Clinical Chemistry and Laboratory Medicine celebrates 60 years – narrative review devoted to the contribution of the journal to the diagnosis of SARS-CoV-2

Abstract

This review is an integral part of the special issue for the 60 years of the journal Clinical Chemistry and Laboratory Medicine (CCLM). The aim of the review is to highlight the role of the clinical laboratory since the emergence of the “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2), which causes Coronavirus disease 2019 (COVID-19), with special focus on the contribution of the journal in generating knowledge in SARS-CoV-2 diagnosis. As of October 30, 2022, a total of 186 CCLM publications were dedicated to COVID-19. Of importance, major International Federation of Clinical Chemistry (IFCC) guidelines related to the diagnosis of COVID-19 were published in CCLM. Between early-2020 and late October 2022, COVID-19 publications represented around 27% of all articles in CCLM, highlighting the willingness of the editorial board to help the field in order to better describe and diagnose this new emerging disease. First launched in 1963 under the name “Zeitschrift für Klinische Chemie”, the Journal was entirely devoted to clinical chemistry in the strict sense. The various topics published in relation to COVID-19 including its diagnosis, its impact on biochemical or hematological measures, as well as biosafety measures, is the perfect example that shows that the journal has greatly diversified over time.

Humoral and cellular response three months following bivalent booster administration

“…This waned e cacy was consistent with the decrease of neutralizing antibodies that represent the rst line of antiviral defense produced by B cells, supporting the role of neutralizing antibodies as a strong correlate of COVID-19 protection from infection (8, 10,[13][14][15]. The determination of immune correlates of vaccine protection are essential to drive vaccination campaigns and for the development of nextgeneration vaccines against COVID-19.…”

“…This was also observed after the administration of additional monovalent mRNA vaccine boosters (3,(6)(7)(8)(9). The decrease in VE was further reduced by the emergence of variants, especially the Omicron variant and its subvariants (i.e., BA.2, BA.2.1.12.1, BA.2.75.2, BA.4, BA.5, BA.4.6, BQ.1.1, XBB), that are characterized by a considerable immune escape (i.e., by mutations in the spike receptor binding domain (RBD) and N-terminal domain (NTD)) from acquired protection through vaccination or previous infection (8, [10][11][12][13].…”

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)

“…Two recent economic analyses revealed that an approach based on sequential testing (SARS-CoV-2 Ag testing first, followed by NAAT in those testing negative) is not only clinically safe, but also is more costeffective than molecular testing alone [6,7]. As concerns the specific diagnostic performance of SARS-CoV-2 Ag testing, both the WHO [8] and the IFCC [5,9] mandate that minimum performance criteria shall be met by SARS-CoV-2 Ag immunoassays, either rapid diagnostic tests (RDT-Ag) or laboratory based, in that they should display ≥0.80 sensitivity and ≥0.97 specificity, respectively, when used in suspected COVID-19 cases (i.e., symptomatic subjects).…”

“…Two recent economic analyses revealed that an approach based on sequential testing (SARS-CoV-2 Ag testing first, followed by NAAT in those testing negative) is not only clinically safe, but also is more cost-effective than molecular testing alone [ 6 , 7 ]. As concerns the specific diagnostic performance of SARS-CoV-2 Ag testing, both the WHO [ 8 ] and the IFCC [ 5 , 9 ] mandate that minimum performance criteria shall be met by SARS-CoV-2 Ag immunoassays, either rapid diagnostic tests (RDT-Ag) or laboratory based, in that they should display ≥0.80 sensitivity and ≥0.97 specificity, respectively, when used in suspected COVID-19 cases (i.e., symptomatic subjects). Recent literature review revealed that although most laboratory-based tests seem to fulfil these performance limits [ 10 ], the diagnostic accuracy of RDT-Ag varies broadly, with average sensitivity of 0.73 (95%CI, 0.69-0.76) in symptomatic subjects, decreasing to 0.55 (95%CI, 0.48-0.62) in those without symptoms [ 11 ].…”

Differential Diagnosis in the Management of Acute Respiratory Infections through Point-of-Care Rapid Testing in a Post-Pandemic Scenario in Latin America: Special Focus on COVID-19, Influenza, and Respiratory Syncytial Virus

“…Rapid antigen testing might be one of the most suitable alternatives for POC testing in many LATAM countries. While molecular testing continues to be the recommended method for the diagnosis of COVID-19, the broad use of this method is constrained in low-resource settings due to limited testing capacity, shortages of reagents/supplies, lack of skilled personnel, long turnaround times, and high costs [200,201]. A study on the optimal use of rapid testing in low-resource countries found that the inclusion of Ag-RDTs in testing strategies was cost-effective and critical in increasing timely testing access.…”