Pushing beyond specifications: Evaluation of linearity and clinical performance of the cobas 6800/8800 SARS-CoV-2 RT-PCR assay for reliable quantification in blood and other materials outside recommendations

Nörz, Dominik; Frontzek, André; Eigner, Ulrich; Oestereich, Lisa; Wichmann, Dominic; Kluge, Stefan; Fischer, Nicole; Aepfelbacher, Martin; Pfefferle, Susanne; Lütgehetmann, Marc

doi:10.1016/j.jcv.2020.104650

Cited by 30 publications

(32 citation statements)

References 28 publications

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“…As RT-qPCR reference method, the cobas6800 SARS-CoV-2 IVD assay was used in conjunction with quantitative external control material by Instand e.V. (Düsseldorf, Germany) to allow for absolute quantification, as previously described [ 7 , 8 ]. To evaluate the ease of handling and implementation of AgPOCTs into clinical routine we conducted a user survey employing a questionnaire (see supplementary Table S1) with 10 participants representing different clinical specialties and professions (3 Intensive Care Unit (ICU) medical doctors, 2 ICU nurses, 3 microbiologists and 2 lab technicians).…”

Section: Methodsmentioning

confidence: 99%

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Olearo

Nörz

Heinrich

et al. 2021

Journal of Clinical Virology

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Background SARS-CoV-2 molecular diagnostics is facing material shortages and long turnaround times due to exponential increase of testing demand. Objective We evaluated the analytic performance and handling of four rapid Antigen Point of Care Tests (AgPOCTs) I-IV (Distributors: (I) Roche, (II) Abbott, (III) MEDsan and (IV) Siemens). Methods 100 RT-PCR negative and 84 RT-PCR positive oropharyngeal swabs were prospectively collected and used to determine performance and accuracy of these AgPOCTs. Handling was evaluated by 10 healthcare workers/users through a questionnaire. Results The median duration from symptom onset to sampling was 6 days (IQR 2-12 days). The overall respective sensitivity were 49.4% (CI95%: 38.9 - 59.9), 44.6% (CI95%: 34.3 - 55.3), 45.8% (CI95%: 35.5 - 56.5) and 54.9% (CI95%: 43.4-65.9) for tests I, II, III and IV, respectively. In the high viral load subgroup (containing >10 6 copies of SARS-CoV-2 /swab, n = 26), AgPOCTs reached sensitivities of 92.3% or more (range 92.3% - 100%). Specificity was 100% for tests I, II (CI95%: 96.3 – 100 for both tests) and IV (CI95%: 96.3 - 100) and 97% (CI95%: 91.5 - 98.9) for test III. Regarding handling, test I obtained the overall highest scores, while test II was considered to have the most convenient components. Of note, users considered all assays, with the exception of test I, to pose a significant risk for contamination by drips or spills. Discussion Besides some differences in sensitivity and handling, all four AgPOCTs showed acceptable performance in high viral load samples. However, due to the significantly lower sensitivity compared to RT-qPCR, a careful consideration of pro and cons of AgPOCT has to be taken into account before clinical implementation.

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Section: Methodsmentioning

confidence: 99%

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Olearo

Nörz

Heinrich

et al. 2021

Journal of Clinical Virology

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“…SARS-CoV-2 RNA was detected by real-time RT-PCR [ 27 ] using the Roche Cobas 6800 system. Viral RNA was quantified (from EDTA plasma and respiratory material) using in vitro transcribed SARS-CoV-2 RNA as standard as described previously [ 28 ].…”

Section: Methodsmentioning

confidence: 99%

Severe liver dysfunction complicating course of COVID-19 in the critically ill: multifactorial cause or direct viral effect?

