Diagnosis, Год журнала: 2023, Номер 10(3), С. 326 - 327
Опубликована: Фев. 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.
Язык: Английский
Clinical Chemistry and Laboratory Medicine (CCLM), Год журнала: 2023, Номер 0(0)
Опубликована: Окт. 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).
Язык: Английский
Процитировано
2
Clinical Chemistry and Laboratory Medicine (CCLM), Год журнала: 2023, Номер 61(9), С. 1661 - 1669
Опубликована: Март 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.
Язык: Английский
Процитировано
1
Research Square (Research Square), Год журнала: 2023, Номер unknown
Опубликована: Март 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.
Язык: Английский
Процитировано
1
Diagnosis, Год журнала: 2023, Номер 10(2), С. 187 - 192
Опубликована: Янв. 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.
Язык: Английский
Процитировано
0
Diagnosis, Год журнала: 2023, Номер 10(3), С. 326 - 327
Опубликована: Фев. 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.
Язык: Английский
Процитировано
0