TY - JOUR
T1 - A modified ultrasensitive assay to detect quantified HIV-1 RNA of fewer than 50 copies per milliliter.
AU - Piwowar-Manning, Estelle M.
AU - Henderson, Terry A.
AU - Brisbin, Lorraine
AU - Jackson, J. Brooks
PY - 2003/8/1
Y1 - 2003/8/1
N2 - We compared the sensitivity and specificity of versions 1.0 and 1.5 and a modified version 1.5 of the AMPLICOR HIV-1 MONITOR ultrasensitive RNA assay (Roche, Indianapolis, IN) by using a virus stock dilution series and plasma samples from HIV-1-infected and uninfected subjects. The modified assay was linear and consistently positive down to 12 copies per milliliter vs 25 copies per milliliter for the other 2 assays. Versions 1.0, 1.5, and modified 1.5, respectively, detected 9 (23%) of 39, 11 (28%) of 40, and 43 (61%) of 71 replicates of a 4-copy-number and 11 (28%) of 40, 17 (46%) of 37, and 88 (90%) of 98 replicates of a 10-copy-number standard. Of 44 patient samples with undetectable levels using version 1.0, 32 (73%) had detectable levels on the modified assay, and 5 (25%) of 20 had detectable levels on version 1.5. None of the assays detected HIV-1 RNA in HIV-1 antibody-negative samples. The modified version 1.5 of the RNA assay is more sensitive for detecting HIV-1 RNA in significantly more patients than are versions 1.0 and 1.5.
AB - We compared the sensitivity and specificity of versions 1.0 and 1.5 and a modified version 1.5 of the AMPLICOR HIV-1 MONITOR ultrasensitive RNA assay (Roche, Indianapolis, IN) by using a virus stock dilution series and plasma samples from HIV-1-infected and uninfected subjects. The modified assay was linear and consistently positive down to 12 copies per milliliter vs 25 copies per milliliter for the other 2 assays. Versions 1.0, 1.5, and modified 1.5, respectively, detected 9 (23%) of 39, 11 (28%) of 40, and 43 (61%) of 71 replicates of a 4-copy-number and 11 (28%) of 40, 17 (46%) of 37, and 88 (90%) of 98 replicates of a 10-copy-number standard. Of 44 patient samples with undetectable levels using version 1.0, 32 (73%) had detectable levels on the modified assay, and 5 (25%) of 20 had detectable levels on version 1.5. None of the assays detected HIV-1 RNA in HIV-1 antibody-negative samples. The modified version 1.5 of the RNA assay is more sensitive for detecting HIV-1 RNA in significantly more patients than are versions 1.0 and 1.5.
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M3 - Article
C2 - 12931558
SN - 0002-9173
VL - 120
SP - 268
EP - 270
JO - American Journal of Clinical Pathology
JF - American Journal of Clinical Pathology
IS - 2
ER -
