Recent Activities - 2020
Comparison of Antibody Detection Assays for SARS-CoV-2
NRL is pleased to announce an agreement with the WHO Emergency Use Group to conduct a comprehensive evaluation of COVID19 serology test kits designed to detect antibodies to SARS-CoV-2 virus. Since the onset of the pandemic, hundreds of serology test kits otherwise referred to as in-vitro diagnostic devices (IVDs) have been released for use without manufacturers being required to undergo formal conformity assessment and provide comprehensive evidence of performance characteristics of the IVD. The removal of this barrier has allowed many new manufacturers to enter the market with devices of unknown quality. There have been many studies of test kits published in both peer-reviewed and non-peer reviewed fora. However, the study designs have often been substandard and therefore the results conflicting. No organisation has undertaken a head-to-head comparison of multiple tests using well-established evaluation principles.
NRL is one of fourteen authorised WHO Prequalification Evaluation Laboratories globally. For decades, NRL performed pre-market evaluation of IVDs on behalf of the Australian Government Therapeutic Goods Administration and has recently been sub-contracted to perform post-market evaluation of SARS-CoV-2 serology assays listed on the Australian Register of Therapeutic Goods. Using the extensive experience in IVD evaluations, NRL and WHO will evaluate up to 40 serology test kits using the same sample set. The evaluation design is comprehensive and assesses all relevant performance characteristics such as analytical and clinical sensitivity, clinical specificity, precision, lot-to-lot variation, limit of detection, seroconversion sensitivity, and the influences of cross-reacting and interfering substances. This study will provide important information for potential procurers and users.
The potential utility of serology assays in the cascade of care for COVID-19 patients is yet to be determined definitively. It is expected that the data arising from this important study will provide evidence as to how different test kits can be used in conjunction with understanding their sensitivity and specificity; identify which serological markers can be used to identify stages of disease and, importantly, identify test kits that report common false reactivity. The results of the study will inform WHO, and therefore the Global Fund and other implementers as to which test kits will be most appropriate for provision to low-middle income countries.