Implementation of Novel Quality Assurance Program for Hepatitis C Viral Load Point of Care Testing

Abstract

All patients should have access to accurate and timely test results. The introduction of point of care testing (PoCT) for infectious diseases has facilitated access to those unable to access traditional laboratory-based medical testing, including those living in remote and regional locations, or individuals who are marginalized or incarcerated individuals. In many countries, laboratory testing for infectious diseases, such as hepatitis C virus (HCV), is performed in a highly regulated environment. However, this is not the case for PoCT, where testing is performed by non-laboratory staff and quality controls are often lacking. An assessment of the provision of laboratory-based quality assurance to PoCT for infectious disease was conducted and the barriers to participation identified. A novel approach to providing quality assurance to PoCT sites, in particular those testing for HCV, was designed and piloted. This novel approach incudes identifying and validating sample types that are inactivated and stable at ambient temperature, creating cost-effective supply chains to facilitate logistics of samples, and the development of a smart phone-enabled portal for data entry and analyses. The creation and validation of this approach to quality assurance of PoCT removes the barriers to participation and acts to improve the quality and accuracy of testing, reduce errors and waste, and improve patient outcomes.

Keywords: hepatitis C virus; pilot; point of care testing; quality assurance.

Figure 1

Results of monthly testing of whole blood dried tube samples for HCV Genotype 3 (blue) stored at −20 °C for 15 months, and Genotype 1 (orange) stored for nine months. Invalid results were obtained for Genotype 1 for the 5th and 8th month.

Figure 2

Box and whisker graph of HCV viral load results of dried tube samples store at various temperatures over a six-to-nine-month period. Media (quartile 1 and quartile 3) results, expressed in log₁₀ IU/mL are presented.

Figure 3

An image of the NRL Competency Panel mobile phone enabled result entry form (a) and representative Levey–Jennings Chart representing normal variation over time. X axis indicates the date of testing and Y axis indicates the Log₁₀ IU/mL result. The change of reagent batch is displayed at the top of the graph. No acceptance limits are represented but would be displayed by horizonal bars across the graph at the upper and lower ranges (b).