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The risk of HCV RNA contamination in serology screening instruments with a fixed needle for sample transfer

Rondahl, E. (author)
Linköpings universitet,Avdelningen för mikrobiologi och molekylär medicin,Hälsouniversitetet
Gruber, M. (author)
Linköpings universitet,Avdelningen för mikrobiologi och molekylär medicin,Hälsouniversitetet
Joelsson, S. (author)
Linköpings universitet,Avdelningen för mikrobiologi och molekylär medicin,Hälsouniversitetet
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Sundqvist, Martin, 1974- (author)
Region Örebro län,Division Clinical Microbiology, Örebro University Hospital, Örebro, Sweden
Åkerlind, Britt (author)
Linköpings universitet,Östergötlands Läns Landsting,Vårdhygien,Avdelningen för mikrobiologi och molekylär medicin,Hälsouniversitetet
Cardell, Kristina (author)
Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för mikrobiologi och molekylär medicin,Hälsouniversitetet,Infektionskliniken i Östergötland
Lindh, Magnus, 1960 (author)
Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine,Dept Clin Microbiol, Gothenburg Univ, Gothenburg, Sweden,Göteborg University
Serrander, Lena (author)
Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för mikrobiologi och molekylär medicin,Hälsouniversitetet,Infektionskliniken i Östergötland
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 (creator_code:org_t)
Elsevier BV, 2014
2014
English.
In: Journal of Clinical Virology. - : Elsevier BV. - 1386-6532 .- 1873-5967. ; 60:2, s. 172-173
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Background: Hepatitis C diagnostics involve antibody screening and confirmation of current infection by detection of HCV RNA positivity. In screening instruments with fixed pipetting needle, there is a risk of sample carry-over contamination. Objectives: The aim of this study was to evaluate the risk of such contamination in a proposed clinical setting. Study design: In the present study, known HCV RNA positive (n= 149) and negative (n= 149) samples were analysed by anti-HCV Abbott in an Architect instrument in an alternating fashion in order to test for contamination. Results: In subsequent retesting of the previously HCV RNA-negative samples, six samples (4%) were positive by the Cobas Taqman assay with a maximum level of 33. IU/mL. The results show that there is a risk for transfer of HCV in the Architect instrument but they also show that the levels of HCV RNA observed are low. Conclusions: We conclude that complementary HCV RNA testing on samples identified as anti-HCV positive by screening can be recommended because the complementary results are reliable in the majority of cases when either HCV RNA is negative or HCV RNA is positive with a level >1000. IU/mL. In a minority of cases, with low HCV RNA after anti-HCV antibody screening, cross-contamination should be suspected and a new sample requested for HCV RNA testing. This strategy would reduce the need for obtaining a new sample from the vast majority of patients with a newly discovered HCV antibody positivity. © 2014 The Authors.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

Keyword

Contamination
HCV
Screening
virus RNA
antibody screening
article
cross contamination
fixed needle
hepatitis C
Hepatitis C virus
human
infection risk
major clinical study
needle
point of care testing
priority journal
risk assessment
RNA analysis
sample size
serodiagnosis
viral contamination
devices
diagnostic procedure
genetics
Hepacivirus
isolation and purification
mass screening
medical device contamination
procedures
Clinical Laboratory Techniques
Equipment Contamination
Humans
RNA
Viral
HCV

Publication and Content Type

ref (subject category)
art (subject category)

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