AMIR & D
Photo: Rapid test for the detection of HIV 4.0 (HIV Ag/Ab Combo 4.0)
INFECTIONS AND VIRUSES

Rapid test for the detection of HIV 4.0 (HIV Ag/Ab Combo 4.0)

Immunochromatographic test for the qualitative detection of the presence of antibodies to HIV type 1, type 2 and/or subtype O and HIV p24 antigen in whole blood, serum or plasma samples.

Relative sensitivity (Ag)
23 / (23+0) = 100%
Relative sensitivity (Ab)
400 / (400+0) = 100%
Relative specificity (Ag)
3522 / (3522+5) = 99,86%
Relative specificity (Ab)
3526 / (3526+1) = 99,97%
Relative specificity (Ag/Ab)
3521 / (3521+5+1) = 99,83%
Overall agreement
(423+3521) / (423+3521+0+6) = 99,85%

Figures are manufacturer data with a 95 % confidence interval.

Registration — available on request ISO 13485:2016