Product Specifications
Determine® HIV-1/2 Ag/ Ab
Combo
|
Catalogue
Number
|
Product
|
Non-CE
|
CE Marked
|
|
Whole Blood*, Serum and Plasma 20
test
|
N/A
|
7D2646
|
|
Whole Blood*, Serum and Plasma 100 test
|
7D2643
|
7D2647
|
|
|
|
|
|
|
|
|
|
Chase Buffer (CE
and Non CE Marked)
|
|
7D2243
|
|
|
EDTA
capillaries
|
|
7D2222
|
7D2227
|
|
Lancets
|
100 contents
|
7D2232
|
7D2232
|
|
Method
|
Lateral flow
|
|
Time to
result
|
20 minutes
|
|
Storage
conditions
|
2-30°C
|
|
Shelf-life
|
10 months
|
|
Sensitivity
|
HIV-1 Positive (885/885) 100%
HIV-2 Positive (133/133) 100%
HIV-1 non B Subtypes (154/154) 100%
HIV-1 Group O (7/7) 100%
Results obtained from patients at the chronic
stage of infection
Determine® HIV-1/2 Ag/Ab Combo identifies infection on average 5
days earlier (range 2-20 days) than 3rd
generation antibody tests and 92.31% of 117 pre- and per-
seroconversion samples tested against 4th
generation EIA tests (see performance data for detailed
results)
|
|
Specificity
|
Specificity of p24 Antigen line (Ag)
Europe 100.00%
Africa
99.49%
Asia 100.00%
South America 100.00%
Global 99.61%
|
Specificity of Antibody line (Ab)
Europe 99.58%
Africa 99.06%
Asia 100.00%
South America 100.00%
Global 99.21%
|
|
Sample
Type
|
Serum/plasma/whole blood
|
|
Kit
size
|
20 and 100 tests
|
|
Kit
contents
|
20 or 100 test units
|
*For Whole Blood please order Chase Buffer
Clinical
Review: Determine HIV - 1/2 Ag/Ab Combo
Click
here - Performance evaluation of the Determine® HIV-1/2 Ag/Ab
Combo, a novel 4th generation rapid test