Detection of SARS-CoV-2 infection in asymptomatic populations using the DiaSorin molecular Simplexa and Roche Cobas EUA assays.
Ontology highlight
ABSTRACT:
SUBMITTER: Antonara S
PROVIDER: S-EPMC8324421 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:ObjectivesFor new analyzers or tests, analytical evaluation is required before implementation in the clinical laboratory. We evaluated the novel Roche Cobas t711 analyzer with six newly developed coagulation assays: the activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen, d-dimer and anti-Xa. The evaluation included imprecision experiments, method comparison with the currently used Stago STA-R Evolution, monitoring of unfractionated heparin (UFH) with aPTT, a fast centrifugation protocol to improve turn-around time, and determination of sample stability in whole blood and plasma.Design and methodsImprecision and method comparison were assessed using commercial quality control samples and patient samples, respectively. For dose monitoring of UFH with the aPTT, samples from patients treated with UFH were used. Samples from healthy volunteers were collected for evaluation of the fast centrifugation protocol (5' 2750×g) and for investigating sample stability over 6-8 h.ResultsResults for between-run precision were within the desirable specification. Method comparison showed an excellent agreement for fibrinogen, d-dimer and anti-Xa. For aPTT, PT and INR, a good correlation was found, but results were significantly lower on the t711 compared to the STA-R Evolution, which is caused by different coagulation activators. Results from the fast centrifugation protocol differed not significantly from the standard protocol (15' 2500×g). Blood and plasma samples were stable at room temperature up to 6 and 8 h, respectively.ConclusionsThe t711 coagulation analyzer with 6 novel tests is suitable for routine use in clinical laboratories.
| S-EPMC6881685 | biostudies-literature
Project description:IntroductionWe evaluated the Roche Elecsys Anti-SARS-CoV-2 and Snibe SARS-CoV-2 S-RBD IgG spike chemiluminescent immunoassays and compared them to existing Roche/Abbott nucleocapsid and Abbott IgM spike assays.MethodsWe enrolled 184 SARS-CoV-2 RT-PCR positive samples and 215 controls (172 pre-pandemic, and 43 cross-reactivity) to evaluate the Roche spike antibody (anti-SARS-CoV-2-S) assay. For the Snibe evaluation, we included 119 RT-PCR positive samples and 249 controls (200 pre-pandemice, 49 cross-reactivity). 98 cases had been tested on three spike assays (Roche total antibody, Snibe IgG and Abbott IgM).ResultsThe Roche anti-SARS-CoV-2-S assay had a CV of 0.5% (0.82U/mL) and 2.3% (8.72U/mL) and was linear from 1.16 to 240U/mL. The Snibe assay was linear from 6.43 to 77.7AU/mL, CV of 5.5% (0.43AU/mL) and 8.8% (0.18AU/mL). The Snibe spike assay was significantly more sensitive than the Abbott IgG assay at 0-6 days POS (35.2% vs 3.6%, mean difference 29.6%, 95% CI 17.5 to 41.8, p < 0.0001). Optimized LORs significantly improved the sensitivity of the Roche spike (48.1%-56.7%) and both nucleocapsid assays (Roche 43.3%-65.5%, Abbott 3.6%-18.5%) in early disease.ConclusionAlthough both spike assays showed higher sensitivity than their nucleocapsid counterparts, lower, optimized LORs provided the most significant improvements to sensitivity.
| S-EPMC8513513 | biostudies-literature
Project description:BackgroundThe SARS-CoV-2 pandemic has created an urgent and unprecedented need for rapid large-scale diagnostic testing to inform timely patient management. However, robust data are lacking on the relative performance of available rapid molecular tests across a full range of viral concentrations.ObjectiveThis study aimed to compare two recently-authorized rapid tests, Cepheid Xpert Xpress SARS-CoV-2 and Abbott ID Now SARS-CoV-2, to the Roche cobas SARS-CoV-2 assay for samples with low, medium, and high viral concentrations.Study designA total of 113 nasopharyngeal swabs from remnant patient samples were tested, including 88 positives spanning the full range of observed Ct values on the cobas assay.ResultsCompared to cobas, the overall positive agreement was 73.9% with ID Now and 98.9% with Xpert. Negative agreement was 100% and 92.0% for ID Now and Xpert, respectively. Both ID Now and Xpert showed 100% positive agreement for medium and high viral concentrations (Ct value <30). However, for Ct values >30, positive agreement was 34.3% for ID Now and 97.1% for Xpert.ConclusionsWhile Xpert showed high agreement with cobas across a wide range of viral concentrations, this study highlights an important limitation of ID Now for specimens collected in viral or universal transport media with low viral concentrations. Further studies are needed to evaluate the performance of ID Now for direct swabs.
