Cost-effectiveness analysis of different COVID-19 screening strategies based on rapid or laboratory-based SARS-CoV-2 antigen testing

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(9), P. e168 - e171

Published: Feb. 27, 2023

To the Editor, Now, in fourth year of coronavirus disease 2019 (COVID-19) pandemic, many important aspects have become clear concerning pathogenesis, clinical management, outcome and, last but not least, regarding diagnostic approach to severe acute respiratory syndrome 2 (SARS-CoV-2) infection.Although it is undeniable that consequences an SARS-CoV-2 infection general population are incomparably milder now compared period when virus initially spread worldwide from China [1], number daily COVID-19 diagnoses still very high.According World Health Organization (WHO), new or recurrent cases exceeds 200,000 February 2023 [2].We also must acknowledge this may be heavily underestimated for a variety reasons discussed elsewhere [3].Thus, strategies only relying on molecular testing, although remaining gold standard detecting SARS-CoV-2, imprudent given reference real-time reverse transcription polymerase chain reaction (RT-PCR) assays characterized by low throughput, long turnaround time and high cost [4], thus paving way using alternative solutions.Among various options, identification quantification antigens means rapid tests (RDT-Ag) laboratory-based immunoassays (LAB-Ag) represent valuable alternatives, endorsed both WHO [5] International Federation Clinical Chemistry Laboratory Medicine [6].Although we certainly recognize sensitivity these basically lower than (i.e., comprised between 70 80%) [7, 8], their usage initial "screening" patients provide saving precious human economic resources, though no comprehensive information exists confirm validity second claim best our knowledge.To end, carried out cost-effective analysis some potential protocols inclusive antigen tests.The study consisted series 294 (mean age, 45 ± 20 years; 55% females) presenting facility Pederzoli Hospital Peschiera del Garda (Verona, Italy), undergo routine testing.According local operating procedures (SOPs), all underwent testing (RDT-Ag, ∼30 min time; Fujirebio Espline SARS-CoV-2; Inc., Tokyo, Japan) enabling fast positive subjects, followed (RT-PCR, 4-6 h Altona Diagnostics RealStar SARSCoV-2 RT-PCR Kit; GmbH, Hamburg, Germany) Ag (LAB-Ag, 45-60 DiaSorin LIAISON Ag; DiaSorin, Saluggia, Italy) same nasopharyngeal sample.The specific

Language: Английский

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Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(8), P. 1506 - 1510

Published: March 8, 2023

Abstract Objectives Given that SARS-CoV-2 antigen tests will represent a pillar for supporting or surrogating molecular testing in the endemic period, we report here clinical performance of new SNIBE Maglumi fully-automated chemiluminescent immunoassay (MAG-CLIA Ag). Methods The study population consisted 181 subjects (mean age 61 ± 21 years; 92 females) undergoing coronavirus disease 2019 (COVID-19) at local diagnostic facility, from December 2022 to February 2023. Routine practice involved collection double nostril nasopharyngeal swab, analyzed duplicate with Ag) and (Altona Diagnostics RealStar RT-PCR Kit) tests. Results A significant Spearman’s correlation was found between MAG-CLIA Ag mean Ct values E S genes (r=−0.95; p<0.001). In all samples, area under curve (AUC) 0.86 (95% CI, 0.81–0.90), 0.71 sensitivity 1.00 specificity 7 ng/L cut-off, increasing 0.98 0.96–1.00) AUC 0.96 (with 0.97 specificity) high viral load samples. When N protein concentration replaced raw instrumental readings (i.e., relative light units [RLU]), samples increased 0.94. RLU value 945 associated 88.4% accuracy, 0.85 sensitivity, 0.95 specificity, 0.77 negative predictive (NPV) positive (PPV), respectively. Conclusions We satisfactory analytical Ag, which could be used as surrogate identifying Broadening reportable range may generate even better performance.

Language: Английский

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

Research Square (Research Square), Journal Year: 2023, Volume and Issue: unknown

Published: March 29, 2023

Abstract Background . This article presents a critical literature review and meta-analysis of diagnostic performance Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA), rapid test (RDT-Ag) adapted for automatic reading with portable instruments, thus potentially combining the advantages point-of-care testing those laboratory-based immunoassay. Methods: We conduced an electronic search in PubMed Scopus keywords "Quidel" OR “SOFIA” AND “Antigen” "SARS-CoV-2" “COVID-19” up to March 24, 2023, identifying articles containing data on accuracy FIA diagnosing acute SARS-CoV-2 infections. selected where was compared that reference molecular assay, sufficient information constructing 2×2 table. Results: A total number 18 (48165 samples; 9.8% positive at testing) were included this meta-analysis, averaging 24 sample cohorts. The (summary area under curve), sensitivity specificity 0.980, 0.76 1.00 all samples, 0.981, 0.81 0.99 samples collected from symptomatic patients, 0.931, 0.55 taken asymptomatic 0.960, 0.77 mixed cohorts respectively. Minor clinically negligible differences could be found by comparing results nasal nasopharyngeal swabs. Conclusion: Ag meets minimum criteria antigenic testing, satisfactory being used as device.

Language: Английский

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SARS-CoV-2 is here to stay: do not lower our guard

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2024, Volume and Issue: 62(6), P. 1017 - 1018

Published: March 26, 2024

Language: Английский

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