Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification

Table 5

Detection of virological failure, that is, HIV-1 RNA load above 1,000 copies/mL according to the WHO [13], by HIV-1 RNA-based Amplix real-time PCR assay and the reference COBAS AmpliPrep/COBAS TaqMan HIV-1 test v2.0 in 215 HIV-seropositive clinical plasma samples from antiretroviral drug-experienced patients^£.

		Reference HIV-1 RNA load (Roche Molecular Diagnostics)
		<1,000 copies/mL	>1,000 copies/mL
Amplix HIV-1 RNA load (Biosynex)	<1,000 copies/mL	45	0
	>1,000 copies/mL	2	168

proportions of HIV-infected, antiretroviral drug-experienced patients diagnosed in virological failure were similar by the reference COBAS AmpliPrep/COBAS TaqMan HIV-1 test v2.0 (168/215 = 78.1%) and the HIV-1 RNA-based Amplix real-time PCR assay (170/215 = 79.1%) (NS by Fisher’s exact test).