| S-EPMC7217789 | biostudies-literature
Project description:The Roche cobas MTB and MTB-RIF/INH assays allow for detection of Mycobacterium tuberculosis complex (MTBC) nucleic acid and rifampicin (RIF) and isoniazid (INH) resistance-associated mutations in an automated, high-throughput workflow. In this study, we evaluated the performance of these assays, employing samples from settings of low and high tuberculosis (TB) burdens. A total of 325 frozen, leftover respiratory samples collected from treatment-naive patients with presumptive TB in Germany (n = 280) and presumptive RIF-resistant TB in Sierra Leone (n = 45) were used in this study. cobas MTB results for detection of MTBC DNA from N-acetyl-l-cysteine-sodium hydroxide (NALC-NaOH)-treated samples were compared to culture results. Predictions of RIF and INH resistance by the cobas MTB-RIF/INH assay were compared to a composite reference standard (phenotypic drug susceptibility testing and line probe assay). Whole-genome sequencing was used to resolve discordances. The overall sensitivity of cobas MTB for detection of MTBC DNA in culture-positive samples (n = 102) was 89.2% (95% confidence interval [CI], 81.7 to 93.9%). The specificity of cobas MTB was 98.6% (95% CI, 96.1 to 99.5%). Sensitivity and specificity for detection of RIF and INH resistance were 88.4% (95% CI, 75.5 to 94.9%) and 97.6% (95% CI, 87.4 to 99.6%) and 76.6% (95% CI, 62.8 to 86.4%) and 100.0% (95% CI, 90.8 to 100.0%), respectively. Discordant results for RIF and INH resistance were mainly due to uncommon mutations in samples from Sierra Leone that were not covered by the cobas MTB-RIF/INH assay. In conclusion, cobas MTB and MTB-RIF/INH assays provide accurate detection of MTBC DNA and resistance-associated mutations in respiratory samples. The influence of regional variations in the prevalence of resistance-conferring mutations requires further investigation.
| S-EPMC8091830 | biostudies-literature
Project description:Automatic assessment of hemoglobin (H), lipaemia (L) and icterus (I) in serum or plasma (HIL indices) is the mainstay for evaluating sample quality. We planned this study to verify whether in-house prepared internal quality control (IQC) materials may be suitable for quality assurance of HIL indices. Pools containing different values of each of the three HIL indices were prepared from routine plasma samples, divided in aliquots and frozen at -20°C. Stability of frozen materials was assessed by thawing one aliquot of each pool after different days of freezing (1, 4, 8, 15, 22 and 29), and by measuring HIL indices on baseline fresh samples and frozen-thawed aliquots with Roche Cobas c702. Five fresh liquid IQCs materials were also measured at the same time points. Intra-assay and inter-assay imprecision of HIL indices calculated with commercial IQC materials ranged between 1.1-2.0% and 1.6-3.3%, respectively. When target values of HIL indices were calculated using frozen-thawed aliquots, the inter-assay imprecision of in-house prepared materials was optimal, even better than that of commercial liquid IQCs (H-index, 0.8% versus 1.6%; L-index, 2.2% versus 2.5%; I-index, 0.8% versus 3.3%). In conclusion, in-house prepared IQC materials are cost-effective alternatives to commercial liquid IQCs for HIL quality assurance.
