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Hugo Troonen, Howard Grey, Gerd Michel
Multicenter Study of the LCx® HIV RNA Quantitative Assay – a New Competitive Reverse Transcriptase-PCR which Targets pol Genomic Region of HIV-1 for the Measurement of Type B, Non-Type B and Group O HIV-1 RNA
Performance characteristics of the Abbott LCx® HIV
RNA Quantitative Assay (LCx HIV) were established in
a multicenter study comparing it with the manual (Amplicor
v1.5) and automated (Cobas) ultra-sensitive
Roche Amplicor? HIV-1 Monitor v1.5, the Bayer Quantiplex? HIV RNA 3.0 (bDNA v3.0), and the Organon NucliSens® HIV QT 2.0 (NucliSens). Within-run precision
of LCx HIV assessed in clinical specimens was SD log10
0.210 at ~50 copies/ml, and log10 0.133 at ~400 copies/ml. Total precision in a reconstituted type B HIV-1 RNA
panel was SD log10 0.380 at 100 copies/ml, and SD log10
0.180 at 1000 copies/ml. Type B HIV-1 RNA sensitivity
(1 ml input) assessed at a 50%, 75% and 95% detection
rate ranged from 29 to 41, 54 to 75 and 94 to 176
copies/ml, respectively. Overall specificity in HIV sero-negative
individuals was 99.78%. Linear regression indicated
close assay correlations and agreements for
measurement of type B HIV-1 RNA. Pearson's correlations
and (Log10LCx=aLog10x + b) linear regressions
were 0.91 (y=0.892 Log10Amplicor + 0.595), 0.93 (y=0.827
Log10Cobas + 0.969), 0.93 (y=0.951 Log10bDNA + 0.550),
and 0.79 (y=0.834 Log10nuclisens + 0.911). LCx HIV was
least affected by the genetic variability of HIV-1. LCx
HIV detected 99% of non-type B HIV-1 group M samples
(subtypes A-G), Amplicor v1.5 detected 96%, and bDNA
v3.0 detected 99%. The assays detected 10/11, 1/11 and
8/11, respectively of the HIV-1 group O samples. LCx
HIV
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 40, 07/2002
Pages: 698 - 704