Roedl

Jarczak

Drolz

et al. 2021

Ann. Intensive Care

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Background SARS-CoV-2 caused a pandemic and global threat for human health. Presence of liver injury was commonly reported in patients with coronavirus disease 2019 (COVID-19). However, reports on severe liver dysfunction (SLD) in critically ill with COVID-19 are lacking. We evaluated the occurrence, clinical characteristics and outcome of SLD in critically ill patients with COVID-19. Methods Clinical course and laboratory was analyzed from all patients with confirmed COVID-19 admitted to ICU of the university hospital. SLD was defined as: bilirubin ≥ 2 mg/dl or elevation of aminotransferase levels (> 20-fold ULN). Results 72 critically ill patients were identified, 22 (31%) patients developed SLD. Presenting characteristics including age, gender, comorbidities as well as clinical presentation regarding COVID-19 overlapped substantially in both groups. Patients with SLD had more severe respiratory failure (paO2/FiO2: 82 (58–114) vs. 117 (83–155); p < 0.05). Thus, required more frequently mechanical ventilation (95% vs. 64%; p < 0.01), rescue therapies (ECMO) (27% vs. 12%; p = 0.106), vasopressor (95% vs. 72%; p < 0.05) and renal replacement therapy (86% vs. 30%; p < 0.001). Severity of illness was significantly higher (SAPS II: 48 (39–52) vs. 40 (32–45); p < 0.01). Patients with SLD and without presented viremic during ICU stay in 68% and 34%, respectively (p = 0.002). Occurrence of SLD was independently associated with presence of viremia [OR 6.359; 95% CI 1.336–30.253; p < 0.05] and severity of illness (SAPS II) [OR 1.078; 95% CI 1.004–1.157; p < 0.05]. Mortality was high in patients with SLD compared to other patients (68% vs. 16%, p < 0.001). After adjustment for confounders, SLD was independently associated with mortality [HR3.347; 95% CI 1.401–7.999; p < 0.01]. Conclusion One-third of critically ill patients with COVID-19 suffer from SLD, which is associated with high mortality. Occurrence of viremia and severity of illness seem to contribute to occurrence of SLD and underline the multifactorial cause.

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“…As RT-qPCR reference method, the cobas6800 SARS-CoV-2 IVD assay was used in conjunction with quantitative external control material by Instand e.V. (Düsseldorf, Germany) to allow for absolute quantification, as previously described [7,8]. To evaluate the ease of handling and implementation of AgPOCTs into clinical routine we conducted a user survey employing a questionnaire (see supplementary Table S1) with 10 participants representing different clinical specialties and professions (3 ICU medical doctors, 2 ICU nurses, 3 microbiologists and 2 lab technicians).…”

Section: Methodsmentioning

confidence: 99%

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Olearo

Nörz

Heinrich

et al. 2020

Preprint

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View full text Add to dashboard Cite

BackgroundSARS-CoV-2 molecular diagnostics is facing material shortages and long turnaround times due to exponential increase of testing demand.ObjectiveWe evaluated the analytic performance and handling of four rapid Antigen Point of Care Tests (AgPOCTs) I-IV (Distributors: (I) Roche, (II) Abbott, (III) MEDsan and (IV) Siemens).Methods100 RT-PCR negative and 84 RT-PCR positive oropharyngeal swabs were prospectively collected and used to determine performance and accuracy of these AgPOCTs. Handling was evaluated by 10 healthcare workers/users through a questionnaire.ResultsThe median duration from symptom onset to sampling was 6 days (IQR 2-12 days). The overall relative sensitivity was 49.4%, 44.6%, 45.8% and 54.9 % for tests I, II, III and IV, respectively. In the high viral load subgroup (containing >106 copies of SARS-CoV-2 /swab, n=26), AgPOCTs reached sensitivities of 92.3% or more (range 92.3%-100%). Specificity was 100% for tests I, II and IV and 97% for test III. Regarding handling, test I obtained the overall highest scores, while test II was considered to have the most convenient components. Of note, users considered all assays, with the exception of test I, to pose a significant risk for contamination by drips or spills.DiscussionBesides some differences in sensitivity and handling, all four AgPOCTs showed acceptable performance in high viral load samples. However, due to the significantly lower sensitivity compared to RT-qPCR, a careful consideration of pro and cons of AgPOCT has to be taken into account before clinical implementation.

show abstract

Pushing beyond specifications: Evaluation of linearity and clinical performance of the cobas 6800/8800 SARS-CoV-2 RT-PCR assay for reliable quantification in blood and other materials outside recommendations

Cited by 30 publications

References 28 publications

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

Severe liver dysfunction complicating course of COVID-19 in the critically ill: multifactorial cause or direct viral effect?

Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR

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