| S-EPMC6034854 | biostudies-literature
Project description:ObjectivesTo analytically and clinically evaluate the semiquantitative Elecsys anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein antibody (S-Ab) assay on the Roche cobas e602 analyzer.MethodsThe S-Ab assay is a 1-step, double-antigen sandwich electrochemiluminescent immunoassay that semiquantitatively measures total IgG, IgM, and IgA antibodies specific for the receptor binding domain of SARS-CoV-2 spike protein in serum or plasma. The S-Ab assay was evaluated for precision, linearity, interference (by hemoglobin, bilirubin, triglycerides, and biotin), cross-reactivity, and clinical performance, and was compared to the qualitative Elecsys anti-nucleocapsid (N-Ab) immunoassay, a lateral flow device that qualitatively detects S-Ab and N-Ab, and an anti-spike enzyme-linked immunosorbent assay (ELISA).ResultsS-Ab assay is precise, exhibits linearity from 0.4 to 250 U/mL, is unaffected by significant cross-reactivity or interferences, and qualitatively demonstrates greater than 90% concordance with N-Ab assay and lateral flow device. Readouts of S-Ab assay correlate with ELISA, which in turn correlates strongly with SARS-CoV-2 virus neutralization assay, and exhibit 100% sensitivity and specificity for COVID-19 patient samples obtained at or more than 14 days after PCR positivity.ConclusionsThe S-Ab assay is a robust clinical test for qualitative and semiquantitative detection of seropositivity following SARS-CoV-2 infection or spike-encoding mRNA COVID-19 vaccination.
| S-EPMC8499855 | biostudies-literature
Project description:We compared the performance of five assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection on nasopharyngeal swab samples: Roche "cobas," Luminex "ARIES," MiRXES "Fortitude," Altona "RealStar," and Thermo Fisher Scientific "TaqPath." A total of 94 nasopharyngeal swab samples were obtained from 80 confirmed coronavirus disease 2019 cases in the first 2 weeks of illness (median, 7 days; range, 2-14 days) and 14 healthy controls. After collection, all samples were transported to the hospital clinical laboratory within 24 h. These samples were tested on all five assays within 3 days of sample receipt. Of the 94 samples, 69 yielded the same result on all platforms, resulting in an agreement of 73.4% (69 of 94). Of these, 14 were the healthy control swabs which all tested negative, demonstrating good specificity across all platforms. The ARIES assay had the lowest detection rate (68.8%), followed by Fortitude (85.0%), RealStar (86.3%), cobas (95.0%), and TaqPath (100%). Statistically significant differences were observed for ARIES, Fortitude, and RealStar when compared against the best performing TaqPath using McNemar's χ2 test. A consensus result was established based on the results obtained by the cobas, Fortitude, RealStar, and TaqPath. Six discrepancies had failed to reach a consensus and were adjudicated using the Cepheid Xpert Xpress SARS-CoV-2. Overall, the TaqPath and cobas assays were the most sensitive at detecting their designated SARS-CoV-2 gene targets. On the other hand, the ARIES assay was the least sensitive, thus warranting the need for assay re-optimization before go-live at the testing laboratory.
| S-EPMC8250924 | biostudies-literature
Project description:Candida auris is a globally emerging fungal pathogen that is associated with healthcare-related infections. The accurate and rapid detection of C. auris is crucial for effective infection prevention, control, and patient management. This study aimed to validate the analytical and diagnostic performance of the DiaSorin Molecular C. auris Detection Kit. The analytical specificity, sensitivity, and reproducibility of the assay were evaluated. The limit of detection (LOD) was determined to be 266 CFU/µL using the ZeptoMetrix Candida auris Z485 strain and standard calibration curves. The assay demonstrated high analytical specificity and showed no amplification against a diverse panel of bacteria and fungi. Clinical validation was conducted using deidentified residual axillary/groin surveillance culture specimens from C. auris culture-positive and culture-negative patients. The DiaSorin Molecular Detection Kit exhibited 100% agreement in sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) when compared to cultures coupled with MALDI-TOF identification. Intra- and inter-reproducibility testing demonstrated consistent and reliable diagnostic performance. This validated assay offers rapid and accurate detection of C. auris, facilitating timely implementation of infection control measures and appropriate patient care. The DiaSorin Molecular C. auris Detection Kit has the potential to aid in controlling the outbreaks caused by this emerging fungal pathogen. Providing a reliable diagnostic tool can contribute to the effective management and containment of C. auris infections in healthcare settings and ultimately improve patient outcomes.
