Prospective comparison of whole-blood- and plasma-based hepatitis C virus RNA detection systems: Improved detection using whole blood as the source of viral RNA
Jt. Stapleton et al., Prospective comparison of whole-blood- and plasma-based hepatitis C virus RNA detection systems: Improved detection using whole blood as the source of viral RNA, J CLIN MICR, 37(3), 1999, pp. 484-489
We previously demonstrated that whole blood contains significantly more hep
atitis C virus (HCV) RNA than plasma, To validate the whole-blood-based HCV
RNA detection method, a prospective comparison of HCV RNA detection in who
le blood and plasma from 50 patients with chronic ii,er disease was underta
ken. Whole-blood and plasma aliquots were independently tested for HCV RNA
by reverse transcriptase (RT) PCR assay, and plasma was tested by the Roche
Amplicor assay, HCV RNA,vas detected in 35 of 50 (70%) whole-blood samples
by RT-PCR but in only 26 of 50 (52%) plasma samples tested by the Amplicor
assay (P < 0.01). HCV RNA was detected in 85% of HCV antibody-positive pat
ients by the whole-blood method compared with 74% of plasma samples by the
Amplicor method. The five HCV antibody-positive subjects who were negative
by whole-blood-based RT-PCR assay were all receiving interferon therapy and
had normal transaminases at the time of testing. HCV RNA was detected in 3
8% of HCV antibody-negative subjects by the whole-blood-based RT-PCR assay
compared with 6.25% of these patients by the Amplicor assay (P < 0.05), The
re were nine samples in which HCV RNA was detected in whole blood but the A
mplicor test was negative. Eight of the nine RNAs prepared from these whole
-blood samples tested positive in the Amplicor assay, thus confirming the s
pecificity of our results. This study demonstrates that whole-blood-based H
CV RNA detection is more sensitive than currently available commercial test
s and that whole-blood RNA is suitable for use in commercial assays.