External quality assessment for the molecular detection of Hepatitis C virus

Chalker, Victoria J.; Rossouw, A.; Mee, Z.; Patel, Priyesh; Vaughan, Helen; James, Veronica

doi:10.1016/j.jcv.2005.10.018

Cited by 5 publications

(2 citation statements)

References 8 publications

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“…With respect to the quantification of HCV RNA by NAT, up to now only a few MSs have been done and none included the use of commercial assays based on the TaqMan system (1,8,11,13).…”

mentioning

confidence: 99%

Quantification of Hepatitis C Virus (HCV) RNA in a Multicenter Study: Implications for Management of HCV Genotype 1-Infected Patients

et al. 2009

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Assessment of the viral load in hepatitis C virus (HCV) genotype 1-infected patients is critical before, during, and after antiviral therapy. In patients achieving a rapid virological response at week 4 of treatment, the viral load at the baseline is considered a predictive criterion of a sustained virological response 24 weeks after the discontinuation of treatment. A >2-log 10 drop in the viral load at week 12 of treatment (early virological response) triggers the continuation of therapy. We organized a multicenter study (MS) for diagnostic laboratories involved in the quantification of HCV RNA. Commercial assays, including two based on real-time reverse transcription-PCR (TaqMan system), and in-house methods, were used by the 61 participants. The overall reproducibility of the commercial quantitative nucleic acid amplification techniques (qNAT) was acceptable. As the intermethod variability among commercial qNAT for HCV RNA was still present, the manufacturers of these test kits should join efforts to harmonize the means of quantification of HCV RNA. This study also shows that caution should be exercised when the baseline viral load is evaluated and when the 2-log 10 reduction after 12 weeks of therapy is interpreted. Finally, this MS confirms the higher sensitivity of the commercial qNAT based on the TaqMan system, making them the elective assays for the monitoring of therapy.

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“…With respect to the quantification of HCV RNA by NAT, up to now only a few MSs have been done and none included the use of commercial assays based on the TaqMan system (1,8,11,13).…”

mentioning

confidence: 99%

Quantification of Hepatitis C Virus (HCV) RNA in a Multicenter Study: Implications for Management of HCV Genotype 1-Infected Patients

et al. 2009

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“…For example, to assess a laboratory ' s ability to use molecular diagnostic technologies within the clinical setting, taking part on profi ciency testing panels providing the laboratory with a series of samples that resemble clinically signifi cant specimens is mandatory. In Europe, several programs for profi ciency testing in molecular diagnostics for infectious diseases have been established including EQUALqual , a project proposed under the auspices of the EC4 and funded by the European Commission (8) , and several commercially available programs provided by, e.g., QCMD (9 -13) , NEQAS (14,15) , and INSTAND (16) . Usually, a higher percentage of correct results is observed with IVD/CE labeled or FDA-approved or -cleared molecular tests or test systems than with laboratory-developed molecular assays.…”

Section: Profi Ciency Testingmentioning

confidence: 99%

Quality assurance and quality control in the routine molecular diagnostic laboratory for infectious diseases

Kessler

Raggam

2012

Clinical Chemistry and Laboratory Medicine (CCLM)

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Molecular diagnostics has become one of the dominant platforms in clinical laboratory medicine. Technological improvements, from automated sample preparation to real time amplifi cation technology, provide the possibility to develop and run assays for a growing number of clinical questions. However, quality assurance and quality control issues have often remained underdeveloped but are still critical. To relate patient results to prior results or to absolute values in clinical practice guidelines, those results need to be comparable across time and methods. This may be achieved either by producing the identical value across methods and test versions or by using reliable and stable conversions. The establishment of international standards and reference materials is thus of paramount importance. This review focuses on general and specifi c issues relevant for quality assurance and quality control in the routine molecular diagnostics laboratory.Keywords: molecular diagnostics; quality assurance; quality control. Accreditation issuesThe framework of common standards including the international standards ISO 9001:2008 and ISO 15189 has been established allowing laboratories to plan and operate a medical testing with an effective quality management system that has strong elements of quality assurance, quality control, and quality improvement. When medical testing laboratories effectively implement this quality management system, they have continuous assurance that they are meeting their customers ' needs and expectations for consistent, accurate, and timely test results.Among several issues, these standards contain certain validation and verifi cation procedures because the suitability of a laboratory technique does not necessarily prove that it would be performed correctly and provide valid results. To prove this, quality management systems have been implemented in the majority of routine diagnostic laboratories. For laboratories in the European Union, the European Union ' s Directive on In Vitro Diagnostic (IVD) Medical Devices (98/79/EC) requires data demonstrating that an IVD achieves the stated performance and will continue to perform properly after it has been shipped, stored, and put to use at its fi nal destination (1) . Additionally, common technical specifi cations enforced for tests or test systems are outlined in the Commission Decision of 7 May 2002 on common technical specifi cations for IVD medical devices (2) . For laboratories in the US, the Food and Drug Administration (FDA) has established regulations based on current ISO standards (3) . In addition to supervision, description, and conformity of processes by the use of standard operating procedures, the validation procedure focuses on the competence of the laboratory providing reliable test results and their correct interpretation. Validation and verifi cation workAs for all medical testing, laboratories performing molecular assays must adhere to established validation practices to ensure confi dence and reliability in test results produced....

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External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China

Wang

Zhang²,

Shen³

et al. 2008

Chinese Medical Journal

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External quality assessment for the molecular detection of Hepatitis C virus

Cited by 5 publications

References 8 publications

Quantification of Hepatitis C Virus (HCV) RNA in a Multicenter Study: Implications for Management of HCV Genotype 1-Infected Patients

Quantification of Hepatitis C Virus (HCV) RNA in a Multicenter Study: Implications for Management of HCV Genotype 1-Infected Patients

Quality assurance and quality control in the routine molecular diagnostic laboratory for infectious diseases

External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China

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