The Importance of External Quality Assessment in HIV Enzyme Immunoassay Testing
The Importance of External Quality Assessment in HIV Enzyme Immunoassay Testing
Introduction
Quality Control (QC) is vital for the clinical laboratory in order to ensure the accuracy and precision of patient test results. Without a robust QC strategy, test system errors could go undetected, potentially resulting in misdiagnosis and inappropriate/delayed patient treatment.
QC can be divided into two main components; Internal Quality Control (IQC) and External Quality Assessment (EQA).
What are IQC and EQA?
IQC is used in the daily monitoring of test system precision and reproducibility. IQC essentially compares the internal laboratory’s performance over time, highlighting any deviations from ‘normal’ performance. While IQC is a good method of testing performance, it is not always robust enough to detect calibration errors or issues associated with ‘wide’ acceptable limits.
In an External Quality Assessment (also known as Proficiency Testing, or PT) program the EQA provider will deliver ‘blind’ samples to all EQA participants. The use of such ‘blind’ samples ensures EQA can be used to measure a laboratory’s bias and accuracy. These samples are analysed by the lab and results are returned to the EQA provider for analysis. The data are examined, means and SDs are calculated, and any outliers are highlighted. Reports are then generated and delivered to each participant, giving a summary of performance in comparison to the rest of the participant group.
Why Should Laboratories Carry out EQA Testing?
The World Health Organisation (WHO) recommends that a robust QA program should be implemented in any lab which carries out HIV testing, and Internal and External quality control should be carried out on an ongoing basis1.
Participating in a rigorous and robust EQA scheme is a requirement of ISO 15189. All labs seeking ISO 15189 accreditation need to be part of an EQA scheme which appropriately challenges their test system.
The Cost of Poor Quality EQA
The most common method of HIV detection is to utilise Enzyme Immunoassay (EIA) antibody testing2. EIA tests are highly sensitive and can be optimised for automation, facilitating high-volume testing. However, with higher volumes of testing comes a higher probability of error. With EIA assays, the most common error encountered is false positive results2.
False positive results have a number of implications. Any screen-positive results must be verified using a confirmatory test; usually a Western Blot assay. The Western Blot is much more labour intensive and expensive than EIA tests, and is not efficient enough for high volume testing2. Therefore, if a laboratory is producing a higher than average number of false positive results due to poor quality assurance practices, they will ultimately spend significantly more time and money on confirmatory tests.
How can EQA Improve HIV Testing Accuracy?
The main use of EQA is to verify the accuracy of laboratory testing. Accuracy refers to the closeness of the obtained result to the ‘true’ value. As EQA is tested using ‘blind’ samples, operator bias is eliminated and the test system can be appropriately challenged.
EQA can also be used as a means of detecting deficiencies with IQC. For example, some IQC providers supply assayed IQC material with very wide acceptable limits, with 2SD often +/- 20% from target value. For this reason, labs may believe their performance is good, but when scrutinized by EQA with narrow acceptable limits, performance will be identified as substandard.
What to Look for in a Good EQA Scheme
Laboratories can join either Local, National or International EQA schemes. An International EQA scheme would provide the best return on investment due to the higher peer group size and more diverse demographic of participants. Some key factors which typify a good quality EQA scheme include:
- Accreditation to ISO 17043 – Being accredited to this standard ensures the EQA scheme is fit for purpose
- Frequent Distribution – Regular EQA analysis allows for rapid identification of errors and any necessary corrective actions can be taken as soon as possible
- Large Number of Participants – Ensures an extensive database of results for a range of analytical methods and instruments. In addition, larger participant groups increase statistical validity of results
- Clinically Relevant Ranges – Analytes should be present at both normal and abnormal ranges, as to ensure medical decision limits are adequately tested
- Comprehensive Reports – Much of the value of participating in an EQA scheme lies in the report generated by the provider. Reports should be comprehensive, providing a range of statistical metrics and charts
How can Randox Help?
The Randox International Quality Assessment Scheme (RIQAS) incorporates all the above features, as well as many others, into the world’s most comprehensive EQA scheme. With more than 45,000 participants worldwide, RIQAS offers unrivalled peer group comparison, and has earned its place as the most popular EQA scheme in the world.
Conclusion
An EQA scheme operates like an early warning system; it can alert the lab and document the need for, stimulate and monitor improvement. However, the improvements themselves must be implemented and maintained by the lab.
Investment in a good EQA scheme can save labs a substantial amount of time and money, so it is worthwhile to invest wisely.
To sign up for RIQAS or to learn more, sign up using the form below!
References
- World Health Organisation, Laboratory Methods For Diagnosis Of HIV Infection In Infants And Children. Geneva: World Health Organisation. 2010;5.
- Fearon M. The laboratory diagnosis of HIV infections. The Canadian Journal of Infectious Diseases & Medical Microbiology. 2005;16(1):26-30.
Your dream career awaits at Randox Teoranta
This festive season, Dungloe-based Randox Teoranta has a message for ambitious students and graduates – that achieving your career dream is possible, and it might not be as far away as you think.
The global healthcare diagnostics firm today launched its annual recruitment drive by asking life scientists, engineers and software developers to reflect on the career dreams they had as children, and to consider the world-class careers on offer in rural Donegal. In previous years, these areas of industry have suffered most from mass emigration of the university graduates who have had to look elsewhere for jobs in their respective fields.
Randox Teoranta wants to let students, graduates and experienced professionals across the island of Ireland, and those further afield who have moved abroad to find work, know that they can find the career they’ve always dreamed of close to home.
Ciaran Richardson, Head of R&D at Randox Teoranta, commented;
“At Randox Teoranta we have scientists working on a range of research projects, including the development of innovative health technologies capable of diagnosing stroke, gastrointestinal disorders and chronic kidney disease. This is following ground breaking developments in 2016 where scientists in Randox Teoranta were involved in the launch of a pioneering new test used to determine a patient’s risk of developing Alzheimer’s disease.
“In addition to those interested in human health we also have scientists who when they were younger wished to pursue a career in the animal research and veterinary science world. These scientists within our veterinary department are involved in the development of novel multiplex tests used to monitor disease spread and improve animal welfare.
“We have software developers who are working with revolutionary technologies – augmented and mixed reality headsets for example – that in their youth they could only have dreamed of”.
“And we have engineers who, as children, loved to take apart their electronic toys and piece them back together. They’re now using their talent to engineer machines which detect disease and save lives. I can think of no better use for their skillset and I’m incredibly proud that our biotechnology hub right here in rural Donegal means that young people from far and wide can achieve their career dreams.”
If you’re at school and currently thinking about university choices, a school leaver, student, graduate, or experienced professional, come along to Randox Teoranta’s Open Day on Friday 22nd December 2017. Parents of students are also welcome to visit the state-of-the-art site in Dungloe, Donegal, where visitors will be treated to an opportunity to view the facility and meet members of the Randox team.
Come and view our hub of pioneering research and development, where cutting-edge science, technology and IT takes place. If you, or someone you know, is interested in a career in life sciences, engineering, software development or software testing, come along to Randox Teoranta on Friday 22nd December.
Don’t just dream it. Make it happen at Randox Teoranta.
The Randox Teoranta Open Morning is on Friday 22nd December 2017 from 10am – 2pm at Randox Teoranta, Meenmore, Dungloe, Co. Donegal.
To find out more tel: +353 7495 22600 or email: randoxpr@randox.com
No booking is required.
