Skip to main content

Advertisement

SpringerLink
Log in

Results of an unannounced proficiency test for the quantification of hepatitis C virus (HCV) RNA in Shanghai, China

  • General Paper
  • Published:
Accreditation and Quality Assurance Aims and scope Submit manuscript

Abstract

Sensitive and accurate hepatitis C virus (HCV) RNA quantification is essential for the management of chronic hepatitis C therapy. Currently, in Shanghai, China, many laboratories offer to quantify the HCV RNA level using various reverse transcription-polymerase chain reaction (rRT-PCR) assays, but the degree of proficiency may vary between them. The objective of this study was to realistically evaluate the performance of clinical laboratories for HCV RNA quantification by a new way of proficiency test program (unannounced inspection). Inactivated chimeric influenza viral particles (CIVP) encapsulating specific RNA sequences of HCV were prepared as positive samples. The sample panel, which consisted of two negative and eight positive samples with different concentrations of CIVP (25 IU/ml to 2.5×106 IU/ml), was distributed to 40 clinical laboratories for HCV RNA quantification. The results reported by the participating laboratories were compared and scored. It was found that 75 % (30/40) of the laboratories obtained an acceptable or better performance score, while the other 10 laboratories had room for improvement. Reported results for individual samples ranged from 125 IU/ml (minimum) to 6.0×104 IU/ml (maximum). The greatest variation was observed for samples with a relatively low concentration. Interlaboratory variability among replicate samples was significantly greater than intralaboratory variability (p < 0.05). Our results demonstrate that there is room for some laboratories to improve their performance in the quantification of HCV RNA in Shanghai. Additionally, this study underlines the importance of unannounced inspection for realistically monitoring the quality of diagnostic laboratories.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Wei L, Lok AS (2014) Impact of new hepatitis C treatments in different regions of the world. Gastroenterology 146(5):1145–1150

    Article  PubMed  Google Scholar 

  2. Ghany MG, Strader DB, Thomas DL, Seeff LB, American Association for the Study of Liver D (2009) Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 49(4):1335–1374

    Article  CAS  PubMed  Google Scholar 

  3. Poordad F, Reddy KR, Martin P (2008) Rapid virologic response: a new milestone in the management of chronic hepatitis C. Clin Infect Dis 46(1):78–84

    Article  PubMed  Google Scholar 

  4. Chevaliez S, Pawlotsky JM (2009) How to use virological tools for optimal management of chronic hepatitis C. Liver Int 29(Suppl 1):9–14

    Article  PubMed  Google Scholar 

  5. de Leuw P, Sarrazin C, Zeuzem S (2011) How to use virological tools for the optimal management of chronic hepatitis C. Liver Int 31(Suppl 1):3–12

    Article  PubMed  Google Scholar 

  6. Gentili G, Pisani G, Saldanha J, Cristiano K, Wirz M, Bisso GM, Mele C, Participants EQA (2003) High proficiency in detecting the six major hepatitis C virus genotypes of laboratories involved in testing plasma by nucleic acid amplification technology. Vox Sang 85(2):114–116

    Article  CAS  PubMed  Google Scholar 

  7. Mancini C, Pisani G, Azzi A, Luisa Zerbini M, Gentili G, Mario Bisso G, Participants MS (2004) Inter-laboratory comparison of qualitative and quantitative detection of hepatitis C (HCV) virus RNA in diagnostic virology: a multicentre study (MS) in Italy. J Clin Virol 30(4):313–319

    Article  CAS  PubMed  Google Scholar 

  8. Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM (2007) Overestimation and underestimation of hepatitis C virus RNA levels in a widely used real-time polymerase chain reaction-based method. Hepatology 46(1):22–31

    Article  CAS  PubMed  Google Scholar 

  9. Shiffman ML, Ferreira-Gonzalez A, Reddy KR, Sterling RK, Luketic VA, Stravitz RT, Sanyal AJ, Garrett CT, De Medina M, Schiff ER (2003) Comparison of three commercially available assays for HCV RNA using the international unit standard: implications for management of patients with chronic hepatitis C virus infection in clinical practice. Am J Gastroenterol 98(5):1159–1166

    Article  CAS  PubMed  Google Scholar 

  10. Pisani G, Cristiano K, Marino F, Luciani F, Bisso GM, Mele C, Adriani D, Gentili G, Wirz M (2009) Quantification of hepatitis C virus (HCV) RNA in a multicenter study: implications for management of HCV genotype 1-infected patients. J Clin Microbiol 47(9):2931–2936

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Schirm J, van Loon AM, Valentine-Thon E, Klapper PE, Reid J, Cleator GM (2002) External quality assessment program for qualitative and quantitative detection of hepatitis C virus RNA in diagnostic virology. J Clin Microbiol 40(8):2973–2980

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Wang LN, Zhang R, Shen ZY, Chen WX, Li JM (2008) External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China. Chin Med J (Engl) 121(11):1032–1036

