PMID- 15163420
OWN - NLM
STAT- MEDLINE
DCOM- 20040812
LR  - 20061115
IS  - 1386-6532 (Print)
IS  - 1386-6532 (Linking)
VI  - 30
IP  - 4
DP  - 2004 Aug
TI  - Inter-laboratory comparison of qualitative and quantitative detection of 
      hepatitis C (HCV) virus RNA in diagnostic virology: a multicentre study (MS) in 
      Italy.
PG  - 313-9
AB  - BACKGROUND: The importance of the standardisation of nucleic acid amplification 
      technology (NAT) assays for the detection of hepatitis C virus RNA is well known 
      today, as many studies carried out in different European countries attest. The 
      results of a previous study performed in Italy (J. Clin. Virol. 1 (2003) 83) by 
      the Italian Society of Clinical Microbiology (AMCLI) showed that the use of 
      external reference standards and of multicentre collaborative studies 
      significantly improves laboratory performance for the qualitative evaluation of 
      HCV RNA. OBJECTIVES: the AMCLI organised a new study on the standardisation of 
      both the qualitative and the quantitative evaluation of HCV RNA with NAT in order 
      to improve the implementation of the diagnostic methods for HCV RNA detection. 
      STUDY DESIGN: seventeen diagnostic centres of major Italian Hospitals 
      participated in this quality control study. The study consisted of testing three 
      panels, each made up of 10 coded samples including negative and positive samples. 
      Positive samples contained four levels of HCV RNA (genotype 1). RESULTS AND 
      CONCLUSION: Seven out of 510 qualitative results obtained were incorrect (1.4%), 
      two false negative and five false positive. The results gave a sensitivity of 
      99.5% and a specificity of 95.8%. Regarding quantitative tests, the geometric 
      mean (GM) and standard deviation (S.D.) could be calculated only for the three 
      highest HCV RNA levels. The percentage of results within the range of GM +/- 0.5 
      log(10) varied from 91% to 100%. Some laboratories had some difficulty in the 
      exact quantification of the lowest (3.00 log IU/ml) as well as of the highest 
      viral levels (6.35 log IU/ml) values, very near to the limits of the dynamic 
      range of the assays. The comparison of the results of this study with that 
      previously carried out one confirms that a regular participation in external 
      quality assessment (EQA) assures the achievement of a high proficiency level in 
      the diagnosis of HCV infection.
FAU - Mancini, Carlo
AU  - Mancini C
AD  - Department of Public Health, University "La Sapienza" of Roma, Piazzale Aldo Moro 
      5, 00185 Rome, Italy. carlo.mancini@uniroma1.it
FAU - Pisani, Giulio
AU  - Pisani G
FAU - Azzi, Alberta
AU  - Azzi A
FAU - Luisa Zerbini, Maria
AU  - Luisa Zerbini M
FAU - Gentili, Giuliano
AU  - Gentili G
FAU - Mario Bisso, Guillermo
AU  - Mario Bisso G
CN  - MS participants
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PL  - Netherlands
TA  - J Clin Virol
JT  - Journal of clinical virology : the official publication of the Pan American 
      Society for Clinical Virology
JID - 9815671
RN  - 0 (RNA, Viral)
RN  - 0 (Reagent Kits, Diagnostic)
SB  - IM
MH  - Hepacivirus/*isolation & purification
MH  - Hepatitis C/*diagnosis/virology
MH  - Humans
MH  - Italy
MH  - *Laboratories
MH  - Nucleic Acid Amplification Techniques/*methods/standards
MH  - Polymerase Chain Reaction/methods
MH  - Quality Control
MH  - RNA, Viral/*blood
MH  - Reagent Kits, Diagnostic
MH  - Reference Standards
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
EDAT- 2004/05/28 05:00
MHDA- 2004/08/13 05:00
CRDT- 2004/05/28 05:00
PHST- 2003/08/04 00:00 [received]
PHST- 2003/12/10 00:00 [revised]
PHST- 2004/01/10 00:00 [accepted]
PHST- 2004/05/28 05:00 [pubmed]
PHST- 2004/08/13 05:00 [medline]
PHST- 2004/05/28 05:00 [entrez]
AID - S1386653204000228 [pii]
AID - 10.1016/j.jcv.2004.01.002 [doi]
PST - ppublish
SO  - J Clin Virol. 2004 Aug;30(4):313-9. doi: 10.1016/j.jcv.2004.01.002.