Reliability of a single-nostril nasopharyngeal swab for diagnosing SARS-CoV-2 infection DOI Open Access
Laura Pighi, Brandon Michael Henry, Simone De Nitto

et al.

Diagnosis, Journal Year: 2023, Volume and Issue: 10(3), P. 326 - 327

Published: Feb. 17, 2023

Diagnosis 2023; aop collected from the left and right naris (22.2 vs. 22.7, p=0.346).To this end, results of our study confirm that collection a nasopharyngeal swab single nostril may be reliable less invasive alternative for diagnosing SARS-CoV-2 infection than collecting standard double-nostril NOS, thus contributing to reduce discomfort potentially enhance testing compliance.

Language: Английский

New insights into SARS-CoV-2 Lumipulse G salivary antigen testing: accuracy, safety and short TAT enhance surveillance DOI Creative Commons
Ada Aita,

Filippo Navaglia,

Stefania Moz

et al.

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 61(2), P. 323 - 331

Published: Oct. 25, 2022

The rapid, accurate and safe detection of SARS-CoV-2 is the key to improving surveillance infection containment. aim present study was ascertain whether, after heat/chemical inactivation, N antigen chemiluminescence (CLEIA) assay in saliva remains a valid alternative molecular testing.In 2022, 139 COVID-19 inpatients 467 healthcare workers were enrolled. In 606 self-collected samples (Salivette), detected by (TaqPath rRT-PCR) chemiluminescent Ag assays (Lumipulse G). effect sample pre-treatment (extraction solution-ES or heating) on recovery verified.Salivary highly (AUC=0.959, 95% CI: 0.943-0.974), with 90% sensitivity 92% specificity. Of 254 positive samples, 29 false positives. We demonstrated that heterophilic antibodies could be cause results. A significant concentration decrease observed ES treatment (p=0.0026), misclassification 43 samples. Heat had minimal impact, correct classification cases maintained.CLEIA salivary provides accurate, timely high-throughput results remain also heat thus ensuring safer work environment. This supports use CLEIA programs.

Language: Английский

Citations

4

Efficiency evaluation of a SARS-CoV-2 diagnostic strategy combining high throughput quantitative antigen immunoassay and real time PCR DOI Creative Commons
Luca Bernasconi, Peter Neyer,

Michael Oberle

et al.

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

Citations

1

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA) DOI Creative Commons
Giuseppe Lippi, Brandon Michael Henry, Mario Plebani

et al.

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

Citations

1

Real-world assessment of the clinical performance of COVID-VIRO ALL IN rapid SARS-CoV-2 antigen test DOI
Laura Pighi, Brandon Michael Henry, Simone De Nitto

et al.

Diagnosis, Journal Year: 2023, Volume and Issue: 10(2), P. 187 - 192

Published: Jan. 20, 2023

Since the external validation of severe acute respiratory syndrome coronavirus 2 antigen rapid diagnostic tests (SARS-CoV-2 RDT-Ags) is a necessary requisite before they can be introduced into routine clinical practice, this study reports results real-world assessment performance new COVID-VIRO ALL IN device.The population consisted in 165 outpatients (median age: 43 years, range: 14-68 years; 66.1% females) who had paired nasal and nasopharyngeal samples collected upon hospital presentation. The were concomitantly tested with AAZ-LMB SARS-CoV-2 RDT-Ag Cepheid Xpert Xpress real-time reverse transcription polymerase chain reaction (RT-PCR).The number subjects positive RT-PCR (i.e., mean Ct value <45) was 116 (70.3%), 109 (66.1%) 86 (52.1%) values <37 <30, respectively. In all samples, displayed 78.8% agreement, 0.698 sensitivity, 1.000 specificity, 0.583 negative predictive (NPV) (PPV) compared to RT-PCR. median testing significantly lower than those (22.8 vs. 32.2; p<0.001). high viral load <30), 92.1% 0.895 0.949 0.983 NPV 0.951 PPV RT-PCR.Although do not exactly match manufacturer, its would enable fast-track identification highly contagious subjects.

Language: Английский

Citations

0

Reliability of a single-nostril nasopharyngeal swab for diagnosing SARS-CoV-2 infection DOI Open Access
Laura Pighi, Brandon Michael Henry, Simone De Nitto

et al.

Diagnosis, Journal Year: 2023, Volume and Issue: 10(3), P. 326 - 327

Published: Feb. 17, 2023

Diagnosis 2023; aop collected from the left and right naris (22.2 vs. 22.7, p=0.346).To this end, results of our study confirm that collection a nasopharyngeal swab single nostril may be reliable less invasive alternative for diagnosing SARS-CoV-2 infection than collecting standard double-nostril NOS, thus contributing to reduce discomfort potentially enhance testing compliance.

Language: Английский

Citations

0