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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The Crucial Role of Laboratory Medicine in Addressing Future Public Health Infectious Threats: Insights Gained from the COVID-19 Pandemic

Diagnostics, Journal Year: 2025, Volume and Issue: 15(3), P. 323 - 323

Published: Jan. 30, 2025

Laboratory testing has played a pivotal role throughout the coronavirus disease 2019 (COVID-19) pandemic, exemplifying importance of in vitro diagnostics addressing public health threats posed by outbreaks infectious diseases. This article aims to present key insights from our expertise, derived evidence gathered during COVID-19 inform strategies for managing future challenges. Current scientific underscores that patient sample not only allows diagnose an acute severe respiratory syndrome 2 (SARS-CoV-2) infection, but also supports outbreak prediction, improved control measures, anticipation pressure on healthcare system, mitigation adverse clinical outcomes, and early detection emerging SARS-CoV-2 variants. Additionally, wastewater monitoring emerged as powerful tool forecasting burden, including both prevalence severity. Collectively, these findings underscore value diagnostic surveillance guiding planning optimizing resource allocation offering valid framework be applied threats, especially any potential “Disease X” may emerge future.

Language: Английский

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An overview of the most important preanalytical factors influencing the clinical performance of SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs)

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 61(2), P. 196 - 204

Published: Nov. 7, 2022

Due to the many technical limitations of molecular biology, possibility sustain enormous volumes severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic testing relies strongly on use antigen rapid tests (Ag-RDTs). Besides a limited analytical sensitivity, manually intensive test procedures needed for performing these tests, very often performed by unskilled personnel or patients themselves, may contribute considerably impair their accuracy. We provide here an updated overview leading preanalytical drawbacks that SARS-CoV-2 Ag-RDT accuracy, and which encompass lower sensitivity in certain age groups, asymptomatic subjects those with longer time from symptoms onset, vaccine recipients, individuals not appropriately trained usage, recently using oral nasal virucidal agents, oropharyngeal swabs saliva, as well circumstances when instructions provided manufacturers are unclear, incomplete scarcely readable intelligible. Acknowledging important will lead way better, more clinically efficient even safer this technology, represents extremely valuable resource management ongoing pandemic.

Language: Английский

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

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 61(5), P. 811 - 821

Published: Nov. 23, 2022

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

Language: Английский

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Pooled analysis of laboratory-based SARS-CoV-2 antigen immunoassays

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(9), P. e165 - e167

Published: Jan. 12, 2023

Language: Английский

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Diagnostic accuracy of Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infection: a pooled analysis

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(7), P. 1133 - 1139

Published: Jan. 12, 2023

Abstract Background This article provides a critical literature review and pooled analysis of diagnostic accuracy the fully-automated Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosis acute infections. Methods An electronic search was conducted in Scopus, PubMed medRxiv using keywords [“Siemens AND CoV2Ag”] OR antigen”] capturing studies that investigated CoV2Ag diagnosing infection against reference molecular test. The retrieved information used constructing 2 × table calculating sensitivity, specificity, Summary Receiver Operating Characteristic Curve (SROC) Agreement. study followed PRISMA (Preferred Reporting Items Systematic Reviews Meta-Analyses) reporting checklist. Results Four totalling 1,310 respiratory samples (612 with high viral load) were finally included our analysis. cumulative area under curve, accuracy, 0.964 (95% CI, 0.957–0.971), 86.9% 84.9–88.7%), 0.79 0.76–0.82) 0.98 0.96–0.99), respectively. negative (NPV) positive (PPV) predictive values 0.77 (0.74–0.79) 0.96–99), sensitivity load (i.e., Ct<29–30) 0.95 0.93–0.97). Conclusions high-throughput approximates minimum performance criteria general antigen testing displays excellent load, thus representing valuable screening solution risk assessment COVID-19 limiting spread.

