Noëlie Béré Henry

Background: The clinical research laboratory plays a pivotal role in the execution of clinical studies. The accurate and consistent registration of patients is dependent on the competent use of laboratory equipment and manual techniques by technicians, ensuring the reliability of the data collected. To support these activities, the Groupe de Recherche Action en Santé (GRAS) has been registered with the College of American Pathologists (CAP) and the Clinical Laboratories Services (CLS) in Johannesburg, South Africa, for external proficiency testing (EPT) of its laboratory, as part of our commitment to quality assurance. The following report details the performance achievements over the past five years. Methods: Proficiency testing (PT) samples are dispatched to GRAS Lab three times a year (quarterly) and the results are generally returned within two to three weeks. In the field of parasitology, challenge specimens were prepared as follows: thick and thin blood films were stained with Giemsa and mounted with strips to protect them for multiple uses. Photographs, also known as whole slide images (WSIs), were also taken. For the biochemistry and haematology tests, a set of five samples were received for processing. All evaluations were carried out in accordance with the GRAS laboratory’s internal procedures. Results: The CAP laboratory’s performance in terms of the diagnosis of malaria and other blood parasites from 2020 to 2024 was 97.3% accurate (ranging from 93.33% to 100%), with 93.33%, 100%, 100%, 93.33% and 100% achieved in 2020, 2021, 2022, 2023 and 2024, respectively. The number of microscopists evaluated annually has been subject to variation according to operational staff at the time of evaluation. A total of 31 microscopists were enrolled in the CLS PT scheme, of which 73.9% were classified as ‘experts’ and 19.2% as ‘reference’ microscopists. In the field of haematology, the PT demonstrated 100% accuracy over the four-year study period. This outcome is indicative of the high-performance levels exhibited by the automated systems under scrutiny and the comparable nature of the data produced by these systems. The same trend was observed in the biochemistry PT results, with an overall score of 92.12%, ranging from 78% to 100%. Conclusions: Proficiency testing has been shown to be an effective tool for quality assurance in laboratories, helping to ensure the accuracy of malaria and other blood parasite diagnoses made by microscopists, as well as the results generated by automated systems. It has been instrumental in assisting laboratories in identifying issues related to test design and performance.

Background: Clinical research lab is a key component of the conduct of clinical studies. Enrolment, follow up of patients is mainly based on the diagnosis skills of lab technicians and automates performance. To overcome this challenge, since 2020, as part of the quality assurance of its lab research activities, GRAS has registered with the College of American Pathologists (CAP) and the Clinical Laboratories Services (CLS) Johannesburg, South Africa for external proficiency testing (EPT) of its laboratory. The performances achieved during these last five years are reported. Methods: PT samples were couriered out three times a year (quadr-month) (hereafter referred to as Q) to GRAS Lab and results were generally due back two to three weeks later. For parasitology, challenges specimen are thick and thin blood films stained with Giemsa and mounted with strip to protected them for multiple use, or photographs also called ̎ whole slide images ̎ (WSI). For biochemistry and haematology, a set of 5 samples were received for processing. All the evaluations were performed according to the GRAS lab internal established procedures. Results: The overall CAP parasitological laboratory performance in term of diagnosis accuracy of malaria parasites and other blood parasites from 2020 to 2024 was 97.3% (ranging from 93,33 to 100%); with 93,33%, 100%, 100%, 93.33% and 100% achieved respectively in 2020, 2021, 2022, 2023 and 2024. Annually, the number of evaluated microscopists varied according to operational staff at the time of evaluation. In total, 31 microscopists were enrolled in CLS PT scheme, with 73.9% graded as “experts” microscopists and 19.2% graded as “reference” microscopists. For haematology, the PT showed 100% accuracy over the 4 years participation indicating the high-performance level of the tested automates and the comparability of data between automates. Same trend was observed for biochemistry PT results with an overall score of 92,12% ranging from 78% to 100%. Conclusion: The Proficiency testing has demonstrated value as an important laboratory quality assurance tool to guaranty the accuracy skill for malaria parasites and other blood parasites diagnosis by lab technicians and results generated by the automates. It has helped laboratories identify issues related to test design and performance.