"Excellent sensitivity of Determine HIV Combo..." at Alere

Excellent sensitivity of a rapid 4th generation HIV test (Determine™ HIV-1/2 Ag/Ab) -based on a blinded evaluation in chronically HIV infected women and men

C. Kahlert1,2, S. Daneel1, A. Witteck1, A. Züst1, P. Schmid1, J. Thierbach3, P. Vernazza1 and the Swiss HIV Cohort Study1Cantonal Hospital St. Gallen, Switzerland, 2Children Hospital St. Gallen, Switzerland, 3Cantonal Hospital, Transfusion, St. Gallen, Switzerland

Rapid point-of-care HIV testing is an essential screening tool for widespread detection of HIV infection and thus an important contribution to HIV prevention. Recently, a 4th generation test with the ability to detect p24-antigen and HIV-antibodies has become available. Pavieet al. (1) challenged the use of this test by reporting an unacceptably low sensitivity at the 2009 IAS meeting. 198 HIV positive individuals with chronic HIV infection have been sequentially tested by several rapid tests using capillary blood. To the great surprise of most experts, the test yielded a low sensitivity for the Determine 3rdand 4thgeneration assays.

The present study was conducted to confirm or reject the low sensitivity presented by Pavieet al. (1). Determine HIV-1/2 Ag/Ab, the most widely used rapid test in Switzerland was prospectively evaluated,

- using capillary blood
- in chronically HIV-infected cART treated individuals
- by adequately trained personnelHypothesis

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"Excellent sensitivity of Determine HIV Combo..."