Evaluation of the new VERSANT HIV-1 RNA 1.0 Assay (kPCR) for quantitative detection of human immunodeficiency virus type 1 RNA.
BACKGROUND
The VERSANT HIV-1 RNA 1.0 Assay (kPCR) for quantitative detection of HIV-1 RNA has recently been introduced.


OBJECTIVE
In this study, the performance of the VERSANT HIV-1 RNA 1.0 Assay (kPCR) was evaluated and compared to the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0.


METHODS
Accuracy, linearity, interassay and intra-assay variations were determined, and a total of 196 routine clinical samples including a high number of HIV-1 subtype non-B samples were investigated.


RESULTS
When accuracy of the new kit was tested, all of the quantifiable results were found to be within -0.5log(10) unit of the expected panel results. Determination of linearity resulted in a quasilinear curve up to the initial concentration of 3.4x10(5)copies/mL. The interassay variation ranged from 12 to 20%, and the intra-assay variation ranged from 8 to 16%. When clinical samples were tested by the VERSANT HIV-1 RNA 1.0 Assay (kPCR) and the results were compared with those obtained by the COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0, the results for 95% of all samples with positive results by both tests were found to be within +/-1.0log(10) unit. The viral loads for all samples measured by the Siemens and Roche assays showed a high correlation (R(2)=0.94); quantitative results obtained by the Siemens assay were usually found to be lower than those obtained by the Roche assay.


CONCLUSIONS
The new VERSANT HIV-1 RNA 1.0 Assay (kPCR) proved to be suitable for use in the routine diagnostic laboratory. The time to results was similar for both of the assays.
Troppan
Katharina T
KT
Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz, Graz, Austria. katharina.troppan@stud.medunigraz.at
Stelzl
Evelyn
E
Violan
Deborah
D
Winkler
Michaela
M
Kessler
Harald H
HH
D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic