.

Analytical performance of the VISITECT CD4 Advanced Disease LFA. Comparison against the flow cytometry results obtained by the FACScalibur, Becton-Dickinson. Performance calculated using a prevalence of 35% of advanced HIV disease.

	FACScalibur, Becton-Dickinson
Table 1a		≤200 CD4	>200 CD4
VISITECT CD4-Advanced disease LFA	≤200 CD4	63	30
	>200 CD4	0	7
Sensitivity	100% (95%-CI: 94-100)
Specificity	19% (95%-CI: 8-35)
Accuracy	47% (95%-CI: 37-57)
Positive predictive value	40% (95%-CI: 36-44)
Negative predictive value	100% (95%-CI: 59%-100%)
	FACScalibur, Becton-Dickinson
Table 1b		≤350 CD4	>350 CD4
VISITECT CD4-Advanced disease LFA	≤200 CD4	84	9
	>200 CD4	0	7
Sensitivity	100% (95%-CI: 96-100)
Specificity	44% (95%-CI: 20-70)
Accuracy	63% (95%-CI: 53-73)
Positive predictive value	49% (95%-CI: 38-60)
Negative predictive value	100% (95%-CI: 59-100)

CD, cluster of differentiation; CI, confidence interval; LFA, lateral flow assay.

Advance HIV prevalence: 35% [2].