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
| Autor: | Howard Grey, Gerd Michel, Hugo Troonen |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Clinical Biochemistry
Gene Products pol Sensitivity and Specificity Virus Acquired immunodeficiency syndrome (AIDS) BDNA test medicine Humans Acquired Immunodeficiency Syndrome biology Reverse Transcriptase Polymerase Chain Reaction Biochemistry (medical) Reproducibility of Results virus diseases RNA General Medicine Viral Load biology.organism_classification medicine.disease Virology Reverse transcription polymerase chain reaction Multicenter study pol Gene Products Human Immunodeficiency Virus Lentivirus HIV-1 RNA Viral Reagent Kits Diagnostic Viral load |
| Zdroj: | Clinical Chemistry and Laboratory Medicine. 40 |
| ISSN: | 1434-6621 |
| DOI: | 10.1515/cclm.2002.120 |
| Popis: | 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 approximately 50 copies/ml, and log10 0.133 at approximately 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 seronegative 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 vs. Amplicor/bDNA Spearman's rank correlations for quantification of non-type B HIV-1 RNA were 0.76/0.84 (A), 0.93/0.93 (C), 0.73/0.99 (D), 0.86/0.98 (E), and 0.40/0.83 (group O). LCx HIV assays consistently detect and quantify type B, non-type B and group O HIV-1 RNA. |
| Databáze: | OpenAIRE |
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