Over the years many diagnostic tests have been employed but recently the molecular diagnostic techniques have become central to the management of patients with HCV and can be used for many different applications. e. g. screening, assessment of viral load, genotyping, resistance and treatment monitoring.
These new PCR based diagnostic tests all can have a positive impact on patient care as they deliver high sensitivity and specificity, allied to a fast turnaround time. In addition to these attributes, the latest technology is driving towards long term, temperature stable reagents, lower cost per test, higher throughput, smaller instruments with simple operation and faster time results.
With the fast pace of new technology and the plethora of systems that are coming to the market, selecting the most appropriate tool for the right clinical setting ,which helps clinicians save costs while providing effective management and care is a challenge.
Today there are a number of high throughput molecular systems from companies such as Roche, Abbott, Beckman Coulter and Hologic. However, recently a “new kid on the block” has appeared in the field of HCV - the Xpert® HCV Viral Load assay used on the Cepheid GeneXpert® system. The GeneXpert system has many useful benefits such as: one minute hands-on time, fast results (105 minutes), broad dynamic range (10-10,000IU/mL), quantitates HCV genotypes 1-6 and built-in controls for result integrity. In addition to this, the GeneXpert system is very scalable and flexible, suitable for all settings ranging from low volume, near patient testing such as GeneXpert Omni*, to high volume laboratory testing such as the GeneXpert Infinity system.
The field of diagnostic in HCV is dynamic and as new tests and drugs come along there are still many open questions for future discussion. For example: (i) which is the most effective-quantitative or qualitative tests? (ii) With the new DAA drug availability, do we still need viral load testing and if so how often? (iii)Can we use qualitative tests during therapy and if so what should be the LOD (Limit of detection) and (iv) Can serologic tests (HCV Ag test) replace confirmation by molecular tests in HCV diagnosis?
*Statements and products depicted are forward-looking. Not available for diagnostic use. Projected release in 2016.