Comparison between the analytical sensitivity and clinical performance of two cobas SARS-CoV-2 tests based on high-throughput and point-of-care systems

Lin, Tsai-Hsiu; Bui, Ngoc-Niem; Chang, Yu‐Chang; Hsu, Li‐Yun; Su, Yang-Di; Chang, Chia-Chuan; Hong, Wei-An; Le, Uyen Nguyen Phuong; Huang, Su-Hua; Lin, Cheng‐Wen

doi:10.37796/2211-8039.1334

Cited by 5 publications

(3 citation statements)

References 17 publications

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“…However, the Ct values of real-time RT-PCR were presented. The previous study revealed that cobas SARS-CoV-2 PCR test on the cobas 6800 system had a limit of detection of 25 to 50 copies/mL, which was also similar to the analytical sensitivity provided by the manufacturer's specification [ 23 , 24 ]. Finally, the performance of the VTRUST COVID-19 Antigen Rapid Test for detecting the SARS-CoV-2 Omicron variant was not known due to our study period being earlier than the emergence of Omicron variant, which needs to be validated in the further study.…”

Section: Discussionmentioning

confidence: 59%

Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

Lin

Chiu

Cheng

et al. 2022

Canadian Journal of Infectious Diseases and Medical Microbiolog

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Background. Rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection have been authorized for emergency use (EUA); however, the performance has not been fully evaluated in clinical contexts. This study aimed to provide evidence regarding the diagnostic performance of SARS-CoV-2 rapid antigen tests compared with the real-time reverse transcription-polymerase chain reaction (RT-PCR) test in the emergency department (ED) and community. Methods. Patients who underwent SARS-CoV-2 rapid antigen tests using the VTRUST COVID-19 Antigen Rapid Test (TD-4531) and real-time RT-PCR on the same day in the ED or community from May 24, 2021, to June 24, 2021, were examined. Results. Paired nasopharyngeal swabs were collected from 4022 suspected COVID-19 patients: 800 in the ED and 3222 in the community. Overall, 62 (1.54%) tested positive, 13 tested indeterminate, and 3947 tested negative by real-time RT-PCR. The sensitivity and specificity of the antigen test were 51.61% and 99.44% (overall), 62.50% and 99.61% (ED), and 31.82% and 99.40% (community), respectively. There were 30 false negatives and 22 false positives. Among the false negatives, 16.67% had a cycle threshold (Ct) value of <25. Conclusion. The VTRUST COVID-19 Antigen Rapid Test showed comparable specificity as real-time RT-PCR for the ED and community, but the sensitivity was relatively low, especially when the Ct value was >25. This test can be useful for the rapid identification of infected subjects in an epidemic situation.

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Section: Discussionmentioning

confidence: 59%

Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

Lin

Chiu

Cheng

et al. 2022

Canadian Journal of Infectious Diseases and Medical Microbiolog

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“…Focusing on the cause of the spontaneous testicular hematoma, the patient denied any recent trauma, sexual activity, or other possible medical interventions that could cause a hematoma. CT scans did not reveal any other possible secondary causes of his hematoma [ 17 , 18 ]. Reviewing the patient’s clinical course, we paid close attention to his underlying reactive arthritis and medication use.…”

Section: Discussionmentioning

confidence: 99%

A Case Report of Intratesticular Hematoma in a Patient with Reiter’s Syndrome

et al. 2023

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We present a case of a 28-year-old male patient with a spontaneous intratesticular hematoma. He had no history of trauma but experienced sudden onset of painful swelling in his right testis. Initially, testicular malignancy was suspected. The tumor marker of testis, including alfa-fetoprotein, lactic dehydrogenase, and β-human chorionic gonadotropin, was within normal range. The patient had been diagnosed with Reiter’s syndrome at the age of 20 and had been treated with sulfasalazine, non-steroidal anti-inflammatory drugs, and acetaminophen for eight years. Various imaging techniques before operation planning, including ultrasonography and computed tomography, revealed a hematoma that accounted for 32% of the testicular volume. During the waiting period before the operation, the patient was diagnosed with a hematoma and avoided a possible diagnosis of malignancy. Follow-up imaging with computed tomography and magnetic resonance imaging confirmed the presence of an intratesticular hematoma that had decreased in size. Since no other related factor contributed to this hematoma, and considering the possible hematological side effects of sulfasalazine, we suggest that this may be a rare side effect of sulfasalazine. Although the patient’s testis was preserved, further fertility should be observed because animal studies have reported that testicular hematoma may cause fertility changes if the initial volume occupied is over 30% of the testis.

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“…In our hospitals, the cobas ® Liat ® system (Roche, Penzberg, Germany), a small instrument for automated RT-PCR testing with a short turnaround time of less than 30 min, has been selected as the primary SARS-CoV-2 screening tool for ED patients [ 15 ]. However, due to a significant number of false-positive results during assay validation, it was determined that any positive Liat ® result has to be confirmed via RT-PCR for the final diagnostic report, in accordance with the 2021 FDA communication [ 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Testing of Emergency Department Patients Using cobas® Liat® and eazyplex® Rapid Molecular Assays

et al. 2023

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Rapid testing for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) of patients presenting to emergency departments (EDs) facilitates the decision for isolation on admission to hospital wards. Differences in the sensitivity of molecular assays have implications for diagnostic workflows. This study evaluated the performance of the cobas® Liat® RT-PCR, which is routinely used as the initial test for ED patients in our hospitals, compared with the eazyplex® RT-LAMP. A total of 378 oropharyngeal and nasal swabs with positive Liat® results were analysed. Residual sample aliquots were tested using NeuMoDx™, cobas® RT-PCR, and the eazyplex® assay. Patients were divided into asymptomatic (n = 157) and symptomatic (n = 221) groups according to the WHO case definition. Overall, 14% of positive Liat® results were not confirmed by RT-PCR. These samples were mainly attributed to 26.8% of asymptomatic patients, compared to 3.8% of the symptomatic group. Therefore, positive Liat® results were used to provisionally isolate patients in the ED until RT-PCR results were available. The eazyplex® assay identified 62% and 90.6% of RT-PCR-confirmed cases in asymptomatic and symptomatic patients, respectively. False-negative eazyplex® results were associated with RT-PCR Ct values >30, and were more frequent in the asymptomatic group than in the symptomatic group (38.1% vs. 5.1%, respectively). Both the Liat® and eazyplex® assays are suitable for testing symptomatic patients. Their use in screening asymptomatic patients depends on the need to exclude any infection or identify those at high risk of transmission.

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Comparison between the analytical sensitivity and clinical performance of two cobas SARS-CoV-2 tests based on high-throughput and point-of-care systems

Cited by 5 publications

References 17 publications

Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

A Case Report of Intratesticular Hematoma in a Patient with Reiter’s Syndrome

SARS-CoV-2 Testing of Emergency Department Patients Using cobas® Liat® and eazyplex® Rapid Molecular Assays

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