| S-EPMC10455898 | biostudies-literature
Project description:Background: Therapeutic drug monitoring of immunosuppressant drugs are used to monitor drug efficacy and toxicity and to prevent organ transplant rejection. This study evaluates the analytical performance of semi-automated electrochemiluminescence immunoassays (ECLIA) for cyclosporine (CSA), tacrolimus (TAC) and sirolimus (SRL) on the Roche cobas e 411 analyzer at a major transplant hospital to assess method suitability and limitations. Methods: Residual whole blood samples from patients undergoing immunosuppressant therapy were used for evaluation. Imprecision, linearity, functional sensitivity, method comparisons and lot-to-lot comparisons were assessed. Results: Total imprecision ranged from 3.3 to 7.1% for CSA, 3.9 to 9.4% for TAC, and 4.6 to 8.2% for SRL. Linearity was verified from 30.0 to 960.9 μg/L for CSA, from 1.1 to 27.1 μg/L for TAC, and from 0.5 to 32.3 µg/L for SRL. The functional sensitivity met the manufacturer's claims and was determined to be <6.5 μg/L for CSA, 1.1 μg/L for TAC, and <0.1 µg/L for SRL (CV≤20%). Deming regression analysis of method comparisons with the ARCHITECT immunoassay yielded slopes of 0.917 (95%CI: 0.885-0.949) and r of 0.985 for CSA, 0.938 (95%CI: 0.895-0.981) and r of 0.974 for TAC, and 0.842 (0.810-1.110) and r of 0.982 for SRL. Deming regression analysis of comparisons with the LC-MS/MS method yielded slopes of 1.331 (95%CI: 1.167-1.496) and r of 0.969 for CSA, 0.924 (95%CI: 0.843-1.005) and r of 0.984 for TAC, and 0.971 (95%CI: 0.913-1.030) and r of 0.993 for SRL. Conclusions: The cobas e 411 ECLIA for CSA, TAC, and SRL have acceptable precision, linearity, and functional sensitivity. The method comparisons correlated well with the ARCHITECT immunoassay and LC-MS/MS and is fit for therapeutic drug monitoring.
| S-EPMC5710386 | biostudies-literature
Project description:Critical evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic assays is needed to guide clinical decision-making and ensure that these assays provide optimal benefit to patients and the public. Here, three commercially available assays with widespread distribution capabilities are compared. A total of 667 specimens, 103 from patients with confirmed SARS-CoV-2 infections and 564 collected prior to the emergence of SARS-CoV-2, were analyzed in parallel using the Roche Elecsys SARS-CoV-2 total antibody and Abbott Alinity SARS-CoV-2 IgG assays; a subset of 55 samples from patients with confirmed SARS-CoV-2 infections was additionally evaluated using the Abbott Architect SARS-CoV-2 IgM assay. Qualitative agreement between the Abbott IgG and Roche total antibody assays was 98.7% (658/667), with Cohen's kappa value of 0.919 (95% confidence interval [CI], 0.867 to 0.972). Qualitative agreements with the Abbott IgM assay were 92.7% (51/55, Abbott IgG) and 85.5% (47/55, Roche total antibody). Diagnostic specificities determined using pre-COVID-19 samples for the Abbott IgG and Roche total antibody assays were 99.65% (95% CI, 98.72 to 99.90%) and 100.00% (95% CI, 99.32 to 100.00%), respectively, spanning claims made by each manufacturer. Diagnostic sensitivities increased for all three assays with increasing time since the onset of symptoms. Among 51 patients with confirmed SARS-CoV-2 infections, 23 (45.1%), 24 (47.1%), and 22 (43.1%) were reactive by the Abbott IgG, Roche total antibody, and Abbott IgM assays, respectively, with sampling times 0 to 56 days post-positive PCR (median/mean, 2/6.2 days). Combining IgG and IgM screening identified 4/55 additional samples with detectable antibodies that would not have been observed using the assays independently. Notably, one immunocompromised patient with confirmed SARS-CoV-2 infection showed no detectable antibodies using any of the three assays 43 days after onset of symptoms.
| S-EPMC7771433 | biostudies-literature