Molecular, serological, and biochemical diagnosis and monitoring of COVID-19: IFCC taskforce evaluation of the latest evidence

Abstract

<jats:title>Abstract</jats:title><jats:p>The global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from initial diagnosis to patient monitoring and treatment. Initial response to this pandemic involved the development, production, and distribution of diagnostic molecular assays at an unprecedented rate, leading to minimal validation requirements and concerns regarding their diagnostic accuracy in clinical settings. In addition to molecular testing, serological assays to detect antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are now becoming available from numerous diagnostic manufacturers. In both cases, the lack of peer-reviewed data and regulatory oversight, combined with general misconceptions regarding their appropriate use, have highlighted the importance of laboratory professionals in robustly validating and evaluating these assays for appropriate clinical use. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 has been established to synthesize up-to-date information on the epidemiology, pathogenesis, and laboratory diagnosis and monitoring of COVID-19, as well as to develop practical recommendations on the use of molecular, serological, and biochemical tests in disease diagnosis and management. This review summarizes the latest evidence and status of molecular, serological, and biochemical testing in COVID-19 and highlights some key considerations for clinical laboratories operating to support the global fight against this ongoing pandemic. Confidently this consolidated information provides a useful resource to laboratories and a reminder of the laboratory’s critical role as the world battles this unprecedented crisis.</jats:p>

Clinical evaluation of four commercial immunoassays for the detection of antibodies against established SARS-CoV-2 infection

“…Despite this high specificity, use of serological assays in an area of low prevalence such as Australia will be associated with lowered positive predictive value and it is likely that serological diagnosis will remain an adjunct to nucleic acid detection for the diagnosis of SARS-CoV-2 infection in specific settings such as retrospective diagnosis where nucleic acid testing is not detected or not performed due to mild or asymptomatic infection. 1,16…”

“…The gold standard for diagnosis relies on the detection of the presence of SARS-CoV-2 nucleic acid most commonly by polymerase chain reaction (PCR). 1 Immunoassays may serve as an adjunct to diagnosis in patients who present late in their illness with only low levels of nucleic acid present in the upper respiratory tract, 2 as well as having a key role in epidemiological serosurveys to determine disease prevalence. 3 In this study, we sought to assess and compare the clinical performance of four commercially available immunoassays using a panel of sera collected from patients who had recovered from their COVID-19 infection.…”

A high-throughput Anti-SARS-CoV-2 IgG testing platform for COVID-19

“…Development of high-throughput serology tests has also been a major focus of large diagnostics companies ( Anon, 2020b ). Due to the specificity challenges associated with high false-positive rates, IgM may not play the primary role in COVID-19 antibody testing ( Marie Louise Landry, 2016 ; Bohn et al, 2020 ). Therefore, we have developed the QuantiVirus™ anti-SARS-CoV-2 IgG test which can be run on Luminex platform for testing 92 samples per run within 3 h. This high throughput assay has a sensitivity of 97.53 % after 14 days from onset of symptoms and specificity of 98.23 %.…”

Response of anti-SARS-CoV-2 total antibodies to nucleocapsid antigen in COVID-19 patients: a longitudinal study

“…The detection of anti-SARS-CoV-2 antibodies is valuable to improve the sensitivity of pathogenic diagnosis for COVID-19, to identify convalescent plasma donors, to screen the population to determine the seroprevalence and to assess the persistence of protection in the population or at the individual level [1][2][3]. A wide range of serology immunoassays have been developed to complement the RT-PCR, with different SARS-CoV-2 antigen targets and formats [4].…”

“…A wide range of serology immunoassays have been developed to complement the RT-PCR, with different SARS-CoV-2 antigen targets and formats [4]. Due to the widespread dissemination of these methods and the limited experience with these new assays, it is crucial for laboratories to rigorously validate these methods before broad introduction into routine clinical practice [1,3,5].…”