[Evaluation of the COBAS ampliprep/COBAS TaqMan system for quantification of human immunodeficiency virus type 1 (HIV-1) RNA by real-time PCR].
BACKGROUND
Viral load quantification is standard for monitoring HIV-1 therapy and is crucial in deciding whether to switch or to continue a current antiretroviral regimen. In Japan, serum is widely adapted as a specimen of the HIV-1 viral load quantification assay.


METHODS
We evaluated an emerging HIV-1 RNA quantification of the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (COBAS TaqMan). The test was evaluated for matrix equivalence between plasma and serum and for correlation with the AMPLICOR HIV-1 Monitor Test v1.5 (Amplicor) for HIV-1 RNA quantification.


RESULTS
The test result from serum specimens showed good correlation with test results from plasma specimens. HIV-1 RNA quantification results using serum specimens correlated well with those obtained by both ultrasensitivity assay and standard Amplicor assay.


CONCLUSIONS
The fully automated COBAS AmpliPrep/COBAS TaqMan HIV-1 Test meets requirements for a wide dynamic range and reliable quantification of HIV-1 RNA in serum clinical specimens.
Teruya
Katsuji
K
AIDS Clinical Center, International Medical Center of Japan.
Oka
Shinichi
S
Fukutake
Katsuyuki
K
Amano
Kagehiro
K
Furutani
Shigeyuki
S
Hayashi
Kunihiko
K
Masaki
Yumiko
Y
Kimura
Satoshi
S
D015497:HIV-1 / Q000737:chemistry*; D006801:Humans; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D019562:Viral Load; D014773:Virology / Q000295:instrumentation*
D012367:RNA, Viral