Language: Английский

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Positivization time of a COVID-19 rapid antigen self-test predicts SARS-CoV-2 viral load: a proof of concept

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 61(2), P. 316 - 322

Published: Oct. 31, 2022

This proof of concept study was aimed to validate the hypothesis that time positivization SARS-CoV-2 self-performed rapid diagnostic tests (RDTs) may reflect actual viral load in specimen.A positive sample with high diluted and concomitantly assayed molecular assay (Xpert Xpress SARS-CoV-2) RDT (COVID-VIRO ALL IN RDT). The (mean cycle threshold; Ct) values times these dilutions were plotted interpolated by calculating best fit. parameters this equation then used for converting into RDT-estimated Ct routine patient samples.The fit between measured could be achieved a 2-degree polynomial curve. exhibited correlation (r=0.996) excellent Deming (y=1.01 × x - 0.18) values. In 30 consecutive patients test, value r=0.522 (p=0.003). slightly improved 0.577 (Deming fit: y=0.44 + 11.08), displaying negligible bias (1.0; 95% CI, -0.2 2.2; p=0.105). Concordance at <20 cut-off 80%, 0.84 sensitivity 0.73 specificity.This demonstrates potential feasibility using RDTs garnering information on acute infection.

Language: Английский

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Technical and health governance aspects of the External Quality Assessment Scheme for the SARS-CoV-2 molecular tests: institutional experience performed in all clinical laboratories of a Regional Health Service

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 61(1), P. 173 - 179

Published: Sept. 17, 2022

Since December 2019, the worldwide public health has been threatened by a severe acute respiratory syndrome caused Coronavirus-2. From beginning, turning point identification of new cases infection, in order to minimize virus spreading among population. For this reason, it was necessary introducing panel tests able identify positive cases, which became crucial for all countries.As Regional Reference Centre, CRQ Laboratory (Regional Quality Control) developed and conducted an External Assessment (EQA) assay, so as evaluate quality real-time reverse transcription polymerase chain reaction (PCR), were used 62 Sicilian laboratories, previously authorized issue certificates COVID-19 diagnosis, on behalf Public Health Service.The qualitative performance test based pooled samples with different viral loads SARS-CoV-2 or human Coronavirus OC43. 75% participating laboratories tested core correctly, while remaining 25% interpreted incorrectly EQA exercise matching negatively standards required.Subsequent inspection visits confirmed incorrect negative certifications private despite possession authorization requirements currently provided current regulations, significant impact SSR.

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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Analytical and clinical evaluations of SNIBE Maglumi chemiluminescent immunoassay for the detection of SARS-CoV-2 antigen in salivary samples

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 0(0)

Published: Oct. 3, 2023

Abstract Objectives In this study, we describe the analytical and clinical performances of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay (MAG-CLIA) on salivary samples. Methods Limit detection (LOD), linearity precision were tested for values close to or below declared LOD. Clinical performance MAG-CLIA was evaluated leftover samples from healthcare workers (HCW) surveillance program, at University-Hospital Padova. Salivary analyzed by Lumipulse G Ag, in case where exceeded 0.41 ng/L, further testing conducted using TaqPathTM COVID-19 RT-PCR (Applied Biosystems, Thermo Fisher Scientific). Results The estimated LOD 3 with repeatability 7.5 %. Good demonstrated diluting two 52.7 ng/L 211.4 ng/L. Of 228 HCW samples, 59/228 (25.9 %) positive, 169/228 (74.1 negative. sAg median level (and interquartile range [IQR]) 5.03 (<0.001–35.8 ng/L) positive <0.001 (<0.001 negative AUC 0.795 (95 % CI: 0.720–0.871). Using best cut-off, 3.5 sensitivity specificity 57.1 42.2–71.2 97.0 93.2–99.0 %), respectively. agreement molecular assay 88.1 (Cohen’s kappa 0.606 [SE=0.066, p<0.001]). Conclusions are satisfactory, also when tested. saliva although elevated, not comparable that nasopharyngeal swabs (NPS).

Language: Английский

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