Implementation considerations – use of POC HCV RNA testing versus lab-based HCV RNA assays

• Use of lab-based versus POC HCV RNA NAT platforms: The decision whether to use POC or lb-based HCV RNA NAT assays depend on a variety of factors, including cost and ease of use and the characteristics of the testing site, for example, storage facilities, infrastructure, level of staff skills and cost. Use of POC assays may also be considered in services caring for specific vulnerable populations, such as people who inject drugs or people in prisons, with high loss to follow-up or in remote locations. Although POC assays may promote and expedite confirmation of viraemia, there are also many excellent examples in which a centralized laboratory-based system has been highly effective when supported by efficient sample transport and rapid electronic delivery of results.
• Priority settings for placement of HCV POC platforms are likely to be where there are populations at high risk of loss to follow-up and at risk of greater morbidity, but where testing volume is not large, such as at harm reduction sites for people who inject drugs, in prisons or rural settings (24, 28-31).
• The optimal placement of a POC instrument is where testing and treatment are at the same site or “one-stop shops”. Use of POC platforms may not achieve expected outcomes if other aspects of the care pathway require patients to travel to another clinic for treatment, with associated transport and other costs. The evidence review showed that the best results for use of POC assays were when they were placed in clinics where HCV testing and treatment were available at the same site, particularly at harm reduction sites for people who inject drugs.
• Multi-disease testing platforms and diagnostic integration across programmes. The introduction of multi-disease testing platforms (for HIV, TB, SARS-CoV-2, HCV), both high-throughput labbased and POC devices, creates additional opportunities for integration that may further expand access and achieve significant system efficiencies and cost-savings. Countries with existing multi-disease testing platforms for HIV viral load or TB testing, and those that are planning for their introduction, can consider collaboration and integration of HCV RNA testing (32).
• Resource considerations: Programmes report various final costs for HCV RNA assays (Fig. 8.1), with many LMICs paying around US$ 10 to $ 30 per HCV RNA test (both centralized laboratory-based and POC testing). The device costs as well as costs associated with operational components should also be considered. Programmes with higher volumes and pooled procurements (including with other disease assays) may achieve lower costs. In the future, increased competition may both increase access and decrease prices.

Operational considerations for use and maintenance of POC RN assays

• Both centralized laboratory and POC RNA NAT testing require strong decentralized systems (for example, quality control assurance, platform service and maintenance, supply chain, trained staff, ongoing mentorship and waste disposal). Planning for the use of POC technologies in particular should consider how sample collection, sample processing and results return can be integrated into the patient care pathway.
• The infrastructure required for POC platforms will depend on the device and assay and should be reviewed and installed prior to implementation. NearPOC technologies will generally require a sturdy table for centrifugation (not required for fingerstick), airconditioning for temperature control, a room with a sealed door to minimize dust, clinical waste disposal bins and access to a sink with running water for basic laboratory cleaning and accident management. If electricity is unstable and interrupted, an online uninterruptable power supply and voltage stabilizer are required for the Xpert device.
• Regular internal quality control (IQC) and external quality assessment (EQA) check to ensure that the assay works properly (quality control) and that the testing service can return the correct result (external quality assessment).
• Staff training. POC assays require training specific to the device used, but laboratory experience is not necessary.
• Transport and disposal. Assays should be transported in conditions similar to storage conditions and disposed of using proper waste management procedures, ensuring that harmful chemicals are not released into the environment. (For example, Xpert cartridges require high-temperature incineration.)