    Google Scholar 

  13. Wood WG (2004) Questionable results–who directs the EQAS organisers? Clin Chem Lab Med 42(9):1073

    Article  CAS  PubMed  Google Scholar 

  14. Jenny RW, Jackson KY (1993) Proficiency test performance as a predictor of accuracy of routine patient testing for theophylline. Clin Chem 39(1):76–81

    CAS  PubMed  Google Scholar 

  15. Wang X, Liu F, Jiang L, Bao Y, Xiao Y, Wang H (2016) Use of chimeric influenza viruses as a novel internal control for diagnostic rRT-PCR assays. Appl Microbiol Biotechnol 100(4):1667–1676

    Article  CAS  PubMed  Google Scholar 

  16. Wang X, Zhang W, Liu F, Zheng M, Zheng D, Zhang T, Yi Y, Ding Y, Luo J, Dai C, Wang H, Sun B, Chen Z (2012) Intranasal immunization with live attenuated influenza vaccine plus chitosan as an adjuvant protects mice against homologous and heterologous virus challenge. Arch Virol 157(8):1451–1461

    Article  CAS  PubMed  Google Scholar 

  17. Valentine-Thon E, van Loon AM, Schirm J, Reid J, Klapper PE, Cleator GM (2001) European proficiency testing program for molecular detection and quantitation of hepatitis B virus DNA. J Clin Microbiol 39(12):4407–4412

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. de Pagter PJ, Schuurman R, de Vos NM, Mackay W, van Loon AM (2010) Multicenter external quality assessment of molecular methods for detection of human herpesvirus 6. J Clin Microbiol 48(7):2536–2540

    Article  PubMed  PubMed Central  Google Scholar 

  19. Sarrazin C, Dragan A, Gartner BC, Forman MS, Traver S, Zeuzem S, Valsamakis A (2008) Evaluation of an automated, highly sensitive, real-time PCR-based assay (COBAS Ampliprep/COBAS TaqMan) for quantification of HCV RNA. J Clin Virol 43(2):162–168

    Article  CAS  PubMed  Google Scholar 

  20. Vermehren J, Maasoumy B, Maan R, Cloherty G, Berkowski C, Feld JJ, Cornberg M, Pawlotsky JM, Zeuzem S, Manns MP, Sarrazin C, Wedemeyer H (2016) Applicability of hepatitis C virus RNA viral load thresholds for 8-week treatments in patients with chronic hepatitis C virus genotype 1 infection. Clin Infect Dis 62(10):1228–1234

    Article  CAS  PubMed  Google Scholar 

  21. Wang X, Liu F, Jiang L, Bao Y, Xiao Y, Wang H (2017) External quality assessment for human papillomavirus 16/18 DNA detection and genotyping in Shanghai, China. Clin Chem Lab Med 55(2):195–202

    Article  CAS  PubMed  Google Scholar 

  22. Candido A, Chionne P, Milazzo L, Dettori S, Madonna E, Taffon S, Kondili LA, Barca A, Hassan HJ, Rapicetta M (2008) Nucleic acid testing (NAT) for HCV RNA in Italian transfusion centres: an external quality assessment. J Clin Virol 41(4):277–282

    Article  CAS  PubMed  Google Scholar 

  23. Mancini C, Zerbini M, Azzi A, Piunno M (2003) Multicentre Italian Study Group (MISG) for the standardisation of hepatitis C virus (HCV) PCR. J Clin Virol 27(1):83–89

    Article  CAS  PubMed  Google Scholar 

  24. Niesters HG (2004) Molecular and diagnostic clinical virology in real time. Clin Microbiol Infect 10(1):5–11

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgements

We appreciate those laboratories and institutions that participated in the PT schemes for this survey on HCV RNA quantification. This work was supported by the Natural Science Foundation of Shanghai (No. 15ZR1436200).

Author information

Author notes

  1. Xueliang Wang and Fen Liu contributed equally to this work.

Authors and Affiliations

  1. Department of Molecular Biology, Shanghai Centre for Clinical Laboratory, 528 Hongshan Road, Pudong, Shanghai, 200126, China

    Xueliang Wang, Lingli Jiang, Yun Bao, Yixiao Yang, Yanqun Xiao & Hualiang Wang

  2. Shanghai Institute of Biological Products, Shanghai, China

    Fen Liu

Authors
  1. Xueliang Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Fen Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Lingli Jiang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yun Bao
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Yixiao Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Yanqun Xiao
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Hualiang Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Hualiang Wang.

Ethics declarations

Conflict of interest

The authors state that there are no conflicts of interest with regard to publication of this article.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Wang, X., Liu, F., Jiang, L. et al. Results of an unannounced proficiency test for the quantification of hepatitis C virus (HCV) RNA in Shanghai, China. Accred Qual Assur 23, 277–284 (2018). https://doi.org/10.1007/s00769-018-1341-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00769-018-1341-9

Keywords

Search

Navigation