Recent Activities - 2018
In December 2018, NRL staff members, Wayne Dimech and Liza Cabuang attended the African Society for Laboratory Medicine (ASLM) meeting In Abuja, Nigeria. NRL is pleased to have participated in each of the previous three ASLM meetings in Capetown, South Africa over the past years. The ASLM meeting brings together laboratory scientists, clinicians and quality managers from the entire African continent and has grown in strength of purpose since its inception, working toward laboratory strengthening and to improve local access to world-class diagnostic services so as to ensure healthy African communities now and for the long-term. So it was pleasing that NRL played a role in the program in 2018 and NRL staff were able to meet many of our international partners and make contact with a number of new, like-minded organisations.
Liza presented a paper entitled “Assuring quality and building trust: Providing high quality, low cost EQAS at both laboratory and community settings”. The aim of this paper was to highlight the importance of access to external quality assurance (EQA) programmes for both laboratory and community testing. As a provider of EQA to more than 70 countries world-wide, NRL recognises the barriers to accessing EQA by facilities testing at point of care (PoC). Access to international commercial EQA is expensive and nucleic acid testing (NAT) EQA requires shipping on dry ice under IATA requirements, importation and customs clearances; and a cold chain to prevent thawing. Since 2016, NRL has developed a range of EQA challenges that remove these barriers and have now ISO 17043 compliant programmes for HIV RNA and DNA (for early infant diagnostics), HCV RNA, HBV DNA, TB (including resistance), STI testing (C. trachomatis, N. gonorrhoea, U. urealyticum, T. vaginalis and M. genitalium) as well as serology PoC for HIV Ag/Ab, HCV, HBV and syphilis.
All of these programmes have been released for 2019. The remaining barrier is the distribution of the programmes. PoC facilities are, by definition, situated in remote geographies that are often difficult to access. Although NRL can reach most facilities using our extensive distribution network, it is resource intensive and time consuming. However, implementing partners and manufacturers of PoC assays are already providing access to the devices. NRL is keen to work with these groups to bundle our unique EQA offerings with the provision of the devices. This will remove the last remaining barrier to quality assured testing and further reduce the cost to testing facilities. It will also provide the implementing partner and/or manufacture access to post market monitoring data generated directly from the field.
As part of the SLPTA/SLMPTA workshops prior to the ASLM conference, Wayne participated in a well-attended workshop entitled “Creating a national EQA program”, alongside several African colleagues. Subsequent to that workshop, Wayne conducted a second 1.5 hour session on “Understanding quality control for infectious disease testing”. This session reviewed the current state of play for quality control for infectious disease serology, reviewing a recent publication by NRL and presenting case studies. Through the use of an interactive polling application, the audience could see the range of responses to commonly occurring situations, demonstrating that there is still uncertainty around the application of QC rules to infectious disease serology.
It was an honour and pleasure for Wayne to be presenting alongside Sten Westgard, who delivered a workshop entitled “Six Sigma to 90-90-90”. Sten’s eloquent presentation raised awareness of the use of six sigma to improve understanding of the performance of diagnostic testing. Both Wayne’s and Sten’s talks indicated that more work needs to be done to understand the performance of HIV viral load (VL) testing. As the final “90” of the UN 90-90-90 is implemented, it is clear that there is limited evidence-based information on how HIV VL testing is performing in the field, especially in remote regions of Africa and using PoC or in-house assays. Discussions at the workshop, and subsequent post-workshop meetings involving interested African parties resulted in a decision for African scientists to take the lead in collecting and analysing data to create a better understanding of VL test performance. Since the ASLM conference, discussions remain on-going in the endeavour that an ASLM, CDC USA, CDC Africa, Westgard and NRL initiative can implemented in 2019.
Further Information on NRL Point-of-Care Testing EQAS can be viewed here