Improved detection of hepatitis C virus infection by transcription-mediated amplification technology in dialysis population.
BACKGROUND
Hepatitis C virus (HCV) infection remains common among patients undergoing maintenance dialysis and plays an adverse effect on survival in this population. Accurate detection of HCV viremia (HCV RNA) in dialysis patients requires a sensitive and specific diagnostic test.


METHODS
The Versant HCV RNA Qualitative Assay, based on transcription-mediated amplification (TMA) technique, was prospectively evaluated in 112 dialysis patients. Performance characteristics of the Versant HCV TMA Assay were evaluated in comparison to the Amplicor((R)) 2.0 HCV test based on polymerase chain reaction (PCR) technique. In addition, anti-HCV serologic tests including third-generation enzyme immunoassay and Recombinant Immunoblot Assay were performed.


RESULTS
Of the 112 specimens tested, 29 were reactive by Versant HCV TMA Assay, yielding an overall prevalence of HCV viremia of 25.9%. The concordance between TMA and PCR techniques was excellent [91% (101/112)]. Eleven specimens (10%) were invalid or equivocal by PCR due to interference phenomena; all 11 specimens had valid TMA results (2 patients being TMA reactive and 9 nonreactive). Four specimens [3.6% (4/112)] that tested PCR-negative and HCV TMA nonreactive were anti-HCV seropositive, consistent with resolved HCV infection. In the group of seronegative samples, one was reactive by TMA Assay [1.25% (1/80)].


CONCLUSIONS
The HCV TMA technology seems a highly sensitive tool for detecting HCV RNA in the dialysis population, with no evidence of specimen interference. One EIA-negative but HCV-RNA-positive patient by Versant HCV TMA Assay was identified. Prospective clinical trials are under way to assess the clinical impact related to the use of HCV TMA technology in dialysis population.
Rao
Vinaya
V
Division of Nephrology, School of Medicine, University of Miami, Miami, FL, USA.
Fabrizi
Fabrizio
F
Pennell
Phillip
P
Schiff
Eugene
E
de Medina
Maria
M
Lane
Jeannine R
JR
Martin
Paul
P
Ivor
Linda
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D006435:Renal Dialysis