A high throughput immuno-affinity mass spectrometry method for detection and quantitation of SARS-CoV-2 nucleoprotein in human saliva and its comparison with RT-PCR, RT-LAMP, and lateral flow rapid antigen test

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2024, Volume and Issue: 62(6), P. 1206 - 1216

Published: Jan. 22, 2024

Abstract Objectives Many reverse transcription polymerase chain reaction (RT-PCR) methods exist that can detect SARS-CoV-2 RNA in different matrices. RT-PCR is highly sensitive, although viral may be detected long after active infection has taken place. proteins have shorter detection windows hence their might more meaningful. Given salivary droplets represent a main source of transmission, we explored the and protein using four platforms including SISCAPA peptide immunoaffinity liquid chromatography-mass spectrometry (SISCAPA-LC-MS) polyclonal capture antibodies. Methods The SISCAPA-LC MS method was compared to RT-PCR, RT-loop-mediated isothermal amplification (RT-LAMP), lateral flow rapid antigen test (RAT) for virus material drool saliva 102 patients hospitalised with SARS-CoV-2. Cycle thresholds (Ct) ( E gene) were RT-LAMP time-to-positive (TTP) NE Orf1a genes), RAT optical densitometry measurements (test line/control line ratio) SISCAPA-LC-MS protein. Results showed low sensitivity (37.7 %) but high specificity (89.8 %). lower (24.5 (100 had (83.0 (100.0 At initial loads (<20 Ct), results obtained correlated (R 2 0.57, p-value 0.002). Conclusions Detection nucleoprotein less frequent than RNA. allowed processing multiple samples <150 min scalable, enabling throughput.

Language: Английский

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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

COVID, Journal Year: 2024, Volume and Issue: 4(2), P. 221 - 260

Published: Feb. 10, 2024

This review provides a comprehensive summary of evidence to explore the role and value differential diagnosis in management Acute Respiratory Infections (ARIs) through point-of-care (POC) rapid testing post-pandemic scenario, paying particular attention coronavirus disease 2019 (COVID-19), influenza, respiratory syncytial virus (RSV). The document builds on literature policies process validation feedback by group seven experts from Latin America (LATAM). Evidence was collected understand scientific policy perspectives ARIs POC testing, with focus countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru. indicates that can serve improve ARI case management, epidemiological surveillance, research innovation, evidence-based decision-making. With multiple types tests available for POC, decisions regarding which use require consideration purpose, resources, test characteristics accuracy, accessibility, affordability, results turnaround time. Based understanding current situation, this set recommendations implementation LATAM, supporting decision-making guiding efforts broad range stakeholders.

Language: Английский

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Clinical assessment of Ortho VITROS SARS-CoV-2 antigen chemiluminescence immunoassay

Diagnosis, Journal Year: 2024, Volume and Issue: 11(2), P. 200 - 202

Published: Jan. 18, 2024

Language: Английский

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The Role and Value of Professional Rapid Testing of Acute Respiratory Infections (ARIs) in Europe: A Special Focus on the Czech Republic, Poland, and Romania

Diagnostics, Journal Year: 2024, Volume and Issue: 14(6), P. 631 - 631

Published: March 16, 2024

This review aims to explore the role of professional diagnostic rapid testing acute respiratory infections (ARIs), especially COVID-19 and influenza, ensuring proper disease management treatment in Europe, particularly Czech Republic, Poland, Romania. The paper was constructed based on a scientific evidence national international policies recommendations, as well process validation by four experts. development new technologies, options, increased awareness negative multidimensional impact ARI profiles transformed differential diagnosis into tangible desirable reality. covers following topics: (1) ARIs, (2) platforms their value, (3) policy landscape, (4) challenges barriers implementation, (5) set recommendations illustrating path forward. findings indicate that testing, including at point care (POC), can have positive case management, antimicrobial antibiotic stewardship, epidemiological surveillance, decision making. Integrating this strategy will require commitment governments academic communities, we identified room for improvement access expansion POC focus countries inclusion relevant policies.

Language: Английский

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Economic Evaluation of COVID-19 Screening Tests and Surveillance Strategies in Low-Income, Middle-Income, and High-Income Countries: A Systematic Review

Medical Science Monitor, Journal Year: 2024, Volume and Issue: 30

Published: March 21, 2024

Economic evaluation of the testing strategies to control transmission and monitor severity COVID-19 after pandemic is essential.This study aimed review economic tests construct a model with outcomes in terms cost test acceptability for surveillance post-pandemic period low-income, middle-income, high-income countries. Material/Methods:We performed systematic following PRISMA guidelines through MEDLINE EMBASE databases.We included relevant studies that reported surveillance.Also, we input current probability, sensitivity, specificity period.

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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Efficiency evaluation of a SARS-CoV-2 diagnostic strategy combining high throughput quantitative antigen immunoassay and real time PCR

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(9), P. 1661 - 1669

Published: March 22, 2023

Abstract Objectives Laboratory testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has played an important role in the effort to prevent and contain local outbreaks. The aim of this study was assess diagnostic accuracy a new fully automated SARS-CoV-2 laboratory-based antigen assay (CoV2Ag) explore efficiency algorithm combining conventional high-throughput molecular assays address potential future challenges pandemic. Methods One thousand two hundred twenty four consecutive nasopharyngeal swabs were tested using RT-PCR CoV2Ag assay. Results overall sensitivity specificity 79.1 97.8%, respectively. When analysis restricted cases with Ct values ≤30, improved 98.1%. Acceptable found when limited patients presenting within one or days symptom onset (80.5 84.8%, respectively). A retrospective use two-step approach during pandemic phase 97 showed reduction number tests by 36.1%, corresponding savings reagent costs technician workload approximately €8,000 10.5 h per day, Conclusions Our data show that proposed represents valid alternative increase phases high positivity rates (>20%) elevated numbers test requests.

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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A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections

Communications Medicine, Journal Year: 2024, Volume and Issue: 4(1)

Published: Dec. 10, 2024

Evaluating diagnostic test accuracy during epidemics is difficult due to an urgent need for availability, changing disease prevalence and pathogen characteristics, constantly evolving testing aims applications. Based on lessons learned the SARS-CoV-2 pandemic, we introduce a framework rapid development, evaluation, validation outbreaks of emerging infections. The based feedback loop between modelling studies public health decision-making, impact interventions. We suggest that building this can help future evaluation platforms better address requirements both patient care health.

Language: Английский

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