59
Results
The FTD HEV assay had already displayed positive results in terms of sensitivity, specifi city and precision as proven in internal evaluations conducted by Fast-track diagnostics. The external confi rmation by QCMD led to the comparison study, comparing the FTD HEV assay with the in-house assay and competitor kit, to determine the most effective kit to utilise. The results are shown in Table 3a and 3b. For the quantifi cation of samples with the FTD HEV assay, three quantifi cation standards given in IU/ml were used, as demonstrated in Figure 1.
Table 3a. A comparison of positive and negative samples (EDTA, serum, ascites and stool) detected by FTD Hepatitis E RNA versus MHH in-house assay
Figure 1. Average quantities (IU/ml) and log10 units from the median difference for the clinical samples tested (serum, EDTA and stool) by FTD Hepatitis E RNA and MHH in-house assay
Conclusion
Table 3b. A comparison of positive and negative samples (EDTA, serum, ascites and stool) detected by FTD Hepatitis E RNA versus competitor assay
RT-PCR is an important tool in diagnosing and preventing the spread of infectious diseases, allowing viruses to be identifi ed quicker and more effectively, ensuring precise and effective treatment options can be employed. Choosing an assay that can perform quickly and effi ciently is benefi cial to the laboratory as it allows test results to be obtained in a timely manner, and guarantees patients receive prompt and accurate treatment, which is important in vulnerable patient groups such as transplant patients in particular.
The results of the recent comparison study, demonstrated that the FTD HEV assay performed with good results compared to the MHH assay and the competitor kit. Since conducting the study, Professor Dr Heiner Wedemeyer has chosen to use the FTD HEV assay for routine diagnostics, allowing MHH to offer effi cient diagnosis and suitable treatment options to prevent further disease transmission and ultimately reduce mortality rates.
References
In comparison to the MHH and competitor assays, the FTD HEV assay demonstrated comparably good results, in sensitivity and specifi city. For EDTA, serum and CPDA the sensitivity was 100%, however a loss of sensitivity and higher discrepancy of quantity unit logs detected was observed with stool samples. Therefore, due to the results the FTD HEV assay is most suited to the use of EDTA blood, serum, CPDA or ascites as the specimen type to collect for the test of hepatitis E virus.
The quantitative results obtained in this study show the satisfactory performance and usability of the FTD HEV assay. This means that the assay can be confi dently selected for use in routine diagnostic procedures, to offer patients prompt and accurate treatment options and improved prognosis.
[1] WHO. (2015). Hepatitis E. Available:
http://www.who.int/mediacentre/factsheets/fs280/en/. Last accessed 18 Sept 2015.
[2] Behrendt, P. Steinmann, E. Manns, M.P. Wedemeyer, H. (2014).The impact of hepatitis E in the liver transplant setting. Journal of Hepatology, 61 (6): 1418-1429.
[3] Wedemeyer, H. Pischke, S. Manns, M.P. (2012). Pathogenesis and treatment of hepatitis e virus infection. Gastroenterology 142 (6): 1388-1397.
[4] Ahmed, A. Ali, I. Ghazal, H. Fazili, J. Nusrat, S. (2015). Mystery of Hepatitis E Virus: Recent Advances in Its Diagnosis and Management. International Journal of Hepatology, 1-6.
[5] Wedemeyer, H. Gruhn, C. Bremer, B. Heckmann, M. Steimer, M. Carman, W. (2015). Clinical evaluation of a novel Fast-track diagnostics multiplex real-time PCR assay for detection and quantifi cation of Hepatitis E virus. Available:
http://www.fast-trackdiagnostics.com/media/218217/poster-eccmid-2015-hepatitis-e.pdf. Last accessed 28th Sept 2015.
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www.labmate-online.com/articles Fast, Accurate Total Organic Carbon (TOC) Analysis Introduced
Beckman Coulter Life Sciences has introduced the QbD1200 Total Organic Carbon (TOC) Analyzer. Designed to be faster for higher TOC sample analysis throughput for the busy QC laboratory, the new instrument also carries out direct TOC analysis for greater quality and regulatory compliance. The QbD1200 is ideally suited for measuring Water For Injection (WFI), Purifi ed Water (PW), bulk sterile water, and cleaning validation samples.
A full 18-point, automated calibration (6 concentrations, 3 replicates each) takes only 90 minutes. The technology underpinning the new system virtually eliminates sample-to-sample carryover to <0.2% so that labs will no longer need to throw away their fi rst sample.
Unlike many TOC analysers, the QBD1200 does a direct TOC measurement. Howie Carpenter, Beckman Coulter Life Sciences Business Unit Manager for TOC, explained: “The measurement obtained from extracting Total Inorganic Carbon (TIC) from the Total Carbon (TC) is error-prone and not suitable for the new quality requirements. It often leads to negative TOC values being reported due to measurement uncertainties between the two sensors.
“Instead, the QbD1200 fi rst removes all TIC from the sample, using dynamic end point detection to ensure everything is removed. It then takes a direct measurement of the remaining TOC in the sample.”
The QbD1200 features a unique implementation of the UV/persulphate oxidation method which combines acid and oxidiser into a single reagent (patent pending). To help provide an attractive total cost of ownership, this single reagent can be purchased as a concentrated stock solution, or prepared by the user following the simple recipe provided.
To help pharmaceutical manufacturers reduce paper records and tightly eliminate the use of USB memory sticks in their laboratory environments, the QbD1200 is designed to export all reports and qualifi cation results, such as Calibration and System Suitability, over Ethernet using a secure FTP protocol to a central server. The lab can then keep all records required for audit in a single location, simplifying record keeping.
The QbD1200 is designed to be used in a 21 CFR part 11 environment, with all data stored in an encrypted database with a complete audit log. As the QbD1200 is a self-contained system and not controlled by an external computer, no Computer System Validation (CSV) is required, simplifying the qualifi cation and validation of the analyser in the regulated pharmaceutical environment.
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